Curocell, Inc.

SEOUL, South Korea--(BUSINESS WIRE)-- On November 10, a global multimodality CDMO, GenScript ProBio and specialized CAR-T therapy firm Curocell signed a strategic partnership MOU for the production of viral vectors necessary for the development of next generation of CAR-T therapy, marking another significant step in their ongoing collaboration. This partnership will broaden the strategic cooperation between the two companies to encompass the entire project, including the development, production, and clinical trials of viral vectors for CAR-T therapy research and development. Viral vectors are vehicles for drug delivery that utilize viruses to transport genetic material to the cellular interior. The demand for viral vectors is rapidly increasing due to the recent growth of the gene therapy market, which uses CAR-T therapy as its main active ingredient. However, it has been noted that a shortage of GMP facilities producing viral vectors is causing delays in the development of gene therapies, including CAR-T therapy. GenScript ProBio Chairman Patrick LIU, stating, “We are delighted to sign an MOU with Curocell, a local leader in CAR-T therapy, for the supply of viral vectors,” and said that this partnership will “deepen our close collaboration to develop CAR-T therapy, not only in Korea but on a global scale.” Curocell CEO Gunsoo Kim said the partnership will allow the two companies to “establish a stable cooperative relationship spanning the entire process, from the developmental stage to the commercialization of CAR-T therapy.” He also stated that “Curocell plans to grow as a global leader in cancer immunotherapies through its partnership with GenScript ProBio, a company expanding its global presence in the field of gene therapy.” Corporate Overview - Curocell “Fight Against Hopelessness: Curocell is spearheading the development of innovative cancer immunotherapies.” Curocell is Korea’s first company specialized in CAR-T treatment, developing CAR-T cell therapies that have become one of the world’s most promising new drugs to emerge in recent years. Curocell’s technology aims to overcome the limitations of existing cancer immunotherapies to treat a wide variety of different cancer types. Curocell is working with top experts in various fields such as CAR-T technology development, biopharmaceutical development, production and GMP, while also collaborating with major Korean hospitals for the systematic development of new CAR-T cell therapies. Curocell is Korea’s first company to obtain regulatory approval to conduct CAR-T clinical trials, and is widely recognized as the country’s leading company in the field of CAR-T cell therapy, possessing a large-scale commercial GMP facility with state-of-the-art equipment to manufacture its products. “CAR-T cell therapy, a next generation cancer immunotherapy” CAR-T(Chimeric Antigen Receptor-T) cell therapy is a next generation cancer immunotherapy that involves modifying a patient’s immune T cells in vitro to express antigens that specifically target cancer cells, then reintroducing them into the patient to destroy the cancer. Through the process of isolating the patient’s immune cells, modifying their genes, and cultivating them en masse, it is possible to achieve complete remission in a terminal leukemia patient with just a single dose where no other treatment options are available. Corporate Overview - GenScript ProBio GenScript ProBio, a subsidiary of GenScript Biotech Corporation, is a global contract research organization (CRO) and contract development and manufacturing organization (CDMO), specializing in the development high-quality, one-stop manufacturing processes for viral vectors in the field of cell and gene therapy (CGT) from its GMP production platforms. The company operates regional offices in the United States, the Netherlands, China (Shanghai and Nanjing), and Hong Kong, supporting clients in the United States, Europe, and Asia through its global business network. Since October 2017, GenScript ProBio has obtained approval for investigational new drug (IND) applications from more than 60 countries worldwide, including countries in Asia, leveraging their well-established network.

