Your Daily Biotechnology Briefing

Novel CAR-T and Immuno-Oncology Therapies Advance Alongside HIV Prevention Innovations

• Legend Biotech has received U.S. FDA Investigational New Drug (IND) application clearance for LB2501, a novel in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting CAR-T cells directly within the patient for relapsed or refractory B-cell malignancies. This marks the first known dual-targeting in vivo CAR-T therapy to receive FDA IND clearance, potentially streamlining treatment by avoiding several manufacturing steps of conventional autologous CAR-T therapies.

  Legendbiotech

• Marengo Therapeutics secured a second U.S. FDA Fast Track Designation for invikafusp alfa, expanding its indication to include unresectable, locally advanced, or metastatic, tumor mutational burden-high (TMB-H) solid tumors that have progressed after prior treatment. This makes invikafusp alfa the first immuno-oncology T-cell agonist to receive Fast Track Designation in a biomarker-defined, tissue-agnostic indication.

  Prnewswire

• Continuity Biosciences, a Manatee County biotechnology company, was awarded a $9.6 million grant from the Gates Foundation to advance its below-the-skin implant for multi-year HIV prevention. This implant offers an alternative to daily oral pills and periodic injections, aiming to reduce the burden of consistent protection, particularly in communities with limited healthcare access.

  Businessobserverfl