Enkay Therapeutics Announces FDA Clearance of IND Application for NK010, a Non-Genetically Modified Allogeneic NK Cell Therapy, to Enter Phase I Clinical Trial in Ovarian Cancer

Jan 18, 2024 17:07 CST Updated 17:07

NK CellTech

Immune Cell Therapy Developer

▎Edited by the WuXi AppTec content team

On January 17, Enke Pharmaceuticals announced the development of itsNon-genetically Modified Natural Killer Cell InjectionNK010 Receives FDA Approval for Phase 1 Clinical Study in the United States. NK010 is a non-gene-modified allogeneic peripheral blood NK cell drug.ThisFirst Choice for Phase 1 Clinical TrialsOvarian CancerIndicationsExplore.

Enkaisai Pharmaceuticals is a biotechnology company focusing on the development of innovative immunocyte therapeutic technologies. The team has over 30 years of experience in exploring NK cell basic biology, preclinical and clinical translational research. The company owns a unique allogeneic peripheral blood NK cell expansion and cryopreservation, gene modification, and clinical “off-the-shelf” ABCDE-NK industrial production platform (a single donation can yield trillions of NK cells), and through synthetic immunology chassis technologies such as logic gate genetic circuits,Achieve intelligent editing of NK cells, enabling them to precisely target cancer cells, accurately adapt to the tumor microenvironment, and match the donor/recipient's effector/target cells.。Previously, Enkaipharma has completedLed by Huagai CapitalSeries A financing.

According to the press release from Enkaicell, NK010 features optimized receptor spectrum, diversified targets, and versatility.High PurityEqual height anti-cancer advantages, with the potential to treat multiple types of tumors. This product also has potentialExtended to Non-Cancer Disease Treatment, and serves as the chassis cell for a subsequent series of synthetic NK cell drugs. Preclinical studies have shown that the NK010 cell injection is effective in liver cancer,Ovarian CancerSolid tumors, as well as animal models of acute myeloid leukemia, have shown good anti-tumor activity.

Founder of EnkaicellProfessor Zhigang TianIntroduction: We are genuinely delighted and proud that the NK010 project has been approved for clinical trials in the United States. At the same time, there is still much to explore, and the team has already begun more in-depth research on the next phase of the project to meet urgent clinical needs. Enka Therapeutics remains committed to its independent innovation route, with several product pipelines in the NK cell field currently advancing, hoping to bring more novel therapies to patients worldwide.

References:

[1]Enkaisai Medicine's NK010 Injection Granted FDA New Drug Clinical Trial Approval in the U.S.Retrieved Jan 18 , 2024, from https://mp.weixin.qq.com/s/4h1w6ysp_dnnZ1RrWL4Jgw

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