An Executive Informational Overview (EIO) is now available on CEL-SCI Corporation, a clinical-stage biotechnology company developing immunotherapy technologies to treat cancer, autoimmune, and infectious diseases. The 86-page report details the Company's business, its strategy, market opportunities, strategic relationships, competition, financials, risks, and more. It is available for download below.
Snapshot of CEL-SCI Corporation
CEL-SCI Corporation (“CEL-SCI” or “the Company”) is a clinical-stage biotechnology company developing immunotherapy technologies to treat cancer, autoimmune, and infectious diseases. The Company is targeting novel therapy candidates that activate and utilize the body’s own immune system against disease. CEL-SCI is developing products based on two technologies: (1) Multikine® (Leukocyte Interleukin, Injection), an immunotherapy nearing the end of a global pivotal Phase 3 trial as a first-line treatment for head and neck cancer; and (2) LEAPS™ (Ligand Epitope Antigen Presentation System), an immunotherapy vaccine technology platform.
The goal of Multikine® is to modulate the body’s immune system to create a two-pronged mechanism of action: eliciting the direct killing of tumor cells and micrometastasis, limiting the possibility of recurrence, while generating a sustainable anti-tumor response, and rendering tumor cells more susceptible to subsequent radiation and chemotherapy treatments. Multikine® is being developed for neoadjuvant administration and could become an integral first-line component of the standard of care (SOC) regimen for advanced primary (previously untreated) head and neck cancers. As a neoadjuvant, Multikine® can stimulate the immune system before it is weakened by the toxic cancer therapies, improving its long-term therapeutic effect.
The LEAPS™ platform is designed to stimulate the immune system to fight bacterial, viral, and parasitic infections more effectively, as well as autoimmune conditions and cancer. LEAPS™ can be designed to produce a specific natural immune response required for the desired therapeutic effect, depending on the type of LEAPS™ construct used.
Key Points of CEL-SCI Corporation
- CEL-SCI’s first indication for Multikine® is as the first treatment immediately following diagnosis (given prior to any other treatment) in advanced primary (previously untreated) squamous cell carcinoma of the head and neck. Usually new cancer treatments are given after the initial treatments. CEL-SCI received Orphan Drug Status/designation from the FDA for this indication.
- In its most recent Phase 2 clinical trial for Multikine®, CEL-SCI reported a 10.5% complete response rate (no clinical or pathology evidence of any remaining cancer) and a 33% improvement in overall survival after only three weeks of treatment, with no reported severe adverse events associated with its use.
- In May 2020, CEL-SCI announced that it had reached the required number of events for the completion of its pivotal Multikine® Phase 3 trial (IT-MATTERS), the largest head and neck cancer study ever conducted. The primary endpoint in the study is a 10% increase in the overall survival of patients treated with the Multikine® treatment regimen + SOC versus patients treated with SOC only. The Company is proceeding with data lock and subsequent analysis of the data and expects to file for regulatory approval in 2021.The LEAPS™ technology is being used to develop therapeutics for rheumatoid arthritis (RA) as the lead indication and COVID 19.
- CEL-SCI operates a dedicated state-of-the art manufacturing facility with over 73,000 sq. ft. of manufacturing and R&D space.
- As of March 31, 2020, CEL-SCI’s cash position was $14.3 million..
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