IND application submitted to FDA for ALA-101 allogeneic CAR-iNKT cell therapy targeting CD19-positive NHL and leukemias
Dr Michael Baker, Chief Executive Officer and Managing Director of Arovella Therapeutics, said: “Filing the IND for ALA-101 is an excellent milestone for Arovella, and we look forward to receiving the feedback from the FDA. It reflects the strength of our scientific and manufacturing foundations and marks the Company’s transition toward becoming a clinical-stage biotechnology company.”
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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).