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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 (NASDAQ:INO) has received approval from India's CDSCO to proceed with the Phase 3 segment of its global Phase 2/3 trial for INO-4800, a DNA vaccine candidate for COVID-19. The INNOVATE trial will assess the efficacy of a two-dose regimen in adults. This follows similar authorizations in Brazil, the Philippines, Mexico, and Colombia. Interim Phase 2 data indicated that INO-4800 was well-tolerated and immunogenic, generating robust immune responses against COVID-19 variants. The vaccine's stability at room temperature may enhance its deployment as both primary series and booster.
INOVIO (NASDAQ: INO) will release its third quarter 2021 financial results on November 9, 2021, post-market. A live conference call is scheduled for 4:30 p.m. ET to discuss the results and provide updates on its DNA Medicines Platform, including the Phase 3 trial for INO-4800, its COVID-19 vaccine candidate. INOVIO has successfully demonstrated its ability to deliver DNA medicines directly into cells and has shown positive results in trials against HPV-related conditions. The company is also conducting international trials for INO-4800 in various countries.
INOVIO (NASDAQ: INO) announced the completion of enrollment for its Phase 1B clinical trial of INO-4500, a DNA vaccine candidate against Lassa fever, involving 220 participants at the Noguchi Memorial Institute in Ghana. This trial marks the first of its kind for Lassa fever in West Africa. Funded by a $56 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI), the study aims to assess the vaccine's safety and immunogenicity. Successful results could advance the vaccine into Phase 2 trials, addressing a significant public health need in an endemic region.
INOVIO (NASDAQ: INO) has signed a non-binding memorandum of understanding (MOU) with Colombia's Ministry of Health to enhance efforts in combating COVID-19 and future health emergencies. This MOU aims to facilitate collaboration in knowledge sharing, technology licensing, and vaccine development in Colombia. The partnership is rooted in INOVIO's DNA medicine platform, which is known for its stability and rapid production capabilities. The agreement also aligns with the Phase 3 clinical trial for INO-4800 in Colombia, as the company aims to address global health threats efficiently.
INOVIO (NASDAQ: INO) announced the online publication of Phase 1 clinical data for its COVID-19 vaccine candidate, INO-4800, in MedRxiv. Among 120 participants, 82.5% received a booster dose, resulting in robust immune responses and no serious treatment-related adverse events. The study indicated durable antibody responses six months after the second dose. INOVIO received regulatory authorization for a global Phase 3 trial in Mexico, Brazil, Colombia, and the Philippines, to further assess INO-4800's efficacy. This DNA vaccine's stability at room temperature positions it for widespread use.
INOVIO (NASDAQ: INO) has received regulatory approval from Colombia's INVIMA to initiate the Phase 3 trial of its COVID-19 vaccine candidate, INO-4800, as part of the global INNOVATE trial. This Phase 3 trial will assess the efficacy of a two-dose regimen in individuals aged 18 and older. Previous Phase 2 data indicated that INO-4800 was well-tolerated and generated strong immune responses. INOVIO aims to address vaccination needs amidst rising COVID-19 rates, leveraging the vaccine's stability and potential as both a primary and booster option.
INOVIO (NASDAQ: INO), a biotechnology company, will showcase three posters at IDWeek 2021, held virtually from September 29 to October 3. Dr. Laurent M. Humeau stated that these presentations highlight their DNA vaccine candidates targeting COVID-19. The showcased abstracts include safety and immunogenicity data for INO-4800, which induced neutralizing antibodies and T-cell activity against SARS-CoV-2 variants. INOVIO focuses on developing DNA medicines for infectious diseases, with a strong track record of over 3,900 patients treated in clinical trials.
INOVIO has received authorization from Mexico's COFEPRIS to conduct Phase 3 clinical trials for its COVID-19 DNA vaccine candidate, INO-4800, as part of the global INNOVATE trial. This development, alongside previous authorizations in Brazil and the Philippines, positions INOVIO to assess the vaccine's efficacy in adults. The Phase 3 trial aims to evaluate a two-dose regimen with a primary endpoint of confirmed COVID-19 cases. INO-4800 is notable for its safety profile and thermostability, potentially contributing to the global pandemic response.
INOVIO (NASDAQ:INO) has announced that Dr. Joseph Kim, President and CEO, will present at three upcoming investor conferences in September 2021. The conferences include:
- H.C. Wainwright 23rd Annual Global Investment Conference - Sept 13-15, recorded presentation available on-demand.
- Oppenheimer Fall Healthcare Life Sciences & MedTech Summit - Sept 21, at 9:55 AM ET, fireside chat format.
- Cantor Fitzgerald Healthcare Conference - Sept 27, at 10:00 AM ET, fireside chat format.
Details on accessing these presentations can be found on INOVIO's Investor Relations page.
INOVIO (NASDAQ: INO) announced regulatory approval from Brazil's ANVISA to proceed with the global Phase 3 segment of the INNOVATE trial for its DNA vaccine candidate INO-4800 against COVID-19. This trial will assess the efficacy of a two-dose regimen in several countries, targeting adults aged 18 and older. The trial aims to confirm the vaccine's safety and immunogenicity, building on positive Phase 2 results. INO-4800 is characterized as stable at room temperature, well-tolerated, and scalable for mass distribution, offering potential advantages in combating COVID-19.
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