Inovio phase 3 trial. INOVIO is committed to developing new, innovative medicines to fight HPV-related diseases, cancer and infectious diseases. Sep 28, 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. Nov 10, 2023 · Like Precigen, Inovio will be able to file for accelerated approval of a treatment for RRP, INO-3107, on the strength of data from a phase 1/2 clinical trial. Oct 21, 2024 · The FDA granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data from its already completed Phase 1/2 trial. 0 mg dose for the Phase 3 segment of the trial Data published as a preprint in MedRxiv INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV Jan 9, 2025 · INOVIO's partner, ApolloBio, continues recruitment into its Phase 3 trial evaluating INO-3100 as a potential treatment for HPV 16/18 positive cervical dysplasia in China. For more information about our clinical trials, please email clinical. Aug 10, 2023 · Inovio is racing against Precigen, which this week told investors the FDA will accept its ongoing phase 1/2 single arm study as a pivotal trial. If approved, VGX-3100 would be Aug 8, 2024 · INOVIO anticipates submitting its revised protocol to the FDA for a Phase 2/3 clinical trial with INO-4201 as a heterologous boost to the FDA licensed Ebola vaccine, Ervebo, in the third quarter. , 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 May 13, 2024 · BLA submission on track for INO-3107 in second half of 2024; if approved under accelerated approval pathway, could be first non-surgical treatment for recurrent respiratory papillomatosis (RRP) Planning initiation of confirmatory trial for INO-3107 based on FDA feedback Advancing plans for Phase 3 trial of INO-3112 in combination with LOQTORZI TM (toripalimab-tpzi) as a potential treatment for On 23 April 2021 Inovio said the U. This article aims to provide a comprehensive overview of these trials and their implications. (NASDAQ:INO) today announced that it has commenced its phase 3 clinical program to evaluate the efficacy of Inovio’s DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV). High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. . (NASDAQ: INO) today announced the completion of target enrollment of 198 participants for its pivotal Phase 3 registration trial ("REVEAL 1") of VGX-3100, a novel DNA-based immunotherapy being tested to treat cervical dysplasia caused by human papillomavirus (HPV). A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VGX-3100 DELIVERED INTRAMUSCULARLY FOLLOWED BY ELECTROPORATION WITHCELLECTRATM 5PSP FOR THE TREATMENT OF HPV-16 AND/OR HPV-18 RELATED HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION (HSIL) OF THE CERVIX Mar 2, 2021 · 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. Mar 19, 2025 · INOVIO's collaborator, ApolloBio, continues recruitment into its Phase 3 trial evaluating INO-3100 as a potential treatment for HPV 16/18 positive cervical dysplasia in China. INOVIO is evaluating candidate VGX-3100 in two Phase 3 trials for precancerous high-grade cervical dysplasia caused by HPV-16 and/or HPV-18. Precigen is scheduled to wrap up its trial in March. Department of Defense discontinued funding for the phase III portion of an ongoing trial of its COVID-19 vaccine candidate, INO-4800, in light of the broad availability of other COVID-19 vaccines in the U. S. Inovio’s study will assess the efficacy of VGX-3100 in Aug 26, 2021 · INOVIO's global Phase 3 efficacy trial receives authorization to proceed from Brazil; other countries to follow INOVIO to conduct INNOVATE Phase 3 efficacy trial with partner Advaccine in areas of world in need of COVID-19 vaccines INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases Jan 4, 2024 · - Combination therapy to be evaluated in a Phase 3 trial in patients with locoregionally advanced, high-risk, HPV16/18-positive head and neck cancer PLYMOUTH MEETING, Pa. Jun 8, 2021 · Phase 3 efficacy trial planned to commence this summer in areas of the world underserved by vaccines News follows recently announced Phase 2 data, which showed INO-4800 to be well-tolerated and immunogenic in all age groups INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer Jun 8, 2017 · FDA removes clinical hold on phase 3; Inovio to immediately begin recruiting subjects Inovio Pharmaceuticals, Inc. Mar 1, 2021 · 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. com. Mar 1, 2021 · Trial achieved primary and secondary efficacy endpoints among all evaluable subjects in the Phase 3 multi-center, randomized, double-blind, placebo-controlled trial VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial INOVIO also continues to partner with QIAGEN to develop a pre-treatment predictive biomarker with the goal of identifying women expected Dec 14, 2021 · INOVIO has clinically shown that a DNA vaccine candidate can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Jan 4, 2024 · This press release contains certain forward-looking statements relating to INOVIO's business, including its plans to develop and commercialize DNA medicines and its expectations regarding its research and development programs, including plans to advance development of INO-3112 in a Phase 3 clinical trial in combination with LOQTORZI Sep 22, 2021 · News follows recent regulatory authorizations to proceed with the trial in Brazil and the Philippines INOVIO and partner Advaccine are collaborating on the global Phase 3 trial in regions underserved by COVID-19 vaccines; to focus on Latin America, Asia, and Africa INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect Nov 3, 2021 · INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2/3 clinical trial; the Phase 3 segment of which has received regulatory approvals to begin in Colombia, Mexico, Brazil, Philippines, and India. and REDWOOD CITY, Calif Data from a retrospective trial evaluating the longer-term benefit of INO-3107 to patients with Recurrent Respiratory Papillomatosis (RRP) involved in a Phase 1/2 trial showed the number of patients who met the criteria for a Complete Response (CR) increased to 50% by the end of year 2 and to 54% in year 3, compared to 28% by the end of the initial 52-week trial 95% of patients in the Apr 23, 2021 · Given universal eligibility and broad availability of COVID-19 vaccines in the U. Aug 25, 2016 · In this phase 3 trial, we randomly assigned adults with relapsed or refractory acute lymphoblastic leukemia to receive either inotuzumab ozogamicin (inotuzumab ozogamicin group) or standard Mar 18, 2025 · INOVIO's collaborator, ApolloBio, continues recruitment into its Phase 3 trial evaluating INO-3100 as a potential treatment for HPV 16/18 positive cervical dysplasia in China. 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 generating DNA medicine candidates with potential to meet urgent global health needs. Dec 14, 2021 · (RTTNews) - INOVIO (INO) issued updates on the phase 3 program for VGX-3100 for HPV-associated cervical high-grade squamous intraepithelial lesions. Oct 10, 2023 · Previously planned Phase 3 trial no longer required to support Biological License Application (BLA) submission If approved, INO-3107 could potentially revolutionize treatment options for patients with Recurrent Respiratory Papillomatosis (RRP), a debilitating rare disease caused by human papillomavirus (HPV) INO-3107 could be the first DNA medicine available in the United States and the first Jan 9, 2025 · INOVIO's INO-3107 demonstrates remarkable durability in RRP treatment with 50% achieving surgery-free status. Mar 2, 2023 · After pooling the data with the results of the earlier phase 3 trial, Inovio reached statistical significance in both the biomarker-based and the all-comer populations. Left untreated, cervical dysplasia can progress to cervical cancer. Oct 26, 2021 · INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2/3 clinical trial; the Phase 3 segment of which has received regulatory approvals to begin in Colombia, Mexico, Brazil and Philippines. The second global phase 3 clinical trial of VGX May 10, 2021 · INO-4800 was shown to be safe, well-tolerated and immunogenic in all age groups Phase 2 results informed INOVIO's selection of 2. Our goal is to deliver on the promise of DNA medicines for patients around the globe. Jun 26, 2019 · Inovio Pharmaceuticals, Inc. Company advances toward BLA submission with strong trial results and $84M cash. Sep 1, 2025 · Understanding the intricacies of Inovio’s Phase 3 clinical trials is essential for stakeholders, including investors, healthcare professionals, and patients. trials@inovio. haq 6d8ur bgp vkxl xfj7r3 z3h ezcm 5g4kclw rv hdda