NKMax America Announces FDA Approval of IND for Phase 1 Trial of SNK01 in Patients with Refractory Cancer

Wednesday, March 6, 2019 General News
Email Print This Page Comment bookmark
Font : A-A+

IRVINE, Calif., March 5, 2019 /PRNewswire/ -- 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 accepted the Investigational New Drug (IND) application for SNK01, an autologous NK cell adoptive immunotherapy
candidate for the treatment of patients with pathologically confirmed cancer refractory to conventional therapy.

"We are very pleased to receive our first US IND approval to begin clinical trials in refractory cancer patients," said Paul Song, MD, CMO and CCO of NKMax America.  "While we collect our initial toxicity data, we are also preparing to submit additional IND applications for combination therapy in cancer as well as for several other non-cancerous diseases."

"Our innovative autologous NK cell technology allows us to expand NK cells from cancer patients," said Amber Kaplan, PhD, CSO of NKMax America.  "We are looking forward to advancing the program further into clinical trials."

SNK01 is an autologous therapy that is manufactured by harvesting a small number of a patient's immune cells.  After harvesting, the NK cells are separated from the blood, purified, activated, and expanded in our cGMP facility.  The activated NK cells are then injected back into the patient to fight against the cancer.

The IND approval allows NKMax America to initiate Phase I clinical trials to assess the safety and tolerability of SNK01 in adults with pathologically confirmed cancer refractory to conventional therapy. 

About NKMax AmericaNKMax America, Inc. is a biotech company specializing in both autologous and allogenic Natural Killer (NK) cell therapy utilizing our proprietary cell expansion and cell activation technology.  This therapeutic technology was developed as a complement to ATGen's first-in-kind in vitro diagnostic test which measures NK cell activity using only 1 ml blood.

For more information on the company, please visit www.nkmaxamerica.com

 

Cision View original content:http://www.prnewswire.com/news-releases/nkmax-america-announces-fda-approval-of-ind-for-phase-1-trial-of-snk01-in-patients-with-refractory-cancer-300807121.html

SOURCE NKMax America, Inc.



Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Press Release Category

Press Release Archive

Stay Connected

  • Available on the Android Market
  • Available on the App Store