CEL-SCI's Multikine Receives Breakthrough Medicine Designation in Saudi Arabia for Head and Neck Cancer Treatment.

CEL-SCI has filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority for its cancer treatment, Multikine. If granted, this would enable immediate patient access and reimbursement in Saudi Arabia. The company has signed a Memorandum of Understanding with a Saudi pharmaceutical company to commercialize Multikine in the region, aligning with Saudi Arabia's Vision 2030 initiative. There is also growing interest from Saudi investment funds to support Multikine's expansion in the Middle East and North Africa.

CEL-SCI Corporation (NYSE American: CVM) has made significant strides in its efforts to expand the availability of its cancer immunotherapy, Multikine. The company has filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for Multikine, a treatment for newly diagnosed previously untreated head and neck cancer. If granted, this designation would enable immediate patient access and reimbursement in Saudi Arabia [1].

The application was submitted by one of Saudi Arabia's leading pharmaceutical and healthcare companies, with whom CEL-SCI has signed a Memorandum of Understanding (MOU) for the commercialization of Multikine in the region. This strategic partnership aligns with Saudi Arabia's Vision 2030 initiative and the National Biotechnology Strategy [2].

Multikine, administered before surgery, is designed to activate a patient's immune system to fight cancer before the ravages of surgery, radiation, and chemotherapy have weakened it. In a Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% compared to 45% in patients treated with standard care alone, and halved the risk of death from 55% to 27% [1].

According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of this designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. The Saudi pharmaceutical company is well positioned to procure reimbursement and accelerate Multikine's sale and commercial launch [1].

There is also growing interest from Saudi investment funds to support Multikine's expansion in the Middle East and North Africa (MENA) region. Several leading Saudi funds have expressed interest in investing in Multikine and CEL-SCI, as well as a potential joint venture to serve the wider MENA market [1].

CEL-SCI is working closely with First Berlin of Germany and its Saudi representatives to advance its commercialization program for Multikine. Martin Bailey, Managing Director and Founder of First Berlin, commented, "CEL-SCI’s prospective new partner is a prominent and innovative leader that has rendered many valuable healthcare services to the Kingdom. The Saudi pharma company’s keen interest in Multikine to make patients’ first cancer treatment more curative is very much in line with their forward-thinking approach and fits well with Saudi Arabia’s Vision 2030 and the National Biotechnology Strategy. We look forward to facilitating the signing of a final partnership agreement and making Multikine available to patients as quickly as possible" [2].

This MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine's global regulatory, patient access/sale, and commercial rollout. CEL-SCI CEO, Geert Kersten, stated, "We’ve had a highly productive working relationship with this prestigious Saudi pharma company, First Berlin, and the SFDA and hope to see Multikine improve longevity and well-being for head and neck cancer patients in Saudi Arabia" [1].

References:
[1] https://finance.yahoo.com/news/cel-sci-multikine-head-neck-131500923.html
[2] https://www.morningstar.com/news/business-wire/20250813431066/cel-scis-multikine-head-and-neck-cancer-immunotherapy-breakthrough-medicine-designation-filed-in-saudi-arabia-allows-for-patient-access-and-reimbursementsale-upon-granting-of-the-designation-which-takes-approximately-60-days-based-on-sfda-timeline