FDA Clears IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL
“We are delighted that CTD402 has received IND clearance from the U.S. FDA for a Phase Ib/II trial with a simplified dose-finding design, accelerating our clinical development timeline in the United States,” stated Jiangtao Ren, Ph.D., President & Chief Scientific Officer (CSO) of Bioheng.“ IIT study results showed an impressive ORR, alongside a favorable safety profile. These results validate our ANSWER® platform’s ability to deliver both rapid therapeutic impact and reduced patient risk, positioning CTD402 as a potential best-in-class therapy for T-cell malignancies.”
Share:
More News
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.
“Many solid tumors remain difficult to treat despite advances in immunotherapy,” said Rustam Esanov, CEO and co-founder of Reprogram Biosciences. “Our approach is differentiated by its reprogramming of the tumor itself into a site of immune activation, rather than relying on exogenous immune cells or broadly acting systemic agents.”
Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).