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Set sail! Lijun PD-1 has reached an overseas licensing cooperation with Bright Peak.
Release time:
2021-12-13
On November 15, 2021, Beijing time, Bright Peak Therapeutics, a U.S. company, announced that its subsidiary, Lijun Biopharmaceuticals, signed a research collaboration and licensing agreement with Bright Peak Therapeutics (hereinafter referred to as BPTx). Lijun Biopharmaceuticals will grant BPTx a paid non-exclusive license for its independently developed recombinant humanized anti-PD-1 monoclonal antibody (LZM009) for the development of novel PD-1 targeted immune cell factors (PD-1 ICs), and authorize BPTx to use LZM009 for the development and commercialization of PD-1 ICs outside of Greater China. The PD-1 ICs will consist of optimized cytokine payloads developed by Bright Peak, which will work synergistically with LZM009 to treat various cancers. PD-1 ICs selectively target and activate cytotoxic CD8+ T cells ("CTL") that express the inhibitory immune checkpoint PD-1, while avoiding widespread activation of other immune cells. Dual targeting (cis-signaling) of two receptors on the same CTL using PD-1 inhibitors and cytokine payloads can enhance their synergistic effects.
BPTx is a biotechnology company developing next-generation cytokine immunotherapies, dedicated to harnessing the powerful biological activity of cytokines while significantly improving their safety. Through BPTx's unique chemical protein synthesis and engineering platform, cytokines can be precisely designed to fine-tune receptor binding and optimize efficacy, while any necessary binding handles can be inserted into the protein structure of the cytokines, allowing the enhanced cytokines to rapidly bind to antibodies, thereby developing innovative immune cytokine therapeutic drugs.
Fredrik Wiklund, President and CEO of BPTx, said: "We are excited to obtain the license for Lijun's anti-PD-1 monoclonal antibody LZM009, and to leverage our proprietary platform technology to extensively develop PD-1 directed immune cytokines. In recent years, PD-1 inhibitors have transformed cancer treatment. However, despite the significant efficacy of PD-1 inhibitor therapy in some patients, it does not work for most patients. Bright Peak's PD-1 ICs have the potential to enhance PD-1 inhibitory activity, bringing hope for immunotherapy to more patients."
Dr. Bertolt Kreft, Chief Scientific Officer of BPTx, said: "We are pleased to apply the technical advantages and versatility of our synthetic protein engineering platform to clinical-stage antibodies, generating PD-1 ICs by combining optimized cytokine payloads with clinical-stage antibodies. PD-1 ICs are designed to utilize the concept of positive signaling cytokines acting on the same cells targeted by anti-PD-1 antibodies. Therefore, they are more effective, more selective, and have an enhanced effect on inducing superior CD8+ T cell responses."
Dr. Liu Jianing, Chief Investment Officer and General Manager of BD Headquarters of Lijun Pharmaceutical Group, said: "The patent for Lijun's PD-1 molecule has broad application potential, and we are pleased to establish a partnership with Bright Peak to explore and realize the dual-targeting effect of new molecules through its innovative conjugation and protein engineering technology platform, benefiting a large number of patients with unmet medical needs." Dr. Yang Jiaming, Deputy General Manager of Lijun Biopharmaceuticals, said: "Lijun Biopharmaceuticals is very willing to leverage its existing pipeline and experience in biopharmaceutical R&D to support global innovative R&D together with partners. We believe this can further demonstrate Lijun Biopharmaceuticals' strength and readiness for global expansion."
According to the terms of the licensing agreement, BPTx will have the rights to develop, manufacture, and commercialize PD-1 ICs globally, while Lijun will have exclusive priority negotiation rights in Greater China. Lijun will receive a one-time cash upfront payment from BPTx, followed by milestone payments for development and registration submissions, as well as sales commissions based on global net sales. BPTx will undertake all activities related to the global development and commercialization of PD-1 ICs, but must comply with Lijun's priority negotiation rights in Greater China.
About LZM009
LZM009 is a human IgG4 monoclonal antibody that binds to the PD-1 molecule on the surface of T cells, blocking the PD-1/PD-1 ligand (PD-L1) pathway and reactivating T cells to kill cancer cells. LZM009 has been approved for clinical trials in China and the United States and has completed clinical dose exploration trials. LZM009 is undergoing Phase Ia extended clinical trials and key clinical trials for thymic cancer in China and has obtained initial safety and efficacy data.
About Bright Peak Therapeutics
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BPTx is a private biotechnology company headquartered in San Diego, USA, and Basel, Switzerland, dedicated to creating next-generation cytokine immunotherapies for patients with cancer and autoimmune diseases. BPTx is developing a new technology for the chemical synthesis of enhanced and synthesizable cytokines, leveraging the strong biological activity of cytokines while avoiding the severe side effects seen in first-generation therapies. BPTx's enhanced cytokines can easily bind to various molecules, such as monoclonal antibodies, creating a new type of "BPTx immune cytokine." BPTx is funded by a leading medical investment consortium.
About Lijun Biopharmaceuticals and Lijun Group
Lijun Biopharmaceuticals is a subsidiary of Lijun Group, established in 2010, specializing in the R&D of innovative antibody drugs, fusion/recombinant protein drugs, and other novel biopharmaceuticals in immuno-oncology, reproductive health, and autoimmune diseases. The company has a mature and diverse product pipeline. It has launched rHCG biosimilar products in the market and obtained marketing approval for IL6R monoclonal antibody biosimilars in China. Its unique recombinant SARS-CoV-2 fusion protein vaccine (V-01) has entered multiple global Phase III clinical trials as a COVID-19 preventive vaccine. Lijun Biopharmaceuticals' product pipeline also includes several antibody/recombinant protein and cell therapy pipelines in clinical and preclinical/concept validation stages. The company has strong CMC capabilities, a clear product development strategy, an experienced management team, and state-of-the-art manufacturing facilities.
Lijun Pharmaceutical Group Co., Ltd. (000513.SZ, 1513.HK) is a leading pharmaceutical company in China, established in 1985, and is an integrated pharmaceutical group with over 8,000 employees. Lijun is primarily engaged in the R&D, manufacturing, sales, and distribution of active pharmaceutical ingredients, small molecules, biologics, traditional Chinese medicine, and diagnostic products, covering multiple therapeutic areas including oncology, reproductive and gynecological health, gastrointestinal, anti-infection, mental health, and endocrinology.
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