Magicell-NK / Medigen Biotech, NKure Therapeutics - LARVOL DELTA

Phase I/II Study: Allogeneic NK-cell Therapy with Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Medigen Biotechnology Corporation

New P1/2 trial • Post-surgery • Surgery • Biliary Cancer • Cholangiocarcinoma • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Medigen Biotechnology Corporation | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Gene obtained TFDA approval to conduct Phase I/II human clinical trials of allogeneic natural killer cell Magicell-NK [Google translation] (MoneyDJ) - "The company’s independently developed allogeneic natural killer cell Magicell-NK in vitro amplification technology has been The Food and Drug Administration (TFDA) of the Ministry of Health and Welfare has applied for a Phase I/II human clinical trial of the application of Magicell-NK allogeneic natural killer cells in postoperative adjuvant therapy combined with chemotherapy in patients with pancreatic duct adenocarcinoma or cholangiocarcinoma. Our company accepted the application today. Notification of approval from TFDA to conduct this clinical trial."

New P1/2 trial • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Medigen Biotechnology Corp. Announces that Taiwan’s Mohw Approves a New Version of the Company’s Collaborative Natural Killer Cell Autologous Cell Therapy Project with Wanfang Hospital [Google translation] (Zonebourse) - "Medigen Biotechnology Corp. announced that Taiwan Mohw approves a new version of the collaboration project between the company and Wanfang Hospital for autologous natural killer cell therapy. Medigen, in collaboration with Taipei Municipal Wanfang Hospital, operated by Taipei Medical University...applied to the Ministry of Health and Welfare (MOHW) on January 22, 2024 for a new version of the Natural Killer (Magicell-NK) autologous cell therapy project for the treatment of stage IV solid tumors, in accordance with the regulation governing the application of a specific medical examination technique and medical device...On June 6, 2024, Medigen received a letter of approval from the Department of Health and Social Care, confirming that Medigen's Cellular Processing Unit complies with Good Tissue Practice...Medigen cellular processing unit....Validity period: From June 4, 2024 to February 2, 2026."

Licensing / partnership • Non-US regulatory • Brain Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Pre-clinical development of ARB011: A CDH17 targeting allogeneic nonviral RNA-based "Flash" CAR-NK therapy for gastrointestinal cancer (AACR 2024) - "Moreover, engineering NK cells with nonviral CAR-encoding mRNA would provide a rapid large-scale manufacturing platform with minimal risk of abnormal genetic alteration mediated by viral integration. To generate the ARB011 CAR-NK cells, ex vivo expanded human peripheral blood NK (Magicell-NK, Medigen, Taiwan) cells were electroporated with mRNA encoding a humanized anti-CDH17 scFv fused with transactivation domains. Overall, the findings suggest that ARB011 could be a novel off-the-shelf, CAR-NK therapy that warrants further studies in animal models and in clinical trials."

IO biomarker • Preclinical • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor • CDH17 • IFNG • LAMP1 • TNFA

Medigen Biotechnology Corp. Files Allogeneic Natural Killer Cell (Magicell-NK) Phase I/II Clinical Trial Application with Taiwan Food and Drug Administration (TFDA) [Google translation] (Zonebourse) - "Medigen Biotechnology Corp. has filed an application with the Taiwan Food and Drug Administration (TFDA) for a phase I/II clinical trial of allogeneic natural killer cells (Magicell-NK)....Upcoming Development Plan: Phase I/II clinical trial will begin after obtaining approval from TFDA and Institutional Review Board (IRB). Expected completion time: The project is expected to be completed in 2029, but the actual schedule will be adjusted depending on the progress of execution. Anticipated obligations: the company will cover expenses related to clinical trials and the corresponding registration fees."

New P1/2 trial • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

【Announcement】The Ministry of Health and Welfare approves the autologous NK cell therapy plan in collaboration between GIA and Xiu Chuan Hospital (stock.yahoo) - "The Ministry of Health and Welfare approved the autologous NK cell therapy plan in cooperation between GIA and Xiu Chuan Hospital....Regulations, apply to the Ministry of Health and Welfare for autologous natural killer NK cells (Magicell-NK) to treat solid cancers....The following matters need to be approved before Xiuchuan Hospital applies to start a project: (1) Cell therapy technology project: Autologous natural killer cell NK cell (Magicell-NK) (2) Indications: Stage IV solid cancer; brain cancer, breast cancer, lung cancer, esophageal cancer, gastric cancer, liver cancer, cholangiocarcinoma, Pancreatic cancer, prostate cancer, colorectal cancer (3) Cell preparation place: Cell preparation factory of Gya Biotechnology Co., Ltd."

Non-US regulatory • Biliary Cancer • Biliary Tract Cancer • Brain Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastric Cancer • Gastroesophageal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer

Development of allogenic nonviral RNA-based CAR-NK therapy targeting CDH17 in relapsed/refractory gastrointestinal cancer. (ASCO 2023) - " Ex vivo expanded human peripheral blood NK (Magicell-NK, Medigen, Taiwan) cells were used in this study. Our findings suggest that a non-viral based CDH17 CAR-NK cell therapy could be a potential allogeneic, off-the-shelf CAR-NK therapy candidate in GI cancer and support the rationale of further investigating it in vivo and clinical trials."

IO biomarker • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immune Modulation • Oncology • Solid Tumor • CDH17 • LAMP1 • TNFA

A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Medigen Biotechnology Corporation

IO biomarker • New P1 trial • Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CA 19-9 • PD-L1