Replay, a genome writing company specializing in reprogramming biology through the design and delivery of large DNA, has partnered with Miltenyi Biotec, a global provider of biomedical research and cellular therapy products and services. The collaboration aims to support the development of a T-cell receptor (TCR) natural killer (NK) cell therapy targeting the tumor-associated neoantigen PRAME, through a licensing and manufacturing agreement.

Under the terms of the agreement, Syena, an oncology-focused engineered cell therapy product company launched jointly by Replay and The University of Texas MD Anderson Cancer Center in February 2023, has obtained an exclusive license to Miltenyi Biotec’s PRAME TCR. Miltenyi Biotec will leverage its CliniMACS Prodigy® closed and automated cell processing platform to manufacture a scalable, GMP-compliant, PRAME-targeted TCR-NK cell therapy product for clinical development and future commercial supply.

PRAME, known as PReferentially expressed Antigen in MElanoma, has been extensively studied as a target for cancer immunotherapy due to its high expression across various tumor types with minimal expression in healthy tissue. Syena is working to create off-the-shelf cell therapies that combine the safety, tolerability, efficacy, and scalability of NK cells with the targeting ability of TCRs for intracellular tumor antigens. The company's first target, NY-ESO-1, is currently under investigation in Phase I/II clinical studies for relapsed or refractory multiple myeloma, synovial sarcoma, and myxoid/round cell liposarcoma.

Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay, expressed enthusiasm for adding PRAME to their expanding portfolio of targets for TCR-NK cord blood-derived cell therapies. The collaboration with Miltenyi Biotec is seen as a significant step toward securing a GMP commercial supply using their CliniMACS Prodigy® cell manufacturing system.

Lachlan MacKinnon, CEO, and Co-Founder of Replay, emphasized the expertise and manufacturing capabilities of Miltenyi Biotec, enabling the swift advancement of clinical development for their cell therapy programs with a GMP-grade, commercial-scale supply of cell therapy products. The agreement reflects confidence in the potential of off-the-shelf TCR-NK therapies against targets with significant medical and commercial promise.

Dr. Boris Stoffel, Managing Director and Member of the Executive Board of Miltenyi Biotec, highlighted the company's 30 years of expertise in developing innovative products and solutions for cell and gene therapy. He expressed excitement about collaborating with Replay and the Syena team on their GMP-compliant PRAME TCR-NK cell therapy product, aligning with Miltenyi Biotec's mission to advance cell therapies for treating patients with cancer and other serious diseases.

 

Source: globenewswire.com

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