HanchorBio Highlights Advancing HCB101 Clinical Program Across Monotherapy and Combination Settings at ESMO-TAT 2026

Phase 1 data demonstrate sustained CD47 target engagement, differentiated safety, and encouraging clinical activity supporting HCB101 as an innate immune checkpoint backbone

[Taipei, Shanghai, San Francisco | March 16, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of updated clinical data for HCB101 at the ESMO Targeted Anticancer Therapies (TAT) Congress 2026 in Paris, France.

Data were presented from the ongoing HCB101-101 Phase 1a monotherapy study (NCT05892718) in an oral session, as well as from the HCB101-201 Phase 1b/2a combination study (NCT06771622) in a poster presentation. Collectively, these findings reinforce HCB101’s differentiated safety profile, sustained CD47 receptor occupancy, and early evidence of antitumor activity across multiple tumor types, especially in combination with established standard-of-care therapies.

HCB101 has recently been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of gastric cancer.

“The CD47 field did not encounter setbacks because the biology was flawed — it stalled because an adequate therapeutic window was not observed due to the lack of structurally engineered SIRPα with differential binding activities,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “Early anti-CD47 antibodies showed biological activity but were limited by hematologic toxicity. Fc-fusion approaches improved tolerability, yet precise calibration of effector function and enhanced target engagement were not achieved. With HCB101, we used AlphaFold-guided structural modeling within our FBDB™ platform to deliberately redesign the SIRPα with desired binding properties while preserving Fc functionality. The objective was clear: sustained high-affinity receptor occupancy without reintroducing the hematologic liability that constrained prior molecules. The Phase 1 data now demonstrate that this balance is achievable. Importantly, HCB101 serves as the molecular foundation for our next-generation multi-functional checkpoint programs, including HCB301.”

Presentation Details:

Presentation ID: 610

Title: First-in-Human Phase 1 Evaluation of HCB101, a SIRPα-Fc Innate Checkpoint Fusion Protein: Safety, Pharmacokinetics, and Receptor Occupancy

Session Name / Location: Proffered Paper session / Auditorium Bordeaux, Palais des Congrès

Date / Time: 16 March 2026 / 16:00 – 17:30 CET

Presentation ID: 66P

Title: Early Safety, Pharmacokinetics, and Translational Profiling of HCB101 in Combination with Standard-of-Care Regimens: Results from the Phase 1b/2a HCB101-201 Study

Session Name / Location: Poster Display session / Foyer, Palais des Congrès

Date / Time: 16 March 2026 / 17:30 – 18:30 CET

Oral Presentation: HCB101-101 Phase 1a Monotherapy

As of the February 2026 data cutoff:

67 patients enrolled across 13 dose levels (0.08 – 36 mg/kg QW)
Maximum tolerated dose not reached
Predominantly Grade 1-2 treatment-related adverse events
Two dose-limiting toxicities (thrombocytopenia): Grade 3 at 2.56 mg/kg and Grade 4 at 36 mg/kg; both resolved
Linear pharmacokinetics (t_1/2~3 days)
Sustained CD47 receptor occupancy >99% at ≥8 mg/kg

Confirmed Clinical Activity:

Confirmed PR in HNSCC (~42% tumor reduction, ≥40 weeks durability)
Confirmed PR in marginal zone lymphoma (~89% tumor reduction, ≥16 weeks durability)
Ten durable stable disease (≥4-9 months) observed across multiple solid tumors

These findings demonstrate a broad therapeutic window and sustained target engagement without the classical hematologic toxicities historically associated with CD47 blockade

Poster Presentation: HCB101-201 Combination Study

HCB101 is being evaluated across multiple established oncology regimens, including chemotherapy, PD-1 inhibitors, anti-VEGF, HER2-targeted, and EGFR-directed therapies. Across combination cohorts:

Well tolerated across gastric cancer (GC), TNBC, CRC, and HNSCC
No unexpected overlapping toxicities
Cytopenias primarily attributable to chemotherapy
No additive hematologic safety signal observed

Selected Highlights:

Second-line Gastric Cancer (Ramucirumab + Paclitaxel): (n=15)

Overall ORR: 60% (9/15); DCR 100% (15/15)
Mid-dose ORR: 100% (5.12 mg/kg), 81% (8 mg/kg)
Dose-level mean tumor shrinkage: -6.0% (2.56 mg/kg), -33.4% (5.12 mg/kg), -46.0% (8 mg/kg), -27.9% (12 mg/kg, ongoing)
Dose-dependent tumor shrinkage, with deepest reduction up to -78.2%

First-line HER2+ Gastric Cancer: (n=5)

Overall ORR: 80% (4/5); DCR 100% (5/5)
Mean tumor shrinkage: -46.6%% (5.12 mg/kg) and -29.0% (8 mg/kg)
No DLT; no HCB101-related SAEs

First-line TNBC: (n=7)

Overall ORR: 42.9% (3/7); DCR 100% (7/7)
Dose-level ORR: 33% (2.56 mg/kg) and 67% (8 mg/kg)
Mean tumor shrinkage: -28.4%% (2.56 mg/kg) and -48.4% (8 mg/kg)
No DLTs; no new overlapping toxicities

These results support the continued development of HCB101 as a macrophage checkpoint backbone that can be integrated into standard-of-care regimens without compromising safety or clinical workflow.

Two HCB101 abstracts were accepted at ESMO-TAT 2026, including an oral presentation and a poster, reflecting strong peer-review recognition of the program’s translational relevance.

“The scientific dialogue at ESMO-TAT was rigorous and highly engaged, with extensive discussion around exposure-response relationships and hematologic differentiation relative to prior CD47 programs,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “Following the oral presentation, much of the discussion centered on whether sustained receptor occupancy could be achieved without cumulative anemia signal – the central question that has historically constrained this field. In monotherapy, we demonstrated durable target engagement at biologically active exposures without a cumulative hematologic liability. At the combination poster, there was significant interest in the 2L gastric cancer data, particularly the dose-dependent activity observed without additive cytopenia. That consistency across settings reinforces our confidence that HCB101 can function as a true innate immune backbone rather than a single-line opportunity. Collectively, these data provide a strong translational foundation for Phase 2 expansion.”

About HCB101: A Next-Generation SIRPα Fc-Fusion Protein

HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing red blood cell binding, a limitation that historically constrained CD47-directed therapies.

Engineered using AI-assisted structural modeling, HCB101 achieves differentiated binding to CD47 on tumor cells while maintaining low affinity for CD47 on red blood cells. Its safety, receptor occupancy, and pharmacologic characteristics are designed to enable integration with established oncology regimens without disrupting standard dosing or clinical workflows.

In ongoing clinical and translational evaluation, HCB101 has demonstrated sustained target engagement and early antitumor activity as both monotherapy and in combination, including in tumor types historically challenging for CD47-directed therapies. Dose escalation and Phase 2 expansion cohorts in gastric, colorectal, and head-and-neck cancers are ongoing.

These attributes support HCB101’s development as a differentiated innate immune checkpoint backbone with broad potential across solid tumors and hematologic malignancies.

About HanchorBio

Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company is led by an experienced team with a proven track record in biologics discovery and global development, aiming to reshape the landscape of cancer therapies. HanchorBio’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics with diverse targeting modalities, designed to activate both innate and adaptive immune pathways and overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has delivered proof-of-concept data in several in vivo tumor animal models. HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations in R&D and scalable CMC strategies.