Inovio Clinical Trials

Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Australia. INO-4800 is in preclinical studies and is planned to advance into Phase 1 clinical trials in the U. INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Added value of this study This is the first report of a randomized, blinded, placebo-controlled clinical trial of INO-4800, a DNA vaccine targeting the SARS-CoV-2 Spike antigen delivered ID followed by EP, in adults at high risk of SARS-CoV-2 exposure. , and in the first quarter INOVIO dosed the first subject in a Phase 1b clinical trial for INO-4500 in Africa. This Phase 2 clinical trial builds on significant clinical benefits demonstrated with INOVIO's HPV-associated DNA medicines across multiple clinical trials. In parallel, INOVIO is working to scale up the. Epub 2020 Dec 24. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Phase II Trial of Inovio's VGX-3100 Show Efficacy in HPV-related Vulvar Pre-cancers. 's (INO) phase I clinical trial of its COVID-19 vaccine candidate INO-4800 has yielded positive results - with 94% of the trial participants demonstrating overall immune. Jul 01, 2020 · US biotech firm Inovio on Tuesday reported encouraging results in preliminary clinical trials for its Covid-19 vaccine candidate. Department of Obstetrics and Gynaecology in a Spanish hospital. Inovio Pharmaceuticals, which developed a potential vaccine for COVID-19 at its San Diego lab, has begun an early Phase 1 human trial for the drug involving 40 healthy adult volunteers in two states. Mar 31, 2021 · The open-label, single-arm trial also showed VGX-3100 to be safe and well-tolerated in treating men and women with HPV-16-/18-associated anal dysplasia. Specifically, VGX-3100 in a Phase 2 proof-of-concept trial for cervical dysplasia demonstrated a response in 43 out of 107 patients in regression of high-grade cervical lesions and. Inovio Pharmaceuticals: ClinicalTrials. Study sites include Central Kentucky Research Associates, Center for Pharmaceutical Research, and the University of Philadelphia. INO-4800 FDA Update. If the company. Apr 23, 2021 · Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia caused by HPV-16 and/or HPV-18. Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. INOVIO is committed to developing new, innovative DNA medicines to treat diseases with urgent global health needs including cancer and infectious diseases. They also began testing versions of their. EClinicalMedicine. R&D collaborators include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University, and Laval University. Job Summary The Clinical Trial Associate (CTA) is responsible for supporting, under the direct supervision of the supervisor/Clinical Project Lead (CPL. Food & Drug Administration (FDA) to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800. Inovio Pharmaceuticals' bid to begin the final leg of clinical trials for its COVID-19 vaccine has suffered a setback after the U. Apr 16, 2020 · COVID-19 vaccines are moving toward clinical trials. Department of Obstetrics and Gynaecology in a Spanish hospital. INOVIO has partnered with Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. 67 and traded slightly further. Its candidate, INO-4800, will only start its phase 3 clinical trials sometime. The PICU pathway for inhaled nitric oxide in management of acute hypoxemic respiratory failure is designed to guide clinicians through a standardized approach to initiating and weaning nitric oxide in patients with acute respiratory failure. Clinical trials are controlled research studies in humans designed to determine if an investigational drug or device is safe and effective. Competing Interest Statement. We have a solid track record. Inovio's vaccine was one of the first to be studied in humans, trailing front-runner Moderna and China's CanSino Biologics in entering clinical testing earlier this year. They also began testing versions of their. Aug 10, 2021 · China’s medical product regulator has approved two Advaccine -sponsored clinical trials to study the safety and ability to elicit immune responses of the combined use of the INO-4800 and a vaccine from China’s Sinovac Biotech, Inovio said in a press release. INOVIO has expanded its Phase 1 trial to older participants in additional cohorts and plan on commencing a Phase 2/3 efficacy trial this summer upon regulatory concurrence. INO-4500 is the first Lassa vaccine candidate to enter Phase 1 trial in the U. 9 24 The trials competed thus far have shown that targeting hTERT with vaccines is safe and can induce immunological responses in 50%–100% of vaccinated patients. (RTTNews) - Inovio Pharmaceuticals Inc. Food & Drug Administration (FDA) to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800. In parallel, INOVIO is working to scale up the. 14 a share, down 28%. 35 per share. INO-4800 FDA Update. Food and Drug Administration had additional questions about. INOVIO has reported that Phase III REVEAL 1 trial of DNA medicine, VGX-3100, to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL), met the primary and secondary endpoints in all evaluable subjects. 0 mg), in a three-to-one randomization (in a. -based company posted losses of -$24. INOVIO currently has the following clinical trials enrolling. This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. 0 mg), in a three-to-one randomization to receive either. Apr 16, 2020 · Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U. and SUZHOU, China, Aug. Also, Inovio announced its projected 2015 launch of clinical trials for INO-5150, an immunotherapeutic treatment for prostate cancer. This Phase 2 clinical trial builds on significant clinical benefits demonstrated with INOVIO's HPV-associated DNA medicines across multiple clinical trials. 9 24 The trials competed thus far have shown that targeting hTERT with vaccines is safe and can induce immunological responses in 50%–100% of vaccinated patients. -based company posted losses of -$24. The trial met all secondary efficacy endpoints. The Plymouth Meeting-based biotechnology company's stock closed trading Monday at $12. R&D collaborators include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University, and Laval University. 0 mg), in a three-to-one randomization (in a. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding. Inovio Pharmaceuticals, headquartered on 660 Germantown Pike in Plymouth Meeting, plans to give the first dose of their vaccine to human volunteers on Monday, April 6, the company announced. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding. Two clinical trials testing booster doses of INO-4800 with CoronaVac, an inactivated COVID-19 vaccine developed by Sinovac, are expected to start this fall in China. The target price ranges between 35 and 6 with the average target price sitting at 13. Food and Drug Administration had additional questions about. INO-4800 COVID-19 Vaccine Clinical Trials. About this study. Inovio's vaccine was one of the first to be studied in humans, trailing front-runner Moderna and China's CanSino Biologics in entering clinical testing earlier this year. "Inovio and its partners are continuing to prepare for a planned Phase II/III trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding to conduct the trial. Inovio starts dosing in Phase II trial of DNA vaccine for MERS. The vaccine candidate consists of a DNA plasmid. , as well as Phase 2 trials in China and South Korea. Department of Defense. This Phase 2 clinical trial builds on significant clinical benefits demonstrated with INOVIO's HPV-associated DNA medicines across multiple clinical trials. Inovio has secured FDA approval for phase 2 segment of Covid-19 DNA vaccine candidate trial. Clinical trials are controlled research studies in humans designed to determine if an investigational drug or device is safe and effective. Inovio Pharmaceuticals Inc. Inovio said it will publish the "full data set" in a medical journal. The trial, called RRP-001, is a clinical trial investigating the efficacy and safety of INOVIO's novel HPV-6/HPV-11 therapy in subjects with RRP. INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced it has dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial for the treatment of Recurrent Respiratory Papillomatosis (RRP). INOVIO's Phase 2 vaccine clinical trials underway. Inovio went on to run Phase 2 trials in the United States as well as in China and South Korea, and posted results of the studies online on May 7, 2021. 