HanchorBio Announces Taiwan FDA IND Approval for the Multi-Regional Clinical Trial of HCB101 to Treat Solid and Hematological Malignancies

HanchorBio Received IND Approval of HCB101 Multi-Regional Clinical Trial By Taiwan FDA

TAIPEI, TAIWAN and SAN FRANCISCO, CA / ACCESSWIRE / July 24, 2023 / HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the Taiwan Food and Drug Administration (TFDA) has approved its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.

"HCB101 is our first program in our pipeline which recently received IND clearance by US FDA and now obtained IND approval from TFDA of this multi-regional, multi-center clinical trial. HCB101 project was initiated in December 2021, and the U.S. IND was submitted in March 2023; the 2.3 year from inception to IND was a record for a biotech company of our size. The opportunity to bring this potential fusion protein to cancer patients who have such a high unmet medical need is at the core of what drives us as a company," said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. "With a strong pipeline targeting both the adaptive and innate immunity and the Fc-based designer biologics (FBDB™) platform we have built, HanchorBio is well positioned to make important impacts in delivering innovative, cutting-edge immunotherapies."

Sean Juo, Ph.D., President and Chief Scientific Officer of HanchorBio, commented, "Leveraging the 'do not eat' signal pathway, HCB101 has demonstrated superior anti-tumor efficacy in our extensive preclinical studies of murine xenograft tumor models when comparing head-to-head with other agents currently being investigated in clinical trials that target the same pathway." "IND approval from TFDA within 23 working days (a speed record) is a testament to our in-house drug development capabilities and strong clinical operations through our partnership with global CRO companies. Our team already initiated this clinical trial in the US, and I look forward to enrolling the first subject soon," said Dora Weng, R.N., M.B.A., Clinical Operations Head of HanchorBio.

About HCB101

Using structure-guided protein design and engineering supplemented with relevant screening technologies, HCB101 is an engineered extracellular domain of SIRPα fused to the Fc region of IgG₄. HCB101 triggers phagocytic activity of the macrophages by blocking the "do not eat" signal between macrophages and tumor cells. Based on the extensive in-vitro and in-vivo preclinical data, HCB101 is potentially a safer and more potent biologic than the anti-CD47 monoclonal antibodies and SIRPa fusion proteins currently being investigated in clinical trials. Furthermore, quantitative RNA transcriptional analysis indicated that HCB101 triggered distinct gene expression profiles inside the tumor and in the tumor microenvironment comparing to other relevant clinical candidates, suggesting that HCB101 might exhibit unique mechanisms of action. Using HCB101 as the foundation, our pipeline will include other arms targeting both adaptive and innate immunity to help revolutionize the treatment of patients with cancer and other debilitating diseases.

About Multi-Regional Clinical Trial of HCB101

HCB101-101 is a multi-regional, multi-center, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma in the United States and Taiwan. The purposes of the study are to evaluate the safety, tolerability, pharmacokinetics, and clinical anti-tumor activity of weekly HCB101 intravenous injections. The US sites initiation of the HCB101-101 is on track within Q3-2023.

About HanchorBio

Based in Taipei, Shanghai, and San Francisco Bay Area, HanchorBio is a global clinical-stage biotechnology company focusing on immuno-oncology. The Company is led by an experienced team of pharmaceutical industry veterans with proven track-record of success in biologics discovery and global development to transcend current cancer therapies. Committed to reactivating the immune system to fight against diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables unique biologics with diverse multi-targeting modalities to unleash both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs.

For more information, please visit: www.HanchorBio.com

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Contact Information

Scott Liu
Founder, Chairman and CEO
scott_liu@hanchorbio.com

Yi Du
Sr. Director of Business Development
yi_du@hanchorbio.com

SOURCE: HanchorBio, Inc.