Synthekine Inc., a company specializing in engineered cytokine therapeutics, today announced that promising preclinical results from its murine STK-009 + SYNCAR-001 program will be presented at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C. The data highlights the potential of this combination to treat autoimmune diseases, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), without the need for lymphodepletion.
Synthekine to Present Promising Preclinical Data on STK-009 + SYNCAR-001 at ACR Convergence 2024
Synthekine Inc. will present preclinical data at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C., highlighting the efficacy of its STK-009 + SYNCAR-001 combination in treating autoimmune diseases without the need for lymphodepletion. The findings, based on murine models, demonstrate that the co-administration of murine STK-009 and SYNCAR-001 effectively depletes CD19+ B cells and delivers curative results in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) models.
In these non-lymphodepleted models, mSTK-009 provided targeted, controlled, and sustained cytokine support, enabling the expansion and activation of mSYNCAR-001 cells. In the SLE model, the combination reduced autoantibody production and reversed severe proteinuria, suggesting improved kidney function. In the RA model, mSTK-009 + mSYNCAR-001 led to the depletion of CD19+ B cells in affected joints, restored synovial tissue, and reversed arthritis.
Notably, in the absence of mSTK-009’s cytokine support, the efficacy of mSYNCAR-001 was significantly diminished in these lymphoreplete models, underscoring the importance of cytokine modulation for therapeutic success.
“We are excited to present these compelling data at ACR, which showcase the potential of STK-009 + SYNCAR-001 to treat autoimmune diseases like SLE and RA without the need for lymphodepletion,” said Debanjan Ray, CEO of Synthekine. “Traditional CD19 CAR-T therapies require lymphodepleting chemotherapy, which can be highly toxic for patients. Our data suggest that our cytokine-inducible approach can provide a safer, more effective alternative. We are currently enrolling patients in our clinical trials for non-renal SLE and lupus nephritis (LN) and are exploring other autoimmune indications.”
About STK-009 + SYNCAR-001
STK-009 + SYNCAR-001 is a two-component, cytokine-inducible cell therapy regimen based on Synthekine’s proprietary orthogonal IL-2 technology. The therapy consists of SYNCAR-001, an autologous CD19-targeting chimeric antigen receptor T cell (CAR-T) engineered to express an IL-2 receptor, and STK-009, an engineered pegylated IL-2 cytokine that selectively signals through the engineered receptor. This combination therapy is being investigated in ongoing Phase 1 trials for CD19+ hematologic malignancies (NCT05665062) and non-renal SLE and LN (NCT06544330). In September 2024, STK-009 + SYNCAR-001 received Fast Track designation from the U.S. FDA for treating severe, refractory SLE without the need for lymphodepletion.
ACR Presentation Details:
- Title: SYNCAR: An Engineered IL-2/IL-2R System That Selectively Enhances CD19 CAR-T Cells to Deplete B Cells and Provide Therapeutic Benefit in SLE and RA Mouse Models Without Lymphodepletion
- Session: SLE – Animal Models Poster
- Session Date & Time: Saturday, November 16, 2024, 10:30 AM – 12:30 PM ET
- Session Type: Poster Session A
- Abstract Number: 0087
A copy of the poster will be available on Synthekine’s website following the presentation.
About Synthekine
Synthekine is advancing selective immunotherapies by leveraging the therapeutic potential of cytokines to improve treatment outcomes for cancer and inflammatory diseases. By engineering cytokines to unlock their full efficacy while minimizing toxicities, the company is developing a pipeline of novel immunotherapies, including modified cytokines, cytokine-enhanced cell therapies, and surrogate cytokine agonists.
