CEL-SCI Corporation (NYSE American: CVM) outlined plans to advance its investigational cancer immunotherapy Multikine through a U.S. confirmatory registration study and a commercial partnership in Saudi Arabia, according to a company press release.

The confirmatory registration study, expected to begin in summer 2026, will enroll 212 newly diagnosed patients with locally advanced resectable head and neck cancer who have low PD-L1 tumor expression and no lymph node involvement. The study is designed to demonstrate improvement in overall survival and support a potential U.S. regulatory submission. Multikine has not been approved by the FDA, and its safety and efficacy have not been established.

In the company's previously completed Phase 3 study of 928 patients, those treated with Multikine before surgery and standard of care achieved a 73% five-year overall survival rate, compared with 45% for patients receiving standard of care alone in the target patient population.

CEL-SCI also announced a partnership with Saudi Amarox for regulatory approval and distribution of Multikine in Saudi Arabia. Under the agreement, Amarox will serve as exclusive distributor upon approval, and the two companies will share net revenue equally following receipt of Breakthrough Medicine Designation. The agreement includes an option for Amarox to distribute Multikine across Gulf Cooperation Council countries, including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates. CEL-SCI retains ownership of all Multikine intellectual property and global rights.

A formal signing ceremony between CEL-SCI and Amarox is scheduled for June 22, 2026, at the BIO International Convention in San Diego.

Head and neck cancer accounts for approximately 900,000 newly diagnosed cases per year globally and is the sixth most common cancer. CEL-SCI estimates the target population for its U.S. study represents approximately 100,000 newly diagnosed patients annually.