en.Wedoany.com Reported - Antengene Corporation announced that the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase I clinical study, ATTRACT, evaluating ATG-201 (a CD19/CD3 bispecific T-cell engager antibody) for the treatment of B cell-related autoimmune diseases. ATG-201 is a CD19-targeted bispecific T-cell engager employing steric hindrance masking technology, designed to eliminate CD19-expressing B cells. By leveraging the bispecific interaction of CD3 and CD19 with T cells and B cells, it harnesses the body's own immune system for precise action, demonstrating potential in treating B cell-driven diseases. Antengene plans to rapidly initiate and advance the Phase I ATTRACT study in China, while also preparing for the clinical development of ATG-201 in Australia.
The ATTRACT study is a Phase I clinical trial, with Professor Li Zhanguo from Peking University People's Hospital serving as the principal investigator. The study aims to evaluate the safety, tolerability, and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell-related autoimmune diseases, encompassing both dose escalation and dose expansion phases. The primary objectives are to assess safety and tolerability and to determine the recommended Phase II dose (RP2D); secondary objectives include evaluating pharmacokinetics, pharmacodynamic profiles, immunogenicity, and preliminary efficacy.
Professor Li Zhanguo stated that patients with refractory B cell-mediated autoimmune diseases still face significant unmet clinical needs, including low remission rates, high relapse risks, and long-term safety concerns. As a bispecific CD3/CD19 T-cell engager, ATG-201 can redirect and activate autologous T cells to achieve precise elimination of pathogenic B cells. This novel mechanism may overcome current treatment limitations. The research team will collaborate closely with Antengene to conduct this Phase I study.
Antengene has entered into an agreement with UCB, granting UCB an exclusive global license to develop, manufacture, and commercialize ATG-201, along with access to related production technologies. Antengene will conduct the first-in-human Phase I clinical trials in China and Australia, after which subsequent clinical development activities will be transferred to UCB. This approval of the clinical trial application for ATG-201 by the China NMPA marks Antengene's strategic expansion from oncology and hematology into the field of autoimmune diseases. Antengene will continue to be guided by unmet clinical needs in developing more innovative therapies.
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