Heyuan Bio Announces First Patient Dosed in Investigator-Initiated Trial of Proprietary BCMA-Targeted CAR-T Candidate HY027 for Relapsed/Refractory Multiple Myeloma

On March 25, 2022, Juventas announced that HY027, the company's self-developed CAR-T therapy candidate product targeting B-cell maturation antigen (BCMA), had completed its initiation in an investigator-led study.Clinical TrialThe first subject was dosed in the trial. The trial, initiated by Professor Lu Gui Qiu, Director of the Lymphoma/Multiple Myeloma Diagnosis and Treatment Center at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, aims to evaluate the safety and efficacy of HY027 in treating relapsed/refractory multiple myeloma. After completing the infusion, the patient is in good condition, and the investigator is currently assessing their safety and efficacy according to the clinical study protocol.

HY027 is a BCMA-targeted CAR-T product fully independently developed by Juventas. By employing a highly specific humanized anti-BCMA scFv sequence, it effectively avoids the generation of anti-drug antibodies. Combined with world-leading manufacturing processes and quality control systems, it is expected to bring rapid, profound, and long-lasting therapeutic effects for patients with relapsed/refractory multiple myeloma and other patient groups. In earlier in vitro and animal experiments, HY027 demonstrated excellent anti-tumor activity.TumorActivity and Persistence.

Professor Qiu Lugui, Director of the Lymphoma/Multiple Myeloma Diagnosis and Treatment Center at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated: "The treatment of relapsed/refractory multiple myeloma has always been a major challenge in clinical practice. CAR-T therapy has become a hot topic in the research of relapsed/refractory multiple myeloma in recent years, with BCMA being the most focused target. We look forward to Juventas' self-developed BCMA-targeted CAR-T product, through differentiated improvement strategies, enhancing the efficacy and applicability of CAR-T cell therapy, and further improving the prognosis of patients with multiple myeloma."

Dr. Li Zhou, CSO of Juventas, stated: "The development of differentiated CAR-T products targeting BCMA is one of the company's key R&D strategies. With the successful reinfusion of the first subject, the R&D center has completed the construction of core capabilities for developing various types of immune cell therapy drugs, including CAR-T, and is further advancing its focused layout on the CAR technology platform, gene editing technology platform, and more."ipsCs Technology Platform, continuously promoting the synergistic effects of various technical platforms, driving technological innovation, and consistently delivering solutions covering hematological tumors, solid tumors, and other clinical needs.Tumor"Differentiated autologous and universal pipeline products in disease areas, striving to enable patients to access safe, effective, and affordable products as soon as possible."

Dr. Lulu Lv, CEO of Juventas, stated: "The successful reinfusion of HY027 demonstrates the company's capabilities in antibody screening,VectorConstruction of upstream R&D capabilities such as building, CAR-T design, preclinical research, process development, quality system establishment, and clinical research implementation, in alignment with the company's steadily advancing CAR-T commercial production system, gradually completing the full-process core competency chain from upstream R&D to commercialization. Currently, the company’s core product, CNCT19 Cell Injection, is proceeding steadily in its registration clinical trials and has entered the new drug application preparation phase. Moving forward, the company will continue to broaden its R&D pipeline through independent research and close collaboration with top-tier institutions in China, progressively achieving platform-based output of pipeline products, striving for breakthroughs in hematology.Tumor, Solid Tumors, andAutoimmunediseases and other fields, achieving new breakthroughs to help more patients benefit from immune cell therapy sooner." (Bioon)

HY027 is an investigational autologous CAR-T therapy candidate targeting B-cell maturation antigen (BCMA), featuring a humanized anti-BCMA scFv as the extracellular domain.TumorAntigen recognition region, with 4-1BB as the intracellular co-stimulatory signal in a second-generation CAR-T structure. Currently, initiated by Professor Qi Luogui, the principal investigator and Director of the Lymphoma/Multiple Myeloma Diagnosis and Treatment Center at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences.Clinical TrialOngoing, the trial will mainly evaluate the safety and efficacy of HY027 in treating relapsed/refractory multiple myeloma.

Multiple Myeloma (MM) is the second most common hematological malignancyTumorAccording to the 2018 GLOBOCAN statistics, there are approximately 160,000 new cases of MM worldwide each year, with about 20,000 new patients annually in China [1], and this number is increasing year by year. Clinically, MM patients exhibit malignant proliferation of terminally differentiated bone marrow plasma cells, leading to the excessive production of pathological immunoglobulins. The over-secretion of immunoglobulins and uncontrolled plasma cell growth can cause damage to end-organs, and disease progression ultimately leads to patient death. Immunomodulatory drugs, proteasome inhibitors, and monoclonal antibody therapies are currently the main treatments for MM. Although these treatments have significantly extended patient survival, MM remains incurable, with patients experiencing repeated relapses, eventually progressing to relapsed/refractory MM. For relapsed/refractory MM, effective treatment options are still lacking, resulting in poor prognosis and significant unmet clinical needs.

References:

[1],Jiangmei Liu, etc. Incidence and mortality of multiple myeloma in China, 2006-2016: an analysis of the Global Burden of Disease Study 2016. J Hematol Oncol. 2019 Dec 10;12(1):136.