0 mg), in a three-to-one randomization (in a. By April, Inovio quickly moved INO-4800 into a clinical trial and injected the vaccine candidate into the arms of 40 healthy volunteers. INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO's COVID-19 DNA Vaccine Candidate (read more) Powering a New Decade of DNA Medicines. Inovio's immunotherapies function exclusively in vivo, and have generated an antigen-specific immune response against targeted diseases in all clinical trials to date. Specifically, INOVIO's lead candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1, the first of two, Phase 3 trials for precancerous cervical dysplasia, demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV-16/18. INOVIO has expanded its Phase 1 trial to older participants in additional cohorts and plan on commencing a Phase 2/3 efficacy trial this summer upon regulatory concurrence. Aug 10, 2021 · China’s medical product regulator has approved two Advaccine -sponsored clinical trials to study the safety and ability to elicit immune responses of the combined use of the INO-4800 and a vaccine from China’s Sinovac Biotech, Inovio said in a press release. About the INO-3107 Phase 1/2 Clinical Trial. 0 mg), in a three-to-one randomization (in a. This Phase 2 clinical trial builds on significant clinical benefits demonstrated with INOVIO's HPV-associated DNA medicines across multiple clinical trials. , and in the first quarter INOVIO dosed the first subject in a Phase 1b clinical trial for INO-4500 in Africa. The clinical scientist is responsible for overall clinical study conduct of Inovio clinical trials including verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. Jun 08, 2017 · Inovio was the first to report the activation – in the body – of significant, antigen-specific functional T cells correlated to statistically significant efficacy in a placebo-controlled, randomized, double-blind phase 2b clinical trial (HPV-related pre-cancer), with a very favorable safety profile. About Lassa Fever Lassa fever, also known as Lassa hemorrhagic fever, is an acute viral disease which occurs mostly in West Africa. This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. Inovio has obtained regulatory approval from China’s Center for Drug Evaluation of the National Medical Products Administration to conduct two clinical trials of heterologous prime-boosting with its Covid-19 vaccine candidate, INO-4800. PLYMOUTH MEETING, Pa. Before a clinical trial begins, the treatment must show that it has potential benefit. The two companies plan to start the phase 3 portion. A second site, the Center for Pharmaceutical Research in Kansas City, MO, is also participating in the trial. Inovio Pharmaceuticals just entered Phase 1 of clinical trials for its COVID-19 vaccine. INOVIO is committed to developing new, innovative DNA medicines to treat diseases with urgent global health needs including cancer and infectious diseases. You can access information on INOVIO’s clinical trials by visiting https://clinicaltrials. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial. Inovio believes these results show its COVID-19 vaccine will witness similar success in clinical trials. , DoD JPEO-CBRND has notified INOVIO that it will discontinue funding for the Phase 3 INO-4800 trial INOVIO adjusts INO-4800 clinical development strategy to focus on global unmet COVID-19 vaccine needs INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to. "Inovio and its partners are continuing to prepare for a planned Phase II/III trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding to conduct the trial. Aug 10, 2021 · China’s medical product regulator has approved two Advaccine -sponsored clinical trials to study the safety and ability to elicit immune responses of the combined use of the INO-4800 and a vaccine from China’s Sinovac Biotech, Inovio said in a press release. , as well as Phase 2 trials in China and South Korea. This Phase 2 clinical trial builds on significant clinical benefits demonstrated with INOVIO's HPV-associated DNA medicines across multiple clinical trials. Inovio believes these results show its COVID-19 vaccine will witness similar success in clinical trials. Inovio’s product pipeline continues to advance immunotherapies across a wide range of infectious diseases and tumor types. If the company. INOVIO reports positive data from HPV immunotherapy trial. The Plymouth Meeting, Pa. Inovio Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application of its DNA vaccine candidate INO-4800 against Covid-19. Inovio Pharmaceuticals Inc. Population. Clinical trials for Inovio's COVID-19 vaccine were put on hold Monday by the U. In the case of Inovio's planned phase 2/3 clinical trial, the obvious question is: "Why did the FDA order a clinical hold?" Inovio mentions in their press release that:. China's medical product regulator has approved two Advaccine -sponsored clinical trials to study the safety and ability to elicit immune responses of the combined use of the INO-4800 and a vaccine. This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. Inovio's trial, which started in April, initially had 40 participants, but three were excluded because they tested positive for COVID-19 and another left the study for non-clinical reasons. Competing Interest Statement. Sep 09, 2021 · Inovio Pharmaceuticals found using ticker (INO) have now 9 analysts covering the stock. PLYMOUTH MEETING, PA — A Montgomery County-based biopharmaceutical company has begun human trials on a coronavirus vaccine. Specifically, VGX-3100 in a Phase 2 proof-of-concept trial for cervical dysplasia demonstrated a response in 43 out of 107 patients in regression of high-grade cervical lesions and. The analyst consensus points to a rating of ‘Hold’. This is an open-label trial to evaluate the safety, tolerability and immunological profile of. Food and Drug Administration, a delay that rattled Wall Street investors and sent its stock tumbling. Inovio Pharmaceuticals just entered Phase 1 of clinical trials for its COVID-19 vaccine. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. Inovio Pharmaceuticals wasn't exactly a contender for the top spot during the vaccine-development scramble in 2020. Strong immune response, safety profile, and tolerability observed in clinical trials. Specifically, INOVIO's primary candidate, VGX-3100, is effective in Phase 3 clinical trial REVEAL1 for the treatment of precancerous cervical dysplasia caused by HPV-16 and / or HPV-18. 09 Jun 2021 (Last Updated June 9th, 2021 17:31) The trial will be carried out in Latin American and Asian countries to assess the safety and efficacy of two doses of INO-4800. Aug 10, 2021 · China's medical product regulator has approved two Advaccine -sponsored clinical trials to study the safety and ability to elicit immune responses of the combined use of the INO-4800 and a vaccine. Dec 07, 2020 · INOVIO has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. The purpose of this Phase I/IIA, open-label, multi-center trial is to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). Food & Drug Administration (FDA) to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800. INO-4800 is in preclinical studies and is planned to advance into Phase 1 clinical trials in the U. Inovio's COVID-19 vaccine candidate, INO-4800, will be evaluated in two clinical trials in China as a booster to Sinovac's vaccine. Sep 09, 2021 · Inovio Pharmaceuticals found using ticker (INO) have now 9 analysts covering the stock. 2021 Jan;31:100689. Posted at 5:48 PM, Dec 16, 2020. The clinical scientist is responsible for overall clinical study conduct of Inovio clinical trials including verification of source documentation versus Case Report Forms to ensure accurate and. The clinical scientist is responsible for overall clinical study conduct of Inovio clinical trials including verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2 clinical trial in the U. Despite publishing interim phase 1 data on INO-4800 in late July, Inovio cannot advance it into later stages due to a continued clinical trial halt by the U. Inovio, a biotechnology company developing a vaccine for the coronavirus, has put its trial on a partial hold as it answers questions from the Food and Drug Administration. Department of Obstetrics and Gynaecology in a Spanish hospital. 