Ligand Biologics Announces Phase II Clinical Collaboration with Bristol Myers Squibb to Evaluate LVGN7409 in Combination with Nivolumab for Non-Small Cell Lung Cancer

Shanghai and SuzhouNovember 28, 2022PR Newswire -- Lijin Biotechnology, an innovative biotechnology company globally leading in the development and commercialization of first-in-class and best-in-class oncology biologics, today announced the launch of an open-label, multi-center, randomized Phase II clinical trial aimed at evaluating the efficacy and safety of LVGN7409 in combination with docetaxel, or in collaboration with Bristol-Myers Squibb, in combination with nivolumab, for advanced/metastatic non-small cell lung cancer (NSCLC).

"The clinical collaboration between Lijin Biotechnology and Bristol-Myers Squibb demonstrates our commitment to exploring combination therapies that complement the mechanisms of our in-house pipeline with other treatments, aiming for new breakthroughs in cancer therapy," said Dr. Wang Jieyi, Founder and CEO of Lijin Biotechnology. "We are very pleased to soon initiate clinical collaborations with Bristol-Myers Squibb in both China and the United States to address unmet clinical needs that current treatment options cannot fulfill."

Recombinant monoclonal antibody LVGN7409 selectively and efficiently activates CD40 in the tumor microenvironment. CD40 is a member of the Tumor Necrosis Factor (TNF) receptor family, also known as TNFRSF5. Activation of CD40 promotes tumor antigen presentation, reverses immunosuppression in the tumor microenvironment, and restores the anti-tumor function of the immune system.

Bristol-Myers Squibb's Nivolumab is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), which blocks its interaction with PD-L1 and PD-L2, unleashing immune responses including anti-tumor functions that are suppressed by the PD-1 pathway.

Docetaxel is an anti-microtubule chemotherapy drug used to treat various cancers, with indications including non-small cell lung cancer, breast cancer, head and neck cancer, gastric cancer, and prostate cancer.

"Lijin Biotechnology believes that the combination therapy of directly activating CD40 and relieving PD-1 inhibition is highly likely to enhance the efficacy of tumor immunotherapy, namely, the combination of LVGN7409 and immune checkpoint inhibitors has demonstrated excellent synergy in drug-resistant and relapsed patients, further validating our preclinical research findings," emphasized Dr. Zonghuang Zhan, Chief Medical Officer. "We also believe that LVGN7409 may play a role in combination regimens with chemotherapy drugs that have immunomodulatory functions, such as docetaxel. Through this Phase II study, we hope to demonstrate that the activation of CD40 can reverse the immunosuppressive tumor microenvironment that leads to drug resistance, thereby enhancing efficacy through combination with existing standard treatments. There is a significant unmet clinical need for refractory non-small cell lung cancer, and we hope to provide effective treatment options for these patients," added Dr. Zhan.

The development of innovative drugs must demonstrate patient benefits through rigorous clinical research—there are no shortcuts. The immune-stimulatory antibodies researched by Lijin Biotechnology (Shanghai) Co., Ltd. are theoretically applicable to the vast majority of cancer types. Compared to other stimulatory antibodies, the antibodies developed based on the xLinkAb platform strike a new balance between safety and efficacy, showing higher drug-like properties—a superiority that has been validated through preclinical and clinical studies. Currently, the field of stimulatory antibodies is still in its infancy but is developing rapidly, holding significant potential to become the next hot area in cancer immunotherapy. Our long-term dedication to stimulatory antibodies has already yielded promising clinical progress. Additionally, Lijin Biotechnology’s pipeline strategy consistently balances efficacy and cost, with the hope of benefiting diverse populations of cancer patients.

According to the terms of the agreement, Lijin Biotechnology (Shanghai) Co., Ltd. is the sponsor of the study, and Bristol-Myers Squibb will provide nivolumab injection for the combination trial. Lijin Biotechnology holds global development and commercial rights for LVGN7409.