FDA Grants Fast Track Status to Immunotherapy Candidate TRQ-1501 for Some Solid Tumors, Lymphomas

TRQ-1501, an experimental immune cell cancer therapy developed by Torque, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of certain hard-to-treat solid tumors and lymphomas.

The designation is given to therapies that show potential to treat serious health conditions, and is intended to accelerate their development and approval by providing more frequent meetings and discussions with the FDA.

“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 a press release.

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

TRQ-1501 was developed using Torque’s Deep-Priming technology. The therapy uses a patient’s own T-cells, which are modified to target multiple tumor proteins — PRAME, WT-1, SSX2, Survivin, and NY-ESO-1 — and able to target a number of cancer types.

The modified T-cells are also loaded with an immune-stimulatory cytokine, called interleukin (IL)-15, together with other immune-stimulatory agents, resulting in a direct immune activation within the tumor microenvironment.

By targeting multiple tumor proteins and promoting immune activation within tumors mostly, Torque’s Deep-Priming platform overcomes some of the key challenges of cellular therapies, which include treatment resistance, the inability to target more than one cancer type, and overactive immune systems.

A Phase 1/2 clinical trial (NCT03815682) is currently recruiting patients with advanced and hard-to-treat solid tumors and lymphomas to evaluate the safety and tolerability of TRQ-1501.

Enrolled patients, a total of 80, will receive escalating doses of TRQ-1501 to determine the safest and most effective dosage, which will then be further tested in the dose-expansion phase.

The trial will evaluate TRQ-1501 alone and in combination with Merck‘s Keytruda (pembrolizumab), a checkpoint blockade immunotherapy designed to prevent cancer cells from avoiding being targeted and killed by immune cells.

“We are grateful to the patients and clinical researchers contributing to Torque’s first Deep-Primed T Cell clinical program,” Bart Henderson, chief executive officer of Torque, said in a press release about the trial.

“We developed Deep-Primed T cells to overcome the main challenges limiting cellular immunotherapy — the ability to target heterogenous tumors, overcome immunosuppression in the tumor microenvironment, and administration as outpatient therapy — and our hope is that this innovative treatment will shift the treatment paradigm, improving patient outcomes in multiple difficult-to-treat solid and hematologic cancers,” he added.