CEL-SCI to Present New Data for Multikine® Head & Neck Cancer Immunotherapy at the European Society for Medical Oncology 2024 Congress

Rhea-AI Summary

CEL-SCI (NYSE American: CVM) announced it will present new data from its Phase 3 study of Multikine at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain. The poster, titled 'Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy,' will be presented on September 14, 2024.

CEL-SCI has received FDA approval to start a confirmatory Registration Study of Multikine for head and neck cancer treatment, based on strong safety and efficacy data from its completed IT-MATTERS Phase 3 study. The study's co-author, Dr. József Tímár, a respected pathologist and Professor at Semmelweis University, will present the findings. CEL-SCI plans to release a press release with the new data before market open on September 16, 2024.

Data to be presented on Saturday, September 14 and published via a press release before the open of market on Monday, September 16

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today reported it will report new data from its Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* at the European Society for Medical Oncology (ESMO) 2024 Congress which takes place from September 13 – 17, 2024 in Barcelona, Spain. A poster titled “Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy” will be presented by the study’s co-author József Tímár MD, PhD, DSc, a prominent and highly respected pathologist.

CEL-SCI has received the go-ahead from the U.S. Food and Drug Administration (FDA) to commence a confirmatory Registration Study of Multikine in the treatment of head and neck cancer based on strong safety and efficacy data from its IT-MATTERS completed Phase 3 study.

Dr. Timar is Professor Department of Pathology, Forensic and Insurance Medicine at Semmelweis University in Budapest, Hungary, and served as the Director of the Central Pathology Laboratory for the IT-MATTERS study. With 174 peer reviewed studies published, Dr. Timar is a founding editor, editor in chief, or a member of the editorial board of four oncology journals. He is the recipient of a dozen honors and awards for excellence in cancer research and teaching.

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. 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.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without Multikine at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced primary head and neck cancer patients who present with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients (globally) annually.

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. 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, 2023. 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.

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Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

When will CEL-SCI (CVM) present new Multikine data at ESMO 2024?

CEL-SCI (CVM) will present new Multikine data on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain.

What is the focus of CEL-SCI's (CVM) poster presentation at ESMO 2024?

The poster presentation focuses on the prognostic significance of diagnostic staging in treatment-naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy (Multikine).

Has CEL-SCI (CVM) received FDA approval for a new Multikine study?

Yes, CEL-SCI (CVM) has received FDA approval to commence a confirmatory Registration Study of Multikine for the treatment of head and neck cancer, based on data from its completed IT-MATTERS Phase 3 study.

Who will present CEL-SCI's (CVM) Multikine data at ESMO 2024?

Dr. József Tímár, a respected pathologist and Professor at Semmelweis University, will present CEL-SCI's (CVM) Multikine data at ESMO 2024.

When will CEL-SCI (CVM) release a press release about the new Multikine data?

CEL-SCI (CVM) plans to release a press release with the new Multikine data before the market opens on Monday, September 16, 2024.