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) presented promising data on its DNA medicines, INO-5401 and INO-9012, combined with PD-1 inhibitor Libtayo in treating newly diagnosed glioblastoma (GBM) at the 2020 SNO Annual Meeting. The interim results demonstrated that 70% of MGMT methylated and 50% of unmethylated GBM patients survived 18 months. A significant immune response was observed, indicating potential for improved survival. This Phase 1/2 trial, involving 52 evaluable patients, is ongoing, with additional data to be released soon.
INOVIO (NASDAQ:INO) has received FDA clearance to begin the Phase 2 segment of its Phase 2/3 clinical trial for INO-4800, a COVID-19 vaccine candidate. The INNOVATE trial aims to assess safety, tolerability, and immunogenicity across various age groups. The trial will enroll around 400 participants at 17 U.S. sites and is funded by the U.S. Department of Defense. The Phase 3 segment remains on partial hold due to unresolved FDA questions regarding the delivery device. INO-4800 offers advantages such as excellent thermostability, allowing for easier distribution.
INOVIO (NASDAQ: INO) reported its third-quarter financial results for 2020, showing total revenue of $236,000, down from $867,000 in Q3 2019. Notably, the company achieved a net income of $19.2 million compared to a net loss of $23.1 million in the same period last year, primarily due to a one-time gain related to the revaluation of convertible bonds and an investment sale. R&D expenses rose to $26.5 million due to increased investment in COVID-19 vaccine development. INOVIO is focusing on its COVID-19 vaccine INO-4800, which is currently under FDA review.
INOVIO (NASDAQ: INO) will release its third-quarter 2020 financial results after market close on November 9, 2020. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide updates on its DNA Medicines Platform, including ongoing COVID-19 vaccine developments. Currently, INOVIO has 15 DNA medicine clinical programs targeting HPV-associated diseases, cancer, and infectious diseases. The company's innovative approach utilizes the CELLECTRA device for efficient delivery of DNA medicines, showing promise in clinical trials involving over 2,000 patients.
INOVIO (NASDAQ:INO) announced a partial clinical hold on its IND for a Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800 due to additional questions from the FDA regarding trial parameters and the CELLECTRA® 2000 delivery device. The company is addressing these inquiries and plans to respond in October, with the FDA set to make a decision within 30 days. Notably, this hold does not affect ongoing Phase 1 trials or the development of other product candidates. INOVIO continues with its coalition partners to advance INO-4800 and seeks funding for the trial.
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.
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