Pipeline Therapeutics Inc. has received FDA clearance to initiate a phase I trial of PIPE-791 in healthy volunteers, with dosing expected to begin in the second half of this year. PIPE-791 is advancing toward clinical development for remyelination and neuroinflammation, with a leading indication of multiple sclerosis (MS).
Tscan Therapeutics Inc. has received IND clearance by the FDA for TSC-200-A0201, a T-cell receptor (TCR) T-cell therapy targeting human papillomavirus 16 (HPV16), an oncogenic virus responsible for some cervical cancers and head and neck squamous cell carcinomas.
Pharmabcine Inc. has received IND approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a phase I trial of PMC-403 in Korea in subjects with neovascular (wet) age-related macular degeneration (AMD).
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).
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.
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