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

Rhea-AI Summary

CEL-SCI Corporation releases video presentation on the impact of recent data on their immunotherapy drug Multikine for the treatment of advanced squamous cell carcinoma of the head and neck.

Positive

• Multikine showed a 5-year survival rate of 73% in the target group, compared to 45% for those who did not receive it. This represents a 28% absolute survival benefit. The results were statistically significant with a p-value of 0.0015 and a hazard ratio of 0.35. Tumor reduction rate was over 13% and tumor downstaging was over 35%. No safety signals or toxicities were observed. The target population for Multikine is estimated to be around 145,000 patients globally, presenting with specific characteristics that make it easy to write a label for drug approval.

Negative

• None.

View the video: https://youtu.be/23WqSM9gI40

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: 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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2022. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231024127901/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What is the impact of Multikine on survival rates in the target group?

Multikine showed a 5-year survival rate of 73% in the target group, compared to 45% for those who did not receive it.

What were the statistical results of the study?

The results were statistically significant with a p-value of 0.0015 and a hazard ratio of 0.35.

What is the target population for Multikine?

The target population for Multikine is estimated to be around 145,000 patients globally, presenting with specific characteristics that make it easy to write a label for drug approval.