Gilead exercises option for Assembly Bio's herpes treatment programs

Gilead Sciences Inc. (NASDAQ: GILD) has exercised its option to exclusively license Assembly Biosciences Inc.'s (NASDAQ: ASMB) herpes simplex virus helicase-primase inhibitor programs, including investigational candidates ABI-1179 and ABI-5366 for recurrent genital herpes treatment.

Assembly Biosciences will receive a $35 million payment for the option exercise, which reflects a $45 million option fee minus $10 million in accelerated funding received in December 2024. The transaction stems from a 2023 collaboration agreement between the companies.

The licensed compounds are designed as once-weekly oral treatments for recurrent genital herpes. Interim Phase 1b data showed both candidates demonstrated antiviral activity and reductions in virus-positive lesions, according to the companies. No new therapies for herpes simplex virus have been approved in the United States or Europe for more than 25 years.

Genital herpes affects over four million people in the United States and major European countries who experience recurrent episodes. HSV type 2 infections typically cause multiple recurrences annually.

Under the licensing agreement, Gilead will have exclusive rights and sole responsibility for further clinical development and commercialization of the programs. Assembly Biosciences remains eligible for up to $330 million in regulatory and commercial milestones, plus tiered royalties on net sales.

Assembly Biosciences also retains the right to opt into sharing 40% of costs and profits in the United States instead of receiving milestones and royalties for that market, following receipt of development plans from Gilead.

The helicase-primase enzyme is essential for herpes virus replication, making it a target for potential therapeutic intervention in chronic suppressive therapy.

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