NANJING, China I July 31, 2023 I Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as “Leads Biolabs” or “Company”) announced today that the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) have approved its first-in-human Investigational New Drug (IND) applications for LBL-034, an anti-GPRC5D/CD3 bispecific antibody invented by Leads Biolabs with global intellectual property rights, for the treatment of relapsed/refractory multiple myeloma. Currently, no GPRC5D-targeting antibody has been approved for marketing.

This is a first-in-human, single-arm, multicenter, open-label, dose-escalation and expansion clinical study, and plans to enroll patients with relapsed/refractory multiple myeloma who have failed prior therapies including but not limited to at least one proteasome inhibitor (PI), one immunomodulator (IMiD) as well as other standard treatments. This study aims to evaluate the safety and tolerability of LBL-034, determine the recommended Phase II dose and assess its efficacy in patients with multiple myeloma.

“Despite recent progress and continuous advancements in multiple myeloma, the time between recurrences has been steadily decreasing, particularly as the number of treatment lines increases. This ultimately leads to emergence of relapsed or refractory multiple myeloma, reaffirming its status as an incurable malignant tumor that poses a serious threat to human life. In light of this challenging reality, the urgent need for more effective and innovative treatment options has never been more evident.” said Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, “LBL-034 adopts a unique molecular design, which enables the drug to specifically bind to GPRC5D-expressing tumor cells with high affinity, and reduces the risk of non-specific activation of T-cells, thereby enhancing anti-tumor efficacy and reducing potential risk of immunotoxicity. LBL-034 demonstrated robust anti-tumor activities and good safety profile in pre-clinical studies. We adhere to our tradition of innovation and aim to deliver an important, novel and effective treatment option for patients with poor prognosis of relapsed/refractory multiple myeloma.”

About GPRC5D:

G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D) is a C-type 7-channel transmembrane receptor protein. GPRC5D is low expressed in normal human tissues but specifically overexpressed in multiple myeloma. The intensity of GPRC5D expression is an independent prognostic factor in multiple myeloma, and its overexpression is significantly associated with reduced overall survival. Therefore, GPRC5D may be an important potential target for the treatment of plasma cell diseases such as multiple myeloma.

About multiple myeloma:

Multiple myeloma is a malignant plasma cell disease caused by abnormal proliferation of clonal plasma cells, accounting for 10-15% of hematologic malignancies and about 1.4% of all malignancies. It is the second most common hematological malignancy in adults after non-Hodgkin’s lymphoma and mostly occurs in the elderly. According to the data released by the World Health Organization (WHO), the number of new cases and deaths of multiple myeloma worldwide in 2020 were 176,000 and 117,000 respectively, and the number of new cases and deaths of multiple myeloma in China were 21,000 and 16,000 respectively. Currently, multiple myeloma is still an incurable malignant tumor, and the five-year survival rate of patients is approximately 24.8% in China, 33.3% in Japan, and 46.7% in the United States. In recent years, with the successful development of proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), selective nuclear output inhibitors, CD38-targeted antibodies, bispecific antibodies, and CAR-T cell therapies, the tumor response rate and survival prognosis have been significantly improved. However, multiple myeloma remains an unmet clinical need for more effective treatments.

About LBL-034:

LBL-034 is a humanized IgG1 subtype asymmetric bispecific antibody targeting both GPRC5D and CD3 and Leads Biolabs fully owns the worldwide intellectual property rights. LBL-034 induces T-cell-mediated killing of myeloma cells by redirecting CD3+ T-cells to myeloma cells expressing GPRC5D.

LBL-034 has the potential to be a transformative best-in-class GPRC5D-targeted immunotherapy for multiple myeloma. Clinical studies are planned to evaluate the safety and efficacy of LBL-034 in patients with relapsed/refractory multiple myeloma.

Nanjing Leads Biolabs Co., Ltd. is a clinical-stage biotechnology company founded in Nanjing by a team of senior U.S.-trained antibody drug developers. Since 2014, Leads Biolabs has been dedicated to the discovery and development of novel antibody drugs with independent intellectual property rights for the treatment of oncology and other major diseases of high unmet medical needs, particularly the challenges in cancer immunotherapy. Our extensive R&D pipeline consist of more than twenty novel tumor immunotherapy molecules based on monoclonal and bispecific antibody technology platforms. Leads Biolabs is committed to providing safe, effective, accessible and affordable new drugs to address the unmet needs of patients around the world.

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SOURCE: Leads Biolabs