Syena Begins Phase 1/2 Trial with First Patient Dosed for Multiple Myeloma TCR-NK Therapy

Syena, a subsidiary of Replay, has initiated a Phase 1/2 clinical trial for its innovative TCR-NK cell therapy, targeting relapsed or refractory multiple myeloma. The therapy, known as NY-ESO-1 TCR/IL-15 NK, is a breakthrough in engineered cell treatments, utilizing natural killer cells derived from cord blood. These cells are equipped with a TCR that specifically targets the NY-ESO-1 antigen, a protein overexpressed in various cancers but not in healthy tissues, making it an ideal target for immunotherapy.

The study, which follows standard lymphodepletion protocols with fludarabine/cyclophosphamide, plans to include up to 44 participants. The primary objectives are to evaluate the safety and efficacy of the treatment. Replay's leadership expressed enthusiasm about the trial's commencement, highlighting the potential of 'off-the-shelf' cell therapies to meet significant medical needs and the rapid progress made thus far.

Syena's development is based on the pioneering work of Professor Katy Rezvani from MD Anderson, who holds an exclusive license for the TCR-NK technology platform. The company's focus on using cord blood donors is anticipated to enhance patient outcomes, and the support from clinical sites and development teams is crucial for the advancement of this novel treatment.

Replay, the parent company, is dedicated to shaping the future of genomic medicine through its genome writing capabilities. It has developed a suite of technologies to overcome current clinical challenges and unlock the full potential of genomic medicine. The company operates a hub-and-spoke model, with Replay focusing on technology development while its product companies, like Syena, leverage these platforms for therapeutic development.

Replay's technology, including its synHSV™ vector, which can deliver significantly larger payloads than AAV, is instrumental in bringing transformative treatments to genetic diseases affecting the skin and eyes. The company is backed by a diverse group of international investors and has raised substantial funding to support its mission.