AIMEDBIO

AMB302 is a first-in-class FGFR3 ADC that targets solid tumors with FGFR3 mutations or overexpression.

FGFR3 is known to be overexpressed in various solid tumors, including bladder cancer (urothelial carcinoma), head and neck cancer, and glioblastoma, while its expression in normal tissues is minimal.

Leveraging a wide therapeutic index, AMB302 has demonstrated improvements in both safety and efficacy compared to conventional ADCs. In preclinical studies, monotherapy with AMB302 extended survival by 107%, and when used in combination with an immune checkpoint inhibitor, it increased the survival period by over 300%.

Based on these excellent tolerability and efficacy results from the preclinical development stage, the Investigational New Drug (IND) application for a Phase 1 clinical trial was approved by the U.S. Food and Drug Administration (FDA) in September 2024 and by the South Korean Ministry of Food and Drug Safety (MFDS) in April 2025. In February 2025, the FDA also granted Orphan Drug Designation (ODD) to AMB302 for the treatment of glioblastoma.

On December 11, 2024, we exclusively licensed the global rights for the development, manufacturing, and commercialization of AMB302 to Biohaven. The asset has been assigned the new code name BHV-1530.

ADC candidate for solid tumors, targeting patient subgroups with overexpression of the target in various cancers, including lung, colorectal, and breast cancer.

AMB303 is a best-in-class ROR1 ADC that targets the surface protein of solid tumor cells where ROR1 is overexpressed, such as in lung, breast, and ovarian cancer. It is an ADC that links our self-developed anti-ROR1 antibody to a cytotoxic payload, the Topo I inhibitor (AMB402), which was co-developed with Samsung Biologics. This is our first ADC developed using only our own technology.

It showed excellent anti-cancer efficacy and tolerability in various ROR1-positive solid tumor models, and is currently undergoing IND-enabling studies and development for entry into clinical trials.