On June 16, 2026 CEL-SCI Corporation (NYSE American: CVM) reported its dual-track strategy to bring Multikine (Leukocyte Interleukin, Injection)* to patients with newly diagnosed locally advanced head and neck cancer through parallel regulatory initiatives in the U.S. and Saudi Arabia.
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The Company plans to commence its Confirmatory Registration Study of Multikine this summer while simultaneously advancing regulatory and commercialization activities in Saudi Arabia through its strategic partnership with Saudi Amarox.
"Following extensive clinical development and close engagement with regulators, we are excited to begin our final Confirmatory Registration Study, aiming to extend lives and improve the quality of life for head and neck cancer patients," said Geert Kersten, Chief Executive Officer of CEL-SCI. "We are also looking forward to participating in next week’s signing ceremony at BIO with Amarox, our Saudi partner, as we advance a second pathway to bring Multikine to patients."
U.S. Registration Pathway
CEL-SCI’s Confirmatory Registration Study will enroll 212 newly diagnosed, previously untreated, locally advanced resectable head and neck cancer patients with low PD-L1 tumor expression and no lymph node involvement—the patient population that demonstrated the greatest benefit in the Company’s completed Phase 3 study.
In that study, patients treated with Multikine before surgery and standard of care therapy achieved a 73% five-year overall survival rate compared to 45% for patients receiving standard of care alone. The confirmatory study is designed to show, among other things, significant improvement in overall survival and support potential registration of Multikine in the United States.
Saudi Market Entry Pathway
CEL-SCI has a strategic partnership with Amarox to support regulatory approval, commercialization and distribution of Multikine in Saudi Arabia. Under the agreement, Amarox is leading local regulatory activities and will be the exclusive distributor of Multikine in the Kingdom upon approval.
The partnership provides a 50%/50% revenue share for Multikine sales in Saudi Arabia upon receipt of Breakthrough Medicine Designation. Amarox is ranked #1 for Saudi-FDA (SFDA) applications for critical and unavailable medicine for 3 consecutive years. CEL-SCI retains ownership of all Multikine intellectual property, manufacturing know-how and global rights. The agreement also includes the option for Amarox to distribute Multikine throughout the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.
CEL-SCI and Amarox will conduct a formal signing ceremony during the BIO International Convention in San Diego on June 22, 2026 to highlight their collaboration and commitment to advancing Multikine in the region.
Addressing a Significant Unmet Need
Head and neck cancer is the 6th most common cancer, with approximately 900,000 newly diagnosed cases per year globally. The newly diagnosed stage 3 and 4 patients with this cancer represent a severe unmet need. The target population of the U.S. Confirmatory Registration Study represents approximately 100,000 newly diagnosed head and neck cancer patients annually. Based on CEL-SCI’s completed Phase 3 study of 928 patients, approximately 70% of head and neck cancer patients are estimated to have low or zero PD-L1 tumor expression, a population for whom currently available checkpoint inhibitors may offer only limited benefit with no definitive overall survival benefit.
About Multikine
Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced 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%.
(Press release, Cel-Sci, JUN 16, 2026, View Source [SID1234668765])