Miltenyi Biotec B.V. & Co. KG. (12/18/23). "Press Release: Miltenyi Biotec and Replay’s Oncology-focused Product Company Syena Enter into Exclusive Licensing and GMP Manufacturing Agreement for PRAME TCR-NK Cell Therapy Based on CliniMACS Prodigy". Bergi

	Organisation	Miltenyi Biotec B.V. & Co. KG
	Group	Miltenyi Biotec (Group)
	Organisation 2	Syena (Replay / MD Anderson)
	Product	CliniMACS Prodigy® platform
	Person	Stoffel, Boris (Miltenyi Biotec 201301 CEO before Memorec Stoffel)
	Person 2	Woolfson, Adrian (Replay 202208 Executive Chair + Co-Founder before Sangamo + Nouscom + Pfizer + BMS)

> Miltenyi Biotec to supply scalable, GMP-compliant, PRAME-targeted TCR-NK cell therapy product using the CliniMACS Prodigy® system for clinical development and future commercial supply

> Syena secures exclusive license to Miltenyi Biotec’s PRAME TCR

> Syena, co-founded by Replay and MD Anderson in 2023, will develop an off-the-shelf PRAME TCR-NK cell therapy, with IND anticipated Q1 2024

Miltenyi Biotec, a global provider of products and services for biomedical research and cellular therapy and Replay, a genome writing company reprogramming biology by writing, designing and delivering big DNA, today announced 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 terms of 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.

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 commence in Q4 of this year.

Dr Boris Stoffel, Managing Director and Member of the Executive Board of Miltenyi Biotec, said: “At Miltenyi Biotec, we bring over 30 years of expertise in developing innovative products and solutions for cell and gene therapy and biomedical research. In line with our mission to advance cell therapies to treat patients with cancer and other serious diseases, we’re excited to collaborate with Replay and the Syena team on their GMP-compliant PRAME TCR-NK cell therapy product.”

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.”

About Miltenyi Biotec

Miltenyi Biotec is a global leader innovating products and services that empower biomedical research and advance cellular therapy. The company's solutions support all stages of cell and gene therapy product development from process and analytical development to commercial-scale manufacturing. Its platform technologies have set industry standards in automated, integrated manufacturing and analysis of complex cellular products such as CAR-T cells, TCR-T cells, gene-modified NK and stem cells. Miltenyi Biotec’s comprehensive product portfolio is complemented by CDMO services for lentiviral vectors and cell manufacturing. The company has more than 4,700 employees in 23 countries and its products have been used in more than 100,000 cell therapy procedures.

Miltenyi Bioindustry, as a division of Miltenyi Biotec, uses its end-to-end expertise towards developing and manufacturing lentiviral vectors and cell and gene therapy products based on the CliniMACS Prodigy® fully automated cell manufacturing platform – from pre-clinical to commercial scale.

Miltenyi Biotec is headquartered in Bergisch Gladbach, Germany. For further information please visit www.miltenyibiotec.com and follow us on LinkedIn and X/Twitter.

About Replay

Replay is a genome writing company, which aims to define the future of genomic medicine through reprogramming biology by writing and delivering big DNA. The Company has assembled a toolkit of disruptive platform technologies — including a high payload capacity HSV platform, a hypoimmunogenic cell therapy platform, and a genome writing platform — to address the challenges currently limiting clinical progress and preventing genomic medicine from realizing its potential.

The Company’s hub-and-spoke business model separates technology development within Replay from therapeutic development in a portfolio of product companies that leverage its technology platforms. For example, the Company recently incorporated a first-in-class engineered TCR-NK cell therapy product company using technology developed by Katy Rezvani, MD, PhD, at The University of Texas MD Anderson Cancer Center in Houston, Texas. Replay’s synHSV™ technology, a high payload capacity HSV vector capable of delivering up to 30 times the payload of AAV, is utilized by Replay’s four gene therapy product companies, bringing big DNA treatments to diseases affecting the skin, eye, brain, and muscle. Replay is led by a distinguished team of academics, entrepreneurs, and industry experts.

The Company raised $55 million in seed financing in July 2022 and is supported by an international syndicate of investors including: KKR, OMX Ventures, ARTIS Ventures, and Lansdowne Partners.

Replay is headquartered in San Diego, California. For further information please visit www.replay.bio and follow us on LinkedIn and X/Twitter.

Contacts

Miltenyi Biotec B.V. & Co. KG – Corporate Communications
Kim Münster
corpcom@miltenyi.com

Replay
Dr Adrian Woolfson/Lachlan MacKinnon
info@replay.bio

ICR Consilium – Media Relations, Replay
Amber Fennell/Tracy Cheung/David Daley
replay@consilium-comms.com

Record changed: 2024-01-20