Patient shows significant response in early study of Bria-IMT + Keytruda for breast cancer.- BriaCell

BriaCell Therapeutics has announced clinical updates of its Phase I/IIa clinical trial of Bria-IMT immunotherapy in a combination Study with Keytruda (pembrolizumab), manufactured by Merck, in patients with advanced breast cancer. The top responder - Remarkable Responder - in the Combination Study experienced a highly remarkable reduction in breast cancer tumors. She is an advanced breast cancer patient who had failed 12 prior regimens with 16 agents (13 chemotherapy agents and 3 hormonal agents). She showed one of the best immune responses and displayed a highly remarkable reduction in breast cancer tumors (metastases) in the adrenal gland and the outer lining of the brain during the Combination Study. Prior to enrollment in the Combination Study, the Remarkable Responder had progressive cancer in spite of aggressive treatment with some of the newest therapies. She remains on the Combination Study treatment.

BriaCell had hypothesized that combining Bria-IMT, which attacks the tumor in a targeted way, with immune �checkpoint inhibitors�, such as Keytruda, which act by awakening the immune system, would lead to more powerful anti-cancer activity compared to that of Bria-IMT alone in advanced breast cancer patients. BriaCell�s hypothesis has been further strengthened: The Remarkable Responder matched Bria-IMT at 2 HLA loci (HLA-C and HLA-DRB3).

BriaCell�s immunotherapy treatment appears most effective when the patient�s HLA-type matches the Bria-IMT HLA-type as concluded in prior Phase IIa proof-of-concept work. The data presented also noted that the Bria-IMT regimen administered with Keytruda was safe and well tolerated. The women who showed the best clinical responses to the combination of the Bria-IMT regimen with Keytruda also showed the best immune responses including a cellular immune response (i.e. activated T cells that fight the cancer) and a humoral immune response (i.e. produced antibodies that target the tumor cells).

In BriaCell�s view, the presentation of the Remarkable Responder�s tumor reduction required public disclosure to avoid selective disclosure of material information. Rather than reporting incremental patient data going forward, it is BriaCell�s intent to present more fulsome patient data sets at major cancer conferences, such as the San Antonio Breast Cancer Symposium on December 10-14, 2019. The latest data were presented at the 2nd Annual Next Gen Immuno-Oncology Congress.