CEL-SCI’S Multikine Reduced 5-year Death Rate From 54% to 22% in Phase 3 Study Patients Who Were Early Tumor Responders Prior to Any Standard of Care Treatment

Rhea-AI Summary

CEL-SCI Corporation (NYSE American: CVM) reported significant findings from its Phase 3 IT-MATTERS study at the ESMO Annual Congress on September 10, 2022. The investigational drug Multikine showed promising results in treating locally advanced primary head and neck cancer, with 5 patients achieving complete tumor response after 3 weeks of treatment, confirmed at surgery. Additionally, 40 patients exhibited partial tumor reductions exceeding 30%. The findings indicate that early responses to Multikine treatment are prognostic for overall survival, supporting the company's plans for a Biologics License Application to the FDA.

Positive

• 5 patients had complete tumor response, confirmed by surgery.
• 40 patients showed greater than 30% reduction in tumor burden.
• Results support plan to submit a Biologics License Application (BLA) to the FDA.

Negative

• None.

• 5 patients had no tumor left following a 3-week treatment of CEL-SCI’s investigational drug Multikine
• Images clearly show tumors in the patients’ oral cavity prior to treatment with Multikine and the disappearance of these tumors before any subsequent standard-of-care treatment, confirmed at surgery
• There were also partial responses of greater than 30% tumor burden reduction resulting from the Multikine treatment prior to subsequent standard of care treatment

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced the availability to the public of an oral presentation delivered by Dr. Philip Lavin of groundbreaking tumor response and increased overall survival in head and neck cancer. This presentation includes data presented at the European Society for Medical Oncology (ESMO) Annual Congress on September 10, 2022 in Paris, France. The ESMO poster presentation was titled “Early response to Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy extends overall survival (OS) in locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN): the IT-MATTERS Study (Clinicaltrials.gov NCT01265849).”

The summary of the most recent data presented from this Phase 3 clinical trial is that a 3-week administration of CEL-SCI’s investigational Multikine* (LI) treatment achieved groundbreaking tumor response and increased overall survival in treatment naïve locally advanced primary head and neck cancer patients who are scheduled to receive surgery and radiotherapy as their indicated treatment.

The study had 45 early tumor responses, including 5 complete and 40 partial responses; all were early tumor responses in that they followed a three-week Multikine treatment, were observed at surgery and occurred before radiotherapy. Early tumor response to Multikine treatment was both prognostic and predictive of overall survival. The Multikine tumor response was differentiating in that it was observed within a week after completion of the fixed 3-week Multikine treatment. The degree of response had a significant impact on subsequent survival, which qualifies Multikine early tumor response as a surrogate marker.

CEL-SCI strongly recommends that readers listen to the oral presentation at https://www.vumedi.com/video/esmo-2022-on-the-it-matters-study-early-response-to-leukocyte-interleukin-injection-io-extends-os-in/.

Dr. Lavin is a well-known biostatistician with a long history of supporting clinical trials for product registrations, reimbursements, and public health advancement. He has served on the faculty of Harvard Medical School at the Harvard School of Public Health for over 25 years and has been in the oncology field since 1974. Dr. Lavin also advised the FDA from 1983 through 2015 on product approvals and public policy matters as a Special Government Employee.

CEL-SCI’s 928-patient Phase 3 IT-MATTERS study was designed to determine if Multikine provided survival and other clinical benefits to patients suffering from locally advanced primary squamous cell carcinoma of the head and neck (SCCHN), oral cavity and soft-palate. Multikine is a mixture of naturally occurring cytokines that regulate the immune system. It is the first investigational cancer immunotherapy being developed as a first-line neo-adjuvant treatment to be provided to previously untreated locally advanced disease SCCHN patients before they receive the current standard of care (SOC), which is either surgery plus radiotherapy or surgery plus radio-chemotherapy. IT-MATTERS was conducted in 23 countries. CEL-SCI is preparing to submit a Biologics License Application (BLA) for marketing approval with the U.S. Food and Drug Administration (FDA) for Multikine.

The presentation available at the LINK includes the following:

• 5 patients were complete responders, with surgical confirmation of clearing all signs of cancer in the oral cavity, and 40 patients were partial responders to Multikine after 3 weeks of Multikine treatment, prior to any SOC treatment. Complete early tumor responses have not ever been reported in the scientific literature for locally advanced primary head and neck cancer according to medical experts.

The presentation delivered by Dr. Lavin included images of two patients who had a complete early response to treatment with Multikine within 5 weeks and prior to the standard of care surgery and radiotherapy and anonymized patient profiles for all the 5 complete responders. Images clearly show tumors in the patients’ oral cavity prior to treatment with Multikine and the disappearance of these tumors before surgery.

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, 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/20221017005374/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What is the main finding of CEL-SCI's recent press release regarding CVM?

CEL-SCI reported that 5 patients achieved complete tumor responses and 40 had partial responses from the Multikine treatment in its Phase 3 IT-MATTERS study.

What is Multikine and what was its role in the study?

Multikine is an investigational drug designed to treat locally advanced primary head and neck cancer, showing significant early tumor response before standard treatment.

What does the early response to Multikine treatment indicate?

The early response to Multikine treatment is prognostic and predictive of overall survival in patients.

When was the data from the Phase 3 trial presented?

The data was presented at the European Society for Medical Oncology (ESMO) Annual Congress on September 10, 2022.

What are CEL-SCI's next steps following the study results?

CEL-SCI plans to submit a Biologics License Application (BLA) to the FDA for Multikine, based on the promising results from the study.