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.
Akeso Inc. has received IND approval by China’s National Medical Products Administration (NMPA) for AK-139, an IL-4Rα/ST2 bispecific antibody under investigation for a number of indications, including respiratory and skin diseases.
Ensoma Inc.’s lead program, EN-374, has been granted orphan drug and rare pediatric disease designations by the FDA for the treatment of X-linked chronic granulomatous disease. Ensoma anticipates filing an IND application for EN-374 in the first half of this year.
CSPC Pharmaceutical Group Ltd. has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for SYS-6017, an mRNA vaccine to prevent herpes zoster infections.
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