Immuno Oncology

TAIPEI – October 30, 2026 -- HanchorBio (TWSE: 7827) has received Taiwan Food and Drug Administration approval for the Investigational New Drug application for HCB303, its trispecific TIGIT-Fc ligand-trap fusion protein, following U.S. FDA clearance. The approval was granted to its wholly owned subsidiary, FBD Biologics Limited, and gives the asset regulatory authorization for clinical investigation in two jurisdictions.

TFDA used a 15-day accelerated pathway for multinational trials

HCB303 cleared through Taiwan's accelerated review route for multinational, multicenter clinical trials, which provides a 15-day review for eligible applications. TFDA has also simplified submission requirements for qualifying first-in-human studies. Under applicable conditions, sponsors no longer need to submit institutional review board approval letters from foreign participating hospitals.

COPENHAGEN – October 29, 2026 -- HERVolution Therapeutics ApS published peer-reviewed data in the Journal of Translational Medicine showing HERV-K expression across the majority of 43 cancer types in RNA sequencing data from 1,353 patients, backing the target rationale for its lead program, IPT-001.

HERV-K expression spans nearly all cancer types examined

The analysis used data from the Copenhagen Prospective Personalized Oncology study (CoPPO, NCT02290522), which enrolled patients with advanced, predominantly pre-treated cancer. Most patients showed more than 100 HML-2 reads per million total reads across the 43 cancer types, cancers of unknown primary and unclassified tumors. The authors say this extends earlier indication-specific reports.

TOKYO – October 29, 2026 -- Astellas Pharma Inc. has secured an exclusive option on a worldwide license to Audax Biosciences' immuno-oncology candidate DAX-044 in a transaction worth up to US$1.34 billion, excluding royalties.

Audax receives US$285 million up front and on option exercise

Audax will receive US$285 million in combined up-front and option-exercise payments. It is also eligible for development and commercial milestones of up to US$1.05 billion, plus tiered double-digit royalties on worldwide net sales if DAX-044 is approved.

Audax carries the program into a Phase 1 study expected to start in 2027. DAX-044 is currently in IND/CTN-enabling development.