NK510 / Base Therap - LARVOL DELTA

World’s First Zero-Off-Target Base-edited NK Cell Therapy Receives IND Approval in Both China and the U.S. (GlobeNewswire) - "Base Therapeutics has announced that its NK510 cell injection, the world’s first zero-off-target base-edited NK cell product, has received IND approvals from both the U.S. FDA and China’s NMPA for clinical trials on advanced solid tumors. This dual approval marks a significant milestone in cancer immunotherapy, leveraging Base Therapeutics' pioneering base-editing technology."

IND • New trial • Solid Tumor

Best Bio: Universal NK cell base editing product accepted by CDE [Google translation] - "On July 30, Bestoncology released relevant information on its WeChat official account, saying that the NK510 cell injection, a universal NK cell product independently developed by Shanghai Bestoncology Biotechnology Co., Ltd...has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (acceptance number: CXSL2400492) for the clinical treatment of advanced solid tumors. It is reported that this is the world's first clinical trial application for a base-edited NK cell product to be accepted."

New trial • Oncology • Solid Tumor

NK510, a Small Genetic Edit, a Giant Leap for NK Cells (ASGCT 2024) - "By knocking out inhibitory receptors in NK cells, we have prompted tumor cell-derived inhibitory ligands to interact with activating receptors (AR), initiating activating signals within the NK cells. This transformation effectively converted an inhibitory ligand into an activating one, resulting in tumor regression in multiple mouse models, including sarcoma."

Infectious Disease • Oncology • Sarcoma • Solid Tumor

AccuBaseTM (ceBE), a second-generation high-fidelity base editor, can proficiently modify genes in a human primary NK cells with minimizing off-target effect (AACR 2024) - "Distinct from the PK data of NK510s, the concentration of NK510-derived gDNA started low at day 1 and reached peak concentration at day 2 (in blood samples) and at day 4 (in liver tissues), respectively. These results demonstrated the efficacy and safety of BED-NK product and underscore the feasibility of combining base editing with ex vivo expansion of NK cells, significantly enhancing their therapeutic potential in clinical settings."

IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • PVR • TIGIT

Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Base Therapeutics (Shanghai) Co., Ltd.

New P1 trial • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Safety and Efficacy of NK510 to Treat NSCLC (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Base Therapeutics (Shanghai) Co., Ltd.

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Safety and Efficacy of NK510 to Treat Gastric Cancer (clinicaltrials.gov) - P1 | N=9 | Enrolling by invitation | Sponsor: Base Therapeutics (Shanghai) Co., Ltd.

Metastases • New P1 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • PD-L1