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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) reported new data from its Phase 3 study of Multikine® at the ESMO 2024 Congress. The data shows that Multikine increased the 5-year survival rate to 82.6% in locally advanced resectable head and neck cancer patients deemed low risk for recurrence, compared to 47.3% with standard care alone. The treatment also demonstrated a 73% reduction in overall risk of death (hazard ratio of 0.27).
These results are highly relevant to CEL-SCI's upcoming 212-patient confirmatory Registration Study, which has received FDA approval. The study will focus on patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and low PD-L1 tumor expression. The data suggests that better diagnostic technology, such as PET scans, could further optimize patient selection and improve Multikine's efficacy.
CEL-SCI (NYSE American: CVM) announced it will present new data from its Phase 3 study of Multikine at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain. The poster, titled 'Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy,' will be presented on September 14, 2024.
CEL-SCI has received FDA approval to start a confirmatory Registration Study of Multikine for head and neck cancer treatment, based on strong safety and efficacy data from its completed IT-MATTERS Phase 3 study. The study's co-author, Dr. József Tímár, a respected pathologist and Professor at Semmelweis University, will present the findings. CEL-SCI plans to release a press release with the new data before market open on September 16, 2024.
CEL-SCI (NYSE American: CVM) has received a pediatric waiver from the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) for Multikine®, its treatment for head and neck cancer. This waiver exempts CEL-SCI from evaluating Multikine in patients under 18 years old as part of the license and marketing clearance review in the UK. CEO Geert Kersten stated that this decision accelerates the path to marketing approval in the UK, while the company prepares to start its confirmatory FDA Registration Study in the U.S. and other locations. The waiver is seen as a positive step towards future marketing clearance for Multikine.
CEL-SCI (NYSE American: CVM) reported its Q3 fiscal 2024 financial results and key developments. Highlights include:
1. Positive bias analysis results for Multikine, supporting its role in increasing patient survival.
2. FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer treatment.
3. Presentation at IDDST Congress showcasing Multikine's efficacy in patients with low tumor PD-L1 expression.
4. Board strengthening with new appointments.
5. R&D expenses decreased to $4.7 million from $5.7 million year-over-year.
6. G&A expenses reduced to $2.0 million from $2.5 million year-over-year.
7. Post-quarter equity fundraise of $10.85 million completed on July 29, 2024.
CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has closed a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The company plans to use the net proceeds to fund the development of Multikine, its lead investigational therapy, as well as for general corporate purposes and working capital. ThinkEquity acted as the sole placement agent for this best-efforts offering. CEL-SCI is preparing to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024. The company's focus remains on activating the immune system to fight cancer and infectious diseases.
CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has announced the pricing of a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The offering, expected to close on July 29, 2024, aims to fund the development of Multikine, their lead investigational therapy, and general corporate purposes. ThinkEquity is acting as the sole placement agent for this best-efforts offering. CEL-SCI's Multikine has completed a pivotal Phase 3 clinical trial for head and neck cancer and received Orphan Drug Status from the FDA. The company plans to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024.
CEL-SCI (NYSE American: CVM) reported positive results from a bias analysis for its Phase 3 study of Multikine in head and neck cancer treatment. The analysis showed no bias in the study, with comparable demographics and baseline characteristics between Multikine-treated and control arms. This supports the reliability of the study data, which demonstrated Multikine's efficacy in extending patient life.
Key findings include:
- 5-year survival rate of 73% in Multikine-treated patients vs. 45% in control group for the target population
- Hazard ratio of 0.35 with an upper limit of 0.66, suggesting a high chance of repeating the survival benefit
- No confounding baseline parameters detected
CEL-SCI is preparing to submit data to regulators for a 212-patient confirmatory registration study, agreed upon with the FDA.
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.
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