09 Jun 2021 (Last Updated June 9th, 2021 17:31) The trial will be carried out in Latin American and Asian countries to assess the safety and efficacy of two doses of INO-4800. INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO’s COVID-19 DNA Vaccine Candidate (read more) Powering a New Decade of DNA Medicines. Inovio Pharmaceuticals Inc. This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in subjects with HPV-6 and/or HPV-11-associated recurrent respiratory papillomatosis (RRP). The infrastructure of 35 sites across the United States – called the Alzheimer’s Clinical Trial Consortium (ACTC) – will address the timeframe, complexity and expense of the recruitment. The clinical scientist is responsible for overall clinical study conduct of Inovio clinical trials including verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. Inovio Pharmaceuticals has reported positive interim results from the initial two cohorts in Phase I clinical trial of its Covid-19 vaccine candidate, INO-4800. Image source: Getty Images. INOVIO has demonstrated that DNA medicines can be delivered directly into cells in the body via a proprietary smart device to safely produce a robust immune response in clinical trials involving more than 2,000 patients in 7,000 administrations. INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U. EClinicalMedicine. 9 24 The trials competed thus far have shown that targeting hTERT with vaccines is safe and can induce immunological responses in 50%–100% of vaccinated patients. About the INO-3107 Phase 1/2 Clinical Trial. Inovio has secured approval from the US Food & Drug Administration (FDA) to begin phase 2 segment of its planned phase 2/3 clinical trial for its Covid-19 DNA vaccine candidate. Apr 16, 2021 · Inovio has reported that results from a study of its DNA Covid-19 vaccine candidate INO-4800 showed it induced a robust T cell response in humans against all spike protein variants of concern. INOVIO is committed to developing new, innovative DNA medicines to treat. INO-4800 contains a specifically designed deoxyribonucleic acid (DNA) plasmid. About Lassa Fever Lassa fever, also known as Lassa hemorrhagic fever, is an acute viral disease which occurs mostly in West Africa. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. , as well as Phase 2 trials in China and South Korea. n a randomized placebo-controlled study we will compare the immunogenicity and anti-reservoir activities of gag/pol DNA versus gag/pol/env DNA (both administered with IL-12). The Phase 2 clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. By April, Inovio quickly moved INO-4800 into a clinical trial and injected the vaccine candidate into the arms of 40 healthy volunteers. In parallel, INOVIO is working to scale up the. Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia. gov Identifier: NCT03185013 Other Study ID Numbers: HPV-301 2016-002761-63 ( EudraCT Number ) First Posted: June 14, 2017 Key Record Dates: Last Update Posted: July 6, 2021 Last Verified: July 2021. Inovio has secured FDA approval for phase 2 segment of Covid-19 DNA vaccine candidate trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Invoio said the agency has "additional questions" about its Phase 2/3 trial, including the unconventional device used to deliver the vaccine into human cells. (INO) said that it has expanded partnership with Advaccine Biopharmaceuticals Suzhou Co. There will be 2 cohorts in this trial. About the INO-3107 Phase 1/2 Clinical Trial. Inovio says COVID-19 vaccine candidate safe, effective in mid-stage trial. Sep 29, 2020 · The US FDA has put a partial clinical hold on P-II/III study of Inovio’s INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial because it has additional questions about the trial; Inovio is actively working to address the FDA’s questions and plans to respond in Oct’2020 after which the FDA will have ~30 days to. For the study, clinical samples were obtained at different timepoints post-vaccination from subjects in the company’s phase I trial of INO-4800 in the US. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial. By April, Inovio quickly moved INO-4800 into a clinical trial and injected the vaccine candidate into the arms of 40 healthy volunteers. Inovio stock makes big gains on news of $71M grant for vaccine delivery device which has regulatory approval and was already used in clinical trials to safely dose more than 2,000 patients in. Department of Defense. 0 mg), in a three-to-one randomization to receive either INO-4800 or placebo, to confirm the more appropriate dosing level for each of three age groups (18-50 years, 51-64 years and 65 years and older) for the. The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. The two companies plan to start the phase 3 portion. Inovio said it will publish the "full data set" in a medical journal. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2 clinical trial in the U. A second site, the Center for Pharmaceutical Research in Kansas City, MO, is also participating in the trial. The Plymouth Meeting, Pa. Cohort A will be participants with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT. 93% lower at $29. , and in the first quarter INOVIO dosed the first subject in a Phase 1b clinical trial for INO-4500 in Africa. Concurrently, Inovio expects its partners Advaccine and IVI to initiate two separate phase-I clinical trials of INO-4800 this summer in China and South Korea, respectively. On November 16, 2020, INOVIO announced it had received clearance from the U. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. By: Mimi Elkalla. This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. Its candidate, INO-4800, will only start its phase 3 clinical trials sometime. CLINICAL TRIALS. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2 clinical trial in the U. The Plymouth Meeting-based biotechnology company's stock closed trading Monday at $12. You can access information on INOVIO’s clinical trials by visiting https://clinicaltrials. Sep 09, 2021 · INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO's COVID-19 DNA Vaccine Candidate PR Newswire (US) - 8/9/2021 8:00:00 AM: INOVIO gets dosing underway in mid-stage INO-4700 MERS study Seeking Alpha - 8/4/2021 8:13:02 AM. The Plymouth Meeting, Pa. INO-5401 and INO-9012 will be delivered by intramuscular (IM) injection followed by electroporation (EP) in combination with cemiplimab and chemoradiation and radiation. Food and Drug Administration had additional questions about. A second site, the Center for Pharmaceutical Research in Kansas City, MO, is also participating in the trial. Overall, Inovio's INO-4800 results were encouraging, and the company plans on starting a phase 2/3 clinical trial this month. 0 mg), in a three-to-one randomization (in a. The company announced the administration of the first dose in a phase 1 US-based clinical trial on April 6th 2020 and the completion of enrollment in the phase 1. INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U. On November 16, 2020, INOVIO announced it had received clearance from the U. About Lassa Fever Lassa fever, also known as Lassa hemorrhagic fever, is an acute viral disease which occurs mostly in West Africa. For the study, clinical samples were obtained at different timepoints post-vaccination from subjects in the company’s phase I trial of INO-4800 in the US. Inovio Pharmaceuticals just entered Phase 1 of clinical trials for its COVID-19 vaccine. The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. It also must meet rigorous government standards and scientific requirements for safety, and have acceptable side effects. A clinical trial is a thorough and carefully controlled evaluation of a new medical test or treatment. Two clinical trials testing booster doses of INO-4800 with CoronaVac, an inactivated COVID-19 vaccine developed by Sinovac, are expected to start this fall in China. Inovio Pharmaceuticals ( NASDAQ:INO) shares soared 61. INOVIO plans to accelerate the testing and scale up of the CELLECTRA 3PSP devices to support large scale manufacturing of INO-4800 doses by the end of 2020. Inovio has secured approval from the US Food & Drug Administration (FDA) to begin phase 2 segment of its planned phase 2/3 clinical trial