NKMax and Merck KGaA, Darmstadt, Germany Expand Clinical Collaboration to Include Phase I/IIa Trial Investigating the Combination of SNK01 With ERBITUX (Cetuximab) in Metastatic NSCLC
SEOUL, South Korea, April 13, 2021 (GLOBE NEWSWIRE) -- NKMax, a biotechnology company harnessing the power of the body's immune system through the development of Natural Killer (NK) cell therapies, announced the expansion of its clinical trial and supply agreement with Merck KGaA, Darmstadt, Germany to conduct a Phase I/IIa open-label, single-center trial evaluating the safety and anti-tumor activity of SNK01 (autologous natural killer cells) in combination with either gemcitabine/carboplatin or gemcitabine/carboplatin plus cetuximab (ERBITUX®)* in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after prior tyrosine kinase inhibitor (TKI) therapy. Preliminary in vitro data from an NKMax study suggested that EGFR-TKI resistant NSCLC cells highly express EGFR and are more efficiently killed by SNK01 in the presence of cetuximab through antibody-dependent cellular cytotoxicity (ADCC). Dr. Jae-Cheol Lee, M.D., Ph.D. from the Department of Oncology and Lung Cancer Center at Asan Medical Center, Seoul, Korea will be acting as principal investigator. This study was approved by Korea's regulatory agency, MFDS, earlier this year as well as by the Asan Hospital IRB. The first patient will soon be enrolled.
“We are pleased to continue studying SNK01 in combination with well-known cancer therapies,” said Sangwoo Park, Chief Executive Officer of NKMax. “Our strategy is to first take our autologous, non-genetically modified NK cell therapy into the clinic for cancer, followed by our allogeneic program later in 2021.”
Under the terms of this agreement, NKMax will be the study sponsor, and Merck KGaA, Darmstadt, Germany will supply cetuximab for a Phase I/IIa clinical trial in NSCLC patients for weekly dosing with 250 mg/m2 cetuximab administered by intravenous injection. The trial will include patients whose disease has progressed after prior TKI therapy for EGFR, ALK or ROS1 alterations at least once will be enrolled to receive SNK01, chemotherapy, and cetuximab. The primary objective of the trial is to assess the safety and drug tolerance of SNK01 administered in combination with cytotoxic chemotherapy or cytotoxic chemotherapy plus cetuximab. The secondary objective of the trial will be to obtain efficacy assessments on the combination treatments. Both parties will have access to the clinical trial data.
NKMax 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 with little loss during cryopreservation.
* ERBITUX® is not approved for any use in metastatic non-small cell lung cancer anywhere in the world.
NKMax Co. Ltd and its subsidiary U.S. company NKGen Biotech are clinical stage biotechnology companies dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite-fold natural killer cell expansion with greatly enhanced cytotoxicity across our autologous and allogenic products which are all derived from peripheral blood. Our first in class autologous product, SNK01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with pembrolizumab in Stage IV non-small cell lung cancer. We have also added another cohort of SNK01 in combination with pembrolizumab or avelumab in refractive PD-L1 positive or PD-L1 negative solid tumors and are planning to initiate a Phase 1 combination trial of SNK01 and AFM24 in EGFR positive solid tumors. Our companies and their commercially licensed cGMP facilities are located in Seongnam South Korea and Santa Ana, California, USA.
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing