Achilles Therapeutics is committed to developing precision tumor-derived T cell therapy targeting clonal cancer neoantigens. Our current therapies are considered investigational, which means that they have not been approved as safe and effective by regulatory health authorities, such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Expanded Access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational drug for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy exists. Per FDA, Expanded Access may be appropriate when all the following apply:
1) A patient has a serious disease or condition, or a patient’s life is immediately threatened by their disease or condition.
2) There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
3) Patient enrollment in a clinical trial is not possible.
4) Potential patient benefits justify the potential risks of treatment.
5) 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.
Achilles Therapeutics is not currently making any of its investigational medicines available on an Expanded Access basis prior to regulatory approval anywhere in the world.
Achilles Therapeutics may revise this Expanded Access Policy at any time and will publish the revised policy accordingly. The posting of this policy by Achilles Therapeutics shall not serve as a guarantee of access to any specific investigational medicine by any individual patient.
This Expanded Access Policy is being posted pursuant to Section 3032 of the 21st Century Cures Act and section 561 of the United States Food, Drug, and Cosmetics Act, as amended.
If you have additional questions, patients should speak with your treating physician. Physicians can contact Achilles Therapeutics via email@example.com.