Entrada Therapeutics Inc. has received authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and research ethics committee to initiate a phase I/II study of ENTR-601-45 for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 45 skipping.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYS-6040 for advanced solid tumors.
Smsbiotech Inc. has gained clearance in Australia to begin a phase I trial of its small mobile stem (SMS) cell therapy for chronic obstructive pulmonary disease (COPD).
Sagimet Biosciences Inc. has obtained IND clearance from the FDA for TVB-3567 (ASC-60), a selective small-molecule fatty acid synthase (FASN) inhibitor set to enter clinical development for the treatment of acne. A first-in-human phase I trial of TVB-3567 in individuals with or without acne is expected to begin this year.
Mindrank Ltd. has announced that the FDA has cleared the company’s IND application for MRANK-106, a potentially first-in-class, orally available dual inhibitor of WEE1 and YES1 kinases, for the treatment of pancreatic cancer, small-cell lung cancer, ovarian cancer, breast cancer and colorectal cancer.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with JMT-108 for advanced malignant tumors.
Bioheng Therapeutics US LLC has obtained IND approval from the FDA for CTD-402, a CD7-targeted universal CAR T-cell therapy, for the treatment of pediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma.
Neurenati Therapeutics Inc.’s NEU-001 has been awarded U.S. orphan drug and rare pediatric disease designations by the FDA for the treatment of Hirschsprung disease.
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17.
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