An autologous mHsp70 targeted NK Cell Therapy that activates NK cells to target and kill cells expressing mHsp70. The therapy begins with selecting patients whom have high mHsp70 expression with our Companion Diagnostic AP-CDx (described below), collecting their peripheral blood mononuclear cells (PBMCs) by leukapheresis, ex vivo activation of PBMCs with our synthetic Hsp70-derived peptide (‘TKD’) and low-dose interleukin-2 (IL-2), reinfused intravenously back to the patient. Clinical trials with ENKASTIM autologous NK Cell therapy have been completed or being planned, as follows:
- Completed Phase I clinical trial involving twelve (12) patients in Germany, eleven (11) with metastatic colorectal cancer and one (1) with non small lung cancer (NSCLC) receiving ENKASTIM after standard of care (SOC). The therapy showed it was safe, well tolerated and had signs of efficacy.
- Completed Phase IIa (randomized, controlled) clinical trial involving fourteen (14) patients with advanced (Stage IIIb) NSCLC in Germany, divided into a treated group of seven (7) patients whom received ENKASTIM after radio-chemotherapy, where five (5) patients experienced a clinical benefit (71%), including one complete response (CR) and one partial response (PR); while in the control group of seven (7) patients, only two had a clinical benefit, no patient had a CR. In the ENKASTIM treated group, one patient subsequently received OPDIVO® (nivolumab), achieved 33 months Progressive Free Survival (PFS), in comparison to median nine (9) months survival with OPDIVO® after radio-chemotherapy historical control.
- Planned Phase IIa Clinical Combination trial. Patients with advanced (Stage III & IV) NSCLC, in the United States who have failed standard of care (radio)chemotherapy / PD(L)-1 checkpoint inhibitor therapy will receive ENKASTIM plus standard of care. If the clinical trial shows the therapy is effective, a Pivotal Phase IIb trial will be planned for accelerated approval.