Precigen to Begin Phase II Study of PRGN-2009, Keytruda in HPV-Positive Cervical Cancer
The FDA granted the firm permission to study the off-the-shelf T-cell vaccine with the immune checkpoint inhibitor in pretreated metastatic HPV-positive cervical cancer patients.
FDA Reviewing Iovance's BLA for Melanoma TIL Therapy; Decision Expected in November
Iovance said the FDA is reviewing its BLA, and if successful, lifileucel could be the first autologous cell therapy approved for solid cancer.
Phio Pharmaceuticals, AgonOx Start Phase I Trial of T-Cell Immunotherapy Combination
The firms will evaluate Phio's self-delivering RNAi compound PH-762 plus AgonOx's autologous tumor-infiltrating lymphocyte therapy in a variety of cancers.
FDA, Industry Taking Steps to Streamline Cell Therapy Regulation, Though Uncertainty Remains
At two recent meetings, representatives from regulatory agencies, industry, and academia discussed ways to foster efficient, more predictable cell therapy regulation.
Nexcella CAR T-Cell Therapy Amyloidosis Trial Yields Promising Safety, Efficacy Data
At ASGCT's annual meeting, researchers shared data suggesting that the autologous cell therapy could benefit patients with the rare, multiple myeloma-associated disease.