GCC2005 / GC Biopharma, Artiva Biotherapeutics - LARVOL DELTA

Phase 1 study of GCC2005, an allogeneic CD5-directed CAR-NK therapy, for patients with Relapsed/Refractory NK/T-cell malignancies (ASH 2025) - P1 | "Patients received a lymphodepleting regimen ofcyclophosphamide and fludarabine (Days –5 to –3), followed by three consecutive weekly infusions ofGCC2005 at escalating dose levels (DLs, 1 × 10⁶ to 3 × 10⁷ CAR-NK cells/kg).The primary endpoints are safety—defined by the frequency, severity, and persistence of adverse events(AEs) graded per NCI CTCAE v5.0, including CRS, ICANS, and acute/chronic graft‑versus‑host disease(GvHD)—and tolerability, as measured by dose‑limiting toxicities (DLTs), the maximum tolerated dose(MTD), and the recommended Phase 2 dose (RP2D). In the absence of anysafety signals to date, the study will proceed with enrollment at the next DL following Safety MonitoringCommittee review.ConclusionsAlthough there is limited data from this FIH Ph1a study, it demonstrates that GCC2005, a CD5-targetingallogeneic CAR-NK therapy, has a favorable safety profile, with no DLT, ICANS, or GvHD of any gradeobserved, and only one transient grade 3 event..."

Clinical • P1 data • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Dermatology • Graft versus Host Disease • Hematological Malignancies • Immunology • Lymphoma • Neutropenia • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD5 • IL15

[ASH 2025] GC Cell’s allogeneic CAR-NK therapy shows promising safety and efficacy in relapsed/refractory T-cell malignancies (Korea Biomedical Review) - "Early responses across the first two cohorts reached 60 percent, including complete responses in both dose levels. One complete responder at dose level one remains in remission for more than nine months, while a dose level two patient, who received only a single infusion due to eligibility issues, achieved complete remission that remains ongoing without additional treatment."

First-in-human • P1 data • Natural Killer/T-cell Lymphoma

GC Cell to present oral, interim phase 1 results for allogeneic CAR-NK candidate GCC2005 (Korea Biomedical Review) - "The initial efficacy assessment of the first five patients showed an objective response rate (ORR) of 60 percent, with 40 percent achieving complete remission (CR) and 20 percent partial remission (PR). One patient has maintained complete remission after just one dose."

P1 data • Natural Killer/T-cell Lymphoma

GC Cell Receives Domestic Patent for CD5-Targeting CAR Immune Cells [Google translation] (BioTimes) - "This patent describes immune cell technology for more effectively treating CD5-positive tumors, a type of cancer cell. It represents a novel approach that maximizes anti-cancer effects by increasing cell activity....GCCell explained that this patent corresponds to the core technology of its CAR-NK treatment candidate, 'GCC2005'."

Patent • Oncology

GC Cell Initiates First Patient Dosing in Phase 1 Clinical Trial for GCC2005, a Promising T‑Cell Lymphoma CD5 CAR-NK Therapy (PRNewswire) - "GC Cell...announced today the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB‑205), a novel CD5 CAR‑NK cell therapy. This 'first patient dosing' marks a critical milestone in the company's collaboration with its ex-APAC partner Artiva Biotherapeutics, as we advance the development of this innovative treatment targeting relapsed or refractory NK and T‑cell malignancies....The ongoing Phase 1 trial...will enroll up to approximately 48 patients diagnosed with relapsed or refractory NK and T‑cell malignancies."

Trial status • Hematological Malignancies • Lymphoma

GC Cell Initiates First Patient Dosing in Phase 1 Clinical Trial for GCC2005, a Promising T‑Cell Lymphoma CD5 CAR-NK Therapy (PRNewswire) - "GC Cell...announced today the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB‑205), a novel CD5 CAR‑NK cell therapy. This 'first patient dosing' marks a critical milestone in the company's collaboration with its ex-APAC partner Artiva Biotherapeutics, as we advance the development of this innovative treatment targeting relapsed or refractory NK and T‑cell malignancies....The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT06699771) will enroll up to approximately 48 patients diagnosed with relapsed or refractory NK and T‑cell malignancies. The primary objectives of the study are to evaluate the safety and tolerability of GCC2005, the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D)."

