ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel super-family of immunomodulators.
ImCheck’s expertise in antibody-based drug discovery and translational research have enabled us to advance our first immuno-oncology program, ICT01, which targets BTN3A to activate γ9δ2T cells, into the clinic in 2020. More details about our clinical trials can be found here:
- EVICTION (NCT04243499)
- EVICTION2 (NCT05307874)
ImCheck’s sole mission is to develop safe and efficacious therapies for patients in need using rigorous and well-designed clinical trials and by ensuring compliance with regulatory standards.
As such, ICT01 is available, under certain eligibility criteria through our clinical trials. Patients should discuss with their physicians whether they are eligible. If enrolling in our clinical trials is not an option for a patient and all other treatment options have been exhausted, the patient and their physician may evaluate expanded access as per FDA guidelines.[1] This is a path for physicians to consider if patients with serious or life-threatening conditions would benefit from having access to an investigational drug outside of the clinical trial setting under the following conditions:[2]
- The patient has a serious or immediately life-threatening 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 access to 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.
ImCheck’s ICT01 drug candidate is still under investigation for its safety and efficacy, therefore ImCheck is restricting ICT01 use and access to its clinical trials at this time. ImCheck will reconsider making ICT01 available through an expanded access program once more safety data has been gathered ; this page will be updated to reflect any changes to our expanded access policy.
This statement cannot be used as a guaranteed access to ICT01 by patients or their physicians.
Questions and requests from physicians can be made through this address ExpandedAccess(at)imcheck(dot)fr. All requests will be acknowledged within 5 (five) business days of receipt.