Rimqarto (anbalcabtagene autoleucel) / Curocell - LARVOL DELTA

Curocell develops Rimqarto, Korea's first CAR-T therapy with superior efficacy [Google translation] (Chosun Biz) - "Curocell applied for the product license for its domestic CAR-T therapy, 'Rimqarto (ingredient name: Anbalcel),' to the Ministry of Food and Drug Safety on the 30th. Curocell is the first pharmaceutical and biotech corporation in South Korea to develop a CAR-T therapy and submit a final approval application...Rimqarto is a treatment for relapsed or refractory large B-cell lymphoma (LBCL), a type of blood cancer...Being selected as a rapid processing candidate allows it to receive approval based solely on the results of phase 2 clinical trials under the 'Advanced Biopharmaceutical Product License Review' regulations....The decision on Rimqarto's domestic approval is expected to be made in the second half of next year."

Korea approval • Korea filing • Diffuse Large B Cell Lymphoma • Large B Cell Lymphoma

Curocell's Anbal-cel wins orphan drug designation for treatment of relapsed or refractory LBCL (Korea Biomedical Review) - "On Tuesday, the Ministry of Food and Drug Safety (MFDS) designated Anbal-cel as an orphan drug in development for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). The MFDS' orphan drug designation facilitates the rapid development and approval of treatments for rare, incurable, and life-threatening diseases....In addition, the period for protecting proprietary data for new drugs under development will be extended from 4-6 years to 10 years....Anbal-cel demonstrated efficacy and safety with a 67.1 percent complete response rate in the final results of its phase 2 clinical trial."

Orphan drug • Diffuse Large B Cell Lymphoma

Gut Microbiome Composition As a Prognostic Marker in CD19-Targeting CAR T-Cell Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (ASH 2024) - "Methods We analyzed 47 patients with R/R DLBCL who were schedule to undergo anti-CD19 CAR T-cell therapy, including 29 patients receiving tisagenlecleucel (tisa-cel) and 18 receiving anbalcatagene autoleucel (anbal-cel). These findings underscore the potential for microbiome modulation as a strategy to overcome CAR T-cell therapy resistance and improve patient outcomes. We are currently conducting functional studies to explore the interplay between the tumor microenvironment and microbiome."

Biomarker • CAR T-Cell Therapy • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Curocell's CAR-T therapy picked as 2nd drug for expediated approval and market launch (Korea Biomedical Review) - "Curocell's Anbal-cel (brand name: Rimqarto), a locally developed CAR-T therapy, has been designated by the government for expedited approval and market launch through a simultaneous process of domestic approval, coverage evaluation, and drug price negotiation....Curocell said Tuesday that its next-generation CAR-T therapy, Anbal-cel, has been selected as the second target drug for the Ministry of Health and Welfare's 'Approval application, reimbursement assessment, and drug price negotiation pilot project.'...Through this pilot project, the drug payment process of MFDS approval, HIRA’s reimbursement assessment, and NHIS’ drug price negotiation have been improved so that drug price negotiation is completed at the same time as the MFDS approval. That shortens the process, which previously took more than 300 days, including 120 days for MFDS’ approval, 150 days for HIRA’s reimbursement evaluation, and 60 days for NHIS’ drug price negotiation."

Korea approval • Reimbursement • Large B Cell Lymphoma • Lymphoma

Curocell's CAR-T therapy wins fast-track designation (Korea Biomedical Review) - "Curocell, a chimeric antigen receptor-T (CAR-T) developer, said its CAR-T therapy Anbal-Cel has won the advanced biomedicine expedited approval from the Ministry of Food and Drug Safety...As the first homegrown CAR-T therapy employing next-generation technology, Curocell expects to file for new drug approval for Anbal-Cel this year, and a market launch in the latter half of next year....Anbal-Cel’s designation enables a dedicated review team to prioritize its evaluation over other products."

Fast track • Korea approval • Launch non-US • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ANBALCABTAGENE AUTOLEUCEL (PD-1 AND TIGIT KNOCK-DOWNED CD19 CAR-T) FOR RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA PATIENTS: RESULT OF A PIVOTAL PHASE 2 STUDY. (EHA 2024) - "They received a target dose of 2x106 cells/kg afterlymphodepletion (cyclophosphamide 500mg/m2 and fludarabine 30mg/m2 for 3 days). Anbal-cel demonstrated high objective response rate with durable response. The data showed not only lowincidence of ≥ grade 3 cytokine release syndrome, but also markedly lower rate of neurological eventcompared to other CAR-T products. We will conduct additional analysis to determine how the OVIS platformhas a positive effect on the process of killing tumor cells."

