FDA News

FDA grants fast track designation to TRQ-1501 T-cell therapy for solid tumors, lymphoma

The FDA granted fast track designation to TRQ-1501, a deep-primed IL-15 T-cell immunotherapy for the treatment of relapsed or refractory solid tumors and lymphomas that express any of five tumor-associated antigens, according to the agent’s manufacturer.

The tumor-associated antigens include PRAME, WT-1, SSX2, survivin and NY-ESO-1.

TRQ-1501 deep IL-15 primed T cells (Torque) in an investigational autologous T-cell immunotherapy that targets multiple antigens expressed on a tumor cell’s surface. It uses Torque’s proprietary “Deep-Priming” technology to develop multitargeted antigen-primed T cells loaded with deep IL-15, a multimer of the IL-15 cytokine, anchored to the T-cell surface, according to a press release.

“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,” Becker Hewes, MD, chief medical officer of Torque, said in the release.

“Working in close collaboration with the FDA supports our goal of improving patient outcomes in multiple difficult-to-treat solid and hematologic cancers,” he added.

A phase 1/phase 2 clinical trial of TRQ-1501 is currently enrolling patients (NCT03815682). The first-in-human, phase 1, open-label, multicenter, dose-escalation portion of the study is designed to determine the safety and tolerability of TRQ-1501 in patients with relapsed or refractory or locally advanced solid tumors or lymphomas.

The trial will evaluate TRQ-1501 as a single agent and in combination with pembrolizumab (Keytruda, Merck). The study will include a dose-escalation phase followed by a dose-expansion phase.

The FDA granted fast track designation to TRQ-1501, a deep-primed IL-15 T-cell immunotherapy for the treatment of relapsed or refractory solid tumors and lymphomas that express any of five tumor-associated antigens, according to the agent’s manufacturer.

The tumor-associated antigens include PRAME, WT-1, SSX2, survivin and NY-ESO-1.

TRQ-1501 deep IL-15 primed T cells (Torque) in an investigational autologous T-cell immunotherapy that targets multiple antigens expressed on a tumor cell’s surface. It uses Torque’s proprietary “Deep-Priming” technology to develop multitargeted antigen-primed T cells loaded with deep IL-15, a multimer of the IL-15 cytokine, anchored to the T-cell surface, according to a press release.

“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,” Becker Hewes, MD, chief medical officer of Torque, said in the release.

“Working in close collaboration with the FDA supports our goal of improving patient outcomes in multiple difficult-to-treat solid and hematologic cancers,” he added.

A phase 1/phase 2 clinical trial of TRQ-1501 is currently enrolling patients (NCT03815682). The first-in-human, phase 1, open-label, multicenter, dose-escalation portion of the study is designed to determine the safety and tolerability of TRQ-1501 in patients with relapsed or refractory or locally advanced solid tumors or lymphomas.

The trial will evaluate TRQ-1501 as a single agent and in combination with pembrolizumab (Keytruda, Merck). The study will include a dose-escalation phase followed by a dose-expansion phase.

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