Immuncell-LC (GCC4002) / Rivaara Immune, GC Biopharma - LARVOL DELTA

Pancreatic cancer tumor disappears with combined immune cell and drug therapy (Chosun Biz) - "Professor Choi Jong-kwon of the Department of Hematology-Oncology at Konyang University Hospital disclosed the results of a study involving a 53-year-old female pancreatic cancer patient who received a combination therapy of anticancer drugs and immune cell therapy...The patient received a total of 17 doses of Immuncell-LC from June 2024 to May 2025. As a result, CT scans confirmed a 'tumor disappearance,' a significant outcome...Radiological tumor disappearance does not necessarily mean a complete cure, as recurrence or progression remains possible....Most notably, the patient's quality of life improved significantly after treatment."

Clinical • Pancreatic Cancer

Retrospective Study of Long-Term Survival of "Immuncell-LC" in Patients Undergoing Curative Resection for HCC in Korea (clinicaltrials.gov) - P=N/A | N=230 | Completed | Sponsor: GC Cell Corporation | Not yet recruiting ➔ Completed

Trial completion • Hepatocellular Cancer • Oncology • Solid Tumor

GC Cell, ’Immuncell LC’ confirms 68% reduction in risk of liver cancer recurrence [Google translation] (HIT News) - P=NA | N=98 | "G.Cell announced on the 4th that it has published research results showing that its immune cell therapy Immuncell LC reduces the risk of recurrence in patients with early-stage hepatocellular carcinoma by 68%....The median observation period was 19.1 months in the Immuncell LC group and 67.7 months in the control group. The results of the analysis showed that the recurrence-free survival rate in the ImmuneCell LC group significantly increased, and the risk of recurrence decreased by 68%."

Clinical data • Hepatocellular Cancer

GC Cell aims to go global with Immuncell-LC backed by long-term data (Korea Biomedical Review) - P=NA | N=230 | "The study, which followed 230 patients for approximately 9.6 years after curative liver cancer treatment, revealed that patients treated with Immuncell-LC achieved a median RFS of 44 months compared to 30 months in the control group. Notably, the nine-year RFS rate was 25.4 percent in the treatment group versus 16.1 percent in the control group....The data showed that patients treated with Immuncell-LC had a 28 percent lower risk of recurrence or death and a 51 percent reduction in liver cancer-specific mortality. However, while overall survival rates at nine years showed a positive trend – 64 percent vs. 56.3 percent in the control group, the difference did not reach statistical significance."

Clinical data • Hepatocellular Cancer

'Immuncell LC' maintains its effectiveness, including extending survival period, in 9-year long-term follow-up [Google translation] (HIT News) - P=Obs | N=162 | NCT01890291 | Sponsor: GC Cell Corporation | "The 9-year long-term follow-up data of GC-Cell ImmunCell LC was released on the 24th (local time) at ASCO GI 2025 in San Francisco...The median progression-free survival period of patients administered ImmunCell-LC was 43.5 months, while that of the untreated control group was 27.4 months....Compared to the 5-year follow-up results announced in 2015, the hazard ratio (HR) for progression-free survival was 0.63 for 5 years vs. 0.74 for 9 years, and the overall survival was 0.67 for 5 years vs. 0.70 for 9 years, which slightly worsened. The hazard ratio is a statistic comparing the hazard rates of the test group and the control group, and is the value obtained by dividing the hazard rate of the test group by the hazard rate of the control group."

Observational data • Hepatocellular Cancer

GC Cell, 'Immuncell LC' Cell Therapy Product Launched at Indonesia Symposium [Google translation] (HIT News) - "GC Cell...announced on the 23rd that it held a symposium for key industry officials in Jakarta, Indonesia, together with PT Bifarma Adiluhung, a leading Indonesian stem cell treatment company...GC Cell explained that since signing a technology transfer agreement with Bipharma in September of last year, it has been transferring technology to Bipharma’s production and quality control team at its headquarters. The company aims to complete the technology transfer within the next six months and commercialize it locally by 2025....The company emphasized that this symposium was prepared to share the mechanism, prescription experience, and clinical cases of GC Cell's anti-cancer immune cell therapy 'Immuncell LC', and that the reliability of the product was increased through active discussions with local oncology medical staff."