Clinical • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PD-1 • TIGIT

[BIO USA 2024] Curocell considers setting up overseas offshoots (Korea Biomedical Review) - "The BIO International Convention (BIO USA) is the world's largest bio conference, bringing together bio companies, investors, and researchers worldwide to discuss innovative technologies and partnerships. This year's event was held in San Diego from last Monday to Thursday, local time....Korea Biomedical Review met with Curocell CEO Kim Gun-soo and asked him about the company's plans to enter overseas markets and the timeline for applying for the license of its homegrown CAR-T drug CRC01 (anbalcabtagene autolucel or Anbal-cel in general name). In the interview, CEO Kim discussed Curocell's goals, business strategy, and the need to expand the domestic CAR-T therapeutic market."

Clinical • Licensing / partnership • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Curocell ahead of NDA… Target for approval of CAR-T treatment in the first half of next year [Google translation] (HIT News) - "As Curocell...is about to submit a New Drug Application (NDA), the Ministry of Food and Drug Safety will announce the approval of CAR-T treatment 'Anbal-cel (ingredient name) in the first half of 2025. The goal is to obtain product approval for ‘Anbalcabtagene Autoleucel’...The final efficacy of the Phase 2 clinical trial of Anbalcell, the main content of the CSR, was the same as the topline results announced in March...'we will complete the phase 1 clinical trial for adult acute lymphoblastic leukemia (ALL), an additional indication for Anbalcell,' and 'In the first half of next year.'....'We aim to submit a new drug approval application to the Ministry of Food and Drug Safety in September 2024 and receive product approval for CAR-T treatment Anbalcell in 2025.'"

Korea approval • Korea filing • Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Curocell applies to the Ministry of Food and Drug Safety for a rapid processing system for ‘Anbalcell’ advanced biopharmaceutical [Google translation] (HIT News) - "Curocell...announced on the 22nd that it had applied to the Ministry of Food and Drug Safety to designate Anbalcell as a target of the advanced biopharmaceutical expedited processing system....The advanced biopharmaceutical expedited processing system is a law designed to quickly launch highly innovative medicines, such as treatments for life-threatening diseases or serious diseases, to the market and support rapid supply to patients. Through this application, Curocell plans to proceed with new drug approval after being designated as an expedited processing target for Anbalcell within the third quarter of this year."

Non-US regulatory • Hematological Malignancies • Oncology

Curocell receives government funding to expand CAR-T treatment into lupus (Korea Biomedical Review) - "Curocell...said it will start developing a next-generation anti-CD19 CAR-T therapy for treatment-resistant systemic lupus erythematosus (SLE) as part of the 2024 Multi-Ministerial Regenerative Medicine Technology Development Program...This initiative, driven by the Ministry of Science and ICT along with the Ministry of Health and Welfare...The company has received funding of 1.07 billion won ($789,959) to support clinical trials for systemic lupus using its advanced CAR-T therapy, Anbal-cell..."

Financing • Systemic Lupus Erythematosus

Kim Geon-soo, CEO of Curocell, 'Commercialization of domestic CAR-T treatment is not far away' [CEO met on-site] [Google translation] (Korea Economic TV) - "Curocell is the company that is speeding up the development of domestic CAR-T treatments. The market's attention is focused on the recent positive results from phase 2 clinical trials....Curocell plans to complete the application for conditional approval of Anvalcel to the Ministry of Food and Drug Safety in September and commercialize it in 2025."

Launch non-US • Non-US regulatory • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Curocell's CAR-T therapy effective to treat DLBCL in phase 2 study (Korea Biomedical Review) - P1/2 | N=91 | NCT04836507 | Sponsor: Curocell Inc. | "Curocell, a Kosdaq-listed biotech company, said it received the topline data from its phase 2 clinical trial for its CAR-T (chimeric antigen receptor-T) therapy, Anbal-cel, to treat diffuse large B-cell lymphoma (DLBCL)....The analysis of the phase 2 clinical trial topline data revealed a complete response rate (CRR) of 67.1 percent among 73 participants, indicating that Anbal-cel completely eradicated cancer cells in these patients....Additionally, the objective response rate (ORR), a primary evaluation metric indicating the proportion of patients who showed a response to the drug, was 75.3 percent....Following these promising results, Curocell plans to apply for domestic drug approval in the latter half of this year."

