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Inovio Pharmaceuticals reports developments in DNA medicines for HPV-related diseases, cancer and infectious diseases. Its updates center on INO-3107, a DNA immunotherapy candidate for recurrent respiratory papillomatosis, including clinical data, scientific publications, FDA review milestones and presentations at medical and biotechnology conferences.
Company news also includes quarterly and annual financial results, business updates, research on DNA-encoded monoclonal antibodies and DNA-encoded protein technology, collaboration activity and capital-structure actions involving common stock, warrants and at-the-market financing programs.
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.
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.