Achieves significant milestones toward commissioning of manufacturing facility in preparation for Biologics License Application for regulatory approval submissions
CEL-SCI Corporation (NYSE American: CVM) today reported that its Multikine* (Leukocyte Interleukin, Injection) cGMP state-of-the-art dedicated manufacturing facility commissioning is substantially complete, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine in the treatment of head and neck cancer.
Originally constructed and validated to supply Multikine for the world’s largest global pivotal Phase 3 trial in locally advanced squamous cell carcinoma of the head and neck, CEL-SCI’s facility has been expanded and upgraded in preparation for submission of Multikine for regulatory approval and commercial scale manufacturing.
In keeping with CEL-SCI Validation Master Plan, industry standards, International Society for Pharmaceutical Engineering (ISPE) guidelines, International Conference for Harmonization (ICH), and in compliance with regulatory guidelines, CEL-SCI is commissioning and qualifying the facility’s utilities, systems, and equipment. The facility will be subject to regulatory review prior to the granting of a commercial manufacturing license and marketing clearance for Multikine in the treatment of head and neck cancer.
“Due to the high degree of manufacturing complexity, company-specific know-how, and trade secrets involved in the production of Multikine, the commissioning of our facility is a substantial part of the BLA which we intend to file with regulators including the U.S., Canada, UK, and Europe. Our team has worked diligently over the past few years adding complex improvements to the facility, to get us to where we are today, and we are very proud of what has been achieved,” stated CEL-SCI’s CEO Geert Kersten.
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 (oral cavity and soft-palate) with the investigational product Multikine first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.
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 enrolled 928 patients.
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.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
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.
Gavin de Windt