Trial status • Natural Killer/T-cell Lymphoma

GC Cell scores nod for domestic phase 1 trial of CD5 CAR-NK for T-cell lymphoma (Korea Biomedical Review) - "GC Cell...said Wednesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its investigational new drug (IND) application submitted in May. The application was for a phase 1 clinical trial of its T-cell lymphoma treatment candidate, GCC2005....Following the IND approval, GC Cell plans to initiate a phase 1 clinical trial by the end of the year. The trial will evaluate the safety, tolerability, and preliminary efficacy of GCC2005 in combination with lymphodepleting chemotherapy in patients with relapsed or refractory T-cell malignancies, in collaboration with approximately six research institutions."

New P1 trial • Cutaneous T-cell Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

GC Cell, the first Korean company to operate a ‘professional partnering booth’ at 2024 BIO USA [Google translation] (BioTimes) - "GC Cell announced that it will carry out global partnering activities at the '2024 Bio International Convention...for four days from June 3 to 6...In addition, on Tuesday, June 4th, the second day of the event, we plan to communicate with industry leaders through the presentation of 'GC Cell's Strategic Roadmap for 2024 and Beyond (Blueprint2.0)' through the Company Presentation Session...Through this partnering activity, GC Cell will export (License Out, L/O) the technology of Immunecell LLC, Korea's first anti-cancer immune cell therapy, which confirmed the great interest and unmet demand from multinational pharmaceutical companies at JP Morgan Healthcare (JPMHC24) early this year....GC Cell will attend the ASCO 2024 conference and the T-Cell Lymphoma conference held before and after BIO USA and once again announce the results of non-clinical research on CD5 CAR-NK, for which the domestic IND submission was recently completed, and GC Cell's own CAR-NK..."

Licensing / partnership • New trial • Preclinical • Oncology

GC Cell submits IND for domestic phase 1 clinical trial for T-cell lymphoma treatment [Google translation] (HIT News) - "GC Cell...submitted a domestic phase 1 clinical trial approval application (IND) for ‘GCC2005 (development code name)’, which is being developed as a treatment for T-cell lymphoma, to the Ministry of Food and Drug Safety. It was announced on the 10th...Starting with this IND application, the company plans to conduct a phase 1 multicenter clinical trial within the year to evaluate the safety, tolerability, and preliminary effectiveness of GCC2005 in combination with lymphodepleting chemotherapy in the treatment of patients with relapsed or refractory T-cell malignancies."

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

GC Cell announces non-clinical results of CD5 CAR-NK pipeline at AACR [Google translation] (HIT News) - "GC Cell...presented the non-clinical study results of GL205/GCC2005...and Immune Cell LCD, an anti-cancer immune cell therapy, at the American Association for Cancer Research...It was announced on the 11th that the state's real-world data (RWD, real-world data) was presented as a poster...In vivo, it showed anticancer effects in various CD5+ T-ALL models (RPMI-8402, CCRF-CEM), and as a result, GCC2005 showed higher survival rate and tumor suppression efficacy compared to the control group (vehicle). In addition, the results showed that efficacy persisted not only at low doses but also with repeated administration, thereby securing an advantage in terms of drug movement in the body (in vivo PK)....In this study, Immune Cell LCD showed actual and significant clinical improvement through cases of combination with Immune Checkpoint Inhibitors (ICI) drugs, raising expectations for the possibility of prescribing in combination with other treatments...'"

Preclinical • Real-world • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

GC Cell to Present Multiple Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024 (PRNewswire) - "GC Cell...has announced poster presentations from studies of its preclinical study of GL205 (GCC2005), a CD5 CAR-NK targeting malignant T-cell lymphoma, and real-world data for the anticancer immunotherapy drug 'Immuncell-LC' at the AACR Annual Meeting 2024....'We are looking forward to sharing data that GL205 (GCC2005) effectively targets CD5 in malignant T-cell lymphomas....Presenting at AACR offers a significant opportunity to globally disseminate our research findings, creating anticipation for the forthcoming clinical trials of GL205 (GCC2005) slated for IND submission this year'."

IND • Preclinical • Retrospective data • Solid Tumor • T Cell Non-Hodgkin Lymphoma

GC Cell license out T-cell lymphoma treatment to US affiliate (Korea Biomedical Review) - "GC Cell said that it has signed a technology export contract for AB-205, a T-cell lymphoma treatment, with Artiva Biotherapeutics, its U.S. affiliate....According to GC Cell, AB-205 is an allogeneic cord blood-derived NK cell therapy drug equipped with a Chimeric Antigen Receptor (CAR) that targets CD5 expressed in T-cell lymphoma....GC Cell will cooperate with Ativa, which will lead the phase 1 clinical trial that meets Korean and FDA guidelines, and conduct additional phase 2 clinical trials in North America and Asia."

Licensing / partnership • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma