To evaluate the safety and tolerability of its SNK01, NKMax America has made a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer.
SNK01 is an autologous natural killer cell therapy made by NKMax in combination with avelumab (BAVENCIO) which is a human anti-PD-L1 therapy while BAVENCIO is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc., in solid tumors.
According to the agreement, NKMax America will provide the sponsorship for the study, and Merck KGaA, Darmstadt, Germany and Pfizer are aimed for supplying the avelumab to add a new study arm to the existing US Phase I clinical trial of SNK01 in refractory solid tumors.
Up to 18 patients will be enrolled who have all types of solid tumor refractory to conventional treatment and independent of PD-L1 status in order to get SNK01 along with a checkpoint inhibitor until getting the progression or unacceptable toxicity. Enrollment of this arm is expected to begin in September 2020. All parties involved in the collaboration will have access to the clinical data.
Avelumab being a human anti-programmed death ligand-1 antibody is depicted in preclinical models to employ the adaptive and innate immune functions. Avelumab has also ability to cause the NK cell-mediated direct tumor cell lysis with the use antibody-dependent cell-mediated cytotoxicity (ADCC) present in vitro.
NKMax America’s Vice Chairman and Chief Medical Officer, Paul Song said, “Much emerging research has identified the vital role NK cells play in tumor response to checkpoint inhibitors in both PD-L1+ and PD-L1 negative tumors. Based on strong clinical results that we presented at ASCO which demonstrated significantly improved response when our SNK01 cells were added to a checkpoint inhibitor, we believe that the IgG1 antibody nature of avelumab along with the greatly enhanced cytotoxicity and CD16 expression of our SNK01 cells may further maximize this anti-tumor potential.”
NKMax America a clinical stage biotechnology company involved in drawing the power of the body’s immune system and restoring and enhancing overall immune integrity with the development of its Natural Killer (NK) cell therapies.