On August 13, 2019 NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that it has dosed the first subject in study SNK01-US01, a phase I clinical trial evaluating SNK, an ex vivo expanded autologous natural killer cell therapeutic, in patients with pathologically confirmed cancer refractory to conventional therapy (Press release, NKMax America, AUG 13, 2019, View Source [SID1234538704]).
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"We are pleased to initiate the first clinical study for SNK in the U.S. We are looking forward to establishing clinical data to support SNK’s potential as a safe and effective treatment for patients with refractory cancers," said Paul Song, MD, CMO and COO of NKMax America.
Stephen Chen, MBA, CTO of NKMax America commented, "Our ability to manufacture and deliver multiple doses of an NK cellular immunotherapy advances us towards our goal of providing a transformative cancer treatment to patients."
The company’s SNK product is an autologous therapy manufactured by harvesting a small number of a patient’s immune cells. After harvesting, NK cells are separated from the blood, purified, activated, and expanded in a cGMP facility. The activated NK cells, known as "SNK" are reinfused in the patient to fight against cancer.
The single arm, dose escalation study evaluates SNK administered intravenously once a week for five weeks at three different dosing levels. Nine subjects will be enrolled in the trial to investigate the safety and tolerability of SNK in adults with pathologically confirmed cancer refractory to conventional therapy.
The SNK study for refractory cancer is currently recruiting participants; for more information about the study, please visit View Source