CEL-SCI is a clinical-stage biotechnology company focused on the research and development of immunotherapy for the treatment of cancer and other serious conditions, with lead investigational therapy Multikine in development as a potential neoadjuvant treatment for head and neck cancer.
Phase 3 · ActiveModality: biological immunotherapy (mixture of natural cytokines and small biological molecules)
Aliases Leukocyte Interleukin, Injection
Partnerships Saudi Amarox Co.: exclusive Saudi Arabia distributor and local representative before the SFDA (May 2026 distribution agreement)
Indications
Locally advanced primary squamous cell carcinoma of the head and neck (SCCHN), newly diagnosed resectable, no lymph node involvement, low PD-L1 tumor expression(Phase 3)
Status note Completed 928-patient Phase 3 (IT-MATTERS) led to 212-patient confirmatory registration study in the target population; FDA indicated May 2024 the company may move forward with it and the study is underway. Breakthrough Medicine Designation application filed with the Saudi FDA August 2025. Company flags going-concern risk and dependence on future financings.
Per-asset detail extracted from the 10-Q filed 2026-08-14. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
No lead program on file for this company.
No active ClinicalTrials.gov trials matched to this company as sponsor or collaborator.
Specialist fund holders
Tracked specialist funds: ADAR1 Capital Management, Aisling Capital, Ally Bridge Group, Avoro Capital Advisors, BVF Partners, Baker Bros. Advisors, Boxer Capital, Braidwell LP, Casdin Capital, Cormorant Asset Management, DAFNA Capital, Deerfield Management, EcoR1 Capital, Frazier Life Sciences, Great Point Partners, Ikarian Capital, Logos Global Management, OrbiMed Advisors, Perceptive Advisors, RA Capital Management, RTW Investments, Sphera Biotech, Stonepine Capital, Tang Capital Partners, Vivo Capital.
None of the tracked specialist funds reported a position in the latest 13F snapshot.
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