Anbal-cel argeting DLBCL completes phase 2 trial Anticipation growing over Korea's first CAR-T therapy ahead of regulatory review Commercial manufacturing scheduled in 2025 at Korea's only CAR-T GMP facility DAEJEON, South Korea, Nov. 1, 2023 /PRNewswire/ -- Curocell, South Korea based CAR-T specialized company (CEO: Gunsoo Kim), 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). This announcement is a significant milestone and is paving the way towards the launch and approval of Korea's first CAR-T therapy. It has also provied typo new hope for the treatment of patients with DLBCL, an aggressive form of cancer that is growing in prevalence within Korea. The Phase 2 clinical trial evaluated the safety, efficacy and tolerability of "Anbal-cel" in patients with relapsed or refractory DLBCL. It was conducted over a period of 20 months starting in February 2022, enrolling a total of 80 patients from six hospitals across Korea, including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, National Cancer Center, Chonnma typo National University Hospital, and Pusan National University Hospital. "Anbal-cel" is a next-generation CAR-T therapy based on Curocell's OVIS™ technology that significantly inhibits the expression of PD-1 and TIGIT, two types of immune checkpoint receptors, which are known to inhibit anti-tumor function/activity of CAR-T cells. This technology has substantially improved the therapeutic performance of CAR-T therapy in patients with relapsed or refractory DLBCL with a poor prognosis. Curocell made international headlines during the company's oral presentation of its Phase 2 clinical trial interim results at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland back in June. The interim results analyzed the efficacy and safety of its CAR-T treatment in 41 patients participating in the Phase 2 trial. The complete response rate (CRR: Rate at which the cancer enters into full remission) observed in the interim results was 71%, showing an improved therpeutic effect compared to the 40 to 50% CRR range for three FDA-approved CAR-T therapies currently on the market. 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. Starting from the expected year of approval in 2025, the company is planning to launch the supply of commercial products from Korea's only large-scale GMP facility dedicated to the production of CAR-T boasting state-of-the-art equipment. CEO of Curocell, Gunsoo Kim said that, "I am extremely proud that we were able to complete Korea's first clinical Trial or study for CAR-T therapy in such a short period of time, which I believe is one of the most remarkable achievement in the history of drug development in Korea." He added, "We will make every effort to obtain approval for Anbal-cel in 2025 and ensure sustained growth for the company through future expansion in our overseas business." The clinical trial for "Anbal-cel" was officially selected by the Korea Drug Development Fund (KDDF) in 2021 as the target of a government grant. It was conducted with the support of the National New Drug Development Project Team, funded by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare. (Project Number: HN21C0653) Corporate Overview "Fight Against Hopelessness: Curocell is spearheading the development of innovative cancer immunotherapies" Curocell is Korea's first company specialized in CAR-T treatment, developing CAR-T cell therapies that have become one of the world's most promising new drugs to emerge in recent years. Curocell's technology aims to overcome the limitations of existing cancer immunotherapies to treat a wide variety of different cancer types. Curocell is working with top experts in various fields such as CAR-T technology development, biopharmaceutical development, production and GMP, while also collaboaring with major Korean hospitals for the systematic development of new CAR-T cell therapies. Curocell is Korea's first company to obtain regulatory approval to conduct CAR-T clinical trials, and is widely recognized as the country's leading company in the field of CAR-T cell therapy, possessing a large-scale commercial GMP facility with state-of-the-art equipment to manufacture its products. "CAR-T cell therapy, a next generation cancer immunotherapy" CAR-T (Chimeric Antigen Receptor-T) cell therapy is a next generation cancer immunotherapy that involves genetically modifying a patient's immune T cells in vitro to express antigens that specifically target cancer cells, then reintroducing them into the patient to destroy the cancer. Through the process of separating the patient's immune cells, modifying their genes, and cultivating them en masse, it is possible to achieve complete remission in a terminal leukemia patient with just a single administration where no other treatment options are available. SOURCE Crucocell Inc.

- 82% ORR (9 of 11 patients) and 82% (9 of 11 patients) CR rate documented after anbal-cel treatment to the patients in relapsed/refractory large B-cell lymphoma - 2 out of 3 patients dosed with 2x105 cells/kg of anbal-cel lasting the complete response for more than 12 months - Well tolerated up to 2X106 cells/kg dose level without DLT and not reached to MTD in Phase 1 dose escalation study DAEJEON, South Korea, June 13, 2022 /PRNewswire/ -- Curocell, Inc., a leading CAR-T company based in South Korea, announced the phase 1 dose-escalation study results documenting an 82% complete remission (CR) rate after a single dose of anbalcabtagene autoleucel (anbal-cel) to relapsed/refractory large B-cell lymphoma patients. Three (3) among 4 patients dosed at 2x105 cells/kg of anbal-cel documented complete remission, and 2 responding patients are maintaining the complete remission for more than a year. Strikingly, all patients dosed with 2x106 cells/kg reported complete remission after a single dose of anbal-cel. The complete phase 1 study results were presented at EHA at EHA (European Hematology Association) congress, Vienna, Austria, Jun 09-17, 2022. The anbal-cel is the CD19 CAR-T integrated with the OVISTM (Overcome Immune Suppression) platform. OVISTM technology consists of a dual knockdown system for two crucial immune checkpoint receptors, PD-1 and TIGIT, in CAR-T cells. "Although CD19 directed CAR-T therapy changed the treatment paradigm for Large B-cell lymphoma, which is one of the most aggressive hematologic malignant cancer, more than 50% of LBCL patients didn't experience the clinical benefit of CD19 CAR-T treatment, and there are still huge unmet medical needs. Anbal-cel's phase 1 study result demonstrates the OVISTM platform's potential to maximize CAR-T's functionality to eradicate tumors. We are very excited about this promising clinical result even though the patient number treated with anbal-cel is limited with a total of 11 and looking forward to the ongoing phase 2 clinical trial to confirm the efficacy and safety of anbal-cel. Furthermore, we believe these data represent the excellence of our next-generation CAR-T technology." said Gunsoo Kim, Curocell's chief executive officer. This phase 1 study was to evaluate the safety and preliminary efficacy in patients with r/rLBCL. Patient was infused as a single intravenous dose with 2x105 cells/kg (Dose Level 1), 7x105 cells/kg (DL2) or 2x106 cells/kg (DL3). Lymphodepletion with cyclophosphamide (500mg/m2) and fludarabine (30mg/m2) was performed for 3 days prior to anbal-cel infusion. Eleven (11) patients with r/r DLBCL were infused with anbal-cel. All patients received two or more prior lines of therapy, and 36% (4/11) received ≥4 prior lines of treatment before the study. No patient experienced DLT during the study. Of the 11 patients, 5 (46%) patients experienced CRS; 3 (27%) were grade 1 or 2 and 2 (18%) experienced grade 3 CRS. The median time to onset of CRS was 7 days (range, 1-16) with a median duration of 5 days (range, 1-19). One patient dosed with 2x106 cells/kg experienced grade 2 ICANS; the time to onset of ICANS was 7 days and lasted for 13 days. This patient had prior CNS involvement history before the study. The frequently reported grade 3/4 treatment related AEs were anemia (2/11, 18%), neutropenia (2/11, 18%), thrombocytopenia (2/11, 18%), CRS (2/11, 18%). Dose-dependent CRC01 expansion was observed; median Tmax was 15.4, 15.8 and 14.5 days at DL1, DL2 & DL3 each; Cmax, AUC0-28 day was dose proportionally increased. Based on promising safety and efficacy data from Phase 1 study, Phase 2 trial has been commenced, and patient enrollment is ongoing. Details of the oral presentation at EHA are as follows: Submission ID: EHA-3438 Title: PHASE 1/2 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 Session Title: Aggressive Lymphoma - CART Session date and time: Saturday, June 11 11:30 - 12:45 Session room: Hall A7 Final Abstract Code: S214 About anbalcabtagene autoleucel (anbal-cel) Anbal-cel, recognized CD19 and is based on OVISTM, a first-in-class CAR-T platform. OVISTM technology downregulates PD1 and TIGIT expression in CAR-T cells. Through overcoming the immune suppression by PD-L1 and TIGIT ligands, OVISTM CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. The Phase 2 clinical trial of anbal-cel has initiated in South Korea in the first half of 2022. About Curocell, Inc. Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVISTM technology intending to improve the clinical efficacy of CAR-T therapies. For more information, visit . SOURCE Curocell, Inc.