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 tumorGPRC5D-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."
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.
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.
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.
For more information, please visit: https://www.leadsbiolabs.com
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