Crown Bioscience Enables HanX Biopharmaceutical to Progress HX009 to Clinical Trials

San Diego, USA — August 22, 2023. Crown Bioscience, a global contract research organization (CRO) and JSR Life Sciences company, has announced that its collaborative work with HanX Biopharmaceutical Co., Ltd. (“HanX”), employing a unique and broad portfolio of preclinical modeling in support of HanX’s successful FDA Investigational New Drug (IND) application, has been published in Scientific Reports, a journal within the Nature portfolio.

The study demonstrated that HX009, an investigational “first-in-class” PD-1 x CD47 bispecific antibody, binds differentially to both PD-1 and CD47 with strong affinity to PD-1 but weakened affinity to CD47. This feature enables better targeting to the tumor microenvironment (TME) and minimizes potential hematological toxicity. In addition, HX009 exhibited enhanced T-cell activating capability over HX008, an approved and marketed anti-PD-1 monoclonal antibody in China.

Specifically, this new study showed that HX009 exerted robust anti-lymphoma activity in two cell-derived xenograft (CDX) models (Raji B-lymphoma and Karpas-299 T-lymphoma) with high CD47 expression. Additionally, custom patient-derived xenograft (PDX) models established by Crown Bioscience, further confirmed the efficacy of CD47 targeting by HX009. In addition, an A20-hCD47 mouse B-lymphoma model developed in hSIRPα/hCD47/PD-1/PD-L1 quadruple knock-in genetically engineered mouse models (HuGEMM^TM) mice, HX009 exhibited superior anti-lymphoma efficacy compared to CD47 or PD-1 targeting alone. These results imply a synergy between CD47 and PD-1 dual targeting.

These Crown Bioscience studies played an important role in supporting the application of HX009 for the treatment of lymphoma in clinical trials. They also played an instrumental role in supporting the clearance of HanX’s FDA Investigational New Drug (IND) application, which has paved the way for a U.S.-based Phase I/II clinical study that will assess HX009 in the treatment of relapsed/refractory lymphoma.

This exciting result exemplifies the value that Crown Bioscience brings to its partners as they seek better solutions for advancing their oncology research. Specifically, the collaboration between scientists from both organizations, utilizing an integrated solution approach, leveraged a comprehensive collection of preclinical and translational studies to investigate the anti-lymphoma activity of HX009.

While HX009 has been studied in Phase I clinical studies in Australia and China in both solid tumor and lymphoma indications, HanX is now expanding the next phase of clinical development globally in a variety of clinical indications. 

Henry Li, PhD, Cofounder, Chief Executive Officer and Chief Scientific Officer of HanX, stated: “We are delighted with the exceptional outcomes of our partnership with Crown Bioscience. By leveraging a wide breadth of in vivo solutions such as cell-derived xenograft (CDX), patient-derived xenograft (PDX), and genetically engineered mouse models, together with translational applications, we were able to conduct a comprehensive evaluation of HX009’s anti-lymphoma activity prior to clinical trials.”

Ludovic Bourre, PhD, VP, Research and Innovation at Crown Bioscience, added: “Our commitment goes beyond identifying the right candidate drug or drug combination. Crown Bioscience consistently invests in expanding the number and diversity of models for drug development, ensuring that our models accurately represent the relevant clinical disease biology and provide a solid foundation for making informed decisions about novel therapeutics such as HanX's HX009.”

This work has laid a robust foundation for the advancement of HX009 as a highly promising therapeutic agent in the treatment of relapsed/refractory lymphoma. To learn more, Crown Bioscience and HanX are hosting an exclusive webinar on Tuesday August 29, 2023, where a team of scientists will discuss the implications of the study. The webinar will provide a unique opportunity to engage with the experts.

For more information or to get in touch, please visit www.crownbio.com