Following the launch of phase 2 clinical trials in March, HanchorBio Inc. is announcing interim data for a concurrent phase 1b dose-escalation trial for HCB101, its breakthrough checkpoint inhibitor (CPI) biologic for cancer treatment. The company presented the data at the 2025 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
Key findings include: favourable safety and tolerability across escalating doses; high-level CD47 receptor occupancy in peripheral immune cells; and early clinical signs of anti-tumour activity, including confirmed partial responses in patients with head and neck cancer (HNSCC) and non-Hodgkins lymphoma.
CPI treatments such as HCB101 are considered 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 tumours, 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,” said Scott Liu, founder, chairman, and CEO of HanchorBio.
“As clinical trials progress, HanchorBio is laying the groundwork to expand possibilities for immunotherapy and have an immense impact on oncology.”
Spanning Taiwan, the US and China, earlier in 2025 the company reached the 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.
With HCB101, HanchorBio achieved investigational new drug (IND) status from inception in 2.3 years. This has helped to attract $80m in funding in recent years.
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