Synthekine's Lupus Therapy SYNCAR-001 + STK-009 Receives FDA Fast Track Designation

Synthekine Inc., a company specializing in engineered cytokine therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational therapy SYNCAR-001 + STK-009. This therapy targets severe, refractory systemic lupus erythematosus (SLE) without the need for lymphodepletion.

SYNCAR-001 + STK-009 utilizes Synthekine's proprietary ortho IL-2 technology, forming a two-component therapy. SYNCAR-001 is an autologous chimeric antigen receptor T cell (CAR-T) designed to target CD19, and it expresses an engineered IL-2 receptor. This receptor selectively interacts with STK-009, an engineered IL-2 cytokine. SYNCAR-001 + STK-009 has shown promise in an ongoing Phase 1 study involving patients with CD19+ hematologic malignancies. The FDA has also recently approved an Investigational New Drug (IND) application for a Phase 1 study of SYNCAR-001 + STK-009 in patients with non-renal SLE and lupus nephritis (LN).

Debanjan Ray, CEO of Synthekine, highlighted the potential of CD19-targeted cell therapies in treating SLE, noting that traditional treatments often require lymphodepleting chemotherapy, which comes with a host of toxic side effects like cytopenias and infections. The Fast Track designation from the FDA will allow Synthekine to expedite the development and review process, potentially broadening the treatment options for patients with lupus and other autoimmune diseases. Ray expressed optimism about bringing SYNCAR-001 + STK-009 to patients in need more swiftly.

The upcoming multi-center, dose-escalation clinical trial will evaluate both the safety and clinical efficacy of SYNCAR-001 + STK-009 in patients with non-renal SLE and LN. Patients will receive a one-time, fixed dose of SYNCAR-001 cells, followed by a defined course of STK-009 administered weekly via subcutaneous injection.

The Fast Track designation aims to support the development and expedite the review process of drugs designed to treat serious and life-threatening conditions with unmet medical needs. This designation also allows for more frequent interactions with the FDA to discuss clinical trial designs and development plans, with the ultimate goal of bringing therapies to patients more quickly.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease marked by inflammation and potential irreversible damage to organs. It affects around 200,000 adults in the U.S. and presents a wide variety of symptoms, making it challenging to diagnose. Currently, there is no known cure for SLE, and existing treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and other immunosuppressants, offer limited benefits.

Lupus nephritis (LN) occurs in up to 50% of SLE patients and is a kidney disease that can begin concurrently with or shortly after the onset of non-kidney related SLE symptoms. Between 10% to 30% of LN patients may develop kidney failure. Current treatment options primarily aim to reduce kidney inflammation, but fewer than half of the patients achieve complete responses.

Synthekine is at the forefront of developing selective immunotherapies using cytokine biology to improve the treatment landscape for cancer and inflammatory diseases. By harnessing insights into cytokine structure and function, Synthekine is engineering therapeutics that maximize the efficacy of cytokines while minimizing their toxicities. The company's pipeline includes modified cytokines, cytokine-enhanced cell therapies, and surrogate cytokine agonists, all designed to provide targeted and effective treatment options for various diseases.