CEL-SCI Presents Phase 3 Multikine Head & Neck Cancer Data at ASCO

Rhea-AI Summary

CEL-SCI Corporation (NYSE American: CVM) presented its poster on the IT-MATTERS study at the ASCO 2022 Annual Meeting in Chicago, discussing the immunotherapy Multikine®'s role in extending overall survival for low-risk locally advanced squamous cell carcinoma of the head and neck. The findings indicate a 14.1% overall survival advantage over standard care after five years, with significant safety results. CEL-SCI plans to submit a Biologic License Application to the FDA based on this Phase 3 study, which is considered the largest of its kind for this indication.

Positive

• Multikine shows a 14.1% OS advantage over standard care at 5 years.
• The study is the largest Phase 3 trial for advanced head and neck cancer.
• Strong safety profile with no significant excess adverse events.

Negative

• None.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced that its abstract and poster titled “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” was presented on June 6, 2022 at the American Society of Clinical Oncology (ASCO)’s 2022 ASCO Annual Meeting in Chicago, Illinois.

Presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., to the largest gathering of cancer experts from academia, industry, patient advocacy and policy, the poster provided detailed data on Multikine®’s (Leukocyte Interleukin, Inj.)* efficacy in extending overall survival in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck. The abstract was selected by ASCO for poster presentation and was well received by oncology experts at the conference.

Based on the results of this pivotal Phase 3 study, including data in the ASCO poster presentation, CEL-SCI intends to file a Biologic License Application with the U.S. Food and Drug Administration (FDA) for approval of this indication.

Link to poster: https://cel-sci.com/wp-content/uploads/2022/06/CEL-SCI-ASCO-2022-Poster-6032-June-6-Head-and-Neck-Cancer-1.pdf

Link to ASCO abstract 6032: https://meetings.asco.org/abstracts-presentations/207201

The conclusions presented in the poster are as follows:

• Safety results were not significantly different between treatment groups.
• Leukocyte Interleukin, LI (MK) neoadjuvant immunotherapy did not add excess safety issues or TEAEs.
• In the Randomized ITT population, early LI (MK) response decreases mortality and is prognostic/predictive of OS.
• ITT Lower Risk LI (MK)+CIZ+SOC absolute OS advantage over SOC alone (Control) increased over time to 14.1% at 5-years; the 0.68 HR corresponds to a 47% prolongation of median survival, having a 46-month median OS advantage over SOC alone. The SCCHN population studied has been without any new therapy options in decades.

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. 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/20220607005371/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What is the IT-MATTERS study presented by CEL-SCI Corporation?

The IT-MATTERS study investigates Multikine's efficacy in improving overall survival in treatment-naive low-risk patients with squamous cell carcinoma of the head and neck.

What were the results of the Multikine study presented at ASCO 2022?

The study reported a 14.1% overall survival advantage at 5 years over standard care, indicating significant potential benefits for patients.

When does CEL-SCI plan to submit the Biologic License Application for Multikine?

CEL-SCI intends to file the Biologic License Application with the FDA based on the results from the IT-MATTERS study.

What is the significance of the ASCO 2022 presentation for CEL-SCI Corporation?

The presentation highlights significant clinical results that could influence regulatory approval and market positioning for Multikine.

What does the safety data from the Multikine study indicate?

Safety results showed no significant differences between treatment groups, suggesting that Multikine does not introduce excess safety issues.