Licensing / partnership • Solid Tumor

GC Cell Symposium with Bifarma Expands Global Impact and Reach for Immuncell-LC (PRNewswire) - "GC Cell...announced the successful completion of its first thought leadership symposium in Jakarta, Indonesia. The event was organized in collaboration with PT Bifarma Adiluhung (Bifarma), a pioneer in Indonesia's stem cell therapy sector, and showcased GC Cell's innovative cancer immunotherapy, Immuncell-LC. Insights into Immuncell-LC's mechanisms of action, real-world treatment experiences, and clinical case studies were key focus areas of the symposium. Indonesian oncologists engaged with renowned Korean medical professionals experienced in applying the therapy in clinical trials, fostering fruitful in-depth discussions about its clinical potential....The six-month program, conducted at GC Cell's headquarters, is on track to enable Bifarma to launch Immuncell-LC in the Indonesian market by 2025."

Clinical • Launch non-US • Hepatocellular Cancer

GC Cell to present long-term efficacy of Immuncell-LC at ASCO GI 2025 (Korea Biomedical Review) - "GC Cell said it will present new findings on its autologous cancer immunotherapy, Immuncell-LC, at the ASCO GI 2025 (Gastrointestinal Cancers Symposium) in San Francisco, the U.S., on Jan. 24....Professor Lee will discuss the topic....which highlights the long-term efficacy results of a nine-year follow-up study from a phase 3 clinical trial conducted in 2015."

Observational data • Hepatocellular Cancer

GC Cell, Announcement of 9-year Extended Tracking Results of ’Immuncell LC’ at US Academic Conference [Google translation] (HIT News) - "GC Cell...will present the results of a 9-year extension follow-up study of the phase 3 clinical trial conducted in 2015 for its autologous anticancer immune cell therapy, 'Immuncell LC', at the American Society of Clinical Oncology's Digestive Cancers Symposium (ASCO GI 2025) in January next year....This presentation will be led by Professor Jeong-Hoon Lee of the Department of Gastroenterology, Seoul National University College of Medicine, who led the study..."

P3 data • Hepatocellular Cancer

GC Cell, PT Bifama of Indonesia and Immunecell LC Technology Transfer Begin in Full Swing [Google translation] (Medipana) - "GC Cell...announced that it has begun the technology transfer process for ImmunCell-LC with PT Bifarma Adiluhung...This technology transfer project is a follow-up work to the licensing agreement with Indonesian Bifarma regarding ImmunCell-LC signed last September, and is a key step in preparing for full-scale commercialization...This technology transfer project will be carried out over the course of approximately six months from November 2024...GC Cell plans to secure milestone revenue upon completion of this technology transfer and generate royalty revenue after local commercialization....In addition, in connection with this technology transfer project, a global symposium among domestic and international Key Opinion Leaders (KOLs) of healthcare experts is scheduled to be held in Indonesia in January 2025. This symposium is expected to be an important opportunity to inform local KOLs of the efficacy and safety of ImmunCell LC and to expand academic exchanges..."

Licensing / partnership • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

GC Cell, Introducing the Long-Term Tracking Results of ImmunCell LC Stock at 2024 AACR-KCA [Google translation] (Medipana) - "At the sponsor booth, GC Cell emphasized the efficacy and safety of ImmunCell LC in liver cancer treatment based on the Randomized Controlled Trial (RCT) data and Real World Data (RWD) data, and held in-depth discussions with researchers. In particular, ImmunCell LC is the only approved immunotherapy cell therapy in Korea, and has attracted the attention of the global academic community with long-term follow-up results of more than 90 months and recent accumulated treatment data of more than 10,000 patients."

Clinical data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

GC Cell's 'ImmunCell LC', a signal of full-scale global expansion... What are the remaining tasks? [Google translation] (Medipana) - "GC Cell is expected to begin full-scale global expansion of its anticancer immune cell therapy 'Immuncell LC'. GC Cell plans to launch Immuncell LC in multiple countries overseas by strengthening overseas partnerships in the next 2 to 3 years and begin full-scale monetization...According to Jeon Ji-won, GC Cell is currently discussing the rights to ImmunCell LC with approximately 33 countries, discussing clinical data with three countries, and technology transfer verification with five countries. This is explained as the result of two major winning strategies: securing positive references in advanced countries' prescription guidance by announcing new RWD (evidence cases) and early advancing into global local major companies through licensing/JV (joint venture)."

