TG Immunopharma Co. Ltd. has announced clearance by the FDA for a clinical trial of TGI-6, a bispecific antibody targeting unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, for solid tumors.
Iaso Biotechnology Co. Ltd. has received FDA approval of the company’s IND application for IASO-782 injection for use in U.S. clinical trials for autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (AIHA).
Alentis Therapeutics AG has received FDA clearance of the company’s IND application for ALE.C04, a first-in-class monoclonal antibody developed to specifically target exposed Claudin-1 (CLDN1) on cancer cells.
Lantern Pharma Inc. has received IND clearance from the FDA for LP-184, which is being developed for advanced solid tumors and central nervous system (CNS) cancers.
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).
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