Inovio Pharmaceu Stock Price, News & Analysis

INOVIO (NASDAQ: INO) has received FDA authorization to proceed with the INNOVATE Phase 3 segment for its COVID-19 vaccine candidate, INO-4800, in the U.S. Following a review of additional information, the FDA lifted a partial clinical hold. This global Phase 3 trial aims to evaluate INO-4800's efficacy in a two-dose regimen among adults 18 years and older. The vaccine, which is notable for its stability and shelf life, is being developed to provide a robust immune response against SARS-CoV-2.

INOVIO (NASDAQ: INO) has appointed four new leaders to strengthen its executive team ahead of commercial operations. Mark Twyman takes on the role of Chief Commercial Officer, Rob Crotty as General Counsel, Asli Gevgilili as Chief Human Resources Officer, and Gene Kim as Chief Corporate Affairs Officer. These appointments aim to leverage their extensive experience in the biotech and pharmaceutical industries to expedite the launch of INOVIO's DNA medicines targeting infectious diseases and cancer. The company is also advancing clinical trials for its vaccine candidates, including INO-4800 against COVID-19.

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.