for its Covid-19 DNA vaccine candidate. Following the approval, the company has commenced a Phase I clinical trial of the vaccine candidate in healthy participants. INO-5401 and INO-9012 will be delivered by intramuscular (IM) injection followed by electroporation (EP) in combination with cemiplimab and chemoradiation and radiation. Inovio Pharmaceuticals (NSDQ:INO) shares dipped after hours today after the company presented its fourth-quarter earnings and touted clinical trial results. Inovio Pharmaceuticals wasn't exactly a contender for the top spot during the vaccine-development scramble in 2020. INOVIO plans to pursue a registrational Phase 3 clinical trial for HPV-16-/18-associated anal dysplasia and apply rare and orphan disease designation for this indication in 2021. Under the funding agreement, Plymouth Meeting-based Inovio (NASDAQ: INO) will work with the International Vaccine Institute and the Korea National Institute of Health on a clinical trial for INO-4800. Inovio, a biotechnology company developing a vaccine for the coronavirus, has put its trial on a partial hold as it answers questions from the Food and Drug Administration. The vaccine dose for the Phase III trial was selected based on data from the Phase II part. INOVIO (NASDAQ:INO), today announced that it has received regulatory allowance for two clinical trials investigating heterologous boosting with INO-4800, its DNA vaccine candidate for COVID-19, through partner and trial-sponsor Advaccine Biopharmaceuticals Suzhou Co. CLINICAL TRIALS. Phase II Trial of Inovio's VGX-3100 Show Efficacy in HPV-related Vulvar Pre-cancers. The Phase 2 clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. Inovio to start Phase III efficacy trial of Covid-19 vaccine. Inovio Pharmaceuticals, which developed a potential vaccine for COVID-19 at its San Diego lab, has begun an early Phase 1 human trial for the drug involving 40 healthy adult volunteers in two states. (RTTNews) - Inovio Pharmaceuticals Inc. Inovio Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application of its DNA vaccine candidate INO-4800 against Covid-19. The trial, which enrolled about 400. The lack of progress. Single-blind stratified randomised clinical trial with masked assessment by a third party. Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia. The biotech hopes it will be able to produce 100 million doses of INO. 93% lower at $29. Inovio believes these results show its COVID-19 vaccine will witness similar success in clinical trials. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. 09 Jun 2021 (Last Updated June 9th, 2021 17:31) The trial will be carried out in Latin American and Asian countries to assess the safety and efficacy of two doses of INO-4800. (Reuters) - Inovio Pharmaceuticals Inc said its COVID-19 vaccine candidate was safe, well-tolerated and produced immune response against the new coronavirus in a mid-stage clinical trial, sending the drug developer's shares up over 3%. INOVIO has several clinical programs aimed at treating specific cancers, including glioblastoma multiforme (GBM), an aggressive malignancy of the brain (INO-5401 in partnership with REGENERON), as well as prostate cancer (INO-5151 in partnership with the Cancer Research Institute and the Parker Institute for Cancer Immunotherapy). EClinicalMedicine. Study sites include Central Kentucky Research Associates, Center for Pharmaceutical Research, and the University of Philadelphia. Department of Defense. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2 clinical trial in the U. INOVIO has reported that Phase III REVEAL 1 trial of DNA medicine, VGX-3100, to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL), met the primary and secondary endpoints in all evaluable subjects. The vaccine candidate consists of a DNA plasmid. INO shares finished the day up 4. Clinical Trial NCT03606213: Inovio) has been studied for HIV prevention and is known to be both safe and highly immunogenic. You can access information on INOVIO’s clinical trials by visiting https://clinicaltrials. INO-4800 FDA Update. Data to be presented at the 'virtual annual meeting' of the American Society for Colposcopy and Cervical Pathology (ASCCP) to be held April 1 and 2, 2020, demonstrates that VGX-3100 (Inovio Pharmaceuticals) is effective in women with vulvar dysplasia. Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia. On November 16, 2020, INOVIO announced it had received clearance from the U. In this phase, the immunogenicity and safety are being tested on 40 subjects who are healthy volunteers. Drug developers are moving their experimental vaccines for COVID-19 into clinical trials at a. 18 34 35 Several trials have also demonstrated a clear. Specifically, INOVIO's lead candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1, the first of two, Phase 3 trials for precancerous cervical dysplasia, demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV-16/18. Inovio Pharmaceuticals Inc. 0 mg), in a three-to-one randomization (in a. INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U. The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. INOVIO plans to pursue a registrational Phase 3 clinical trial for HPV-16-/18-associated anal dysplasia and apply rare and orphan disease designation for this indication in 2021. Single-blind stratified randomised clinical trial with masked assessment by a third party. The Plymouth Meeting-based biotechnology company's stock closed trading Monday at $12. Under the funding agreement, Plymouth Meeting-based Inovio (NASDAQ: INO) will work with the International Vaccine Institute and the Korea National Institute of Health on a clinical trial for INO-4800. INOVIO's Phase 2 vaccine clinical trials underway. About Lassa Fever Lassa fever, also known as Lassa hemorrhagic fever, is an acute viral disease which occurs mostly in West Africa. INO-4500 is the first Lassa vaccine candidate to enter Phase 1 trial in the U. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. INOVIO (Nasdaq: INO), the makers of the DNA-based vaccine INO-4800, reports positive interim clinical data from the first two Phase 1 clinical trial cohorts. 60 per share but have since dropped -2. Nov 01, 1999 · The first published experience of iNO treatment in term newborns reported initial doses ranging from 6 to 20 ppm to 80 ppm. Inovio Pharmaceuticals just entered Phase 1 of clinical trials for its COVID-19 vaccine. Competing Interest Statement. Inovio Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application of its DNA vaccine candidate INO-4800 against Covid-19. Inovio Pharmaceuticals ( NASDAQ:INO) shares soared 61. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2 clinical trial in the U. Single-blind stratified randomised clinical trial with masked assessment by a third party. Inovio starts dosing in Phase II trial of DNA vaccine for MERS. High-risk HPV. Jul 06, 2021 · To date, a number of clinical trials have been performed using immunotherapies to target hTERT, including vaccination. It remains INOVIO's and CEPI's goal to making INO-4500 available for possible emergency use as a stockpile product after successful completion of the Phase. 