Healthcare Industry News: HSMN NewsFeed
News Release - June 18, 2019
FDA Grants Fast Track Designation for Torque's First Deep-Primed T Cell Cancer Immunotherapy Program, TRQ-1501CAMBRIDGE, Mass., June 18, 2019 -- (Healthcare Sales & Marketing Network) -- Torque, a clinical-stage immuno-oncology company developing Deep-Primed™ T Cell Therapeutics to direct immune power deep within the tumor microenvironment, announced today that 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.
About Torque's Deep-Primed™ Immune Cell Therapy Platform
Torque is developing a new class of Deep-Primed™ cellular immunotherapy designed to overcome the key challenges limiting broad use of cellular therapy in oncology, including the capability to target tumors that express multiple heterogeneous antigens, the ability to overcome the immunosuppressive microenvironment that shuts down T cell function, and the need for outpatient treatment with a high margin of safety. Torque uses its Deep-Priming technology to develop multi-targeted, antigen-primed T cells that carry surface-anchored immune-stimulatory drugs to drive a full immune response within the tumor microenvironment against tumors with heterogenous antigens.
Torque's Deep-Priming platform uses advanced cell process engineering to:
- prime and activate T cells to target multiple tumor antigens and
- tether immune-stimulatory drugs to the surface of these multi-target T cells to direct immune activation in the tumor microenvironment
- using a proprietary technology platform, without genetic engineering, for a high margin of safety.
In hematologic cancers, this new class of immune cell therapeutics has the potential to improve on the initial success of single-target CAR T therapeutics with expanded efficacy and also move cell therapy treatment out of the hospital with a high margin of safety. For solid tumors, Deep-Primed T cells have the potential to enable efficacy against tumors with heterogeneous antigens protected by hostile microenvironments, which are not readily addressable with the first generation of immune cell therapies.
About Torque (www.torquetx.com)
Torque is a clinical-stage immuno-oncology company developing Deep-Primed™ T cell immunotherapy to direct immune power deep within the tumor microenvironment. Torque's lead product candidate—TRQ-1501 (Deep IL-15 Primed T cells)—is in a Phase 1/2 clinical trial for solid tumors and hematologic cancers. The company is based in Cambridge, Massachusetts.
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