SAN DIEGO and BASEL, Switzerland, Nov. 16, 2021 (GLOBE NEWSWIRE) — Bright Peak Therapeutics, Inc., a biotechnology company developing next-generation cytokine immunotherapies, today announced that it has entered into a license agreement with Livzon Mabpharm, Inc. (“Livzon”), a subsidiary company of Livzon Pharmaceutical Group, to use LZM009, Livzon’s proprietary anti-PD-1 monoclonal antibody currently in late-stage clinical trials, to develop novel PD-1 targeted immunocytokines (“PD-1 ICs”). The PD-1 ICs will be comprised of optimized cytokine payloads developed by Bright Peak conjugated to LZM009 for the treatment of a variety of cancers. PD-1 ICs are designed to selectively target and activate cytotoxic CD8+ T cells (“CTLs”) that express the inhibitory immune checkpoint PD-1 while avoiding the broad activation of other immune cells. Dual targeting of two receptors on the same CTL with a PD-1 inhibitor and a cytokine payload (cis-signaling) offers the added potential for synergistic efficacy.
Bright Peak is dedicated to creating next-generation immunotherapies that exploit the potent biological activity of cytokines while showing a significantly improved safety profile. Using Bright Peak’s unique chemical protein synthesis and engineering platform, cytokines can be precisely designed to fine-tune receptor binding, optimize efficacy, and simultaneously insert conjugation handles at any desired site in a protein. This allows for rapid conjugation of enhanced cytokines as payloads to commonly used antibodies, creating novel and proprietary “Bright Peak Immunocytokines.” One of the many advantages of Bright Peak’s technology is the ‘off-the-shelf’ ability to convert existing therapeutic antibodies into dual-targeting immunocytokines by a simple and rapid chemical process. The platform also readily enables the screening of various cytokine payloads with differential properties to elicit the desired biological effects. Moreover, Bright Peak’s approach allows the use of antibodies ‘as-is,’ avoiding the complex process of generating recombinant antibody-cytokine fusion proteins which involves lengthy protein expression, optimization and cell-line development.
“We are delighted to license Livzon’s anti-PD-1 monoclonal antibody LZM009 to broadly develop PD-1 directed immunocytokines by leveraging our proprietary platform technology,” said Fredrik Wiklund, President and Chief Executive Officer of Bright Peak. “PD-1 inhibitors have changed the landscape of cancer therapy in recent years. However, despite the remarkable efficacy observed in a subset of patients treated with PD-1 inhibitors, most patients do not respond. Bright Peak’s PD-1 ICs have the potential to enhance the activity of PD-1 inhibition to bring the promise of immunotherapy to a greater number of patients.”
“We are excited to apply the power and versatility of our synthetic protein engineering platform to generate PD-1 ICs by conjugating optimized cytokine payloads to a clinical stage antibody. PD-1 ICs are designed to utilize the concept of cis-signaling cytokines acting on the same cell that is targeted by the anti-PD-1 antibody. As a result, they are more potent and selective and have an increased capacity to induce superior CD8+ T cell responses,” said Bertolt Kreft, Ph.D., Chief Scientific Officer of Bright Peak.
“Livzon’s PD-1 molecule has proprietary patents with broad application potential, and we are very happy to enter into an agreement with Bright Peak who possesses an innovative conjugation and protein engineering technology platform to explore and achieve dual-targeting effects of novel molecules to benefit patients with unmet medical needs,” said Jianing Liu, Ph.D., Chief Investment Officer and Head of BD of Livzon Pharmaceutical Group. “Livzon Mabpharm is more than happy to support innovative global R&D with inspiring partners leveraging on our existing pipelines and experience in biologics, and we believe this is one step further to demonstrate Livzon MabPharm’s capabilities and readiness for global outreach,” said Jiaming Yang, Ph.D., Executive Vice President of Livzon Mabpharm, Inc.
Under the terms of the license agreement, Bright Peak will receive the right to develop, manufacture and commercialize PD-1 ICs on a worldwide basis while Livzon retains certain rights of first negotiation to obtain exclusivity in the greater China territory. Livzon will receive a one-time upfront cash payment from Bright Peak and is eligible to receive additional cash payments upon the achievement of future development and regulatory milestones, as well as royalties in the low-to-mid single digit percentage range on worldwide net sales. Bright Peak will solely control and fund all activities related to development and commercialization on a worldwide basis, subject to Livzon’s right of first negotiation in greater China.
LZM009 is a human IgG4 monoclonal antibody which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T cells to kill cancer cells. LZM009 has been approved for clinical trials and completed clinical dose exploration trials in both China and the United States. LZM009 is undergoing extensive clinical trials, including pivotal trials in thymic cancer in China, with promising initial safety and efficacy data.
About Bright Peak
Bright Peak is a privately held biotechnology company based in San Diego, USA and Basel, Switzerland dedicated to creating next-generation cytokine immunotherapies for the treatment of patients with cancer and autoimmune disease. Bright Peak is pioneering a novel technology to chemically synthesize enhanced and conjugatable cytokines that exploits the potent biological activity of cytokines while avoiding the severe side effects associated with first-generation therapies. Bright Peak’s enhanced cytokines can be easily conjugated to a diverse array of molecules, such as monoclonal antibodies, creating a novel class of “Bright Peak Immunocytokines.” Bright Peak is funded by a syndicate of leading healthcare investors.
About Livzon MabPharm and Livzon Pharmaceutical Group
Livzon MabPharm, a subsidiary company of Livzon Pharmaceutical Group, was founded in 2010, and specialized in R&D of innovative antibody drugs, fusion/ recombinant protein drugs, and other novel biologics in immune oncology, reproduction and autoimmune diseases. The company has a mature and diversified product pipeline. The company has launched a rHCG biosimilar product, and obtained BLA approval for IL6R McAb biosimilar in China. The company’s proprietary Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) has entered multiple global Phase III clinical trials as a COVID-19 prophylaxis vaccine. The company also has a number of antibody/recombinant protein products in clinical development and cell therapy products in the preclinical/POC stage. Livzon MabPharm is equipped with strong CMC capabilities, clear product development strategy, a seasoned management team and state-of-the-art manufacturing facilities.
Livzon Pharmaceutical Group Inc., (000513.SZ, 1513.HK), a leading PRC pharmaceutical company established in 1985, is a fully-integrated pharmaceutical group with more than 8,000 employees. Livzon is principally engaged in the research and development, manufacturing, sales and distribution of active pharmaceutical ingredients, small molecules, biologics, traditional Chinese medicine as well as diagnostic products in various therapeutic areas including oncology, reproduction and gynecology, gastroenterology, anti-infection, neurology and endocrinology.