CEL-SCI Announces The Potential Impact On The Clinical Development Of Its Immunotherapy Multikine Resulting From A Recent U.S. FDA Oncologic Drugs Advisory Committee Meeting; Multikine Has Shown Survival Benefit And Favorable Safety Profile In A Randomized Controlled Phase 3 Study Of Treatment Naïve Resectable Locally Advanced Head And Neck Cancer Patients With Low PD-L1 Expression

• Oncologic Drugs Advisory Committee (ODAC) determines risks outweigh benefits in some cancers for frontline immune checkpoint inhibitors, including blockbuster drugs such as Keytruda and Opdivo, in patients with low PD-L1 expression
• Multikine has shown survival benefit and favorable safety profile in a randomized controlled Phase 3 study of treatment naïve resectable locally advanced head and neck cancer patients with low PD-L1 expression
• Multikine has potential as a combination drug with current checkpoint inhibitors such as Keytruda which is projected to be the top selling drug in the world with $27 billion in 2024 sales
• To the Company's knowledge, Multikine is the only neoadjuvant immunotherapy that has shown overall survival benefit in the low and negative PD-L1 head and neck cancer population

CEL-SCI Corporation (NYSE:CVM) today announced the potential positive impact on the clinical development of its immunotherapy Multikine (Leukocyte Interleukin, Injection)* resulting from a recent U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting, a public forum.

FDA advisory committees provide independent expert advice to the FDA on the safety and effectiveness of new and marketed drugs and help the agency make sound and informed decisions. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.

The September 27, 2024 ODAC meeting evaluated the use of checkpoint inhibitors on patients with various cancers. PD-L1 is the biomarker most often used for patient selection for checkpoint inhibitors, the most successful class of cancer drugs including Keytruda and Opdivo. The FDA sought the ODAC's opinion on the following:

• adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population
• differing risk-benefit assessments in different subpopulations defined by PD-L1 expression
• adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression

Following a thorough analysis of peer-reviewed published data, the panel of experts on the ODAC voted 10-2 and 11–1 against the risk-benefit profile for PD-L1 inhibitors in various cancers in two separate votes. Most ODAC members expressed concerns about the lack of benefit demonstrated for patients with low PD-L1 expression, while some members pointed to evidence that the use of the immune checkpoint inhibitors may add unnecessary toxicities for patients while also increasing financial burdens on patients.

Checkpoint inhibitors were an estimated $48 billion global market in 2023, with PD-L1 inhibitors representing 73% of the market. Current labeling for approved checkpoint inhibitors in the indications evaluated by the FDA's ODAC include broad approvals for all patients, regardless of PD-L1 expression.