Discussion of Results of CEL-SCI’s Phase 3 Trial Is Now Available

Rhea-AI Summary

CEL-SCI Corporation (NYSE American: CVM) reported significant results from its Phase 3 trial of Multikine in advanced primary head and neck cancer, demonstrating a 14.1% increase in 5-year survival rates (62.7% vs 48.6%) for patients receiving the therapy plus standard treatment. The company plans to file for FDA approval based on these findings. Multikine is an investigational immunotherapy containing multiple cytokines, aimed at enhancing the immune response before surgery and radiotherapy. The discussion of results took place at the Annual Shareholder Meeting on July 1, 2021.

Positive

• 14.1% increase in 5-year survival benefit in Phase 3 trial.
• Plans to file for FDA approval based on successful trial results.
• Unique treatment approach by administering Multikine before standard care.

Negative

• None.

CEL-SCI Corporation (NYSE American: CVM) today announced that the discussion at the Annual Shareholder Meeting, on July 1, 2021 at 10:00 am EDT, regarding its Phase 3 head and neck cancer trial results is available at https://edge.media-server.com/mmc/p/ou79u5bv.

The discussion on the Phase 3 results was presented by Geert Kersten the Chief Executive Officer, Dr. Eyal Talor the Chief Scientific Officer and John Cipriano the Senior Vice President of Regulatory Affairs. In the landmark Phase 3 study, Multikine® produced a significant 14.1% 5-year survival benefit (62.7% vs 48.6%) in the group of advanced primary head and neck cancer patients who received surgery plus radiotherapy. The Company plans to file for FDA approval in this patient population.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational cancer immunotherapy that is known to contain 14 natural human cytokines, the body’s immune system regulators including interleukins, interferons, chemokines, and colony stimulating factors which are elements of the body’s natural mix of defenses against cancer and other diseases. A patented, mass-produced, off the shelf and ready to use non-autologous biological product, Multikine is manufactured using a proprietary process following Good Manufacturing Practice (GMP) requirements from Source Leukocytes, an FDA licensed product, at CEL-SCI’s manufacturing facility near Baltimore, Maryland.

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 treated patients who are newly diagnosed with 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 unique. The study showed excellent survival benefit for those patients who received Multikine plus surgery and radiation. When chemotherapy was added the survival benefit was negated.

The Company’s LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment for COVID-19 infection. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release and statements made at the annual meeting may contain 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. Words when used in this press release and at the annual meeting, such as "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. 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, 2020. 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, and 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/20210702005311/en/

FAQ

What were the results of CEL-SCI's Phase 3 trial for Multikine?

The Phase 3 trial showed a 14.1% increase in 5-year survival rates for patients receiving Multikine plus surgery and radiotherapy.

When is CEL-SCI planning to file for FDA approval?

CEL-SCI plans to file for FDA approval following the positive results from the Phase 3 trial.

What is Multikine and how does it work?

Multikine is an investigational cancer immunotherapy containing 14 natural human cytokines designed to strengthen the immune response against cancer.

What is the significance of the July 1, 2021 meeting for investors?

The July 1, 2021 meeting highlighted the promising results of the Phase 3 trial and the company's future plans, which are crucial for investors.