Replay, a genome writing company reprogramming biology by writing, designing and delivering big DNA, and Miltenyi Biotec, a global provider of products and services for biomedical research and cellular therapy, entered into a licensing and manufacturing agreement to support the development of a GMP-compliant T-cell receptor (TCR) natural killer (NK) cell therapy targeting the tumor-associated neoantigen, PRAME.

Under the agreement, Syena, the oncology-focused engineered cell therapy product company launched jointly by Replay and The University of Texas MD Anderson Cancer Center in February 2023, has secured an exclusive license to Miltenyi Biotec’s PRAME (PReferentially expressed Antigen in MElanoma) TCR. Miltenyi Biotec will use 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 provision of future commercial supply.

According to Replay, PRAME has been extensively investigated by researchers as a target for cancer immunotherapy. It is highly expressed across a broad range of tumor types and has minimal expression in healthy tissue. It is the second validated cancer neoantigen to be targeted by Syena, which is creating the next generation of off-the-shelf cell therapies combining the safety, tolerability, efficacy, and scalability of NK cells with the ability of TCRs to target intracellular tumor antigens. The company’s first target, NY-ESO-1, is being investigated in relapsed or refractory multiple myeloma, synovial sarcoma, and myxoid/round cell liposarcoma.

Following two recent IND clearances, the Phase I/II clinical studies are anticipated to begin soon.

Adrian Woolfson, executive chairman, president, and co-founder of Replay said, “PRAME is an extensively validated target for immunotherapy in both solid tumors and hematological malignancies. It comprises a compelling addition to our expanding portfolio of targets for our first-in-class engineered TCR-NK cord blood derived cell therapies. We are, additionally, delighted to have Syena partner with Miltenyi Biotec at this early stage to use their CliniMACS Prodigy cell manufacturing system to lock down our GMP commercial supply.”

Lachlan MacKinnon, CEO, and co-Founder of Replay, said, “Miltenyi Biotec’s extensive expertise and manufacturing capabilities will enable us to swiftly advance the clinical development of our cell therapy programs by providing a GMP-grade, commercial-scale supply of cell therapy products. This agreement demonstrates our confidence in our off-the-shelf TCR-NK therapies against a target with significant medical and commercial potential.”