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 a collaboration with Thermo Fisher Scientific to manufacture its DNA COVID-19 vaccine candidate, INO-4800. The partnership aims to scale up production to potentially 100 million doses in 2021, pending FDA approval. Thermo Fisher will manage the drug substance manufacturing and filling processes, joining existing partners in INOVIO's global consortium. INO-4800 has demonstrated excellent thermal stability and does not require freezing, which is crucial for global distribution. INOVIO is also preparing for Phase 2/3 trials, supported by $71 million in funding from the U.S. Department of Defense.
INOVIO (NASDAQ:INO), a biotechnology firm, announced presentations at three investor conferences in September. Dr. Joseph Kim, President and CEO, will lead the sessions: H.C. Wainwright on September 14 at 9:30 a.m. ET, Cantor Global Healthcare on September 17 at 10:40 a.m. ET, and Oppenheimer on September 23 at 10:50 a.m. ET. INOVIO focuses on DNA medicines targeting infectious diseases and cancer, with 15 clinical programs in development. Their proprietary CELLECTRA device enhances DNA delivery into cells, promising a robust immune response against high-risk HPV and COVID-19 variants.
INOVIO (NASDAQ: INO) reported its financial results for Q2 2020, highlighting significant advancements in its DNA vaccines, particularly INO-4800 for COVID-19. The Phase 1 trial showed 100% immunological response among participants, with plans to initiate a Phase 2/3 study in September. Total revenue reached $267,000, a rise from $136,000 in Q2 2019, but the net loss increased to $128.7 million, mainly due to convertible bond valuation. Cash reserves rose to $371.7 million, bolstered by an ATM sales agreement.
INOVIO (NASDAQ: INO) announced positive results for its COVID-19 DNA vaccine, INO-4800, in a non-human primate study. The vaccine provided protection against live SARS-CoV-2 virus 13 weeks post-vaccination, showing significant memory T and B cell responses. Results indicated reduced viral loads in the lungs and nasal passages. The study demonstrated seroconversion after a single dose, with antibody levels comparable to recovered COVID-19 patients. INO-4800 is in Phase 1 trials in the U.S. and is set to enter Phase 2/3 trials this summer.
INOVIO (NASDAQ: INO) has received orphan drug designation from the FDA for INO-3107, a DNA medicine targeting recurrent respiratory papillomatosis (RRP), a rare disease caused by HPV types 6 and 11. This designation provides various incentives, including a tax credit and 7 years of market exclusivity. The ongoing Phase 1/2 trial aims to recruit 63 subjects to assess the drug's efficacy and safety, with the primary goal of doubling the time between surgical interventions. Current RRP treatments are limited to surgery, making this development crucial for affected patients.
INOVIO announced positive interim clinical data for its COVID-19 vaccine candidate, INO-4800, derived from Phase 1 trial cohorts. The vaccine has been included in the U.S. government's Operation Warp Speed, aiming for early 2021 availability. The trial demonstrated a 94% immunological response rate among participants, and INO-4800 effectively prevented viral replication in animal models. INOVIO plans to expand the trial to include older participants and is set to initiate a Phase 2/3 efficacy trial this summer following regulatory approval.
INOVIO (NASDAQ: INO) has appointed Gene Kim as President of INOVIO Asia and Mammen Mammen as Senior VP of Clinical Development. Mr. Kim, with extensive CFO experience in Korean firms, will drive corporate development in Asia, particularly South Korea. Dr. Mammen, an expert in military vaccines, will oversee clinical development for INO-4800, the company's COVID-19 DNA vaccine. INO-4800 is notable for its stability at room temperature, crucial for mass immunization efforts. INOVIO continues to advance its DNA medicine platform with 15 clinical programs targeting various diseases.