Bioray Pharmaceutical Co. Ltd.’s IND application for BRY-812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumors, has been accepted by the China National Medical Products Administration (NMPA).

Laekna Therapeutics Shanghai Co. Ltd. has received FDA clearance of its IND application to initiate clinical development with LAE-102 in the U.S.

Indapta Therapeutics Inc. has gained IND clearance from the FDA to commence a first-in-human phase I trial of IDP-023, an allogeneic natural killer (NK) cell therapy, in patients with relapsed or refractory multiple myeloma and lymphoma, anticipated to begin in the second half of this year. The study will explore three different dose levels of Indapta’s G-NK cells alone and in combination with IL-2 and the monoclonal antibodies rituximab and daratumumab.

Antengene Corp. Ltd. has received FDA clearance of its IND for a phase I study of the first-in-class...

Nuvectis Pharma Inc. has received IND clearance from the FDA for NXP-900, a novel inhibitor of...

Rocket Pharmaceuticals Inc. has received IND clearance from the FDA for RP-A601, an AAV.rh74-based gene therapy candidate for the treatment of arrhythmogenic cardiomyopathy due to plakophilin 2 pathogenic variants (PKP2-ACM). RP-A601 offers the potential for a one-time, curative alternative to medical therapy, implantable cardioverter defibrillators and ablations.

Tonix Pharmaceuticals Holding Corp. has received FDA clearance of its IND application to support a phase I trial with TNX-1500, an anti-CD40L monoclonal antibody. The first indication Tonix is seeking for TNX-1500 is the prevention of organ rejection in patients receiving a kidney transplant. Enrollment in the phase I study is expected to open in the third quarter of this year.

Onquality Pharmaceuticals LLC has received FDA clearance of its IND application for OQL-036, a potential prophylactic treatment for capecitabine-induced hand-foot syndrome (HFS).