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Immunotech Biopharm's CAR-T-19 Injection Receives Breakthrough Therapy Designation in China for B-ALL

• Immunotech Biopharm's CAR-T-19 injection has been granted breakthrough therapy designation by China's Center for Drug Evaluation (CDE) for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). • The designation, for patients aged 25 and under, is based on promising clinical efficacy and safety data observed with the CAR-T-19 injection in treating B-ALL. • This breakthrough therapy designation will expedite the clinical development of CAR-T-19 injection and accelerate its availability to patients in need, offering more intensive guidance from the CDE. • CAR-T-19 injection has shown efficacy in clinical studies, leading to the acceptance of its investigational new drug application for B-ALL by the CDE in August 2019.

Immunotech Biopharm Ltd. has announced that its CAR-T-19 Injection, an anti-CD19 single-chain antibody chimeric antigen receptor T-cell injection, has received breakthrough therapy designation from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). This designation is specifically for the treatment of patients aged 25 and under who are suffering from relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).
The breakthrough therapy designation was granted based on the compelling clinical efficacy and safety data demonstrated by the CAR-T-19 injection. According to the NMPA's guidelines, this designation will prioritize the drug's development, offering more intensive communication and guidance from the CDE to accelerate its progress. Drugs with this designation may also be considered for conditional approval and priority review when submitting a new drug application.

Clinical Development and Trial Progress

The CAR-T-19 injection is indicated for the treatment of pediatric and young adult patients (up to 25 years old) with B-ALL. Clinical studies have already demonstrated the efficacy of this product candidate. The investigational new drug (IND) application for CAR-T-19 injection, with B-ALL as the clinical indication, was accepted for processing by the CDE in August 2019. Approval of the IND for clinical trials was received in December 2020, paving the way for clinical trials.
Following IND approval, Immunotech Biopharm initiated a Phase I clinical trial for CAR-T-19 injection. The Phase I clinical trial protocol and proposed timetable were presented at a kick-off conference in Beijing on February 25, 2021. In October 2023, the company applied to the CDE to commence Phase II clinical trial work, marking continued progress in the drug's development.

Implications of Breakthrough Therapy Designation

The breakthrough therapy designation is designed to expedite the clinical development of innovative drugs that show significant clinical advantages. It provides opportunities for more intensive CDE guidance and discussion regarding clinical trials and development strategy, as well as priority review later in the process. This designation underscores the potential of CAR-T-19 injection to address the unmet medical needs of young patients with relapsed or refractory B-ALL.
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Reference News

[1]
Immunotech Biopharm Ltd Announces CAR-T-19 Injection Receives Breakthrough Therapy ...
marketscreener.com · Dec 11, 2024

Immunotech Biopharm's CAR-T-19 Injection, an anti-CD19 CAR-T cell therapy, received breakthrough therapy designation for...

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