Welcome to our dedicated page for Inovio Pharmaceuticals news (Ticker: INO), a resource for investors and traders seeking the latest updates and insights on Inovio Pharmaceuticals stock.
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), 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.
INOVIO (NASDAQ: INO) reported a net loss of $82.1 million, or $0.39 per share, for Q2 2021, compared to a loss of $128.7 million, or $0.83 per share, in Q2 2020. Total revenue slightly increased to $273,000 from $267,000. Operating expenses rose to $83.5 million from $33.4 million, driven primarily by R&D costs associated with manufacturing scale-up for COVID-19 vaccine INO-4800. INOVIO continues advancing its COVID-19 vaccine initiatives, including the INNOVATE Phase 3 trial and the new pan-COVID-19 vaccine INO-4802.
INOVIO (NASDAQ:INO) announced regulatory approval to initiate two clinical trials in China for its COVID-19 DNA vaccine candidate, INO-4800. The trials, sponsored by Advaccine Biopharmaceuticals and Sinovac, will investigate the safety and immunogenicity of a heterologous prime-boost regimen with INO-4800 and Sinovac's CoronaVac. Following successful preclinical results demonstrating strong immune responses, the trials aim to enhance vaccination strategies against emerging COVID-19 variants. If successful, INO-4800 could serve as both a primary and booster vaccine.
INOVIO (NASDAQ: INO) has commenced Phase 2 trials for INO-4700, a DNA vaccine aimed at combating the Middle East Respiratory Syndrome (MERS). This multi-center study, involving around 500 healthy volunteers in Jordan and Lebanon, seeks to assess the safety and immunogenicity of the vaccine. The trial builds on promising results from a previous Phase 1 trial, where 98% of participants developed an immune response. Funded by a $56 million CEPI grant, INOVIO aims to provide a preventive vaccine against MERS, a deadly disease with a high fatality rate.
INOVIO (NASDAQ: INO) will release its second quarter 2021 financial results on August 9, 2021, after market close. A conference call will follow at 4:30 p.m. ET, providing insights into its DNA Medicines Platform and ongoing COVID-19 vaccine developments. The company aims to address financial results and business updates.
Notably, INOVIO's lead candidate VGX-3100 has shown promising results in clearing high-grade cervical lesions in clinical trials, while INO-4800 is currently in Phase 2 trials for COVID-19.
INOVIO (NASDAQ: INO) announced an expansion of its partnership with Advaccine Biopharmaceuticals to conduct a global Phase 3 trial for INO-4800, a DNA vaccine targeting COVID-19. The trial will evaluate the safety and efficacy of a two-dose regimen in adults across Latin America and Asia, with an emphasis on underserved regions. The Phase 3 trial follows promising Phase 2 results showing INO-4800's good tolerance and immunogenicity. The estimated cost of the trial is about $100 million, which will be shared equally with Advaccine.
Geneos Therapeutics announced positive preliminary results from its GT-30 trial, a phase I/II study of personalized vaccine GNOS-PV02 combined with pIL-12 and pembrolizumab for patients with advanced hepatocellular carcinoma (HCC). Out of 10 evaluable patients, the overall response rate was 30%, with 3 achieving partial response and 7 exhibiting disease control. The treatment was generally safe, with no serious adverse events reported. Additionally, interim results from a compassionate use case showed a patient with anaplastic astrocytoma remained recurrence-free for 36 months after treatment.
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