Synthekine Doses First Patient in Phase 1 Clinical Trial of Orthogonal IL-2 and CD19 CAR-T Combination Therapy, STK-009 + SYNCAR-001, for Treatment of CD19+ Hematologic Malignancies

MENLO PARK, Calif.--(BUSINESS WIRE)-- Synthekine Inc., a leader in engineered cytokine therapeutics, today announced that the first patient has been dosed in a Phase 1 clinical trial of its orthogonal IL-2 and CD19 CAR-T combination therapy, STK-009 + SYNCAR-001, in adults with relapsed or refractory CD19+ hematologic malignancies. STK-009 + SYNCAR-001 is a two-component therapy consisting of SYNCAR-001, a CD19-targeting chimeric antigen receptor T cell (CAR-T) which expresses an engineered IL-2 receptor allowing it to selectively receive a signal from STK-009, an engineered pegylated IL-2 cytokine.

“SYNCAR-001 + STK-009 is our second clinical stage program at Synthekine and represents another key milestone in our journey to develop novel cytokine therapeutics for patients with refractory cancers,” said Debanjan Ray, chief executive officer of Synthekine. “Our orthogonal IL-2 system is a unique platform that breaks new ground in the field of cell therapy. Combining STK-009 with SYNCAR-001 has the potential to overcome key limitations associated with current CD19 CAR-T cell therapies, such as poor expansion and limited persistence following T cell transfer. These limitations have been shown to correlate with poor response and relapse, particularly in challenging hematological malignancies. We look forward to further evaluating STK-009’s ability to offer a safer approach with improved efficacy and durability.”

Published results from preclinical studies show that treatment with STK-009 resulted in both systemic and intratumoral expansion and activation of SYNCAR-001 cells. As a result, even with substantially reduced cell doses, SYNCAR-001 together with STK-009 treatment was able to drive complete responses in large lymphoma tumors in preclinical models.

“While CAR-T cell therapies have had a major impact for patients with CD19+ hematologic malignancies, only a subset of these patients have durable benefit,” said Naiyer Rizvi, M.D., chief medical officer of Synthekine. “We believe that controllable, selective and sustained cytokine support is central to the advancement of this class of treatment, and STK-009 + SYNCAR-001 has the potential to drive deeper and more durable responses while avoiding serious toxicities related to uncontrolled CAR-T cell expansion for patients in need of better treatment options.”

The first-in-human Phase 1 clinical trial of SYNCAR-001 + STK-009 is an open-label, multi-center study enrolling patients with CD19+ hematologic malignancies. For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05665062.

About Synthekine

Synthekine is harnessing the potential of cytokine therapeutics to develop selective immunotherapies designed to improve the treatment paradigm of cancer and inflammatory disease. Using insights on cytokine structure and function, the company engineers therapeutics designed to unlock the full efficacy potential of cytokines while avoiding their associated toxicities. Synthekine is applying principles of cytokine partial agonism and immunological specificity across multiple protein engineering platforms to create a broad and deep pipeline of product candidates. These novel immunotherapies include modified cytokines, cytokine-enhanced cell therapies and surrogate cytokine agonists. For more information, visit www.synthekine.com, and follow us on Twitter @synthekine and LinkedIn.

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