Taiwan-based HanchorBio is making significant strides in the immuno-oncology market with its novel CD47-targeting therapeutic HCB101, now advancing through Phase I clinical trials. The company's innovative approach, based on its proprietary Fc-Based Designer Biologics (FBDB) platform, has shown promising anti-tumor effects and a favorable safety profile.
Enhanced CD47 Targeting Mechanism
HCB101 represents a third-generation approach to CD47-targeted therapy, addressing limitations of previous generations. The drug's engineered SIRP α protein structure achieves 100 times greater affinity for CD47 compared to earlier versions, significantly enhancing its ability to block the "don't eat me" signal that cancer cells use to evade immune system detection. This improvement results in approximately 1,000-fold stronger prevention of tumor cell immune evasion.
Dr. Scott Liu, founder and chairman of HanchorBio, explains: "By targeting CD47, we can create a versatile immunotherapy that not only has the potential to treat a variety of cancers but also offers the possibility of improving patient survival rates."
Comprehensive Clinical Development Program
The company's recent $25 million Series B funding is supporting an ambitious clinical development program for HCB101. The trials target multiple cancer types, including:
- Head and neck cancer
- Triple-negative breast cancer
- HER2-positive gastric cancer
- Colorectal cancer
- Small-cell lung cancer
Preclinical studies have demonstrated HCB101's efficacy across 78 tumor models, including patient-derived xenografts (PDX). The drug has shown particular promise in treating both hematologic malignancies and solid tumors, even demonstrating effectiveness as a monotherapy against large tumors of approximately 300 mm³.
Pipeline Expansion with Novel Tri-functional Biologics
Building on HCB101's success, HanchorBio is developing two first-in-class multi-functional biologics:
HCB301, which received FDA IND approval in June 2024, combines:
- Enhanced SIRP α targeting
- Anti-PD-L1 antibody fragment
- TGF-β trap
HCB303, planned for IND submission in 2025, features:
- Enhanced SIRP α targeting
- Anti-PD-L1 component
- TIGIT-targeting antibody
These novel therapeutics are designed to address multiple resistance mechanisms to PD-1 therapy, potentially offering broader and more effective treatment options for cancer patients.
Manufacturing and Commercial Strategy
HanchorBio is establishing a Good Manufacturing Practice (GMP) facility to ensure long-term production capacity. The company aims to license HCB101 to global pharmaceutical companies following Phase 1b and 2a trials, with potential upfront payments projected in the hundreds of millions of dollars.
Dr. Liu emphasizes the importance of product strength in the competitive immuno-oncology landscape: "The most important thing is how good the data is when the Phase 2 or Phase 3 trial results are unblinded."
With over $80 million in total funding and a growing pipeline of innovative immunotherapies, HanchorBio is positioning itself as a significant player in the next generation of cancer treatments. The company's focus on developing multi-functional biologics, representing only 1.6% of global development efforts, demonstrates its commitment to pushing the boundaries of cancer immunotherapy.
