BriaCell Therapeutics Corp. announced that it has accepted a letter of intent from Dr. Massimo Cristofanilli, Director of Breast Medical Oncology and Associate Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties' plans and commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell's novel immunotherapy, Bria-IMT??, in combination with a check point inhibitor (CPI), in early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC) patients in the neoadjuvant setting. The clinical trial is designed to address the urgent and unmet need in high-risk TNBC patients who failed the current standard of care, a neoadjuvant regimen combination with check point inhibitors.

The clinical trial are designed to evaluate the safety, and efficacy of the Bria-IMT combination regimen withCPI in early TNBC patients who completed neoadjuvant therapy and did not achieve pathological complete remission (pCR). The primary endpoint of event-free survival (EFS) will be compared to the EFS of 55% in the historical control from Keynote 522 (Schmid et al, NEJM 2022; 386:556-567). TNBC patients have fewer treatment options and tend to have a better prognosis and survival outlook.