GCC2003 / GC Biopharma, Artiva Biotherapeutics - LARVOL DELTA

GC Cell: AB-201 Receives Approval for Advanced Regenerative Medicine Clinical Trial and Regulatory Exception [Google translation] (Nate) - "Yonsei Cancer Center (Professor Jeong Min-gyu) plans to conduct the study on patients with advanced HER2-positive gastric cancer and gastroesophageal junction cancer, and Konyang University Hospital (Professor Choi Jong-kwon) plans to conduct the study on patients with advanced HER2-overexpressing breast cancer. GCCell is responsible for manufacturing, storing, transporting, and managing AB-201 (GCC2003) for the clinical trial."

New trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • HER2 Positive Breast Cancer

A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Artiva Biotherapeutics, Inc. | N=133 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

GC Cell, Anticancer Drug 'AB-201' Australian Phase 1 Trial Withdrawn… Focus on Domestic Clinical Trials [Google translation] (Medipana) - "On the 11th, GC Cell announced through 'Key Management Matters Related to Investment Decision' that it voluntarily withdrew the clinical trial plan for the Australian phase 1 'AB-201'...The phase 1 is a multinational (Korea and Australia), multi-institutional, open clinical trial to evaluate the safety and anti-tumor activity of AB-201 in patients with advanced HER2-positive solid cancer and to determine the recommended dose for phase 2...The number of patients participating in the clinical trial is planned to be up to 48, and the clinical trial implementation institutions are planned to be three hospitals in Australia...However, unlike when the clinical trial was planned, the current treatment environment has changed, and it is assessed that subject registration will be limited....Accordingly, GC Cell decided to discontinue the Australian clinical trial in order to select and focus on domestic clinical trials to accelerate subject registration."

Trial termination • Oncology • Solid Tumor • HER-2

GC Cell's Promising AB-201 Cancer Treatment to Begin Phase 1 Trials Using Lunit AI Platform (PRNewswire) - "GC Cell...is proud to announce the approval from both the Australian Human Research Ethics Committee (HREC) and the Korean Ministry of Food and Drug Safety (MFDS) for a Phase 1 Investigational New Drug (IND) trial for its AB-201 cancer treatment....Additionally, GC Cell is excited to reveal a strategic partnership with Lunit...to enhance precision and clinical intelligence of AB-201's efficacy evaluation by applying its advanced AI technology, in addition to traditional Immunohistochemistry (IHC) based assessments."

Licensing / partnership • New P1 trial • Non-US regulatory • Oncology • Solid Tumor

GC Cell, Lunit partner for CAR-NK cell therapy development with AI (Korea Biomedical Review) - "GC Cell said Thursday that it has signed a co-development agreement with Lunit, a medical AI company, for AB-201, GC Cell's allogeneic chimeric antigen receptor-natural killer (CAR-NK) cell therapy targeting solid tumors. Under this accord, GC Cell will conduct a phase 1 study of AB-201 by utilizing Lunit's AI biomarker, Lunit SCOPE IO, which Lunit is developing."

Licensing / partnership • Solid Tumor

GC Cell pursues multi-country clinical trials for CAR-NK in Australia and Korea [Google translation] (Medifonews) - "GC Cell...simultaneously applied for a phase 1 clinical trial plan (IND) for 'AB-201', an allogeneic CAR-NK cell therapy targeting solid cancer, to the Ministry of Food and Drug Safety of Korea and the Australian Human Research Ethics Committee (HREC). Announced on the 17th...This clinical trial is a multinational, open-label, dose-escalation and expansion phase 1 clinical trial targeting up to 48 patients with HER2-overexpressing breast cancer and gastric/gastroesophageal junction cancer, which are solid tumors. It is designed to test the safety and partial efficacy of 'AB-201'. The purpose is to evaluate and set the recommended dose (RP2D) for phase 2 clinical trials....The company plans to secure high-quality clinical data on various races by simultaneously pursuing clinical trials in Korea and Australia as the first human administration clinical trial for 'AB-201'."

New P1 trial • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

GC Cell, IQVIA team up for multicountry clinical trials of CAR-NK cell therapy for solid cancers (Korea Biomedical Review) - "GC Cell said on Friday that it signed an agreement with IQVIA, the world's largest contract research organization (CRO), to conduct a multicountry phase 1 clinical trial of its CAR-NK cell therapy targeting solid tumors, AB201....Accordingly, GC Cell plans to conduct multicountry clinical trials of AB-201, starting with Australia. AB-201 is an off-the-shelf cryopreservable allogeneic cell and gene therapy that targets solid tumors such as human epidermal growth factor receptor 2HER2-overexpressing breast and gastric cancers."

Licensing / partnership • New P1 trial • Breast Cancer • Gastric Cancer

A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors (clinicaltrials.gov) - P1/2 | N=133 | Not yet recruiting | Sponsor: Artiva Biotherapeutics, Inc. | Initiation date: Mar 2023 ➔ Aug 2023

Trial initiation date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors (clinicaltrials.gov) - P1/2 | N=133 | Not yet recruiting | Sponsor: Artiva Biotherapeutics, Inc.

Metastases • New P1/2 trial • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

"Artiva Biotherapeutics Announces FDA Allowance of IND for AB-201, a HER2-Targeted CAR-NK for the Treatment of Solid Tumors https://t.co/2GWIuzPvpO" (@NewsFromBW)

FDA event • Oncology • Solid Tumor • HER-2

Artiva Biotherapeutics Announces FDA Allowance of IND for AB-201, a HER2-Targeted CAR-NK for the Treatment of Solid Tumors (Businesswire) - "Artiva Biotherapeutics, Inc...announced...that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for AB-201. AB-201 is an allogeneic HER2-targeted chimeric antigen receptor NK (CAR-NK) cell therapy for the treatment of solid tumors in the outpatient setting with the option for repeat dosing. Starting in the first half of 2023, Artiva plans to conduct a clinical study of AB-201 in HER2-expressing cancer patients at multiple clinical sites in the U.S."

IND • New trial • Bladder Cancer • Breast Cancer • Gastric Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Development of AB-201, a novel allogeneic anti-HER2-specific CAR-NK cell therapy for the treatment of HER2+ tumors (SITC 2021) - "A significant survival benefit over non-transduced NK cells or trastuzumab controls was demonstrated in the HCC1954 model. Conclusions Data presented herein suggests that AB-201, a highly pure and readily expandable HER2-directed CAR NK cell product, has potential to be an effective therapy in the treatment of HER2+ tumors."

Oncology • Solid Tumor • CXCR3 • HER-2 • NCAM1 • NKG2D

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