CEL-SCI's Multikine Receives Breakthrough Medicine Designation in Saudi Arabia, Enabling Patient Access and Reimbursement.

CEL-SCI Corporation has filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority for its Multikine head and neck cancer immunotherapy. The designation would allow for patient access and reimbursement/sale in approximately 60 days. The company has signed a Memorandum of Understanding with a Saudi pharmaceutical company for commercialization in the Kingdom of Saudi Arabia, with a final partnership agreement expected in Q3 2025.

July 2, 2025 - CEL-SCI Corporation (NYSE American: CVM) has filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority (SFDA) for its Multikine head and neck cancer immunotherapy. The designation, if granted, would allow for patient access and reimbursement/sale in approximately 60 days in Saudi Arabia. The company has also signed a Memorandum of Understanding (MOU) with a leading Saudi Arabian pharmaceutical company for the commercialization of Multikine in the Kingdom, with a final partnership agreement expected by the end of Q3 2025 [1].

Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed, previously untreated head and neck cancer. The drug aims to activate a person’s immune system to fight cancer before the ravages of surgery, radiation, and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer 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 of care alone and halved the risk of death from 55% to 27% [1].

The SFDA’s Breakthrough Medicine Program aims to facilitate and accelerate the development and review of new drugs that address unmet medical needs in serious or life-threatening conditions. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation [1].

CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy, and chemotherapy 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 [1].

Several leading Saudi funds have expressed interest in investing in Multikine and a potential joint venture to serve the wider Middle East and North Africa (MENA) market. CEL-SCI is working closely with First Berlin of Germany and its Saudi representatives to advance its commercialization program for Multikine [1].

The company's CEO, Geert Kersten, stated, "This MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine’s global regulatory, patient access/sale, and commercial rollout. 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://www.businesswire.com/news/home/20250813431066/en/