HLCN061 / Healios - LARVOL DELTA

Antitumor effects of natural killer cells derived from gene-engineered human-induced pluripotent stem cells on hepatocellular carcinoma. (PubMed, Cancer Immunol Immunother) - "The eNK cells (HLCN061, developed by HEALIOS K.K.) are human iPSC-derived NK cells differentiated from clinical-grade iPSCs in which IL-15, CCR2B, CCL19, CD16a, and NKG2D have been introduced...The TRAIL and perforin/granzyme B pathways are largely involved in this cytotoxic mechanism, as indicated by the reduction in cytotoxicity induced by TRAIL inhibitory antibodies and concanamycin A, which inhibits perforin/granzyme B-mediated cytotoxicity. Our data suggest that eNK cells, whose functions have been enhanced by genetic engineering, have the potential to improve HCC treatment."

Journal • Gene Therapies • Hepatocellular Cancer • Oncology • Solid Tumor • CCL19 • CCR2 • FCGR3A • GZMB • IFNG • IL15 • NKG2D • TNFA

Healios' research and development on eNK cells selected for AMED open call project [Google translation] (Yahoo Finance) - "Helios...announced that its research and development on eNK cells has been selected as a supported research topic for the 'Basic Technology Development Project for the Industrialization of Regenerative Medicine and Gene Therapy (Project to Promote the Industrialization of Regenerative Medicine, Cellular Medicine, and Gene Therapy) (Development Support Project)' for the fiscal year 2024, which was publicly solicited by the Japan Agency for Medical Research and Development (AMED)....aims to develop a groundbreaking treatment with a mechanism of action completely different from existing treatments for malignant pleural mesothelioma, a rare disease with a very poor prognosis and limited treatment options. The maximum amount of the subsidy is 59.9 million yen per year. The company stated that there is currently no impact on its performance for the fiscal year ending December 2024."

Financing • Mesothelioma • Solid Tumor

Announcement of eNK cell research results presentation at the 83rd Annual Meeting of the Japanese Cancer Society [Google translation] (Nikkei) - "The 83rd event will be held at Fukuoka International Conference Center/Fukuoka Marine Messe from September 19th to 21st, 2024...At the Japanese Cancer Society Academic Meeting...we announced our research and development We would like to inform you that we will be presenting a poster about the results of our ongoing research on eNK cells....eNK cells were used in lung cancer orthotopic engraftment model mice, liver cancer subcutaneous transplant model mice, and gastric cancer abdomen. Having an antitumor effect on membrane seeding model mice and mesothelioma subcutaneous transplantation model mice; Cancer organoids derived from lung cancer patients, which have an environment similar to cancer in living bodie. However, we have confirmed that it has similar antitumor effects."

Preclinical • Liver Cancer • Lung Cancer • Mesothelioma • Oncology • Skin Cancer • Solid Tumor

At the 30th Academic Meeting of the Japanese Society for Gene and Cell Therapy Announcement regarding the production of CAR-eNK cells [Google translation] (Nikkei) - "The 30th Japan Conference will be held at the Pacifico Yokohama Conference Center on Sunday. At the Academic Meeting of the Society for Gene and Cell Therapy...CAR-eNK cells with chimeric antigen receptor (CAR) introduced as next-generation eNK cells...We are proceeding with research...Introducing CAR into eNK cells We hope that this will further enhance the ability to attack cancer cells...HLCN061...eNK cells were used in lung cancer orthotopic engraftment model mice, liver cancer subcutaneous transplant model mice, and gastric cancer abdomen...In addition, we are currently conducting joint research with the National Cancer Center, a national research and development agency...Furthermore, we are collaborating with Hiroshima University, a national university corporation, to develop cancer immune cell therapy for hepatocellular carcinoma using eNK cells...We are conducting joint research with Hyogo University of Medicine on the development of cancer immune cells against..."

Licensing / partnership • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Mesothelioma • Oncology • Solid Tumor

Verification of the effect of human allogeneic iPS cell-derived gene-engineered NK cells (eNK cells HLCN061) on mesothelioma (AACR 2024) - "In a mouse subcutaneous tumor model, the eNK cell treatment group suppressed tumor growth compared to the untreated group (p≦0.05). RNA-seq showed increased expression of granulysin, IL2RB, cathepsin W, etc. in subcutaneous tumors treated with eNK cells."

Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Solid Tumor • CCL19 • CCR2 • IL15 • NKG2D

Helios establishes eNK cell development subsidiary [Google translation] (Medical News) - "...Japan's Helios announced on the 11th that it would establish a subsidiary to promote research and development of 'HLCN061', an NK cell (eNK cell) derived from Taga iPS cells...Helios signed a basic agreement with Saisei Ventures, a venture capital firm, at the time of establishing a subsidiary, and the fund operated by this company reviewed an investment of 1 to 2 billion yen in the subsidiary, while supporting financing using subsidies made with...The subsidiary is scheduled to be established in August and plans to conduct a phase 1 clinical trial in 2025."

Licensing / partnership • New P1 trial • Oncology • Solid Tumor

HLCN-061 demonstrates enhanced persistence, migration and cytotoxicity in preclinical models (Bioworld) - "Researchers from Healios K.K. presented preclinical data for HLCN-061, a novel gene-engineered human induced pluripotent stem cell (iPSC)-derived NK cell product being developed for the treatment of solid tumors." "

Preclinical • Oncology • Solid Tumor

HLCN061: An ""Off-the-Shelf"" Gene Engineered Human iPSC-Derived NK Cell Product for the Treatment of Solid Tumors (ASGCT 2023) - "Finally, HLCN061 did not show any cytotoxicity against normal human PBMC. Thus, these in vitro and in vivo proof-of-concept studies promise that HLCN061 might be a good adoptive cell therapy product for the treatment of solid tumors."

IO biomarker • Graft versus Host Disease • Immunology • Oncology • Solid Tumor • CCL19 • CCR2 • IFNG • IL15 • NKG2D

Announcement of iPSC derived gene-modified NK cell development targeting solid tumors (PRNewswire) - “HEALIOS K.K…has been moving forward with efforts to create next generation immunotherapies for solid tumors by combining its iPS cell and gene editing technology expertise. In this notice we are disclosing that we have decided to add the development of allogeneic, iPS cell derived gene-modified natural killer (NK) cells to our pipeline (development code: HLCN061).”

Pipeline update

Newly added product (PRNewswire) - Preclinical, Oncology, Solid tumor

Pipeline update