09 Jun 2021 (Last Updated June 9th, 2021 17:31) The trial will be carried out in Latin American and Asian countries to assess the safety and efficacy of two doses of INO-4800. With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly. Inovio Pharmaceuticals, headquartered on 660 Germantown Pike in Plymouth Meeting, plans to give the first dose of their vaccine to human volunteers on Monday, April 6, the company announced. Advaccine has extensive experience in co-development of INO-4800 with INOVIO, including sponsoring both Phase 1 and Phase 2 clinical trials in China for INO-4800. There will be 2 cohorts in this trial. Advaccine has extensive experience in co-development of INO-4800 with INOVIO, including sponsoring both Phase 1 and Phase 2 clinical trials in China for INO-4800. Feb 11, 2020 · Inovio to start Phase 1/2 clinical study of INO-3107for RRP (Credit: Darko Stojanovic/Pixabay. Mar 31, 2021 · The open-label, single-arm trial also showed VGX-3100 to be safe and well-tolerated in treating men and women with HPV-16-/18-associated anal dysplasia. Food & Drug Administration (FDA) to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Australia. Inovio to start Phase III efficacy trial of Covid-19 vaccine. This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. Population. Dec 07, 2020 · INOVIO has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. Inovio Pharmaceuticals, headquartered on 660 Germantown Pike in Plymouth Meeting, plans to give the first dose of their vaccine to human volunteers on Monday, April 6, the company announced. PLYMOUTH MEETING, Pa. The trial, called RRP-001, is a clinical trial investigating the efficacy and safety of INOVIO's novel HPV-6/HPV-11 therapy in subjects with RRP. INOVIO reports positive data from HPV immunotherapy trial. Inovio Pharmaceuticals, which developed a potential vaccine for COVID-19 at its San Diego lab, has begun an early Phase 1 human trial for the drug involving 40 healthy adult volunteers in two states. INO-4500 is the first Lassa vaccine candidate to enter Phase 1 trial in the U. We will determine for. Food and Drug Administration had additional questions about. Dive Brief: The Food and Drug Administration has placed a partial clinical hold on Inovio's experimental coronavirus vaccine, suspending the planned start of late-stage testing. Inovio further said: " In addition, this partial clinical hold does not impact the advancement of Inovio's other product candidates in development. For questions or more information please email clinical. INOVIO has reported that Phase III REVEAL 1 trial of DNA medicine, VGX-3100, to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL), met the primary and secondary endpoints in all evaluable subjects. 2021 Jan;31:100689. Inovio Pharmaceuticals has reported positive interim results from the initial two cohorts in Phase I clinical trial of its Covid-19 vaccine candidate, INO-4800. INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced it has dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial for the treatment of Recurrent Respiratory Papillomatosis (RRP). The Phase 2 clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. Mar 31, 2021 · The open-label, single-arm trial also showed VGX-3100 to be safe and well-tolerated in treating men and women with HPV-16-/18-associated anal dysplasia. Apr 16, 2020 · Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. The vaccine dose for the Phase III trial was selected based on data from the Phase II part. Data to be presented at the 'virtual annual meeting' of the American Society for Colposcopy and Cervical Pathology (ASCCP) to be held April 1 and 2, 2020, demonstrates that VGX-3100 (Inovio Pharmaceuticals) is effective in women with vulvar dysplasia. 2% after hours to $11. Also, Inovio announced its projected 2015 launch of clinical trials for INO-5150, an immunotherapeutic treatment for prostate cancer. gov Identifier: NCT03185013 Other Study ID Numbers: HPV-301 2016-002761-63 ( EudraCT Number ) First Posted: June 14, 2017 Key Record Dates: Last Update Posted: July 6, 2021 Last Verified: July 2021. Inovio, a biotechnology company developing a vaccine for the coronavirus, has put its trial on a partial hold as it answers questions from the Food and Drug Administration. Apr 16, 2021 · Inovio has reported that results from a study of its DNA Covid-19 vaccine candidate INO-4800 showed it induced a robust T cell response in humans against all spike protein variants of concern. , DoD JPEO-CBRND has notified INOVIO that it will discontinue funding for the Phase 3 INO-4800 trial INOVIO adjusts INO-4800 clinical development strategy to focus on global unmet COVID-19 vaccine needs INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to. Inovio is set to commence the international Phase III segment of Phase II/III INNOVATE clinical trial assessing its deoxyribonucleic acid (DNA) vaccine candidate, INO-4800, for Covid-19. INO shares finished the day up 4. Inovio Pharmaceuticals just entered Phase 1 of clinical trials for its COVID-19 vaccine. Dec 07, 2020 · INOVIO has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. Specifically, INOVIO's lead candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1, the first of two, Phase 3 trials for precancerous cervical dysplasia, demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV-16/18. Clinical trials for Inovio's COVID-19 vaccine were put on hold Monday by the U. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. Inovio, one of more than 125 life sciences companies around the world working on a potential Covid-19 vaccine, had hoped to initiate the late-stage clinical trial by the end of September. The trial, called RRP-001, is a clinical trial investigating the efficacy and safety of INOVIO's novel HPV-6/HPV-11 therapy in subjects with RRP. , a Chinese biotech firm, [2] in order to speed its acceptance by regulatory authorities in China , with plans to begin human clinical trials of a candidate vaccine in China during the first half of 2020. Price Action Moderna's shares closed 0. , as well as Phase 2 trials in China and South Korea. Inovio starts dosing in Phase II trial of DNA vaccine for MERS. Inovio's trial, which started in April, initially had 40 participants, but three were excluded because they tested positive for COVID-19 and another left the study for non-clinical reasons. In all, during the span of the past decade, Inovio has claimed it has developed a vaccine. Inovio has secured approval from the Brazilian health regulatory agency, ANVISA, to start the international Phase III part of Phase II/III INNOVATE clinical trial assessing its Covid-19 deoxyribonucleic acid (DNA) vaccine candidate, INO-4800. Nov 01, 1999 · The first published experience of iNO treatment in term newborns reported initial doses ranging from 6 to 20 ppm to 80 ppm. INOVIO (Nasdaq: INO), the makers of the DNA-based vaccine INO-4800, reports positive interim clinical data from the first two Phase 1 clinical trial cohorts. INOVIO is committed to developing new, innovative DNA medicines to treat diseases with urgent global health needs including cancer and infectious diseases. Food and Drug Administration had additional questions about. INOVIO's lead immunotherapy candidate, VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, cleared high-risk HPV-16 and/or HPV-18 in a Phase 2b clinical trial. INOVIO (NASDAQ:INO), today announced that it has received regulatory allowance for two clinical trials investigating heterologous boosting with INO-4800, its DNA vaccine candidate for COVID-19, through partner and trial-sponsor Advaccine Biopharmaceuticals Suzhou Co. INOVIO has several clinical programs aimed at treating specific cancers, including glioblastoma multiforme (GBM), an aggressive malignancy of the brain (INO-5401 in partnership with REGENERON), as well as prostate cancer (INO-5151 in partnership with the Cancer Research Institute and the Parker Institute for Cancer Immunotherapy). INOVIO has reported that Phase III REVEAL 1 trial of DNA medicine, VGX-3100, to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL), met the primary and secondary endpoints in all evaluable subjects. The vaccine candidate consists of a DNA plasmid. With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. Inovio, a biotechnology company developing a vaccine for the coronavirus, has put its trial on a partial hold as it answers questions from the Food and Drug Administration. Clinical Trials. Inovio went on to run Phase 2 trials in the United States as well as in China and South Korea, and posted results of the studies online on May 7, 2021. Specifically, INOVIO's primary candidate, VGX-3100, is effective in Phase 3 clinical trial REVEAL1 for the treatment of precancerous cervical dysplasia caused by HPV-16 and / or HPV-18. High-risk HPV. Sep 09, 2021 · Inovio Pharmaceuticals found using ticker (INO) have now 9 analysts covering the stock. Concurrently, Inovio expects its partners Advaccine and IVI to initiate two separate phase-I clinical trials of INO-4800 this summer in China and South Korea, respectively. Sep 09, 2021 · Inovio Pharmaceuticals found using ticker (INO) have now 9 analysts covering the stock. Apr 16, 2021 · Inovio has reported that results from a study of its DNA Covid-19 vaccine candidate INO-4800 showed it induced a robust T cell response in humans against all spike protein variants of concern. Food and Drug Administration, a delay that rattled Wall Street investors and sent its stock tumbling. The company is scheduled to announce the results of its Phase 1 clinical trial this month. The PICU pathway for inhaled nitric oxide in management of acute hypoxemic respiratory failure is designed to guide clinicians through a standardized approach to initiating and weaning nitric oxide in patients with acute respiratory failure. May 03, 2021 · VGX-3100 progress in clinical trials optimistic, had in 2021 Nian 3 Yue 1 Ri, Inovio announced VGX-3100 Shou multicenter, randomized, double-blind, placebo-controlled III clinical trial results on the show, for all subjects evaluable Achieve the primary endpoint of clinical efficacy and all secondary endpoints. A clinical trial is a thorough and carefully controlled evaluation of a new medical test or treatment. The company announced. Concurrently, Inovio expects its partners Advaccine and IVI to initiate two separate phase-I clinical trials of INO-4800 this summer in China and South Korea, respectively. in April with up to $9 million funding from CEPI. INOVIO has assembled a global coalition of collaborators, partners, and funders to rapidly advance the development of INO-4800. INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U. 0 mg), in a three-to-one randomization to receive either INO-4800 or placebo, to confirm the more appropriate dosing level for each of three age groups (18-50 years, 51-64 years and 65 years and older) for the. Inovio to start Phase III efficacy trial of Covid-19 vaccine. Inovio has secured approval from the Brazilian health regulatory agency, ANVISA, to start the international Phase III part of Phase II/III INNOVATE clinical trial assessing its Covid-19 deoxyribonucleic acid (DNA) vaccine candidate, INO-4800. Of those vaccines currently undergoing clinical trials, Inovio Pharmaceuticals started recruiting patients in April 2020 to test the INO-4800 experimental vaccine. Inovio Pharmaceuticals has reported positive interim results from the initial two cohorts in Phase I clinical trial of its Covid-19 vaccine candidate, INO-4800. There will be 2 cohorts in this trial. INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced it has dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial for the treatment of Recurrent Respiratory Papillomatosis (RRP). The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. Sep 29, 2020 · The US FDA has put a partial clinical hold on P-II/III study of Inovio’s INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial because it has additional questions about the trial; Inovio is actively working to address the FDA’s questions and plans to respond in Oct’2020 after which the FDA will have ~30 days to. This position assists in various tasks. Study sites include Central Kentucky Research Associates, Center for Pharmaceutical Research, and the University of Philadelphia. Inovio said it will publish the "full data set" in a medical journal. The Plymouth Meeting, Pa. Inovio Pharmaceuticals wasn't exactly a contender for the top spot during the vaccine-development scramble in 2020. Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. (Reuters) - Inovio Pharmaceuticals Inc said its COVID-19 vaccine candidate was safe, well-tolerated and produced immune response against the new coronavirus in a mid-stage clinical trial, sending the drug developer's shares up over 3%. Inovio Pharmaceuticals Inc. Despite publishing interim phase 1 data on INO-4800 in late July, Inovio cannot advance it into later stages due to a continued clinical trial halt by the U. INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced it has dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial for the treatment of Recurrent Respiratory Papillomatosis (RRP). INOVIO's lead immunotherapy candidate, VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, cleared high-risk HPV-16 and/or HPV-18 in a Phase 2b clinical trial. For more information, visit www. Participants were given two 1mg or 2mg doses of INO-4800. EClinicalMedicine. gov Identifier: NCT03185013 Other Study ID Numbers: HPV-301 2016-002761-63 ( EudraCT Number ) First Posted: June 14, 2017 Key Record Dates: Last Update Posted: July 6, 2021 Last Verified: July 2021. INO-4500 is the first Lassa vaccine candidate to enter Phase 1 trial in the U. May 03, 2021 · VGX-3100 progress in clinical trials optimistic, had in 2021 Nian 3 Yue 1 Ri, Inovio announced VGX-3100 Shou multicenter, randomized, double-blind, placebo-controlled III clinical trial results on the show, for all subjects evaluable Achieve the primary endpoint of clinical efficacy and all secondary endpoints. The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. A second site, the Center for Pharmaceutical Research in Kansas City, MO, is also participating in the trial. Inovio Pharmaceuticals just entered Phase 1 of clinical trials for its COVID-19 vaccine. SAN DIEGO (KGTV) - Like Pfizer, Moderna. Inovio Pharmaceuticals Brief Summary: This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Apr 16, 2021 · Inovio has reported that results from a study of its DNA Covid-19 vaccine candidate INO-4800 showed it induced a robust T cell response in humans against all spike protein variants of concern. Inovio has dosed the first participants in Phase II clinical trial of its deoxyribonucleic acid (DNA) vaccine candidate, INO-4700, to prevent Middle East Respiratory Syndrome (MERS). Inovio stock makes big gains on news of $71M grant for vaccine delivery device which has regulatory approval and was already used in clinical trials to safely dose more than 2,000 patients in. INOVIO has partnered with Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. 67 and traded slightly further. Inovio Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application of its DNA vaccine candidate INO-4800 against Covid-19. China's medical product regulator has approved two Advaccine -sponsored clinical trials to study the safety and ability to elicit immune responses of the combined use of the INO-4800 and a vaccine. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Feb 11, 2020 · Inovio to start Phase 1/2 clinical study of INO-3107for RRP (Credit: Darko Stojanovic/Pixabay. Competing Interest Statement. Inovio Pharmaceuticals Inc. INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO’s COVID-19 DNA Vaccine Candidate (read more) Powering a New Decade of DNA Medicines. Jul 06, 2021 · To date, a number of clinical trials have been performed using immunotherapies to target hTERT, including vaccination. Inovio, a biotechnology company developing a vaccine for the coronavirus, has put its trial on a partial hold as it answers questions from the Food and Drug Administration. 's (NASDAQ: INO) coronavirus vaccine trials are also expected to begin this month. Following the approval, the company has commenced a Phase I clinical trial of the vaccine candidate in healthy participants. In all, during the span of the past decade, Inovio has claimed it has developed a vaccine. INOVIO has assembled a global coalition of collaborators, partners, and funders to rapidly advance the development of INO-4800. , as well as Phase 2 trials in China and South Korea. Sep 09, 2021 · INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO's COVID-19 DNA Vaccine Candidate PR Newswire (US) - 8/9/2021 8:00:00 AM: INOVIO gets dosing underway in mid-stage INO-4700 MERS study Seeking Alpha - 8/4/2021 8:13:02 AM. INOVIO's lead immunotherapy candidate, VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, cleared high-risk HPV-16 and/or HPV-18 in a Phase 2b clinical trial. INO-4800 contains a specifically designed deoxyribonucleic acid (DNA) plasmid. In all, during the span of the past decade, Inovio has claimed it has developed a vaccine. This is an open-label trial to evaluate the safety, tolerability and immunological profile of. There will be 2 cohorts in this trial. CLINICAL TRIALS. Apr 16, 2021 · Inovio has reported that results from a study of its DNA Covid-19 vaccine candidate INO-4800 showed it induced a robust T cell response in humans against all spike protein variants of concern. 