Antengene has received Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) to begin the Phase I ATTRACT study of ATG-201, a CD19 × CD3 bispecific T-cell engager (TCE), for the treatment of B-cell-related autoimmune diseases.

ATG-201 is a CD19-targeting bispecific antibody that uses steric hindrance masking technology and is designed to eliminate CD19-expressing B cells. By engaging both CD3 on T cells and CD19 on B cells, the therapy aims to harness the body's immune system to selectively target disease-causing B cells associated with autoimmune disorders.

Following the approval, Antengene plans to start the Phase I ATTRACT study in China and is also preparing for the clinical development of ATG-201 in Australia.

The ATTRACT trial will be led by Professor Zhanguo Li of Peking University People’s Hospital. The first-in-human Phase I study will assess the safety, tolerability and preliminary efficacy of ATG-201 as a monotherapy in adult patients with B-cell-related autoimmune diseases.

The study will include dose-escalation and dose-expansion stages. Its primary goals are to evaluate safety and tolerability and to identify the recommended Phase II dose. Secondary objectives include assessing pharmacokinetic and pharmacodynamic profiles, immunogenicity and early signs of clinical effectiveness.

B-cell-mediated autoimmune diseases continue to present significant treatment challenges, including low remission rates, a high risk of relapse and concerns over long-term safety. ATG-201 has been developed to provide a targeted approach by redirecting and activating the patient’s own T cells to eliminate harmful B cells.

Antengene has previously entered into an agreement with UCB, granting the company an exclusive worldwide licence to develop, manufacture and commercialise ATG-201, along with access to its manufacturing technology. Antengene will conduct the first-in-human Phase I studies in China and Australia before transferring further clinical development activities to UCB.

The IND approval marks an important milestone for Antengene as it expands its focus beyond oncology and haematology into autoimmune diseases. The company said the development reflects its strategy to address areas of high unmet medical need and strengthen its pipeline of innovative therapies for patients worldwide.

 

Source: antengene.com

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