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Inovio Pharmaceuticals, Inc. (NASDAQ: INO) is a pioneering United States-based biotechnology company dedicated to combating cancers and infectious diseases through DNA medicines. The company's innovative approach harnesses active DNA-based immunotherapies and vaccines to both treat and prevent these conditions.
Inovio's core technology revolves around its DNA plasmids, which are small circular DNA molecules crafted to produce specific proteins to target and fight diseases, delivered via their proprietary CELLECTRA® electroporation devices. This technology enables the body to produce its own disease-fighting proteins and immune responses, without the need for traditional adjuvants or nanoparticles.
The company's flagship candidate, INO-3107, targets Recurrent Respiratory Papillomatosis (RRP), a chronic and rare disease caused by HPV-6 and HPV-11. Inovio has shown significant clinical progress with INO-3107, and after receiving Breakthrough Therapy designation and Orphan Drug designation from both the FDA and the European Commission, it is on track to submit a Biologics License Application (BLA) under the FDA's accelerated approval program. With successful clinical trials demonstrating a robust immune response and a reduction in the need for surgical interventions, INO-3107 stands as a potential game-changer for RRP patients.
In addition to INO-3107, Inovio's expansive product pipeline includes several other promising candidates in various stages of development. These include INO-3112 for HPV-16/18 positive head and neck cancer, INO-4201 as an Ebola vaccine booster, and INO-5401 for glioblastoma, showcasing the versatility and broad applicability of the company's DNA medicine platform.
Inovio has established numerous strategic partnerships and collaborations to enhance its research and development efforts. Key partners include Roche, MedImmune, the University of Pennsylvania, DARPA, Drexel University, NIH, and the U.S. Military HIV Research Program. These collaborations not only bolster Inovio's scientific capabilities but also facilitate the swift advancement of its clinical programs.
Financially, Inovio has maintained a disciplined approach to managing its resources. The company recently projected its cash runway to extend into the second quarter of 2025, following positive feedback from the FDA on the accelerated approval pathway for INO-3107. This financial stability is crucial as Inovio prepares for potential commercialization of its lead candidates.
Inovio's commitment to innovation and its effective strategic execution position it as a formidable player in the biopharmaceutical industry, dedicated to bringing groundbreaking DNA medicine solutions to market. For more information, visit www.inovio.com.
INOVIO Pharmaceuticals announced a public offering of $150 million in common stock, with plans to grant underwriters a 30-day option for an additional 15%. Proceeds will fund clinical development, specifically for INO-4800, and cover general corporate expenses. BofA Securities, Jefferies, and Cantor are managing the offering. This follows their shelf registration statement filed with the SEC, effective January 20, 2021. The offering is subject to market conditions, and there are no guarantees regarding its completion.
INOVIO (NASDAQ: INO) announced promising results from a Phase 2 trial of VGX-3100 for HPV-16/18-associated vulvar dysplasia. At six months post-treatment, 63% of participants showed a clinically significant reduction in lesions, a stark contrast to the typical 2% spontaneous resolution rate. Notably, 15% of participants had resolved lesions with no detectable virus. The trial confirmed VGX-3100's safety, with no severe adverse events reported. INOVIO plans to advance to Phase 3 development based on these results, representing a potential breakthrough in non-surgical treatment options.
INOVIO (NASDAQ: INO) announces a collaboration with Advaccine Biopharmaceuticals to commercialize its COVID-19 DNA vaccine candidate INO-4800 in Greater China, including Mainland China, Hong Kong, Macao, and Taiwan. Advaccine will exclusively develop, manufacture, and market INO-4800 for an upfront payment of $3 million and potential milestone payments totalling $108 million. INOVIO will receive royalties on annual net sales. The collaboration leverages Advaccine’s manufacturing capabilities and clinical data to support INOVIO’s global regulatory filings while advancing the Phase 2 clinical trial of INO-4800 in China, involving 640 subjects.
INOVIO (NASDAQ: INO) has published peer-reviewed Phase 1 clinical data for its COVID-19 DNA vaccine candidate, INO-4800, in EClinicalMedicine. The study involved 40 healthy adults and demonstrated that INO-4800 generated an immune response in all participants with favorable safety, showing only six minor adverse events. The vaccine maintains stability at room temperature over a year, aiding global distribution. INOVIO is advancing to Phase 2 trials, funded by the U.S. Department of Defense, further validating the vaccine's safety and efficacy in upcoming segments.
INOVIO (NASDAQ: INO) announced a $37.6 million grant from DARPA to develop DNA-encoded monoclonal antibodies (dMAbs) targeting SARS-CoV-2. This funding will complement INOVIO's ongoing INO-4800 vaccine trial, enhancing treatment options for COVID-19. The dMAb technology offers rapid, cost-effective production of antibodies, overcoming limitations of traditional methods. The collaboration includes The Wistar Institute and AstraZeneca, aiming to advance dMAb candidates into preclinical studies and human trials within a year.
INOVIO (NASDAQ: INO) and Advaccine Biopharmaceuticals have initiated the Phase 2 clinical trial for INO-4800, a DNA vaccine candidate against COVID-19, in China. The trial, which is independent of the ongoing U.S. trial, aims to enroll 640 participants aged 18 and older, focusing on safety and immunogenicity. Dr. Joseph Kim, INOVIO's CEO, emphasized the collaboration's significance in accelerating vaccine development. The trial will consist of two doses at varying levels, providing critical data to support further evaluations of INO-4800.
INOVIO (NASDAQ:INO) announced positive Phase 2 results for its DNA medicine VGX-3100, which treats HPV-16/18-associated anal dysplasia. The trial showed a 50% resolution of precancerous anal lesions in subjects six months post-treatment, indicating VGX-3100 is safe and well-tolerated. The study involved 23 participants, with the primary endpoint being the absence of dysplasia and HPV-16/18 detected in tissue samples. INOVIO plans to initiate a Phase 3 trial and seek rare disease designation for this treatment in 2021, amidst rising anal cancer incidences attributed to HPV.
INOVIO (NASDAQ: INO) announced the initiation of the Phase 2 segment of its INNOVATE clinical trial for its COVID-19 vaccine candidate, INO-4800, with the first subject dosed. The trial aims to enroll around 400 participants at 17 U.S. sites, focusing on safety, tolerability, and immunogenicity to confirm dosing levels for subsequent Phase 3 evaluation. Funded by the U.S. Department of Defense, the trial signifies an important step in INOVIO's response to the pandemic, leveraging its DNA technology known for its safety profile and thermostability.
INOVIO (NASDAQ: INO) has entered a partnership with Kaneka Eurogentec S.A. to manufacture its COVID-19 vaccine candidate, INO-4800, using GMP plasmid production. This collaboration enhances INOVIO's existing global manufacturing network, which includes Thermo Fisher Scientific and others, aiming to produce hundreds of millions of doses. The planned Phase 2/3 clinical trial, titled INNOVATE, is backed by DoD funding and is designed to assess the vaccine's safety and efficacy. INO-4800 boasts an impressive stability profile, requiring no freezing for transportation.
On November 23, 2020, INOVIO announced the dosing of the first subject with its DNA medicine INO-3107 in a Phase 1/2 clinical trial targeting Recurrent Respiratory Papillomatosis (RRP). This trial aims to evaluate the efficacy and safety of INO-3107, which has received Orphan Drug Designation from the FDA. RRP is a severe condition caused by HPV types 6 and 11, leading to recurring airway tumors. The trial involves 63 subjects and seeks to demonstrate an increase in time between surgical interventions. INOVIO's innovative approach may significantly alter the treatment landscape for this rare disease.
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