Aimed Bio announced on December 14 that it has signed an exclusive global licensing agreement with U.S.-based Biohaven for the development and commercialization of its FGFR3-targeting antibody-drug conjugate (ADC) AMB302 (BHV-1530), which utilizes a topoisomerase I (TOP1) inhibitor payload. Specific details regarding the upfront payment and total deal size were not disclosed.

Biohaven, initially known for its focus on neurological diseases, has been transitioning into an oncology-focused company since its acquisition and restructuring in 2022. Following its $11.6 billion buyout by Pfizer, the company was re-established under the Biohaven name and has since pursued new opportunities in cancer therapeutics. Earlier this year, Biohaven struck a deal with Merus for the development of bispecific antibody ADCs, further signaling its commitment to oncology.

The deal with Aimed Bio marks a strategic move by Biohaven to secure a first-in-class FGFR3 ADC candidate in clinical development.

Aimed Bio co-developed AMB302 with China-based GeneQuantum and received FDA clearance for a Phase 1 clinical trial in 2023. 

Preclinical studies demonstrated AMB302’s antitumor efficacy in various solid tumors, including urothelial carcinoma, head and neck cancer, and glioblastoma. The candidate showed particular promise in models with FGFR3 alterations and FGFR3 protein overexpression.

Biohaven plans to initiate a first-in-human Phase 1 clinical trial for AMB302 in solid tumor patients in the first half of this year.

The CEO of Aimed Bio commented, “This agreement is a testament to Aimed Bio’s technological capabilities being recognized in the global market. We are confident that this represents a significant milestone, reflecting the asset’s technical value and potential.” He added that the partnership with Biohaven, known for its strong global clinical development capabilities, is expected to enhance the likelihood of successful development.

With this partnership, Aimed Bio aims to further its global ambitions in oncology by leveraging Biohaven’s expertise in clinical development and commercialization.