Curocell Completes Korea's First Phase 2 Clinical Trial for Next-Generation CAR-T

• Anbal-cel targeting 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 provided 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, Chonnam 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 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.