Chime Biologics Forms mAb Development and Manufacturing Deal with Leads Biolabs and BeiGene

Chime Biologics, a China-based contract development and manufacturing organization, announced on June 30, 2023 that it has established three-way strategic collaboration with Nanjing Leads Biolabs (Leads Biolabs), a China-based clinical-stage R&D biotech company, and BeiGene, a biotechnology company with headquarters in China and the United States. The goal of this collaboration is to accelerate the development and global manufacturing of LBL-007, a novel monoclonal antibody (mAb) that was developed independently by Leads Biolabs for cancer treatment.

Phase I clinical trial data of LBL-007 in patients with later-stage solid tumors were announced at the 2021 annual meeting of the American Society of Clinical Oncology, according to a company press release. LBL-007 is currently moving into the clinical Phase II stage.

Leads Biolabs had previously reached an authorization and cooperation agreement with BeiGene under which Leads Biolabs granted an exclusive global development and production license to BeiGene for the mAb, as well as a commercial manufacturing license outside China.

Under the new three-way collaboration, Chime Biologics will cooperate with Leads Biolabs to accelerate the filing of an investigational new drug (IND) application and provide clinical trial materials in China. To achieve IND filing, Leads Biolabs has provided Chime Biologics with its supporting data and information related to the production of LBL-007 and clinical trial materials in mainland China.

Meanwhile, BeiGene and Chime Biologics are also establishing a strategy to facilitate IND applications overseas and clinical trial materials supply outside of China. BeiGene is also providing Chime Biologics support for clinical development and manufacturing of clinical trial materials to enable multiple clinical trials. The companies are seeking indications in colorectal cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, and other solid tumors. According to the press release, clinical trials have been conducted in various countries worldwide, including Australia and the United States.

“We are so pleased to cooperate with BeiGene … and Chime Biologics … LBL-007 is the first innovative antibody drug with global intellectual property which we developed independently. I believe that the development and commercialization of LBL-007 can be expedited through our triangular cooperation, so we can address unmet medical needs and bring hope to cancer patients,” said Kang Xiaoqiang, founder, chairman, and CEO of Leads Biolabs, in the release.

“[LBL-007] has launched nearly ten Phase I and II clinical trials worldwide in the last year, with indications covering colorectal cancer, non-small cell lung cancer, head and neck squamous cell cancer, melanoma, and other solid tumor cancers. I believe that this cooperation will bring new opportunities for the medical community to further conquer cancer,” said Wang Lai, global R&D director of BeiGene, in the release.

Source: Chime Biologics