CEL-SCI Announces Publication of ASCO 2022 Abstracts

Rhea-AI Summary

CEL-SCI Corporation (NYSE American: CVM) announced the publication of two abstracts at the ASCO Annual Meeting, which will be presented by Dr. Eyal Talor. The abstracts focus on the pivotal Phase 3 Multikine clinical trial for head and neck cancer, highlighting a study that shows immunotherapy can extend overall survival in low-risk patients. The Phase 3 study, which began in 2011 and enrolled 928 patients, aims to prove survival benefits by monitoring death events.

Multikine, a unique investigational product, received Orphan Drug designation from the FDA for its neoadjuvant therapy approach.

Positive

• Publication of two abstracts at the ASCO Annual Meeting enhances visibility and credibility of the Multikine clinical trial.
• Study indicates that Multikine immunotherapy may improve overall survival in low-risk patients with head and neck cancer.

Negative

• None.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced the American Society of Clinical Oncology (ASCO) has published two abstracts related to CEL-SCI’s pivotal Phase 3 Multikine® (Leukocyte Interleukin, Inj.)* head and neck cancer clinical trial. The poster will be presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., at the 2022 ASCO Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois.

Abstract titles and corresponding links are as follows:

• “Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study.” Link to abstract: https://meetings.asco.org/abstracts-presentations/207201

• “Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only.” Link to abstract: https://meetings.asco.org/abstracts-presentations/207202/

ASCO is the largest cancer meeting in the world, bringing together thousands of cancer experts from academia, industry, patient advocacy and policy.

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 radiochemotherapy (the current standard of care for these patients). This approach is unique. 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. CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of advanced primary head and neck cancer.

Multikine is designed to help the immune system “see” 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. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To prove an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups.

The Company’s LEAPS technology is being developed for rheumatoid arthritis. 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, 2021. 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/20220527005092/en/

COMPANY CONTACT:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What did CEL-SCI Corporation announce regarding its Multikine clinical trial?

CEL-SCI announced the publication of two abstracts related to its Phase 3 Multikine clinical trial for head and neck cancer.

When and where will the ASCO Annual Meeting take place?

The ASCO Annual Meeting will be held from June 3-7, 2022, in Chicago, Illinois.

What does the Phase 3 Multikine study aim to prove?

The study aims to prove an overall survival benefit for patients treated with Multikine before standard therapies.

What is the significance of the Orphan Drug designation for Multikine?

The Orphan Drug designation from the FDA indicates potential therapeutic benefits for treating head and neck cancer.

What is the patient enrollment status for the Phase 3 Multikine study?

The Phase 3 study was fully enrolled with 928 patients as of September 2016.