In a stride towards the development of innovative treatments for cancer, the U.S. Food and Drug Administration (FDA) has granted approval for the Phase I/II clinical trials of LBL-033, an anti-MUC16/CD3 bispecific antibody developed by Leads Biolabs. The biotech company is set to investigate the safety, efficacy, and pharmacokinetics of LBL-033 in combating advanced solid tumors, including ovarian cancer.

This bispecific antibody, LBL-033, has a unique design targeting MUC16 – a type I transmembrane protein highly expressed in a variety of malignant tumors. The design of this antibody is aimed at better aggregation in MUC16-overexpressing tumor cells while reducing the non-specific activation of CD3. This approach is intended to improve the treatment’s efficacy and minimize potential side effects such as cytokine release syndrome.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, emphasized the value of this development. “The FDA’s approval and constructive suggestions during the IND review process lay a solid foundation for the rapid, high-quality, and effective development of this novel targeted immunotherapy,” Dr. Cai said.

Ovarian cancer, the second most common gynecologic malignancy in developed countries, remains a significant threat to women’s health. In 2020, over 300,000 new cases were reported worldwide, with approximately 207,000 women losing their lives to the disease. Despite the current standard care for advanced ovarian cancer achieving an efficiency rate of over 80%, recurrence is a prevalent issue, with relapses occurring in 50-70% of patients. More effective treatments are needed to address these challenges.

LBL-033 is a biological product that aims to transform the cancer treatment landscape. As a T-cell engager, LBL-033 targets MUC16-expressing tumor cells and CD3-expressing T cells, thus promoting cell-specific killing of MUC16-positive tumor cells. This process also fosters a shift in the tumor microenvironment towards enhancing tumor immunity, resulting in tumor cell death.

The potential of LBL-033 has not gone unnoticed by regulatory authorities. Prior to the recent FDA approval, the National Medical Products Administration (NMPA) in China gave its green light for clinical trials of LBL-033 on February 16, 2023. The first participant was successfully dosed at Sun Yat-sen University Cancer Center on April 27, 2023, making LBL-033 the first bispecific antibody targeting MUC16/CD3 approved for clinical trial in China.

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