An updated 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 98-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), a novel immunotherapy first-line treatment that has completed a 10 year Phase 3 trial for head and neck cancer; and (2) LEAPS™ (Ligand Epitope Antigen Presentation System), an immunotherapy peptide 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 while generating a sustainable anti-tumor response to extend survival. Multikine® is being developed for neoadjuvant (before surgery) administration and could become an integral first-line component of the standard of care (SOC) regimen for locally 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 (e.g., rheumatoid arthritis) 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 initial 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 (SCCHN). CEL-SCI received Orphan Drug Status/designation from the U.S. Food and Drug Administration (FDA) for this indication.
- The Company’s 10-year Phase 3 trial showed that Multikine® significantly extended the lives of patients with locally advanced primary SCCHN treated with surgery and radiotherapy (noting there has been no FDA approval for new products in first-line therapy for those who get surgery as a first treatment in over 50 years).
- CEL-SCI is completing and submitting a Biologics License Application (BLA) to the FDA for approval of Multikine® to treat advanced primary head and neck cancer on patients scheduled to receive surgery and radiotherapy as their primary treatments.
- Roughly 210,000 patients globally and 25,000 in the U.S. would be eligible for Multikine® treatment if approved. CEL-SCI’s data is favorable compared to approved SCCHN therapies, with an absolute survival benefit of 14.9% (difference between 62.7% versus 48.6% survival at five years), a good percentage of partial and even complete tumor responders in only three weeks, and a favorable toxicity profile.
- CEL-SCI has completed the commercial scale buildout of its 73,000 sq. ft. Multikine® manufacturing and R&D facility in anticipation of market demand once it receives regulatory approval and is finishing the validation of the manufacturing facility.
- As of December 31, 2022, CEL-SCI’s cash position was $18 million.
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