NEW YORK – IASO Biotherapeutics said this week that China's National Medical Products Administration has cleared two Initial New Drug applications for the firm's investigational CAR T-cell therapy CT120. With the clearances, IASO Bio will begin evaluating the autologous treatment for CD19/CD22-positive relapsed or refractory B-cell non-Hodgkin lymphoma, as well as relapsed or refractory B-cell acute lymphoblastic leukemia. According to Wen Wang, IASO Bio's CEO and chief medical officer, CT120 is the world's first fully human CD19- and CD22-targeting CAR T-cell therapy candidate to enter clinical development.
Roche subsidiary Genentech said this week that the US Food and Drug Administration has accepted its supplementary biologics license application for atezolizumab (Tecentriq) as an adjuvant treatment following surgery and platinum-based chemotherapy for PD-L1-positive early-stage non-small cell lung cancer patients. The company submitted data from the Phase III IMpower010 study, which demonstrated that atezolizumab reduced the risk of death or disease recurrence by 34 percent in this patient population compared to best supportive care. The agency will evaluate the submitted data within its priority review and real-time oncology review programs and issue a decision by December.
BioNTech this week completed its acquisition of Kite's solid tumor neoantigen T-cell receptor R&D platform and clinical manufacturing facility in Gaithersburg, Maryland. The companies did not disclose financial terms of the deal, which was announced in July. The acquisition adds another cell therapy to BioNTech's pipeline, which already includes two CAR T-cell therapies in preclinical development, and expands its manufacturing footprint in the US.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.