Launch • Licensing / partnership • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Immuncell LC Co., Ltd., Proves ‘Stability and Efficacy’… Promotes Expansion of Indications [Google translation] (HIT News) - "GC Cell is pursuing research and development to expand the indications of Immuncell LC beyond the existing hepatocellular carcinoma. Based on the excellent immune anticancer efficacy confirmed through clinical data accumulated over a long period of time, the company plans to expand the scope of application to a wider range of solid cancers....'ImmunCell LC can effectively recognize and kill cancer cells through two pathways: CTL and CIK cells.'"

Pipeline update • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

GC Cell's Immuncell-LC shows potential as adjuvant therapy for HCC at ESMO (Korea Biomedical Review) - P3 | N=230 | NCT00699816 | Sponsor: GC Cell Corporation | "In a session on preoperative and postoperative adjuvant therapy for hepatocellular carcinoma (HCC) at the ESMO 2024 in Barcelona, Spain, Professor Tim Meyer of UCL Cancer Institute, the U.K., spoke positively about immunotherapy's importance in treating HCC....The study was a phase 3 trial of Immuncell-LC in 230 patients with HCC who had undergone curative resection (percutaneous ethanol injection, radiofrequency ablation, or surgical resection), showing a recurrence-free survival (RFS) rate of 37 percent (HR=0.63; 95 percent CI 0.43-0.94) and an overall survival (OS) rate of 79 percent. Longer-term follow-up of five years confirmed RFS of 33 percent (HR=0.67; 95 percent CI 0.48-0.94, P=0.01) and OS of 67 percent (HR=0.33; 95 percent CI, 0.15-0.76, P=0.0060."

P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Retrospective Study of Long-Term Survival of "Immuncell-LC" in Patients Undergoing Curative Resection for HCC in Korea (clinicaltrials.gov) - P=N/A | N=230 | Not yet recruiting | Sponsor: GC Cell Corporation

New trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

GC Cell, Immuncell LC Co., Ltd. Full-scale Entry into Indonesia [Google translation] (Medipana) - "GC Cell announced on the 10th that following the strategic partnership signed with PT Bifarma Adiluhung (Bifama), a leading Indonesian stem cell therapy company, in June, it has signed a technology transfer and licensing-out (L/O) agreement for ImmunCell-LC...The total contract size for this technology transfer, targeting Indonesia, the largest pharmaceutical market in Southeast Asia, is approximately KRW 16 billion, and if launched as planned in 2025, double-digit royalties linked to sales will be received starting next year. The details were kept confidential by agreement between the two companies....If it is launched as scheduled in 2025, it will be the first anticancer cell therapy in Indonesia, which will be very significant."

Launch non-US • Licensing / partnership • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

GC Cell and Taiwan Lucas collaborate on developing immune cell therapy [Google translation] (HIT News) - "GC Cell...announced on the 22nd that it has signed a strategic collaboration agreement with Taiwan's Lukas Biomedical (Chairman Eric Tang) for the development of immune cell therapy and market expansion....Through this collaboration agreement with Lucas Biomedical, GC Cell plans to conduct joint research on the mechanism of action and clinical data of autologous immune cell therapy and strengthen the global awareness of T cell therapy. Through this, it is expected to promote the clinical efficacy and safety of autologous immune cell therapy as well as enter the global market and further expand ImmuneCell LC....Under this agreement, GC Cell will provide domestic clinical trial data (Real World Data, RWD) of ImmuneCell LC, and Lucas Biomedical will share research and clinical data of LuLym-T secured in Taiwan, and cooperate in additional process development and expansion of clinical indications in the future."

Licensing / partnership • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

GC Cell and Checkpoint Therapeutics Advance Collaborative Cancer Research (GlobeNewswire) - "GC Cell...and Checkpoint Therapeutics...have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint’s anti-PD-L1 antibody with dual mechanism of action, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer ('CIK') T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. This collaboration will initially focus on conducting in vitro combination studies to evaluate the synergistic effects of these two therapies on cancer cell destruction....The anticipated synergy between cosibelimab’s antibody-dependent cellular cytotoxicity ('ADCC') mechanism of action and Immuncell-LC’s robust autologous CIK T cell response is supported by extensive research. This combination is expected to leverage immune system components more effectively in targeting and eliminating cancer cells."

