The U.S. FDA Approved the Phase I/II Clinical Trial Application to Evaluate LBL-033, An Anti-MUC16/CD3 Bispecific Antibody Developed by Leads Biolabs, in Advanced Solid Tumors Including Ovarian Cancer

NANJING, China, June 16, 2023 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") today announces that the phase I/II clinical trial application for LBL-033, an anti-MUC16/CD3 bispecific antibody, for the treatment of ovarian cancer and other malignant tumors, has been approved by the FDA (U.S. Food and Drug Administration). At present, no antibody product targeting MUC16 has been approved for marketing both inside and outside China.

The study is a multicenter, open-label, dose-escalation and expansion phase Ⅰ/Ⅱ clinical study. The phase Ⅰ part aims to evaluate the safety, tolerability, and pharmacokinetics of LBL-033 for the treatment of subjects with advanced malignancies, and to provide recommended doses for subsequent clinical studies. The primary objective of the Phase Ⅱ part is to evaluate the efficacy of LBL-033.

"I am pleased to see that the FDA has quickly approved the clinical trial application of LBL-033 in the United States, and I am grateful for the good suggestions given by the FDA during the IND review process. These have laid a good foundation for the rapid, high-quality and effective development of this new targeted immunotherapy." said Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, "LBL-033 adopts a unique bispecific antibody molecule design to allow better drug aggregation in MUC16-overexpressing tumor cells and to reduce the non-specific activation of CD3, which may help improve efficacy and reduce side effects such as cytokine release syndrome. We look forward to the clinical evaluation of the safety and efficacy of this innovative drug in order to bring it to the general population of cancer patients as soon as possible."

About MUC16:

MUC16 (Mucin16, mucin 16) is a highly glycosylated type I transmembrane protein that is abundantly expressed in epithelial cells, providing a protective lubricating barrier against infection. However, MUC16 is abnormally highly expressed in a variety of malignant tumors, including ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, pancreatic cancer, non-small cell lung cancer and gastric cancer, and is involved in the regulation of immune escape, tumor cell proliferation and metastasis.

About ovarian cancer:

Ovarian cancer is the second most prevalent gynecologic malignancy in developed countries and the first of the three major gynecologic malignancies in terms of mortality, posing a serious threat to women's health. 314,000 new cases were diagnosed worldwide in 2020 and about 207,000 women died from the disease, with a rising trend year by year. Epithelial carcinoma is the most common type, accounting for about 80-90% of ovarian malignancies. Epithelial ovarian cancer frequently occurs in women aged 50-70 years. Currently, there is no effective and sufficiently accurate screening procedure to detect early-stage ovarian cancer. First-line platinum/paclitaxel-based chemotherapy is the standard of care for advanced ovarian cancer, with an efficiency rate of more than 80%. 5-year survival rate is 40-50%, and the survival rate for intermediate and advanced stages is approximately 30%. However, recurrence still occurs in 50-70% of patients. For patients with recurrent disease, treatment aims mainly to reduce symptoms and improve patients' quality of life. Therefore, there is a need to develop more effective treatment modalities to reduce the relapse rate and prolong the relapse-free interval.

About LBL-033:

As a T-cell engager, the bispecific antibody LBL-033 targeting MUC16-expressing tumor cells and CD3-expressing T cells, mediates cell-specific killing of MUC16-positive tumor cells by promoting the secretion of immune cytokines, and changes the tumor microenvironment in a direction favorable to tumor immunity, resulting in tumor cell death.

LBL-033 is an innovative biological product which has not been marketed both at home and abroad, and was granted IND approval for clinical trial by the NMPA (National Medical Products Administration) on February 16, 2023. On April 27, 2023, the first participant has been successfully dosed at Sun Yat-sen University Cancer Center. LBL-033 is the first bispecific antibody targeting MUC16/CD3 that has been approved for clinical trial in China.

Nanjing Leads Biolabs Co., Ltd. is a clinical-stage R&D biotech company founded in Nanjing by a team of senior U.S.-educated antibody drug developers. Since 2014, Leads Biolabs has been dedicated to the research and development of novel antibody drugs with independent intellectual property rights for the treatment of oncology and other major diseases, mainly focused on the unmet pharmaceutical needs, especially the problems and challenges in tumor immunotherapy areas. Leads Biolabs already have a rich R&D pipeline with more than twenty novel tumor immunotherapy antibody projects based on monoclonal antibody and bispecific antibody development technology platform. Leads Biolabs will continue to expand its innovation to provide patients with safe, effective, accessible and affordable new drugs to meet the unmet pharmaceutical needs.

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

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SOURCE LEADS BIOLABS