Replay Announces First-Ever TCR-NK Cell Therapy Enters Clinical Trials for Advanced Sarcomas

Mar 16, 2024 11:53 CST Updated 11:53

Replay

Next-Generation Genomic Medicine Technology Researcher

Recently, biopharmaceutical company Replay announced that the phase 1/2 study of its candidate drug NY-ESO-1 TCR/IL-15 NK has begun, with the first patient having received dosing. NY-ESO-1 TCR/IL-15 NK is an engineered T-cell receptor natural killer (TCR NK) cell therapy for the treatment of advanced synovial sarcoma and myxoid/round cell liposarcoma. This cell therapy is based on scientific discoveries by Professor Katy Rezvani and was co-developed by Replay and MD Anderson.

July 24, 2023, University of TexasMD Anderson（MD Anderson) Cancer Center and Replay announce that the Investigational New Drug (IND) application for NY-ESO-1 TCR/IL-15 NK has been approved by the U.S. Food and Drug Administration (FDA).

The development of NY-ESO-1 TCR/IL-15 NK is being carried out by Syena, an oncology product company co-founded by Replay and the University of Texas MD Anderson Cancer Center.Syena has an MDAndersonExclusive License Agreement for the TCR NK Platform. This first-class engineered cell therapy consists of umbilical cord blood-derived NK cells that express affinity-enhanced T-cell receptors (TCR) targeting the NY-ESO-1 cancer-associated antigen, which is highly immunogenic and expressed across various types of cancer cells. The ability of NY-ESO-1 to elicit both humoral and cellular immune responses, along with its limited tissue expression, makes it a compelling target for cancer immunotherapy.

Sarcoma Clinical Trials

The Phase I/Ib study will evaluate the safety and efficacy of NY-ESO-1 TCR/IL-15 NK in patients with synovial sarcoma and myxoid/round cell liposarcoma. The drug will beAdministered after lymphodepletion with standard doses of fludarabine/cyclophosphamide (Flu/Cy), the study will enroll approximately 44 patients.

Dr. Katy Rezvani

Replay Executive Chairman, President, and Co-founder Adrian Woolfson previously stated: "Syena is leveraging the scalability and allogeneic properties of engineered cord blood-derived NK cells to democratize cell therapy for cancer treatment. The FDA's previous IND approval for the first human TCR NK protocol marks an important milestone for Syena. Syena is one step closer to providing a first-class 'off-the-shelf' engineered TCR NK therapy for patients with solid tumors."

RezvaniPreviously stated: "Synovial and myxoid/round cell liposarcoma exhibit high levels and frequencies of cellular expression of NY-ESO-1, making them an excellent tumor type for establishing proof-of-concept for the TCR NK platform. I am pleased with the team's progress and look forward to the results of the Phase I/Ib study."

" About Replay "

Replay is a gene-editing company headquartered in San Diego, California, aiming to reprogram cells by editing and delivering large DNA. The company has assembled a disruptive platform technology toolkit, including an HSV delivery platform with high payload capacity.So far, the company hasRaised $85 million and gained support from an international consortium of investors, including KKR, OMX Ventures, ARTIS Ventures, Lansdowne Partners, and the Bill & Melinda Gates Foundation.。

Source:https://www.globenewswire.com/

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