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) announced a $37.6 million grant from DARPA to develop DNA-encoded monoclonal antibodies (dMAbs) targeting SARS-CoV-2. This funding will complement INOVIO's ongoing INO-4800 vaccine trial, enhancing treatment options for COVID-19. The dMAb technology offers rapid, cost-effective production of antibodies, overcoming limitations of traditional methods. The collaboration includes The Wistar Institute and AstraZeneca, aiming to advance dMAb candidates into preclinical studies and human trials within a year.
INOVIO (NASDAQ: INO) and Advaccine Biopharmaceuticals have initiated the Phase 2 clinical trial for INO-4800, a DNA vaccine candidate against COVID-19, in China. The trial, which is independent of the ongoing U.S. trial, aims to enroll 640 participants aged 18 and older, focusing on safety and immunogenicity. Dr. Joseph Kim, INOVIO's CEO, emphasized the collaboration's significance in accelerating vaccine development. The trial will consist of two doses at varying levels, providing critical data to support further evaluations of INO-4800.
INOVIO (NASDAQ:INO) announced positive Phase 2 results for its DNA medicine VGX-3100, which treats HPV-16/18-associated anal dysplasia. The trial showed a 50% resolution of precancerous anal lesions in subjects six months post-treatment, indicating VGX-3100 is safe and well-tolerated. The study involved 23 participants, with the primary endpoint being the absence of dysplasia and HPV-16/18 detected in tissue samples. INOVIO plans to initiate a Phase 3 trial and seek rare disease designation for this treatment in 2021, amidst rising anal cancer incidences attributed to HPV.
INOVIO (NASDAQ: INO) announced the initiation of the Phase 2 segment of its INNOVATE clinical trial for its COVID-19 vaccine candidate, INO-4800, with the first subject dosed. The trial aims to enroll around 400 participants at 17 U.S. sites, focusing on safety, tolerability, and immunogenicity to confirm dosing levels for subsequent Phase 3 evaluation. Funded by the U.S. Department of Defense, the trial signifies an important step in INOVIO's response to the pandemic, leveraging its DNA technology known for its safety profile and thermostability.
INOVIO (NASDAQ: INO) has entered a partnership with Kaneka Eurogentec S.A. to manufacture its COVID-19 vaccine candidate, INO-4800, using GMP plasmid production. This collaboration enhances INOVIO's existing global manufacturing network, which includes Thermo Fisher Scientific and others, aiming to produce hundreds of millions of doses. The planned Phase 2/3 clinical trial, titled INNOVATE, is backed by DoD funding and is designed to assess the vaccine's safety and efficacy. INO-4800 boasts an impressive stability profile, requiring no freezing for transportation.
On November 23, 2020, INOVIO announced the dosing of the first subject with its DNA medicine INO-3107 in a Phase 1/2 clinical trial targeting Recurrent Respiratory Papillomatosis (RRP). This trial aims to evaluate the efficacy and safety of INO-3107, which has received Orphan Drug Designation from the FDA. RRP is a severe condition caused by HPV types 6 and 11, leading to recurring airway tumors. The trial involves 63 subjects and seeks to demonstrate an increase in time between surgical interventions. INOVIO's innovative approach may significantly alter the treatment landscape for this rare disease.
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.
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