0 mg), in a three-to-one randomization to receive either INO-4800 or placebo, to confirm the more appropriate dosing level for each of three age groups (18-50 years, 51-64 years and 65 years and older) for the. Inovio says COVID-19 vaccine candidate safe, effective in mid-stage trial. Inovio has obtained regulatory approval from China’s Center for Drug Evaluation of the National Medical Products Administration to conduct two clinical trials of heterologous prime-boosting with its Covid-19 vaccine candidate, INO-4800. Feb 23, 2021 · About INOVIO's Phase 1B Clinical Trial for INO-4500 INOVIO's Phase 1B clinical trial, LSV-002, will enroll approximately 220 adult participants who are 18-50 years old, with the primary endpoints. Sep 09, 2021 · INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO's COVID-19 DNA Vaccine Candidate PR Newswire (US) - 8/9/2021 8:00:00 AM: INOVIO gets dosing underway in mid-stage INO-4700 MERS study Seeking Alpha - 8/4/2021 8:13:02 AM. INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U. Competing Interest Statement. in April with up to $9 million funding from CEPI. Inovio has dosed the first participants in Phase II clinical trial of its deoxyribonucleic acid (DNA) vaccine candidate, INO-4700, to prevent Middle East Respiratory Syndrome (MERS). INO-4800 contains a specifically designed deoxyribonucleic acid (DNA) plasmid. According to th. Inovio’s product pipeline continues to advance immunotherapies across a wide range of infectious diseases and tumor types. Mar 31, 2021 · The open-label, single-arm trial also showed VGX-3100 to be safe and well-tolerated in treating men and women with HPV-16-/18-associated anal dysplasia. Job Summary The Clinical Trial Associate (CTA) is responsible for supporting, under the direct supervision of the supervisor/Clinical Project Lead (CPL. RRP is a rare disease caused by the human. Following the approval, the company has commenced a Phase I clinical trial of the vaccine candidate in healthy participants. About the INO-3107 Phase 1/2 Clinical Trial. Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia. Clinical Trial NCT03606213: Inovio) has been studied for HIV prevention and is known to be both safe and highly immunogenic. Two clinical trials testing booster doses of INO-4800 with CoronaVac, an inactivated COVID-19 vaccine developed by Sinovac, are expected to start this fall in China. PLYMOUTH MEETING, Pa. Specifically, INOVIO's lead candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1, the first of two, Phase 3 trials for precancerous cervical dysplasia, demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV-16/18. Following the approval, the company has commenced a Phase I clinical trial of the vaccine candidate in healthy participants. INOVIO has several clinical programs aimed at treating specific cancers, including glioblastoma multiforme (GBM), an aggressive malignancy of the brain (INO-5401 in partnership with REGENERON), as well as prostate cancer (INO-5151 in partnership with the Cancer Research Institute and the Parker Institute for Cancer Immunotherapy). It remains INOVIO's and CEPI's goal to making INO-4500 available for possible emergency use as a stockpile product after successful completion of the Phase. Inovio said it will publish the "full data set" in a medical journal. Brief Summary: This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 disease in participants at high risk of exposure to SARS-CoV-2. Mar 31, 2021 · The open-label, single-arm trial also showed VGX-3100 to be safe and well-tolerated in treating men and women with HPV-16-/18-associated anal dysplasia. Invoio said the agency has "additional questions" about its Phase 2/3 trial, including the unconventional device used to deliver the vaccine into human cells. This position assists in various tasks. The trial met all secondary efficacy endpoints. The company announced. Phase II Trial of Inovio's VGX-3100 Show Efficacy in HPV-related Vulvar Pre-cancers. 3 million, or -14¢ per share, on sales of $5. [email protected] The trial, which enrolled about 400. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding. 7% in April, according to data provided by S&P Global Market Intelligence, as the company began human trials of its coronavirus vaccine. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a global Phase 3 clinical trial, as well as Phase 2 trials in China and South Korea. Inovio has secured approval from the Brazilian health regulatory agency, ANVISA, to start the international Phase III part of Phase II/III INNOVATE clinical trial assessing its Covid-19 deoxyribonucleic acid (DNA) vaccine candidate, INO-4800. INO-4800 FDA Update. EClinicalMedicine. (RTTNews) - Inovio Pharmaceuticals Inc. INOVIO's lead immunotherapy candidate, VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, cleared high-risk HPV-16 and/or HPV-18 in a Phase 2b clinical trial. They also began testing versions of their. Competing Interest Statement. INOVIO currently has the following clinical trials enrolling. The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. 0 mg), in a three-to-one randomization to receive either INO-4800 or placebo, to confirm the more appropriate dosing level for each of three age groups (18-50 years, 51-64 years and 65 years and older) for the. (INO) said that it has expanded partnership with Advaccine Biopharmaceuticals Suzhou Co. Apr 16, 2021 · Inovio has reported that results from a study of its DNA Covid-19 vaccine candidate INO-4800 showed it induced a robust T cell response in humans against all spike protein variants of concern. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2 clinical trial in the U. The company announced the administration of the first dose in a phase 1 US-based clinical trial on April 6th 2020 and the completion of enrollment in the phase 1. Clinical trials are controlled research studies in humans designed to determine if an investigational drug or device is safe and effective. May 03, 2021 · VGX-3100 progress in clinical trials optimistic, had in 2021 Nian 3 Yue 1 Ri, Inovio announced VGX-3100 Shou multicenter, randomized, double-blind, placebo-controlled III clinical trial results on the show, for all subjects evaluable Achieve the primary endpoint of clinical efficacy and all secondary endpoints. Also, Inovio announced its projected 2015 launch of clinical trials for INO-5150, an immunotherapeutic treatment for prostate cancer. INOVIO is committed to developing new, innovative DNA medicines to treat. Scientists at Inovio’s R&D site in San Diego. Phase II Trial of Inovio's VGX-3100 Show Efficacy in HPV-related Vulvar Pre-cancers. INOVIO's lead immunotherapy candidate, VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, cleared high-risk HPV-16 and/or HPV-18 in a Phase 2b clinical trial. The vaccine candidate consists of a DNA plasmid. The biotech hopes it will be able to produce 100 million doses of INO. It's also the most advanced candidate in a class of vaccines that use small DNA molecules called plasmids to instruct the body's cells to build proteins mimicking those found. Dec 07, 2020 · INOVIO has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. , as well as Phase 2 trials in China and South Korea. We will determine for. The PICU pathway for inhaled nitric oxide in management of acute hypoxemic respiratory failure is designed to guide clinicians through a standardized approach to initiating and weaning nitric oxide in patients with acute respiratory failure. INOVIO plans to accelerate the testing and scale up of the CELLECTRA 3PSP devices to support large scale manufacturing of INO-4800 doses by the end of 2020. Inovio Pharmaceuticals has reported positive interim results from the initial two cohorts in Phase I clinical trial of its Covid-19 vaccine candidate, INO-4800. Department of Defense 11/16/2020 PLYMOUTH MEETING, Pa. INO-4800 COVID-19 Vaccine Clinical Trials. Apr 16, 2020 · Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. Inovio, a biotechnology company developing a vaccine for the coronavirus, has put its trial on a partial hold as it answers questions from the Food and Drug Administration. Clinical trials are controlled research studies in humans designed to determine if an investigational drug or device is safe and effective. Single-blind stratified randomised clinical trial with masked assessment by a third party. Inovio believes these results show its COVID-19 vaccine will witness similar success in clinical trials. Inovio has obtained regulatory approval from China’s Center for Drug Evaluation of the National Medical Products Administration to conduct two clinical trials of heterologous prime-boosting with its Covid-19 vaccine candidate, INO-4800. The rationale for doses used in these clinical trials was based on concentrations that had been found to be effective in animal experiments by the same investigators. plans to initiate Phase 2/3 study trials of INO-4800, its experimental vaccine candidate against the novel coronavirus, in September and produce at least 1 million. Two clinical trials testing booster doses of INO-4800 with CoronaVac, an inactivated COVID-19 vaccine developed by Sinovac, are expected to start this fall in China. Inovio Pharmaceuticals has reported positive interim results from the initial two cohorts in Phase I clinical trial of its Covid-19 vaccine candidate, INO-4800. Inovio's trial, which started in April, initially had 40 participants, but three were excluded because they tested positive for COVID-19 and another left the study for non-clinical reasons. With funding from the Coalition for Epidemic Preparedness Innovations (CEPI), the Phase I trial initially recruited 40 healthy adults aged 18 to 50 years at two sites in the US. