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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) announced participation in the Jefferies 2021 Virtual Healthcare Conference on June 1, 2021. Dr. Joseph Kim, President and CEO, will engage in a fireside chat and 1x1 investor meetings at 2:00 PM EDT. INOVIO focuses on developing DNA medicines for infectious diseases, cancer, and HPV-associated conditions, with 15 clinical programs underway. Their proprietary delivery device, CELLECTRA®, allows plasmids to enter cells, generating immune responses without altering individual DNA. INOVIO has conducted over 7,000 applications in clinical trials, showcasing robust efficacy in various programs.
INOVIO (NASDAQ:INO) announced the appointment of Roger D. Dansey, M.D. to its Board of Directors, enhancing its expertise in drug development. Dr. Dansey, currently Chief Medical Officer at Seagen, has extensive experience at Merck, Gilead, and Amgen, where he led notable oncology projects. His expertise will support INOVIO's focus on its late-stage product development programs, including DNA medicines for glioblastoma and COVID-19. This strategic move aims to leverage Dr. Dansey's background to further commercialize INOVIO's innovative treatments.
INOVIO's next-generation Pan-COVID-19 vaccine candidate, INO-4802, has shown strong potential in preclinical studies, inducing robust neutralizing antibodies and T cell responses against several COVID-19 variants, including the original Wuhan strain and the B.1.1.7, B.1.351, and P.1 strains. The dual-track development approach aims to address both pandemic and endemic COVID-19 considerations. Clinical trials for INO-4802 are planned for later this year, enhancing INOVIO's strategy to provide effective cross-variant immunity.
INOVIO (NASDAQ: INO) reported its Q1 2021 financial results with total revenue of $371,000, down from $1.3 million in Q1 2020. The company posted a net loss of $54.4 million, or $0.27 per share, compared to a loss of $32.5 million, or $0.26 per share, in the previous year. INOVIO announced positive Phase 2 trial results for its COVID-19 vaccine candidate, INO-4800, demonstrating safety and immunogenicity across age groups. The company plans a global Phase 3 trial for INO-4800 and continues development of its DNA medicines for HPV-related diseases and cancer.
INOVIO (NASDAQ: INO) announced positive results from its Phase 2 clinical trial for INO-4800, its DNA vaccine candidate against COVID-19, conducted across 16 U.S. sites with approximately 400 participants. The data showed that INO-4800 was safe, well-tolerated, and immunogenic across all age groups tested, with a significant immune response observed in participants receiving a 2.0 mg dose compared to a 1.0 mg dose. INOVIO plans to submit these results to the FDA and proceed to a global Phase 3 trial, recognizing the need for effective COVID-19 vaccination.
INOVIO (NASDAQ:INO), a biotechnology company specializing in DNA medicines for infectious diseases and cancer, is scheduled to present at two virtual investor conferences in May 2021. The first is the Bank of America Merrill Lynch Health Care Conference on May 12 at 9:30 AM ET, followed by the RBC Global Healthcare Conference on May 18 at 9:45 AM ET. Both presentations will be available on INOVIO's website. INOVIO's lead candidate, VGX-3100, is the first DNA medicine to achieve efficacy endpoints in a Phase 3 trial for treating HPV-related cervical dysplasia.
INOVIO (NASDAQ: INO) will release its first quarter 2021 financial results on May 10, 2021, after market close. The company will host a live conference call and webcast at 4:30 p.m. ET to discuss these results and provide an update on its DNA Medicines Platform, including ongoing COVID-19 vaccine developments. INOVIO's VGX-3100 has achieved efficacy endpoints in a Phase 3 trial for treating precancerous cervical dysplasia, marking a significant achievement in DNA medicine.
INOVIO (NASDAQ:INO) announced it will transition to a predominantly ex-U.S. Phase 3 trial for its COVID-19 vaccine candidate, INO-4800, due to the changing landscape of COVID-19 vaccinations. The Department of Defense will discontinue funding for the Phase 3 segment of the INNOVATE trial but will continue funding the ongoing Phase 2 segment. This decision does not reflect the vaccine's data or INOVIO’s performance. INOVIO is also evaluating its pan-COVID variant vaccine, INO-4802, and remains committed to addressing pandemic and endemic vaccine needs.
INOVIO (NASDAQ: INO) has released promising results from a study on its COVID-19 vaccine candidate, INO-4800. The study indicates that INO-4800 generates a robust T cell response against all tested SARS-CoV-2 variants. Additionally, neutralizing activity against the UK and Brazilian variants is comparable to the original strain. INOVIO plans to report Phase 2 results in Q2 and move to Phase 3 shortly after. The vaccine's stability at room temperature and potential for multiple boosts highlight its significance in pandemic management.
INOVIO (NASDAQ:INO) has appointed Michael Cordera as Executive Vice President and General Counsel, effective March 15, 2021. Reporting directly to CEO Dr. J. Joseph Kim, Cordera will oversee the legal team's strategy. He brings extensive life sciences experience from his previous role at Eagle Pharmaceuticals and has held various legal positions internationally. This leadership change comes as INOVIO advances its development of DNA medicines targeting infectious diseases and cancer, with 15 clinical programs currently underway.
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