HX-009

SAN DIEGO--(BUSINESS WIRE)-- Crown Biosciences Inc., a global contract research organization (CRO) and JSR Life Sciences company, has announced that its collaborative work with HanX Biopharmaceuticals, Inc. (“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 (HuGEMMTM) 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. ### About Crown Bioscience Crown Bioscience, a JSR Life Sciences company, is a global CRO that provides preclinical and translational platforms to help our customers advance their research and development in oncology, immuno-oncology, and immune-mediated inflammatory diseases. We are the exclusive preclinical CRO to offer tumor organoid services with the well-established Hubrecht Organoid Technology. In addition, we have developed the largest commercially available PDX collection in the world. We focus on helping our customers develop novel therapies to maximize the chances that patients receive the right treatment at the right time. Founded in 2006, Crown Bioscience has 14 facilities across the United States, Europe, and Asia. For more information or to get in touch, please visit About HanX HanX is a global biopharmaceutical company that develops innovative immuno-oncology antibody-based drugs, such as novel BsAb antibodies to address significant unmet medical needs. HanX brings together experts from both China and the U.S., to aid in activities ranging from early discovery, process development, business development, and clinical research. The company aims to accomplish its ambitious goals by relying on in-house research and development in combination with external global collaborations.

WUHAN, China, May 22, 2023 /PRNewswire/ -- Hanx Biopharmaceuticals, Inc. (HanxBio), announced that the company has received Investigational New Drug (IND) approval to start clinical trial of the potentially first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb), HX009, in Patients with relapsed/refractory Lymphoma. This is a Phase IB/II clinical study to be conducted in the United States to evaluate HX009 in the treatment of lymphoma patients who have failed standard therapy. This is another important milestone of HX009 development as well as in the company's drug development program. HX009 has been studied in Australia and China in both solid tumor and lymphoma indications. The approval by FDA to start clinical trial in US strengthens the development of HX009 globally, and enhances the company's position in the field of bispecific antibody research. Dr. Lei Zhang, CMO of HanxBio, said: "We are very pleased that our HX009 program has received clinical trial research approval from the US FDA. Although immune checkpoint inhibitors (ICIs) have shown great promises in a wide range of oncology indications, there still remains many challenges including in lymphoma. Therefore, it is of great value to develop the next generation of ICIs, including BsAb, such as dual targeting CD47 and PD-1 BsAb like HX009. We look forward to rapidly advancing the clinical development of HX009, bringing new treatment options to patients to meet unmet medical needs." About HANX BIOPHARMACEUTICALS, Co., Ltd. Hanx Biopharmaceutical Co., Ltd. is a global biopharmaceutical company that develops innovative immune-oncology antibody drugs. It brings together well-known experts, from both China and United States, from early discovery, process development, business development, to clinical research. The company leverages expertise to develop proprietary and novel cancer therapies, including innovative treatments such as novel BsAb antibodies to address significant unmet medical needs, and to help patients around the world. The company aims to accomplish goal through in-house research development as well as external global collaborations. ABOUT HX009 HX009 is the global first-in-class bispecific PD-1/CD47 antibody developed by HanxBio. Phase I clinical studies have been conducted in Australia and China. The company is expanding the next phase clinical development globally in various clinical indications. SOURCE Hanx Biopharmaceutical Co., Ltd.