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. INO-4500 is the first Lassa vaccine candidate to enter Phase 1 trial in the U. (RTTNews) - Inovio Pharmaceuticals Inc. Inovio Pharmaceuticals, which developed a potential vaccine for COVID-19 at its San Diego lab, has begun an early Phase 1 human trial for the drug involving 40 healthy adult volunteers in two states. INOVIO currently has the following clinical trials enrolling. -based company posted losses of -$24. Sep 09, 2021 · Inovio Pharmaceuticals found using ticker (INO) have now 9 analysts covering the stock. Also, Inovio announced its projected 2015 launch of clinical trials for INO-5150, an immunotherapeutic treatment for prostate cancer. INOVIO (Nasdaq: INO), the makers of the DNA-based vaccine INO-4800, reports positive interim clinical data from the first two Phase 1 clinical trial cohorts. It's also the most advanced candidate in a class of vaccines that use small DNA molecules called plasmids to instruct the body's cells to build proteins mimicking those found. Drug developers are moving their experimental vaccines for COVID-19 into clinical trials at a. For Patients: Clinical Trials Publications. Population. Specifically, INOVIO's lead candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1, the first of two, Phase 3 trials for precancerous cervical dysplasia, demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV-16/18. The infrastructure of 35 sites across the United States – called the Alzheimer’s Clinical Trial Consortium (ACTC) – will address the timeframe, complexity and expense of the recruitment. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2 clinical trial in the U. Inovio's vaccine was one of the first to be studied in humans, trailing front-runner Moderna and China's CanSino Biologics in entering clinical testing earlier this year. INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced it has dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial for the treatment of Recurrent Respiratory Papillomatosis (RRP). Advaccine has extensive experience in co-development of INO-4800 with INOVIO, including sponsoring both Phase 1 and Phase 2 clinical trials in China for INO-4800. China's medical product regulator has approved two Advaccine -sponsored clinical trials to study the safety and ability to elicit immune responses of the combined use of the INO-4800 and a vaccine. Inovio Pharmaceuticals (NSDQ:INO) shares dipped after hours today after the company presented its fourth-quarter earnings and touted clinical trial results. Single-blind stratified randomised clinical trial with masked assessment by a third party. This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. A second site, the Center for Pharmaceutical Research in Kansas City, MO, is also participating in the trial. Food and Drug Administration had additional questions about. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. Oct 20, 2009 · Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced the initiation of a phase-I clinical study of Inovio's Pennvax-B preventive DNA vaccine delivered using its proprietary electroporation technology. INOVIO and Advaccine have been working together to advance the clinical development of INO-4800 in China. INOVIO is committed to developing new, innovative DNA medicines to treat diseases with urgent global health needs including cancer and infectious diseases. Apr 23, 2021 · Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia caused by HPV-16 and/or HPV-18. Consistent with our mission, we encourage awareness of and participation in our clinical trials. , a Chinese biotech firm, [2] in order to speed its acceptance by regulatory authorities in China , with plans to begin human clinical trials of a candidate vaccine in China during the first half of 2020. There will be 2 cohorts in this trial. CLINICAL TRIALS. Inovio believes these results show its COVID-19 vaccine will witness similar success in clinical trials. Inovio, one of more than 125 life sciences companies around the world working on a potential Covid-19 vaccine, had hoped to initiate the late-stage clinical trial by the end of September. The Phase 2 clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1. Despite publishing interim phase 1 data on INO-4800 in late July, Inovio cannot advance it into later stages due to a continued clinical trial halt by the U. INOVIO is also assessing nonclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization. In the case of Inovio's planned phase 2/3 clinical trial, the obvious question is: "Why did the FDA order a clinical hold?" Inovio mentions in their press release that:. INOVIO has assembled a global coalition of collaborators, partners, and funders to rapidly advance the development of INO-4800. Food & Drug Administration (FDA) to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800. Brief Summary: This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 disease in participants at high risk of exposure to SARS-CoV-2. Inovio Pharmaceuticals' bid to begin the final leg of clinical trials for its COVID-19 vaccine has suffered a setback after the U. Sep 09, 2021 · INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO's COVID-19 DNA Vaccine Candidate PR Newswire (US) - 8/9/2021 8:00:00 AM: INOVIO gets dosing underway in mid-stage INO-4700 MERS study Seeking Alpha - 8/4/2021 8:13:02 AM. With funding from the Coalition for Epidemic Preparedness Innovations (CEPI), the Phase I trial initially recruited 40 healthy adults aged 18 to 50 years at two sites in the US. INO-5150 was originally a collaborative project with Roche, but the licensing agreement was terminated and the two companies announced plans to continue their co-development of INO-1800, a treatment for Hepatitis B. Posted at 5:48 PM, Dec 16, 2020. INO-4500 is the first Lassa vaccine candidate to enter Phase 1 trial in the U. , as well as Phase 2 trials in China and South Korea. Also, Inovio announced its projected 2015 launch of clinical trials for INO-5150, an immunotherapeutic treatment for prostate cancer. Inovio starts dosing in Phase II trial of DNA vaccine for MERS. PLYMOUTH MEETING, PA — A Montgomery County-based biopharmaceutical company has begun human trials on a coronavirus vaccine. Food and Drug Administration, a delay that rattled Wall Street investors and sent its stock tumbling. A second site, the Center for Pharmaceutical Research in Kansas City, MO, is also participating in the trial. Inovio said it will publish the "full data set" in a medical journal. Inovio Pharmaceuticals (NSDQ:INO) shares dipped after hours today after the company presented its fourth-quarter earnings and touted clinical trial results. 0 mg), in a three-to-one randomization (in a. INOVIO has several clinical programs aimed at treating specific cancers, including glioblastoma multiforme (GBM), an aggressive malignancy of the brain (INO-5401 in partnership with REGENERON), as well as prostate cancer (INO-5151 in partnership with the Cancer Research Institute and the Parker Institute for Cancer Immunotherapy). Inovio to start Phase III efficacy trial of Covid-19 vaccine. Specifically, INOVIO's primary candidate, VGX-3100, is effective in Phase 3 clinical trial REVEAL1 for the treatment of precancerous cervical dysplasia caused by HPV-16 and / or HPV-18.