On August 13, 2025 CEL-SCI Corporation (NYSE American: CVM) reported that a Breakthrough Medicine Designation application has been filed with the Saudi Food and Drug Authority (SFDA) for Multikine* (Leukocyte Interleukin, Injection) in the Kingdom of Saudi Arabia by one of the Kingdom’s premier pharmaceutical and healthcare companies (Press release, Cel-Sci, AUG 13, 2025, View Source [SID1234655223]). CEL-SCI has signed a Memorandum of Understanding (MOU) with this Saudi pharma company for the commercialization of Multikine in Saudi Arabia. A final partnership agreement is expected during the 3rd quarter of 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is 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% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia.

The Saudi pharma company is well positioned to procure reimbursement and to accelerate Multikine’s sale and commercial launch.

Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, 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.

Martin Bailey, Managing Director and Founder of First Berlin, the lead advisor, 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."

"This MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine’s global regulatory, patient access/sale and commercial roll out," stated CEL-SCI CEO, Geert Kersten. "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."

About the SFDA’s Breakthrough Medicine Program

The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks.

Eligibility includes having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation:

Target serious debilitating or life-threatening conditions with unmet medical need.
The medicinal product is likely to offer major advantages over methods currently used.
The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
The product is not registered at any regulatory authority at the time of submission of the designation request.