Epirium Bio Inc. has obtained IND clearance from the FDA for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor.
Arbor Biotechnologies Inc. has gained IND clearance from the FDA for ABO-101, a novel gene editing therapeutic designed to address primary hyperoxaluria type 1 (PH1). A phase I/II study in adult and pediatric patients with PH1 is expected to begin in the first half of 2025.
Vigeneron GmbH has received IND approval from the FDA for VG-801, a novel mRNA trans-splicing gene therapy to treat Stargardt disease and other retinal dystrophies associated with mutations in the ABCA4 gene. IND clearance enables initiation of a phase I/II trial, with a clinical trial application (CTA) submission to the EMA also planned in the coming months.
Splicebio S.L. has gained IND clearance from the FDA for its lead program SB-007, a protein splicing gene therapy to address the root genetic cause of Stargardt disease.
Astria Therapeutics Inc. has gained IND clearance from the FDA for STAR-0310, a monoclonal antibody OX40 antagonist being developed for atopic dermatitis.
Nextcure Inc. has reported IND clearance from the FDA enabling initiation of a phase I trial of LNCB-74, a B7-H4-targeting antibody-drug conjugate (ADC) being developed for various cancers.
Base Therapeutics (Shanghai) Co. Ltd.’s NK-510 cell injection, a zero-off-target base-edited natural killer (NK) cell product, has received approvals to start clinical trials from both the U.S. FDA and China’s NMPA for clinical trials for advanced solid tumors.
Beijing Avistone Biotechnology Co. Ltd. has obtained IND clearance from the FDA for ANS-03, a next-generation tyrosine kinase inhibitor (TKI) targeting both ROS proto-oncogene 1 (ROS1) and neurotrophic tropomyosin receptor kinase (NTRK).
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