Benzinga | Jul 7, 2021 07:05AM EDT

PureTech Announces Clinical Trial and Supply Agreement with BeiGene to Evaluate LYT-200 and Tislelizumab in Patients with Difficult-to-Treat Solid Tumors

PureTech Health plc (NASDAQ:PRTC, LSE: PRTC))) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced a clinical trial and supply agreement with an affiliate of BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160))) to evaluate BeiGene's tislelizumab, an anti-PD-1 immune checkpoint inhibitor, in combination with PureTech's LYT-200, an investigational monoclonal antibody targeting galectin-9, for the potential treatment of difficult-to-treat solid tumor indications that are associated with poor survival rates.

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PureTech announced a clinical trial and supply agreement with BeiGene to evaluate BeiGene's tislelizumab, an anti-PD-1 immune checkpoint inhibitor, in combination with PureTech's LYT-200, an investigational monoclonal antibody targeting galectin-9, for the potential treatment of difficult-to-treat solid tumor indications that are associated with poor survival rates. (Photo: Business Wire)

Galectin-9 is a pivotal immune modulator widely expressed in multiple difficult-to-treat tumor types and involved in the regulation of tumor promoting inflammatory and immunosuppressive pathways. Inhibition of galectin-9 with targeted antibodies leads to upregulation of immunostimulatory cytokines and anti-tumor activity in preclinical cancer models. LYT-200 is currently being evaluated as a single agent in the first phase of an adaptive Phase 1/2 clinical trial, which, based upon the trial protocol, will be followed by the portion of the trial intended to investigate LYT-200 in combination with tislelizumab. PureTech expects to report topline Phase 1 results in the fourth quarter of 2021. In addition, PureTech plans to investigate LYT-200 as a single agent and in combination with other anti-cancer treatments, including chemotherapy and other immunotherapies.

Tislelizumab is potentially differentiated from the currently approved programmed cell death protein 1 (PD-1) antibodies in an engineered fragment crystallizable region (Fc region), which in preclinical studies has been shown to minimize potentially negative interactions with other immune cells. Tislelizumab has been approved in China for four solid tumor indications and regulatory decisions are pending for two additional indications. In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan.

"After a decade of optimizing use of immuno-oncology therapies, such as the checkpoint inhibitors that have certainly provided a paradigm shift in treating malignant diseases, we in the industry are eager to advance novel breakthrough agents and combinations to serve a wider range of cancer patients. Patients need new options as the first wave of immunotherapies work only in a small percentage of them. Well thought-out combination immunotherapy regimens may be that way forward," said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech. "We believe LYT-200 has the potential to engage the immune system against what are currently intractable cancers, both as a single agent and in combination with checkpoint inhibitors. We look forward to evaluating whether LYT-200 in combination with BeiGene's tislelizumab can improve outcomes for patients with metastatic solid tumors."

Under the terms of the agreement, PureTech will maintain control of the LYT-200 program, including global R&D and commercial rights. BeiGene has agreed to supply tislelizumab for use in combination with LYT-200.