- CEL-SCI Corporation (CVM, Financial) to file for regulatory approval of Multikine in Saudi Arabia with expected response in 60 days.
- Exploring partnerships for Multikine commercialization and manufacturing in the Middle East and North Africa (MENA).
- Head and neck cancer incidence in MENA projected to double by 2030.
CEL-SCI Corporation (CVM) announced its intention to file for regulatory approval of its cancer immunotherapy treatment, Multikine, with the Saudi Food and Drug Authority (SFDA). The application will seek Conditional Approval with Breakthrough Therapy designation, leveraging data from a completed Phase 3 study involving 928 patients. The SFDA is expected to respond within approximately 60 days following the submission.
In alignment with Saudi Arabia's Vision 2030, CEL-SCI is evaluating potential partnerships with local companies to facilitate the commercialization and manufacturing of Multikine throughout the Middle East and North Africa (MENA) region. These partnerships may involve funding, regulatory support, and establishing a local manufacturing facility.
The initiative arrives at a critical time as the incidence of head and neck cancer in the MENA region is anticipated to double by 2030, escalating at a rate twice that of the expected global incidence. In the Gulf Cooperation Council countries, the incidence risk of head and neck cancer stands at approximately 1.6%.
CEL-SCI Corporation, headquartered in Vienna, Virginia, specializes in developing immunotherapy treatments and is committed to advancing health outcomes with the help of technologies like Multikine. The company views these efforts as a strategic step to contribute to Saudi Arabia's aspiration to be a regional leader in the biotech sector.
