Expanded Access Policy

Torque Therapeutics is dedicated to the discovery and development of a new class of T cell therapeutics for patients with solid tumors and hematologic malignancies. This novel class of T cell therapeutics directs immune power deep within the tumor microenvironment. Our goal is to provide patients with access to our investigational therapies through ongoing clinical trials.

“Expanded Access,” also referred to as “compassionate use,” is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. The U.S. Food and Drug Administration (FDA) has set forth guidelines when considering expanded access.

According to the FDA, expanded access may be appropriate when all of the following apply:

  • Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential patient benefit justifies the potential risks of treatment.
  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

At this time, Torque does not offer an expanded access program for its investigational therapies. We believe that participation in our ongoing clinical trial is the best way for patients to access our Deep-Primed™ T Cell Therapeutics. For information about our current clinical trial, please visit https://clinicaltrials.gov/ct2/show/NCT03815682?term=TRQ-15&rank=1.

Consistent with the 21st Century Cures Act, Torque may revise this policy at any time.

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