NKMax America Receives FDA Clearance of IND for Phase I/2a Trial of their Natural Killer Cell Therapy (SNK01) in Combination with Trastuzumab or Cetuximab for the Treatment of Advanced/Metastatic HER2- or EGFR- Expressing Cancers
SANTA ANA, Calif., June 02, 2020 (GLOBE NEWSWIRE) — NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for SNK01 in combination with trastuzumab (Herceptin) or cetuximab (Erbitux) for the treatment of advanced/metastatic HER2- or EGFR- expressing cancers.
The company plans to initiate a Phase 1/2a open-label, multi-center trial (Study SNK01-102) to evaluate the safety and anti-tumor activity of its expanded autologous natural killer cells in combination with trastuzumab or cetuximab in third quarter of this year.
“It is well known that NK cells play a vital role in antibody dependent cell-mediated cytotoxicity (ADCC) directed killing of cancer cells and that some of the poor responses to trastuzumab and cetuximab can be attributed to the inherent weakness of the innate immune system of treated patients,” said Paul Song, M.D., Vice Chairman and Chief Medical Officer of NKMax America. “Our preclinical research highlights our ability to exponentially increase NK cell cytotoxicity and generate high CD16 expression to optimize the ADCC pathway helping to overcome these limitations. Early data suggests that our NK cells can cross the blood brain barrier, so we are eager to test SNK01 in all patients with advanced/metastatic HER2- or EGFR- mutated tumors who have limited options and especially in those with brain metastases.”
About NKMax America
NKMax America Inc. is a clinical stage biotechnology company 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 its autologous, allogenic, and CAR-NK 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 Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA.
For more information on the company, please visit www.nkmaxamerica.com
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing