FDA Grants Fast Track Designation for First Deep-Primed T Cell Cancer Immunotherapy Program

Torque announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Torque's first Deep-Primed™ T cell immunotherapy program, TRQ-1501 (Deep IL-15 Primed T cells). The Fast Track designation is for the treatment of relapsed or refractory solid tumors and lymphomas that express any of five tumor-associated antigens (PRAME, WT-1, SSX2, Survivin, and NY-ESO-1). Torque is currently conducting a Phase 1/2 clinical trial of TRQ-1501 for this indication.

"Patients with relapsed or refractory solid tumors and lymphomas have a poor prognosis and limited treatment options. We are delighted to receive this Fast Track designation of TRQ-1501 for a broad, tumor-agnostic indication, which provides significant flexibility for our clinical trial program," said Becker Hewes, MD, Chief Medical Officer of Torque. "Working in close collaboration with the FDA supports our goal of improving patient outcomes in multiple difficult-to-treat solid and hematologic cancers."

The FDA's Fast Track designation is designed to facilitate the development and expedite the regulatory review of drugs and biologics that have shown the potential to address an unmet medical need associated with a serious or life-threatening disease. Fast Track status provides for more frequent interactions with the FDA during drug development and the possibility of Priority Review of New Drug or Biologic Licensing Applications.

TRQ-1501 is an investigational immune cell therapy produced from a patient's own T cells, which are primed to target multiple tumor-associated antigens (PRAME, WT-1, SSX2, Survivin, NY-ESO-1) and loaded with Deep IL-15 (a multimer of IL-15 cytokine) anchored to the T cells' surface. A Phase 1/2 clinical trial of TRQ-1501 in solid cancers and lymphoma is currently enrolling (NCT03815682) and will evaluate TRQ-1501 both as a single agent and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy.

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