TAIPEI, SHANGHAI, and SAN FRANCISCO, June 28th, 2024 – HanchorBio Inc., a global clinical-stage biotechnology company focusing on the discovery and development of innovative immuno-biomedicines to treat a wide variety of patients suffering from hard-to-treat solid tumors or hematological malignancies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB301, for the treatment of patients with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. HCB301 is an engineered tri-specific fusion protein comprised of an anti-PD-L1 (Ig) V domain, a parallel-engineered human SIRPα (Ig) V domain fused to an IgG4 Fc protein, and an engineered human transforming growth factor- (TGF) trap at the Fc tail that creates synergies between innate immunity checkpoint, an adapted immunity checkpoint, and an immune suppressive cytokine to triggers the modulation of tumor microenvironment, potentially addressing a novel multi-specific immune-therapy approach to tackling cancer.
“The IND clearance marks another significant milestone as we advance our pipeline of multi-targeting Fc-based designer biologics (FBDB™) immunotherapy in cancers,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “This is our second IND clearance within 3.5 years since the inception of the company and underscores our focused dedication towards developing safe and effective treatments derived from our FBDB™ platform to re-engage innate and adaptive immunity through multifunctional designs to overcome the inadequacies of anti-PD1/L1 therapies. HCB301 IND is the first tri-specific fusion protein targeting SIRPα/CD47, PD-1/PD-L1, and TGFβ/TGFβ trap pathways simultaneously.”
“Based on our in-vitro and in-vivo pre-clinical studies, HCB301 has demonstrated remarkable inhibition of multiple tumor cell lines and murine xenograft tumor models of solid and hematological malignancies, compared with TGF trap, anti-PD-L1 agents, anti-CD47 agents, in either multi-specific antibody or in their disparate soluble combinations,” said Jonathan Wang, Ph.D., Senior Director of Research Department of HanchorBio. “Unlike other CD47-blocking agents, HCB301 exhibits lower binding activity in preclinical settings to human red blood cells (RBCs), but similar binding activity to platelets, with no obvious abnormality of RBC or platelet levels being observed in the repeat-dose cynomolgus monkey toxicology studies.”
“ Given the encouraging outcomes thus far regarding HCB101 (an engineered extracellular domain of SIRPα fused to the Fc region of IgG4 as a safer and more potent biologic than the anti-CD47 monoclonal antibodies) in our ongoing Phase 1 trial (NCT05892718), we are optimistic about the potential benefits that may emerge of HCB301 based on the foundation of HCB101,” stated by David Sun, M.D., Ph.D., Senior Vice President of Global Clinical and Medical Affairs of HanchorBio. “Our medical and clinical teams look forward to advancing the clinical development of HCB301 to bring clinically meaningful benefits to patients as early as possible.”
About HCB301
Using structure-guided protein design and engineering supplemented with relevant screening technologies, HCB301 is a tri-specific fusion protein: an engineered IgV domain of human SIRPα fused to an anti-PD-L1 (Ig) V domain and an engineered human TGFRII. This results in blocking the checkpoint CD47 simultaneously with T-lymphocyte checkpoint PD-L1 blocking while inhibiting the activities of TGF-mediated immune-suppression functions. HCB301 exhibits good safety profiles in the repeat-dose cynomolgus monkey toxicology studies, as no obvious abnormality of RBC or platelet levels was observed, and a unique differential binding to tumor cells vs. RBC binding and subsequent significant decreases in phagocytosis may potentially reduce patient’s risk of anemia, thrombocytopenia, or any other cytopenia while maintaining potent anti-tumor activities.
About Multi-regional Clinical Trial of HCB301 (NCTXXXX)
HCB301-101 is a multiregional, multicenter, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas in the United States, Australia, and Taiwan. The study evaluates the safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of weekly HCB301 intravenous injections. The HCB301 IND is on track to be reviewed by the Australia Therapeutic Goods Administration (TGA) and the Taiwan FDA.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio is led by an experienced team of pharmaceutical industry veterans with a 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 inadequacies of anti-PD1/L1 therapies. 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 HanchorBio or follow us on LinkedIn.