Newcelx Ltd. has submitted a pre-IND briefing package to the U.S. FDA to support a proposed first-in-human trial of NCEL-101 in combination with tegoprubart, an investigational anti-CD40L monoclonal antibody being developed by Eledon Pharmaceuticals Inc.
Biotle has received a clinical trial notice from China’s National Medical Products Administration (NMPA) for its IND application for BTL-203, the company’s bispecific FcRn inhibitor being developed for the treatment of multiple autoimmune diseases.
Shanghai Henlius Biotech Inc.’s HLX-3902, a trispecific antibody targeting STEAP1xCD3xCD28, has received approval from the Human Research Ethics Committee (HREC) in Australia and has been filed with the Therapeutic Goods Administration (TGA). The T-cell engager is intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors.
Scribe Therapeutics Inc. has obtained clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a first-in-human study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD). The phase I study will enroll adults with elevated LDL-C at increased cardiovascular risk at sites in Australia and New Zealand.
Hangzhou Qihan Biotech Co. Ltd. has obtained IND clearance from the FDA for QT-019C, a universal allogeneic CAR T-cell therapy for autoimmune diseases. QT-019C cell injection is an off-the-shelf allogeneic CAR T-cell therapy engineered from healthy donor leukapheresis products to stably express two distinct CARs targeting CD19 and BCMA.
Matter Bio has submitted its first IND application to the FDA for Lm-LLO-TT, the company’s lead therapeutic candidate, seeking to initiate a first-in-human phase I/IIa trial in patients with pancreatic ductal adenocarcinoma (PDAC).
Mekanistic Therapeutics Inc. has obtained IND clearance from the FDA for MTX-531, the company’s lead oncology candidate. A phase I study will be conducted in patients with advanced solid tumors characterized by dysregulated EGFR and/or PI3K signaling, including head and neck and endometrial cancers. Dosing is expected to begin in the third quarter.
China’s National Medical Products Administration (NMPA) has granted clinical trial clearance to SYH-2095 tablets, a novel lysine acetyltransferase 6 (KAT6) inhibitor codeveloped by CSPC Pharmaceutical Group Ltd. and Hangzhou Innogate Pharma Co. Ltd. for the treatment of advanced malignant tumors. SYH-2095 received IND clearance in the U.S. last month.
The University of Texas MD Anderson Cancer Center has received IND clearance from the FDA to initiate a phase I trial of a novel CAR T-cell therapy, JV-394, for patients with relapsed or refractory CD94-positive T/natural killer (NK) cell lymphomas.
Chengdu Origen Biotechnology Co. Ltd. and Vanotech Ltd. have announced IND clearance by the FDA for KHN-921 for the treatment of hypertrophic cardiomyopathy (HCM) associated with MYBPC3 mutations.
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