On June 17, 2025 HanchorBio Inc., a pioneer of immunotherapy biologics, reported interim data for a concurrent Phase 1b dose-escalation trial (NCT05892718) for HCB101, its breakthrough checkpoint inhibitor (CPI) biologic for cancer treatment (Press release, Hanchor Bio, JUN 17, 2025, View Source [SID1234653966]). The company presented the data at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held May 31 – June 4 in Chicago, Illinois.
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Key findings include:
Favorable safety and tolerability across escalating doses
High-level CD47 receptor occupancy in peripheral immune cells
Early clinical signs of anti-tumor activity, including confirmed partial responses in patients with head and neck cancer (HNSCC) and non-Hodgkins lymphoma
HCB101: The best-in-class next generation of CPI
CPI treatments such as HCB101 are considered particularly promising forms of immunotherapy because they activate the body’s own defenses to kill cancer cells. They work by blocking proteins like CD47 — also known colloquially as the ‘don’t eat me’ protein — that allow cancer cells to evade detection. Compared to chemotherapy, CPI has demonstrated greater long-term remission and broader efficacy across various cancers.
While previous generations of CPI treatments tended to be either safe or effective, HCB101 stands out for its potential to achieve both. Utilizing the engineered signal-regulatory protein α (SIRPα) that targets CD-47, it has demonstrated efficacy against both solid and hematologic tumors, while earlier clinical trial data from the completed Phase 1a confirmed 100% safety across all dose levels. It can also be used as both a standalone treatment and in combination with other therapies. In terms of efficacy, HCB101 demonstrated a 26.7% disease control rate in the Phase 1a data, with 16.7% of subjects maintaining disease control for over four months.
"HCB101 solves the challenge that traditional CPI-based treatments face — the trade-off between safety and efficacy," commented Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. "As clinical trials progress, HanchorBio is laying the groundwork to expand possibilities for immunotherapy and have an immense impact on oncology."
HCB101’s ongoing multi-region Phase 2 trial
Spanning Taiwan, the United States, and China, earlier in 2025 the company reached the key milestone of conducting a Phase 2 trial for HCB101, which has enrolled an even distribution of participants from diverse populations and included multiple cancer types, such as lung, head and neck, stomach, and breast cancers. The US portion of the trial has been approved by the US Food and Drug Administration (FDA) and will be conducted through US healthcare institutions.
A streamlined pipeline powered by in-depth expertise
With HCB101, HanchorBio has established a record for a biotech company of its size — achieving investigational new drug (IND) status from inception in 2.3 years. This has helped to attract USD 80 million in funding in recent years and demonstrates how the company distinguishes itself:
A highly streamlined pipeline
End-to-end approach
Over 30 years of industry expertise
A seasoned research team
State-of-the-art R&D facilities
HanchorBio further stands out for using its proprietary Fc-Based Designer Biologics (FBDB) platform, which has successfully fostered multiple pipeline programs from discovery to clinical trials.