GCC2004 / GC Biopharma - LARVOL DELTA

GC Cell's new drug candidate selected as a project for the inter-ministerial regenerative medical technology development project [Google translation] (Medical Observer) - "GC Cell...announced on the 8th that the project to develop a treatment for systemic lupus erythematosus using its new drug candidate, 'CD19 CAR-NK', was selected for the 2025 pan-ministerial regenerative medical technology development project...The inter-ministerial regenerative medicine technology development project is a national research and development project jointly promoted by the Ministry of Science and ICT and the Ministry of Health and Welfare, which will invest a total of KRW 595.5 billion (KRW 542.3 billion from the government and KRW 53.2 billion from the private sector) by 2030....The project (25C0201L1) aims to secure non-clinical data and obtain approval for a domestic phase 1 clinical trial plan (IND) by 2026 for the indication of systemic lupus erythematosus (SLE)."

Financing • New P1 trial • Systemic Lupus Erythematosus

GC Cell, CD19 CAR-NK new drug candidate selected for 'National New Drug Development Agency Project' [Google translation] (BioTimes) - "GCCell...announced on the 22nd that its B-cell lymphoma treatment candidate 'GCC2004' (CD19 CAR-NK) was selected as a non-clinical stage support project for the 2024 2nd National New Drug Development Project by the National Drug Development Fund....GCC2004 is a CD19-targeting CAR-NK cell therapy that maximizes the activity of CAR-NK cells with a patented CAR signaling domain and co-expresses IL-15 to enhance persistence and anticancer efficacy in the body."

Financing • Hematological Malignancies

Artiva Biotherapeutics Establishes U.S. Research and Manufacturing Facility for NK Cell Therapy Pipeline Development and Clinical Supply (Businesswire) - “Artiva Biotherapeutics…announced the expansion of the Company’s U.S. facilities in San Diego. The new 52,000-square-foot facility will include research and process development laboratories and a multi-suite custom-built Good Manufacturing Practices (GMP) manufacturing center to support NK and CAR-NK cell production for Artiva’s pipeline development and clinical trial supply…The company’s CAR-NK programs include AB-201, a novel HER2-specific CAR-NK cell therapy for the treatment of HER2+ solid tumors, and AB-202, a CD19-specific CAR-NK cell therapy for the treatment of B-cell malignancies, both with plans to file INDs in 2022.”

Commercial • IND • Breast Cancer • Hematological Malignancies • HER2 Positive Breast Cancer • Oncology

Artiva Biotherapeutics Announces Exclusive Worldwide Collaboration and License Agreement with Merck to Develop Candidate CAR-NK Cell Therapies (Businesswire) - "Artiva Biotherapeutics, Inc...announced...that it has entered into an exclusive worldwide collaboration and license agreement with Merck, known as MSD outside the United States and Canada, to develop novel chimeric antigen receptor (CAR)-NK cell therapies targeting solid tumor-associated antigens....Artiva’s internal CAR-NK programs include AB-201, a novel HER2-specific CAR-NK cell therapy for the treatment of HER2+ solid tumors, and AB-202, a CD19-specific CAR-NK cell therapy for the treatment of B-cell malignancies, which is being developed under Artiva’s master license and option agreement with GC LabCell Corporation, with plans to enter clinical trials in 2022."

Licensing / partnership • New trial • Hematological Malignancies • Oncology • Solid Tumor