Le Lézard
Classified in: Health, Science and technology
Subjects: TRI, FDA

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


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 America
NKMax 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

 

SOURCE NKMax America, Inc.


These press releases may also interest you

at 09:55
Shop Candelabra has evolved into Meadow Blu. The company is proud to announce the new brand and identity, which comes after nearly two years of planning. The rebrand includes a new website, meadowblu.com, as well as a new look and identity across all...

at 09:48
Chubb is celebrating the 10th anniversary of its proprietary and award-winning digital Worldview® platform which provides real-time access to Chubb's systems and expertise in one easy to use application. The platform helps risk managers at large U.S....

at 09:35
Technavio has been monitoring the IT asset management software market and it is poised to grow by $ 353.78 mn during 2020-2024, progressing at a CAGR of 7% during the forecast period. The report offers an up-to-date analysis regarding the current...

at 09:35
Join Endace, Gigamon and IBM for an hour-long webinar focusing on innovative approaches to discovering and confidently finding unalterable evidence of Advance Persistent Threats (APTs). WHAT: Attendees will learn about the following topics: The...

at 09:35
Scener, the co-watching platform where people can connect and interact while streaming the shows they love, announced it is the exclusive watch party affiliate for Comic-Con@Home, supporting its lineup of virtual screenings for films and anime....

at 09:31
Ricoh USA, Inc. today announced that Fusion Cross-Media, a commercial print provider, has reinvented its business goals to adapt to these difficult times, meeting evolving customer needs while contributing to local charities. After public safety...



News published on 5 march 2019 at 14:56 and distributed by: