[Edaily Reporter NA EUN-KYUNG ] #Aimed Bio Inc. announced on the 22nd that “AMB302” (development code BHV-1530), an FGFR3-targeted antibody-drug conjugate (ADC) for which the company has licensed the technology, demonstrated an objective response in a Phase 1 clinical trial.

This candidate is currently being developed by Biohaven in the United States. According to the company, objective responses—including confirmed partial responses—were observed across various cancer types and patient populations in the Phase 1 clinical trial.

BHV-1530 demonstrated anticancer activity not only in tumors with FGFR3 mutations but also in tumors with wild-type FGFR3 overexpression. The company explained that, unlike existing FGFR small-molecule inhibitors—which were primarily developed for patients with FGFR3 mutations—it has confirmed the potential to expand the treatment population to include patients with FGFR3 overexpression.

The company stated that the ongoing Phase 1 dose-escalation trial has not yet reached a dose-limiting toxicity (DLT), and no class-related toxicities reported with existing FGFR inhibitors have been observed to date. Biohaven plans to present additional clinical data at the European Society for Medical Oncology (ESMO 2026) this October.

Biohaven recently signed a contract with Regeneron for the supply of clinical-grade drug substances and plans to begin a combination clinical trial of BHV-1530 with the PD-1 immunotherapy “Livtayo” in the second half of this year.

Aimed Bio Inc. official stated, “Based on the published clinical results, we assess AMB302 as a proof-of-concept (PoC) that has demonstrated therapeutic potential in real patients within the FGFR3 ADC class,” adding, “Since responses have been confirmed not only in tumors with FGFR3 mutations but also in those with FGFR3 overexpression, there is potential for the drug to be developed for a broader patient population than existing FGFR inhibitors.”

The representative continued, “We expect to further expand the treatment potential based on the safety data confirmed to date and future combination studies with immuno-oncology drugs,” adding, “We will continue development to provide new treatment options for patients who do not respond to standard therapy or whose disease has recurred.”