NKMax America has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate the safety and tolerability of SNK01, the company’s autologous natural killer cell therapy in combination with avelumab (BAVENCIO®), a human anti-PD-L1 therapy co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc., in solid tumors.
Under the terms of this agreement, NKMax America will be the study sponsor, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for a new study arm that will be added to the existing US Phase I clinical trial (NCT03941262) in refractory solid tumors. Under the amendment, up to 18 patients with all solid tumor types refractory to conventional treatment and independent of PD-L1 status will be enrolled to receive SNK01 plus a checkpoint inhibitor until progression or unacceptable toxicity. Enrollment of this arm is expected to begin in September 2020. Both parties will have access to the clinical data.
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. It has been shown in preclinical models to engage both the adaptive and innate immune functions. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
NKMax America has developed its own proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogenic NK cells from numerous donors which have near total expression of activating receptors like CD16, NKG2D, NKp30, and NKp46. In addition, its unique technology raises the cytotoxicity of the expanded NK cells nearly 8000% with little loss during cryopreservation.
“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,” said Paul Song, Vice Chairman and Chief Medical Officer.
Avelumab (BAVENCIO®) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.