CEL-SCI to Begin U.S. Registration Study for Multikine in Summer 2026, Pursues Saudi Partnership
CEL-SCI plans to start patient enrollment in summer 2026 for a 212-patient U.S. registration study of its cancer immunotherapy Multikine, with the goal of seeking early accelerated approval. The company is also advancing a strategic partnership with Saudi Amarox to commercialize Multikine in Saudi Arabia, where it has submitted a Breakthrough Medicine Designation application. These initiatives build on Phase 3 data showing Multikine improved 5-year survival in head and neck cancer patients from 45% to 73%.
CEL-SCI announced plans to commence patient enrollment in a pivotal U.S. registration study for its cancer immunotherapy Multikine in summer 2026, while also advancing commercialization efforts in Saudi Arabia through a strategic partnership.
The company, along with its contract research organization Ergomed, expects to start enrollment for the 212-patient U.S. Confirmatory Registration Study for Multikine (Leukocyte Interleukin, Injection) in newly diagnosed locally advanced head and neck cancer patients. Pre-surgical tumor responses can be assessed within weeks after full enrollment, creating the potential for early accelerated approval in the U.S. CEL-SCI plans to seek accelerated approval based on early tumor response data. The FDA concurred with the company's target patient selection criteria and agreed to the conduct of this confirmatory study.
In a parallel development, CEL-SCI and Saudi Amarox will conduct a signing ceremony at the BIO 2026 conference for a strategic agreement to advance the commercialization and distribution of Multikine in Saudi Arabia. The company is actively engaged with potential partners and investors in the Saudi market. A Breakthrough Medicine Designation application for Multikine for the treatment of head and neck cancer has been submitted to the Saudi Food and Drug Authority. If granted, the designation will allow patient access to Multikine for the indication, as well as reimbursement and sale in Saudi Arabia.
The clinical foundation for these efforts is the completed randomized controlled Phase 3 study of 928 patients, described as the largest study ever conducted in head and neck cancer. In that study, Multikine, given right after diagnosis and before any other treatment, significantly increased the 5-year overall survival rate of the treated patient population to 73% versus 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.
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 patient's immune system to fight cancer before the immune system is weakened by surgery, radiation, and chemotherapy. The therapy has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.