CEL-SCI to File for Regulatory Approval of Multikine in Saudi Arabia—Pursuing Local Partnerships for Commercialization and Manufacturing to Serve Middle East and North Africa Market
Concluded a successful meeting with Saudi Food and Drug Authority
CEL-SCI was encouraged to apply for Conditional Approval with Breakthrough Therapy Designation based on data from its concluded Phase 3 study
Evaluating Saudi Arabia-based partnerships to potentially fund local manufacturing and launch Multikine throughout the region
VIENNA, Va., April 23, 2025--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that it met with the Saudi Food and Drug Authority (SFDA) to discuss the development of Multikine cancer immunotherapy* (Leukocyte Interleukin, Injection), the vast amount of Multikine data available to support a marketing application for its use as a treatment of head and neck cancer, and the possible pathways to a marketing application in Saudi Arabia.
Based on discussions with the SFDA, CEL-SCI is preparing to submit a regulatory filing for the approval of Multikine as a neoadjuvant (pre-surgical) treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The submission will be made based on all data from CEL-SCI’s concluded 928-patient randomized controlled Phase 3 study and is expected to be filed as a Conditional Approval with Breakthrough Therapy designation. The SFDA’s usual response time for a complete submission for such an application is thought to be approximately 60 days after filing.
"Our data was well received by the SFDA in a recent meeting. In consideration of their response, our intention is to file for Conditional Approval of Multikine with Breakthrough Therapy designation based on our completed Phase 3 data," stated CEL-SCI CEO Geert Kersten.
"In alignment with the Saudi Kingdom’s Vision 2030 initiatives, we are currently evaluating potential partnerships with local Saudi companies to commercialize Multikine, conduct clinical trials in Saudi hospitals and to establish a local Multikine manufacturing facility that would serve the entire Middle East and North Africa (MENA) market. We envision such a partnership encompassing funding, regulatory support, post-approval commercial launch, and distribution," Kersten concluded.
The Kingdom of Saudi Arabia’s Vision 2030 includes a National Biotechnology Strategy, which is poised to position the Kingdom as a regional and global biotech hub with a far-reaching impact in biomanufacturing and medical innovation. The National Biotechnology Strategy aims to establish an advanced local bio-manufacturing platform to boost the Kingdom’s self-sufficiency in producing biologics and biosimilars, enable global export opportunities, drive growth of the broader biotech sector in the Kingdom, and reduce healthcare costs.
The incidence of head and neck cancer in the MENA region is expected to double by 2030, from incidence levels cited in a 2012 study. This rate of increase is two times higher than that of the projected worldwide incidence rate. In the Gulf Cooperation Council countries (GCC) of Saudi Arabia, Bahrain, Oman, Kuwait, Qatar, and the United Arab Emirates, the incidence risk of head and neck cancer is estimated to be 1.6%.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, 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), given right after diagnosis and before surgery, 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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients 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, inability to finalize a partnering agreement 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, 2024. 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.
