Immpact Bio USA Inc. has obtained IND clearance from the FDA for IMPT-514, a CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with multiple sclerosis (MS). A phase I trial will focus on patients who have suboptimal disease control despite prior treatment with high efficacy disease-modifying therapies in all forms of MS.

Innovec Pharmaceutical Technology Co. Ltd. (Innovec Biotherapeutics) has received FDA clearance for its IND application for IVB-103, an AAV-based gene therapy for neovascular age-related macular degeneration (AMD).

Cidara Therapeutics Inc. announced in its Q2 filing that it received IND clearance for its drug-Fc conjugate (DFC) immunotherapy CBO-421 in July of 2024.

Precision Biosciences Inc. has announced that its experimental allogeneic T cell therapy azercabtagene zapreleucel (azer-cel) for the treatment of multiple sclerosis (MS) has received IND clearance from the FDA.

Tr1x Inc. has announced that the FDA has cleared its IND application for its engineered Tr1 Treg cell therapy TRX-103 for treatment-refractory Crohn’s disease.

Innorna Co. Ltd.’s IN-016 has received orphan drug status from the U.S. FDA for the treatment of progressive familial intrahepatic cholestasis (PFIC). Earlier in July, IN-016 had been granted Rare Pediatric Disease Designation. PFIC is a group of rare genetic disorders associated with defects in bile acid secretion or transport, resulting in unwanted bile accumulation within the liver.

Umoja Biopharma Inc. has received clearance from the FDA to begin a first-in-human trial of its CAR T product UB-VV111. The company expects to dose the first patient by the end of 2024.

Gigagen Inc., a subsidiary of Grifols SA, has received clearance from the FDA of its IND application to conduct a phase I trial of GIGA-2339 for the treatment of hepatitis B virus (HBV) infections.