CEL-SCI to Present New Phase 3 Data at European Congress on Head & Neck Oncology

Rhea-AI Summary

CEL-SCI Corporation (NYSE American: CVM) announced that it will present new data from its pivotal Phase 3 study on March 8, 2023, at the 10th European Congress on Head & Neck Oncology in Lisbon, Portugal. The study, the largest ever for newly diagnosed locally advanced squamous cell carcinoma of the head and neck, involved 928 patients and aimed to assess the investigational product Multikine before standard treatments. Multikine, which received Orphan Drug designation from the FDA, seeks to harness the immune system's potential before conventional therapies. A summary of the findings will be published after the presentation.

Positive

• Presentation of new data from the largest Phase 3 study for head and neck cancer on March 8, 2023.
• Multikine received Orphan Drug designation from the FDA for neoadjuvant therapy.
• Unique study design administering Multikine before standard treatments aims to enhance immune response.

Negative

• None.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced it will present new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), on March 8, 2023 at the 10th European Congress on Head & Neck Oncology in Lisbon, Portugal. CEL-SCI will publish a summary of the findings shortly after the presentation.

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 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 locally advanced primary head and neck cancer.

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. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To test for 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 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/20230303005051/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

www.cel-sci.com

Source: CEL-SCI Corporation

FAQ

What is the purpose of CEL-SCI Corporation's Phase 3 study?

The purpose of the Phase 3 study is to evaluate the effectiveness of the investigational product Multikine in treating newly diagnosed locally advanced squamous cell carcinoma of the head and neck before standard therapies.

When will CEL-SCI present its latest data?

CEL-SCI will present its latest data on March 8, 2023, at the 10th European Congress on Head & Neck Oncology in Lisbon, Portugal.

What is Multikine and its significance for head and neck cancer patients?

Multikine is an investigational therapy designed to stimulate the immune response against tumors before traditional treatments like surgery or chemotherapy.

What designation has Multikine received from the FDA?

Multikine has received Orphan Drug designation from the FDA, which is intended for therapies that treat rare conditions.

What are the next steps after the presentation of the Phase 3 study results?

A summary of the findings from the presentation will be published shortly after the event, detailing the outcomes of the study.