Welcome to our dedicated page for Cel-Sci Corporation news (Ticker: CVM), a resource for investors and traders seeking the latest updates and insights on Cel-Sci Corporation stock.
Cel-Sci Corporation (symbol: CVM) is at the forefront of biotechnology, dedicated to advancing immunotherapy solutions for cancer and infectious diseases. Established in 1983 and headquartered in Vienna, Virginia, Cel-Sci is committed to harnessing the power of the human immune system to combat a variety of health challenges.
The company's leading investigational immunotherapy, Multikine (Leukocyte Interleukin, Injection), is currently in Phase III clinical trials for the treatment of head and neck cancer. This breakthrough therapy aims to improve survival rates by leveraging the body's natural defenses.
In addition to Multikine, Cel-Sci is pioneering the Ligand Epitope Antigen Presentation System (LEAPS), a pre-clinical patented T-cell modulation process designed to stimulate the immune system to fight bacterial, viral, and parasitic infections, and conditions such as autoimmune diseases, allergies, transplantation rejections, and cancer. Their innovative pipeline includes LEAPS-H1N1-DC, as well as product candidates CEL-2000 and CEL-4000 for the treatment of rheumatoid arthritis. The company is also developing LEAPS COV-19 to address the COVID-19 pandemic, in collaboration with the University of Georgia's Center for Vaccines and Immunology.
Cel-Sci's core capabilities extend to drug discovery, research, development, and the manufacturing of complex biological substances. The company's multifaceted approach not only targets cancer but also seeks to provide solutions for a wide range of infectious and autoimmune diseases. By focusing on these areas, Cel-Sci aims to deliver groundbreaking treatments that can significantly improve patient outcomes and quality of life.
Recent achievements and ongoing projects underscore Cel-Sci's commitment to innovation and excellence in the biotechnology field. The company's robust pipeline and strategic collaborations position it as a significant player in the quest for effective immunotherapies, offering hope to millions affected by cancer and other debilitating conditions.
Stay updated with the latest news and developments from Cel-Sci Corporation to track their progress and breakthroughs in cancer and immunotherapy research.
CEL-SCI (NYSE American: CVM) has appointed Robert Watson as Chairperson of the Board. Watson, who joined the board in 2017, has an extensive background in the healthcare sector, particularly in capital formation and partnerships. He has facilitated over $750 million in transactions throughout his career.
Watson's appointment comes at a pivotal moment for CEL-SCI, as the company prepares for a confirmatory Registration Study for its immunotherapy drug, Multikine. The FDA approved this study based on positive efficacy and safety data from over 750 patients. Multikine showed a 73% survival rate compared to 45% in the control group at five years post-treatment.
The forthcoming study will enroll 212 patients with advanced primary head and neck cancer, a condition impacting an estimated 100,000 patients annually. Watson expressed confidence in confirming the drug’s efficacy and safety, emphasizing his commitment to CEL-SCI’s mission.
CEL-SCI announced promising data for its investigational drug Multikine at the IDDST Annual Congress in Budapest. Dr. Eyal Talor presented findings showing that Multikine significantly improves overall survival in head and neck cancer patients with low PD-L1 expression levels. Specifically, the 5-year survival rate for Multikine-treated patients was 73%, compared to 45% in the control group. The hazard ratio was 0.35, indicating a 5-year death risk reduction from 55% to 27%. The company is planning a confirmatory FDA registration study.
CEL-SCI announced that Dr. Giovanni Selvaggi, a renowned oncology expert, has joined as a Clinical Advisor. Dr. Selvaggi has been pivotal in the approval of lung cancer drugs such as Zykadia and Opdivo. CEL-SCI's Multikine immunotherapy has shown significant efficacy in head and neck cancer, improving 5-year survival to 73% compared to 45% in controls. The FDA has approved a confirmatory Registration Study for Multikine. Dr. Selvaggi will support CEL-SCI in navigating this trial, aiming for regulatory approval.
CEL-SCI (NYSE American: CVM) reported its Q2 fiscal 2024 financial results. Key clinical and corporate developments included FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer, following strong Phase 3 results with a 28% survival benefit at 5 years. The new study will enroll 212 patients.
Financial highlights for the period ending March 31, 2024: R&D expenses decreased by $2.5M to $9M, G&A expenses increased slightly to $4.6M, and net loss narrowed by $2.2M to $14M. CEL-SCI also raised $7.75M through a public stock offering. Other notable developments: completion of a state-of-the-art manufacturing facility and a key waiver from the European Medicines Agency for Multikine's commercialization in Europe.
CEL-SCI has received FDA approval for a confirmatory study of its cancer immunotherapy Multikine for head and neck cancer patients, based on strong Phase 3 data showing a 73% survival rate with Multikine. The study will enroll 212 patients and aims to confirm the results of the Phase 3 trial, paving the way for potential approval. The FDA acknowledged the unmet need for improved therapies in this patient population, supporting approval for Multikine.
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