Licensing / partnership • Oncology

GC Cell's 'Immuncell LC' RWD, Abstract Adopted by the European Society for Surgical Oncology [Google translation] (HIT News) - "GC Cell (CEO James Park) announced on the 5th that the results of the real-world data (RWD) study on Immuncell LC, an anticancer immune cell therapy, were accepted as an abstract at the European Society of Surgical Oncology (ESSO) conference. ESSO 2024 is scheduled to be held in Belgium from October 2nd to 4th....The company explains that the adoption of the abstract at this European Society for Surgical Medical Oncology (ESSO) is significant in that it analyzed various combination options and patient groups that showed actual clinically significant improvement through real-world data related to combination administration of Immuncell LC, following the presentation of the abstract at AACR 2024."

Real-world • Oncology • Solid Tumor

GC Cell “Remaining NK Cell Research with MSD Continues” [Google translation] (docdocdoc.co.kr) - "GC Cell has opened up about the termination of its joint research and development contract for CAR-NK cell therapy for solid cancer with its US affiliate Artiva Biotherapeutics...This is an announcement made just one day after the company announced through a public notice on the 25th that it had been notified of the termination of a joint research and development contract with Merck Sharp & Dohme Corp...In addition, GC Cell announced that the joint research between Artiva and MSD on the combination of the allogeneic NK cell therapy 'AlloNK (development name AB101)' and the triple-specific NK cell engager will continue....'we plan to use this opportunity and experience as a foundation to actively seek out partnerships and promote domestic and international clinical trials of our own pipeline based on the domestically commercialized ImmuneCell LC and the proven core technology platform CAR-NK...'"

Licensing / partnership • Hematological Malignancies • Immunology • Leukemia • Lupus • Lymphoma • Oncology • Solid Tumor • Systemic Lupus Erythematosus

GC Cell Signs an MOU with PT Bifarma Adiluhung, an affiliate of KALBE group (PRNewswire) - "GC Cell...is proud to announce the establishment of an MOU for strategic partnership with Bifarma, a frontrunner in stem cell therapy within Indonesia with comprehensive capabilities in R&D, GMP-compliant manufacturing, and the commercialization of cell therapies. Bifarma is a Subsidiary of Southeast Asia's Leading Pharmaceutical, PT Kalbe Farma Tbk. This strategic partnership marks a significant step towards entering the Indonesian market and expanding into the innovative cell therapy sector, particularly to facilitate the entry of 'Immuncell-LC', the only approved autologous T-cell therapy for liver cancer surgery in Korea. The MOU also includes discussions on technology transfer and broad cooperation on the development of additional NK cell therapy pipelines."

Licensing / partnership • Hepatocellular Cancer • Liver Cancer

GC Cell launches ‘Immune Cell LCD’, “A hidden gem…entering the global market” [Google translation] (Biospectator) - "GC Cell has begun full-fledged global expansion of ‘Immuncell-LC’, the company’s flagship cell therapy product. Immune Cell LCD is a cytokine-induced killer cell (CIK) treatment that was approved and marketed in Korea in 2007 as an adjuvant for hepatocellular carcinoma (HCC) surgery...Immune Cell-LC is currently sold only domestically, but GCell expects to be able to advance into global markets, including the United States, based on Immune-Cell-LC's competitive data confirmed in the liver cancer post-surgery therapy setting, where there is a large unmet medical need....Immune Cell LCD is a cell therapy product made up of cytokine-induced killer cells (CIK)."

Commercial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

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 and BioCentriq Execute Process Transfer Agreement in Anticipation of the U.S. entry of Immuncell-LC Inj. (PRNewswire) - "GC Cell...has announced a strategic partnership with BioCentriq, a cell therapy contract development and manufacturing organization (CDMO) and US affiliate of GC Cell. This important partnership lays the foundation to bring GC Cells' proven cell-based immunotherapy, Immuncell-LC to the North American market. The execution of a Process Transfer Agreement with BioCentriq effectively lays the foundation for the U.S. launch of Immuncell-LC through utilization of BioCentriq's cell therapy process development, analytical method development and manufacturing expertise...Immuncell-LC is the only commercially available adoptive cell therapy treatment of early-stage HCC.."

Licensing / partnership • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor