#USA #Maryland #Immunotherapy #HanchorBio #HCB301

HanchorBio Showcases HCB301 at SITC 2025

HanchorBio Inc., a notable global player in the biotechnology field, made headlines at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) held in National Harbor, Maryland, from November 5-9, 2025. The company presented preclinical data for its pioneering tri-specific immunotherapeutic agent, HCB301. This innovative fusion protein is designed to simultaneously target three significant mechanisms in oncology: SIRPα-CD47 interactions, PD-1/PD-L1 pathways, and TGFβ signaling. The results of this study are considered a game-changer in next-generation cancer therapies.

A Revolutionary Approach to Cancer Treatment

HCB301's multi-pronged strategy focuses on activating both the innate and adaptive immune systems to combat solid tumors. Traditional cancer therapies often fall short in immunologically 'cold' environments where tumors exhibit resistance to standard treatments. HCB301 aims to break through this barrier with a strategic blend of three key functions:

1. Blocking SIRPα-CD47: This action enhances macrophage-mediated phagocytosis, allowing immune cells to more effectively engulf and eliminate cancer cells.
2. Targeting PD-1/PD-L1: This disruption restores the function of exhausted T-cells, re-energizing the immune response against tumors.
3. Neutralizing TGFβ: By trapping active TGFβ, HCB301 seeks to overcome the immunosuppressive signals often present in the tumor microenvironment (TME).

The design aims to surmount the limitations associated with current immune checkpoint inhibitors, highlighting its potential to target suppressive TMEs effectively.

Presentation Highlights and Future Directions

During the conference, HanchorBio's preclinical data on HCB301 (SITC Poster #P321) was featured prominently. The results indicated:

• - Strong Immune Activation: HCB301 triggered significant antibody-dependent cellular phagocytosis (ADCP), promoting tumor-associated macrophage activation and increasing the infiltration of CD8+ T cells, essential for mounting an effective immune response.
• - Enhanced Antitumor Efficacy: Across various models, including CT26, MC38, and B16F10, HCB301 showcased superior inhibition of tumor growth compared to other single- or dual-target therapies.
• - TGFβ Suppression: Notably, HCB301 effectively neutralized active TGFβ, a critical factor in reversing immunosuppression within the TME, thereby restoring T cell function and enhancing overall antitumor responses.
• - Fc-Effector Tuning: The selective engineering of the Fc region of HCB301 optimized immune activation while aiming to minimize potential off-target toxicities, a common concern in immunotherapy.

These findings were supported by Dr. Wenwu Zhai, HanchorBio's Chief Scientific Officer, who emphasized that HCB301 was specifically designed to address resistance mechanisms that limit the effectiveness of current PD-1 or CD47 therapies. He stated, "Our preclinical data show that HCB301 delivers synergistic immune activation and tumor control, strongly supporting its advancement into the clinic."

HCB301: Medical and Developmental Implications

HCB301 stands out as a first-in-class tri-specific recombinant Fc-fusion protein. The combination of high-affinity domains and precise targeting mechanisms offers substantial promise in improving cancer treatment outcomes. The protein's favorable safety profile was also highlighted in cynomolgus monkey studies, which indicated a reduced risk of adverse blood-related conditions while maintaining its potent anti-tumor effects.

In 2025, HCB301 achieved Investigational New Drug (IND) clearance and commenced first-patient dosing in both the US and China. HanchorBio is moving forward with the ongoing Phase 1 study (HCB301-101; NCT06487624), which is a multicenter, open-label trial designed to evaluate the safety and preliminary efficacy of HCB301 in patients suffering from advanced solid tumors or relapsed and refractory classical Hodgkin lymphoma.

About HanchorBio

HanchorBio Inc. operates across Taipei, Shanghai, and San Francisco, specializing in cutting-edge immuno-oncology solutions. The company's leadership consists of seasoned professionals with extensive backgrounds in biologics discovery and international development. HanchorBio is steadfast in its mission to enhance tumor immunotherapy through its proprietary Fc-Based Designer Biologics (FBDB™) platform, which facilitates novel, multifunctional immunotherapies. By reinforcing both innate and adaptive immunity, HanchorBio seeks to overcome the challenges presented by existing cancer therapies.

For additional details regarding HCB301 and HanchorBio's innovative strategies, please visit their website at HanchorBio.com.