CEL-SCI Releases Video Detailing Recent Phase 3 Findings & its Plans To Seek Immediate Regulatory Approvals

Author: Benzinga Newsdesk | October 24, 2023 08:21am

CEL-SCI Corporation (NYSE:CVM) today released a video presentation in which the Company's CEO, Geert Kersten, shares the most recent data presented at the European Society for Medical Oncology (ESMO) Congress and the data's impact on propelling the Company's immunotherapy drug Multikine* (Leukocyte Interleukin, Injection) toward regulatory approval for the treatment of newly diagnosed, advanced squamous cell carcinoma of the head and neck (SCCHN). Mr. Kersten carefully explains how it is that patients in the target group who were treated with Multikine had a 5-year survival rate of 73% as compared to only 45% for those who did not receive Multikine, cutting the risk of death by half. He goes on to present CEL-SCI's regulatory submissions plan and timelines based on these compelling findings for a patient population that has not had a new treatment approved in in the U.S. in many decades.

Summary of Multikine Results in the Target Population:

• 73% survival for Multikine vs 45% in the control at 5 years
• 28% absolute survival benefit
• Statistically significant p=.0015 and hazard ratio = 0.35
• Tumor reduction rate >13% and tumor downstaging >35%
• No safety signals or toxicities vs standard of care
• Target population of an estimated 145,000 patients (global, annual) who present with:
  • No nodal involvement and no extracapsular spread
  • Low PD-L1 tumor expression (different from high PD-L1 targeted by checkpoint inhibitors)
• Physicians routinely assess these features at baseline; no extra tests needed
• These features make it easy to write a label for the approval of Multikine, which is essential for drug approval

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). This approach is called neo-adjuvant. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. CEL-SCI has completed a 928 patient Phase 3 clinical trial in locally advanced primary head and neck cancer patients.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

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