On December 7, 2020 Synthekine Inc., an engineered cytokine therapeutics company, reported in vivo data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing STK-009, its orthogonal IL-2 ligand, improved the efficacy and durability of SYNCAR-001, its CD-19 targeted CAR-T cell therapy modified with an orthogonal IL-2 receptor (Press release, Synthekine, DEC 7, 2020, View Source [SID1234572367]). The data were delivered in a poster presentation by Paul-Joseph Aspuria, Ph.D., of Synthekine.
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"While CAR-T therapies have proven to be very effective in treating hematological malignancies, the lack of sustained activity and CAR-T cell persistence limits their full therapeutic potential in lymphoma," said Martin Oft, M.D., chief development officer at Synthekine. "The presented data demonstrate our orthogonal IL-2 system is well positioned to overcome these shortcomings. STK-009 demonstrates the ability to expand CAR-Ts in vivo in pre-clinical models, allowing for a lower starting dose of CARs while achieving deep and durable efficacy with the possibility to re-expand resting CARs long after initial transfer. We look forward to advancing STK-009 and SYNCAR-001 and filing an IND for the program in 2021."
In both disseminated and subcutaneous RAJI lymphoma models in mice evaluating the efficacy of STK-009 with SYNCAR-001, STK-009 dosing drove increased levels of circulating SYNCAR-001 cells, resulting in complete responses. STK-009 expanded both CAR-T effector cells and stem cell memory cells, resulting in deep initial responses and long-term immune surveillance. Data on STK-009 from a multiple-ascending dose study in non-human primates were also presented, showing STK-009 was well tolerated, had long exposure, and had no effect on cells expressing only the wild type IL-2 receptor. A copy of the poster is available on Synthekine’s website.
"Selectivity of this orthogonal IL-2 ligand is fundamental, as more promiscuous activity on bystander cells could lead to systemic toxicity and limit the therapeutic potential of this combined treatment," said Dr. Aspuria. "Based on the data we presented, we are optimistic about the potential for STK-009 and SYNCAR-001 to overcome hurdles faced by CD-19 cell therapy today."