VIENNA, Va. - CEL-SCI Corporation (NYSE American: CVM) has announced significant progress in the development of its investigational cancer treatment, Multikine (Leukocyte Interleukin, Injection), including the completion of its manufacturing facility commissioning in January 2024, and key regulatory advancements.
The company reported that its Phase 3 clinical trial for Multikine demonstrated a significant reduction in the risk of death for patients with certain types of head and neck cancer. Specifically, the study found a 73% survival rate at five years for patients treated with Multikine, versus 45% for the control group. This represents a 28.6% absolute overall survival benefit, with a statistically significant p-value of 0.0015. The findings were presented at the European Society for Medical Oncology (ESMO) Congress in October 2023.
Multikine, a neoadjuvant immunotherapy, was shown to be particularly effective for a target population of patients with newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) who have no lymph node involvement and low PD-L1 tumor expression. These patients can be identified using routine diagnostic tests, which facilitates the potential labeling of Multikine for drug approval.
In addition to the clinical developments, CEL-SCI has completed the commissioning of its dedicated manufacturing facility, a critical step toward submitting a Biologics License Application (BLA) for Multikine. The company has also engaged with several major regulatory agencies, including the FDA, EMA, MHRA, and Health Canada, to discuss the approval process for Multikine.
CEL-SCI has submitted data and a proposed study protocol to the FDA for a confirmatory study of 212 patients in Q1 2024. Health Canada has advised the company to request advance consideration for approval, while the UK's National Institute for Health and Care Excellence (NICE) has selected Multikine for evaluation as a potential new standard of care for SCCHN. Moreover, the EMA's Paediatric Committee granted a product-specific waiver, which aids in the commercialization process in the EU.
The company also made strides in protecting its intellectual property, filing a patent for the use of Multikine in tumors expressing low levels of PD-L1. Additionally, CEL-SCI presented new data at several scientific conferences throughout 2023, further supporting Multikine's potential as a treatment for head and neck cancer.
CEL-SCI is actively pursuing regulatory pathways for accelerated or conditional approvals to provide immediate patient access to Multikine. The company believes that the clinical data and the completion of its manufacturing facility position it favorably for eventual regulatory clearance.
The information provided in this article is based on a press release statement from CEL-SCI Corporation.
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