AbelZeta Pharma has received U.S. FDA clearance of its IND application for prizlon-cel, an anti-CD20/CD19 bispecific CAR-T, for the treatment of relapsed or refractory large B-cell lymphoma.
In the same press release, AbelZeta revealed that it had regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights relating to prizlon-cel back in July. In a $245 million deal originally inked in May 2023, J&J, through its former Janssen subsidiary, secured an ex-China collaboration and license agreement for prizlon-cel and other CAR-T assets. The agreement was amended in December 2023, giving Janssen the option to obtain exclusive commercialization rights in China for prizlon-cel and other assets.
AbelZeta says it is currently working with the FDA to finalize the protocols for clinical development in third- or later-line LBCL patients previously treated with CAR-T therapies and second-line LBCL patients that are CAR-T therapy treatment naïve. Meanwhile, the registrational phase 2 clinical trial of prizlon-ce for r/r LBCL in CAR-T therapy naïve patients in China is still ongoing.
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