P2 data • Regulatory • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Curocell, ‘Anbalcell’ clinical trial approved for secondary central nervous system lymphoma [Google translation] (HIT News) - "At the 1st Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee, Curocell...was selected by Professor Deokhyun Yoon of the Department of Oncology at Seoul Asan Medical Center as a researcher for 'Anbal-cel', which is being conducted for patients with secondary central nervous system lymphoma. It was announced on the 1st that the clinical trial was approved...The clinical research plan is an exploratory, high-risk clinical study that uses Anbalcel to treat patients with primary or refractory central nervous system lymphoma or secondary central nervous system lymphoma."

New trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Curocell, 'Anbalcel' Selected as one of the top 10 excellent projects for the National New Drug Development Project [Google translation] (HIT News) - "Curocell...announced on the 14th that the next-generation CD19 CAR-T treatment 'Anbal-cel' was selected as one of the top 10 outstanding projects in the national new drug development project....Anbalcel is a next-generation CAR-T treatment that uses Curocell's OVIS technology to significantly reduce the expression of two types of immune checkpoint receptors, 'PD-1' and 'TIGIT'."

Clinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Curocell Completes Korea's First Phase 2 Clinical Trial for Next-Generation CAR-T (PRNewswire) - "Curocell, South Korea based CAR-T specialized company...has completed Phase 2 clinical trial for its next-generation CD19 CAR-T therapy 'Anbal-cel' that targets relapsed or refractory DLBCL (Diffuse Large B-cell Lymphoma)....Curocell plans to officially announce the final results of its Phase 2 clinical trial for 'Anbal-cel' in the first half of next year and submit an BLA application to Korea's Ministry of Food and Drug Safety for approval next September."

Non-US regulatory • P2 data • Trial completion • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase II study of anbal-cel, novel anti-CD19 CAR-T therapy with dual silencing of PD-1 and TIGIT: Drug characteristics, immunologic and genetic biomarkers associated with treatment outcome and toxicities (ESMO 2023) - P1/2 | "The most frequently detected mutations were related to cell cycling, epigenetic regulation, immune escape, apoptosis etc. Changes in ctDNA concentration were reversely correlated with treatment outcome. Conclusions Anbal-cel's unique immunologic and genetic changes demonstrated potential to correlate with treatment outcomes and warrant to confirm with more data."

Biomarker • Clinical • IO biomarker • P2 data • Oncology • B3GAT1 • CD27 • CD38 • CD8 • HAVCR2 • ICOS • IL4 • IL5 • KLRD1 • LAG3 • NECTIN2 • PD-1 • PD-L1 • PVR • TIGIT

Curocell completes phase 2 study of CAR-T therapy for DLBCL (Korea Biomedical Review) - "Curocell announced that it has concluded the phase 2 clinical trials of its CAR-T (chimeric antigen receptor-T) drug, Anbal-cel, for treating diffuse large B-cell lymphoma (DLBCL) as it recently completed administering the treatment to the final patient...Speaking at a press conference on Friday notifying the company's planned initial public offering in November, CEO Kim Gun-soo said the company will get the trial results early next year....Then, Curocell will present the results at a cancer meet in the first half and seek biological license application (BLA) in the second half."

Enrollment closed • P2 data • Regulatory • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Curocell sees ‘Kosdaq listing in November barring unexpected variables’ (Korea Biomedical Review) - "Curocell is conducting phase 2 clinical trials of CRC01 (anbalcabtazine autolucel, or anbal-cel), a CD19-targeted CAR-T therapy. It is conducted on patients with relapsed or refractory diffuse large B-cell lymphoma. It plans to complete the phase 2 study this year and apply for marketing authorization to the Ministry of Food and Drug Safety in the second half of next year....Curocell expects to administer CRC01 to Korean patients as early as 2025 following the approval of the new drug."

Non-US regulatory • Trial completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase 2 Study of Anbalcabtagene Autoleucel, Novel Anti-CD19 CAR-T Therapy with Dual Silencing of PD-1 and TIGIT: Interim Analysis Result (ICBMT 2023) - No abstract available

P2 data • PD-1 • TIGIT

Curocell begins clinical trial of CAR-T therapy for ALL patients (Korea Biomedical Review) - "Curocel said Wednesday that it has completed administering the first patient group in the phase 1 clinical trial of its CAR-T therapy candidate, CRC01 (anbalcaptagin-otoryucel or anbal-cel) for relapsed or refractory adult acute lymphoblastic leukemia (ALL) patients. The phase 1 study evaluates the safety, maximum tolerated dose, and potential therapeutic benefit of anbal-cel in about 10 relapsed or refractory adult ALL patients divided into three cohorts (low, medium, and high dose). The clinical trial will be conducted at Samsung Medical Center, Asan Medical Center, the Catholic University of Korea Seoul St. Mary's Hospital, Severance Hospital, and Seoul National University Hospital."

Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Curocell announced encouraging updates on the next-generation anti-CD19 CAR-T, Anbalcabtagene-autoleucel at International Conference on Malignant Lymphoma (ICML) 2023 (PRNewswire) - P1/2 | N=91 | NCT04836507 | Sponsor: Curocell Inc. | "Curocell Inc...announced updated Phase 2 interim results for Anbalcabtagene-autoleucel (anbal-cel) on June 15, 2023, at ICML (International Conference on Malignant Lymphoma)....The Phase 2 study of anbal-cel was conducted to evaluate the efficacy and safety in patients with r/r LBCL....41 patients with r/r LBCL were infused with anbal-cel....84% ORR (32/38), 71% CR (27/38) were reached, and durable complete response was monitored as CR at 1 month was 68% (26/38), CR at 3 months was 61% (19/31) and CR at 6 months was 60% (12/20) where median follow-up as 6.3 months....Curocell is planning on submitting an NDA to MFDS in mid-2024 and recently completed the construction of the largest commercial GMP facility for CAR-T production in Daejeon, Korea."

Commercial • Non-US regulatory • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

PHASE 2 STUDY OF ANBAL-CEL, NOVEL ANTI-CD19 CAR-T THERAPY WITH DUAL SILENCING OF PD-1 AND TIGIT IN RELAPSED OR REFRACTORY LARGE B CELL LYMPHOMA - INTERIM ANALYSIS RESULT (ICML 2023) - "Anbal-cel demonstrated unique characteristics in product profile which demonstrated potential to correlate with treatment outcomes and warrant to confirm with more data."

IO biomarker • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCR7 • CD4 • CD8 • CSF2 • IFNG • IL10 • IL15 • IL2 • PD-1 • TIGIT

Curocell, Ministry of Food and Drug Safety approved rapid test method..”Shortening CAR-T manufacturing“ [Google translation] (Biospectator) - "Curocell has tested the sterility test, mycoplasma negative test, and replicable virus negative test among the quality test methods of the autologous CD19 CAR-T 'anbalcabtagene autoleucel' (anbal-cel)' from the Ministry of Food and Drug Safety announced on the 8th that it was approved for the first time in Korea to change from....Curocell is planning to complete phase 2 clinical trials of Anbelcell for diffuse large B-cell lymphoma (DLBCL) this year and apply for new drug approval next year....Curocell said that when the approved rapid test method is applied, it takes 7 days for the sterility test and 1 day for the other two tests, and through this, the entire CAR-T manufacturing period can be shortened from about 40 days to 14 days."

Non-US regulatory • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Curocell, published interim results of CATI phase 2 at the International Lymphoma Society [Google translation] (Financial News) - "Domestic bio venture Curocell announced on the 3rd that the interim results of the phase 2 clinical trial of 'Anbal-cel', which is being developed as a CAR-T (chimeric antigen receptor T cell) treatment, will be released in June. The abstract containing the interim results of phase 2 of Anbal-cel was selected for oral presentation at the 17th International Lymphoma Society (ICML) held in Lugano, Switzerland from June 13."

P2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase 1/2 study of anbalcabtagene autoleucel, novel anti-CD19 CAR-T cell therapy with dual silencing of PD-1 and TIGIT in relapsed or refractory large B-cell lymphoma. (ASCO 2022) - P1/2 | "Lymphodepletion with cyclophosphamide (500mg/m2) and fludarabine (30mg/m2) was performed for 3 days prior to Anbal-cel infusion. Anbal-cel demonstrated promising efficacy and tolerable safety profile in this dose escalation study. Based on this phase 1 study, phase 2 patient enrollment will be commenced in Mar 2022 to evaluate the response rate, duration of response of CRC01 as well as safety. In addition, various biomarker studies are planned to investigate the differential mode of action of Anbal-cel during phase 2 study."

CAR T-Cell Therapy • IO biomarker • P1/2 data • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • CD19 • PD-1 • TIGIT