VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced it has completed the expansion of its existing dedicated Multikine* (Leukocyte Interleukin, Injection) cGMP manufacturing facility. The expansion was undertaken in anticipation of filing a Biologics License Application (BLA) which, if approved, will allow Multikine produced in the facility to be commercially distributed. The construction, which began in 2020, expanded the facility and added various upgrades to ensure it will be in compliance with all requirements of the FDA’s Current Good Manufacturing Practice (GMP) regulations. The facility’s production capacity has been doubled to meet anticipated market demand for Multikine once it is licensed. The renovations also anticipate that additional personnel will be required to staff a second manufacturing shift to meet the eventual market demand for Multikine. Following an $11 million investment to increase production, CEL-SCI staff recently moved back into the renovated facility.
“We are now validating the facility and will begin preparing our facility license application for Multikine. We continue to hire and train additional personnel required to efficiently operate the manufacturing facility in compliance with all federal and state requirements,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported topline results in June 2021 from its landmark pivotal Phase 3 study of Multikine as a neoadjuvant treatment of advanced primary previously untreated head and neck cancer, which is believed to be the largest study in the world for this indication.
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. This study milestone occurred in late April 2020 and database lock occurred in December 2020. The study results announced in June 2021 showed excellent survival benefit for those patients who received Multikine plus surgery and radiation. In the other treatment arm, when chemotherapy was added to the radiotherapy, the survival benefit was negated.
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, 2020. 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.
