• Replay and its oncology-focused product company Syena launched in collaboration with MD Anderson to target KRAS, p53, HPV16 and MAGE in expanded pipeline of engineered T-Cell Receptor-Natural Killer (TCR-NK) cell therapies
• TCRs discovered by cancer immunotherapy pioneer, Steven Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at National Institutes of Health’s National Cancer Institute
San Diego, California, London, UK, December 18, 2023 – Replay, a genome writing company reprogramming biology by writing and delivering big DNA, today announced that it has entered into an exclusive, worldwide license agreement with the National Institutes of Health (NIH) for intellectual property related to a library of T-Cell Receptors (TCRs) directed against multiple cancer neoantigens. These will be developed by Replay’s oncology-focused product company, Syena, to expand its pipeline of engineered T-Cell Receptor-Natural Killer (TCR-NK) cell therapies.
The TCRs, targeting validated cancer neoantigens KRAS, p53, HPV16 and MAGE, were discovered by Steven Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NIH National Cancer Institute’s (NCI) Center for Cancer Research and a pioneer of immunotherapies and gene therapies for advanced cancers.
Replay and The University of Texas MD Anderson Cancer Center launched Syena in February 2023 to create the next generation of engineered cell therapies, combining the safety, tolerability, efficacy and scalability of NK cells with the ability of TCRs to target intracellular tumor antigens. The portfolio of TCRs licensed from NIH expands Syena’s pipeline of engineered cell therapies that utilize its first-in-class TCR-NK cell platform, based on the scientific discoveries of Katy Rezvani, M.D., Ph.D., Professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson.
Preclinical development of the new TCR-NK programs will advance alongside the clinical development of Syena’s lead engineered TCR-NK cell therapy candidate targeting NY-ESO-1, and the PRAME program announced today. First-in-human Phase 1 studies of NY-ESO-1 TCR/IL-15 NK in patients with advanced synovial sarcoma, myxoid/round cell liposarcoma and relapsed or refractory multiple myeloma, will commence in Q4 of this year.
Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay, said: “The TCRs licensed from NIH address several cancer neoantigens of medical importance and will significantly expand our first-in-class, engineered TCR-NK therapy operations. These new targets will help establish TCR-NKs as a transformative ‘off-the-shelf’ engineered cell therapeutic modality with the potential to benefit patients across multiple different solid tumor and hematological malignancy indications.”
Lachlan MacKinnon, CEO and Co-Founder of Replay, said: “Engineered TCR-NK cells have the potential to form the basis of the next-generation of cancer cell therapies. With its now robust and diversified pipeline of TCR-NKs directed against multiple neoantigen targets commonly expressed in tumors, Syena is further positioning itself to be a leader in the field.”
Katy Rezvani, Scientific Founder of Syena, said: “TCR-antigen specificity remains at the heart of improved cancer immunotherapy. With this new collection of TCRs licensed from Dr Rosenberg’s laboratory at NIH we are excited to be bringing unique TCRs with the highest level of tumor specificity into Syena’s expanding engineered TCR-NK cell therapy pipeline.”
Steven Rosenberg, Chief, Surgery Branch in the Center for Cancer Research at NCI, said: “Advances in immunotherapy and gene therapy have transformed cancer care. And yet the most significant challenge in oncology remains finding cures for the metastatic, solid tumors of common cancers, which continue to cause around 90% of cancer deaths. The emergence of engineered TCR-NK cells as a potential therapeutic modality for cancer therapy is worth considering.”
Pursuant to the terms of the license agreement, Replay has been granted worldwide rights to develop, manufacture and commercialize the NIH’s TCR library within Syena’s first-in-class engineered TCR-NK cell platform. NIH will receive an undisclosed upfront payment from Replay and will be eligible for certain clinical, regulatory, and sales milestone payments, as well as royalties on net sales of products covered by the license.
Replay is a genome writing company, which aims to define the future of genomic medicine by designing, 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, M.D., Ph.D., 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.
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