CEL-SCI Reports Phase 3 Tumor PD-L1 Biomarker Data Demonstrate Multikine’s Increased Efficacy and Points to Potential for Combination With Checkpoint Inhibitors for Head & Neck Cancer

• Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors which most often show longer survival in a proportion of patients with a higher level of tumor cell PD-L1 expression
• Combination therapy could boost patient outcomes
• CEL-SCI has filed a patent for the use of Multikine in tumor expressing low levels of PD-L1

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced new data from a biomarker analysis of its pivotal Phase 3 study in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 10, 2023 in Montreal, Canada, in the presentation titled “Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study”. The Leukocyte Interleukin Injection (LI) [aka Multikine*] talk, was delivered by Philip Lavin, PhD, lead biostatistician for over 80 regulatory approvals/clearances who has also served on multiple U.S. Food and Drug Administration (FDA) review panels. Dr. Lavin is the lead biostatistician for CEL-SCI’s IT-MATTERS study.

Tumor cell PD-L1, also known as PD-L1 (Programmed Death-Ligand 1), a protein that plays a crucial role in immune system regulation, is a target pathway for immune checkpoint inhibitors, a major class of oncology drugs. These work by blocking the interaction between tumor cell PD-L1 and the PD-1 receptor. The global PD-L1/PD-1 therapeutics market was valued at $34.8 billion in 2022 and includes two drugs approved for head and neck cancer, specifically unresectable recurrent or metastatic SCCHN, Keytruda and Opdivo.

While pembrolizumab (Keytruda) and nivolumab (Opdivo) are approved for use in recurrent and metastatic head and neck cancer, CEL-SCI’s Phase 3 data showed that Multikine prolonged overall survival in the lower risk for recurrence advanced primary head and neck cancer patients and more so in a subset comprising >70% of the lower-risk patients (all had low levels (defined as TPS

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