Gene Key Life's iNKT Cell Therapy GKL-006 Receives IND Acceptance for Advanced Pancreatic Cancer

Sep 28, 2024 10:14 CST Updated 10:14

Gene Key

Developer of Immune Cell Product Technologies and Provider of Clinical Application Services

Click the image to register for free2025 IBI EXPO

September 28, 2024

eMedClub News

Recently, according to the CDE official website,Beijing Gene Key Life Technology Co., Ltd. ("Gene Key" for short) received CDE acceptance for the IND application of another indication of its cell therapy product "GKL-006 Injection" —— unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.。

2025 (3rd) Biopharmaceutical Innovation Industry Conference

Pre-registration Opened

Gene Key Life was founded in 2015, focusing on iNKT immune cell therapy research. It has currently developed immune cell products and treatment methods for various malignant tumors such as liver cancer. What is little known is the story of the founder, Feng Jikai, who is now a robust and energetic entrepreneur. He was a late-stage liver cancer patient who had been repeatedly told by doctors six years ago that his condition was critical. He miraculously recovered after receiving iNKT immune cell therapy.

Gene Key Life Technology owns multiple patents, one of which is titled "Invariant Natural Killer T Cells (iNKT) Expressing Chimeric Antigen Receptor Targeting GPC3 and Their Preparation and Application." This invention details the Gene Key Life Technology GPC3 iNKT cell therapy. The patent describes: the chimeric antigen receptor includes a single-chain antibody GPC3-ScFv recognizing the C-terminal epitope of GPC3, connected in tandem with the hinge region, transmembrane region, and intracellular signaling domain of CD8. The preparation of chimeric antigen receptor-modified iNKT cells involves constructing the chimeric antigen receptor pRRL-gc33-28BBz, infecting iNKT cells, and obtaining GPC3-targeted iNKT cells after specific in vitro expansion. In this invention, nucleic acids encoding the chimeric antigen receptor protein, including plasmids containing the nucleic acid, viruses containing the plasmid, and genetically modified iNKT lymphocytes transduced by the virus can be effectively used in tumor immunotherapy.

Feng Jikai, founder of Beijing Gene Key Life Technology Co., Ltd, previously stated in an interview that the company has applied for four patents. Within three years, it is expected to successfully apply for more than 15 patents and products, forming a product pipeline.” Feng Jikai is optimistic about the future development potential of iNKT cells: “iNKT cells can save patients' lives in hospitals, and outside of hospitals, they can be used for health and beauty purposes, offering a very broad market prospect.”

Major Breakthrough of the Company:

(1) Completed the safety and efficacy validation of iNKT cell therapy for primary liver cancer for the first time globally;

(2) GKL-006 Injection for the treatment of unresectable primary hepatocellular carcinoma received the National Medical Products Administration (NMPA) registration clinical trial approval (Clinical Trial Notice No.: 2023LP02333);

(3) GKL-006 Injection for the prevention of high-risk recurrence in patients with primary hepatocellular carcinoma after radical resection has received the clinical trial approval (Clinical Trial Notification No.: 2024LP01859) from the National Medical Products Administration (NMPA).

(4) GKL-006 Injection for Unresectable Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma Accepted by the National Medical Products Administration (NMPA) for IND.

China has initially completed the core technology breakthrough and industrial upgrading in the field of iNKT cell therapy, achieving a "leading" position in this area and contributing to the accelerated development of new quality productive forces.

Welcome everyone to register for the 2025 IBI EXPO conference and keep pace with the times. Below is the 2024 IBI EXPO.Video Highlights of the Event.

Registration and Event Inquiry

IBI EXPO 2025 (3rd) Biopharmaceutical Innovation Industry ConferenceWill beMarch 1, 2025 to March 2, 2025InSuzhou International Expo CenterGrandly held. The theme of the conference isCollaboratively Build the Full Chain, Innovate and Transform the New Ecosystem。

The conference will invite300+Guest Speaker, Opening30+Forum activities, covering hundreds of hot topics, aroundCell and Gene Therapy, Radiopharmaceuticals, Antibody Innovation Conjugation, Targeted Protein Degradation, Stem Cell Regeneration, mRNA Vaccines and Nucleic Acid Drugs, Exosomesetc.New Molecular Drugs,AI Drug Discovery, Organoids, Novel Delivery Vehiclesetc.Cutting-edge Technology，Engage in exchange and discussion, and collaborate.Pharmaceutical companies, research institutions, clinical resources, supply chain enterprises, investment and financing institutions, park governmentsThrough the efforts of multiple parties, cutting-edge innovations are being transformed from scientific research to industrial applications, injecting a source of development into the biotech innovation pharmaceuticals market.

Free Participation:Teacher Yang 15517201185

Free Exhibition:Teacher Yuan 15572286596

Speech & Media:Teacher Wang 18701871600

Click"Read the original text"Lock in Early Bird Discounts

Exciting Live Broadcast Preview

Press and hold to scan the QR code to participate immediately ↓

Recommendation

October 7 (Monday) 16:30-18:30

2024 Nobel Prize Live Broadcast Event: "Nobel Prize in Progress"

Statement and Copyright Notice

Disclaimer: This article aims to convey industry development information and explore the frontier progress of biomedicine. The content of the article represents the author's viewpoint, and does not represent the position of Yi Mai Ke, nor does it constitute any value judgment, investment advice, or medical guidance. If necessary, please consult a professional for investment or visit a正规 hospital for medical advice.

Copyright Statement:Welcome to share the article on your personal WeChat Moments. Unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For reprinting, please leave a message below the article to obtain authorization.

DianDian "Share”、“Like"and"In Sight", charge me up a bit~"