Aclaris Therapeutics Inc. has gained IND clearance from the FDA for ATI-052, a bispecific anti-thymic stromal lymphopoietin (TSLP)/interleukin-4 receptor (IL-4R) monoclonal antibody being developed to treat certain immuno-inflammatory diseases. A phase Ia/Ib trial, including a proof-of-concept portion in an undisclosed indication, will begin in the current quarter.
Neuronos Ltd., a subsidiary of Beyond Air Inc., has announced BA-102 has been awarded U.S. orphan drug designation for the treatment of Phelan-McDermid syndrome.
Xellsmart Biopharmaceutical (Suzhou) Co. Ltd. has announced IND clearances by the FDA for its XS-411 and XS-228 cell therapies, for Parkinson’s disease and amyotrophic lateral sclerosis (ALS), respectively.
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
Curevac NV announced that the FDA has cleared its IND application for a phase I clinical study of CVHNLC in patients with squamous non-small-cell lung cancer (sqNSCLC). CVHNLC is Curevac’s investigational mRNA-based precision immunotherapy.
Resvita Bio Inc.’s RVB-003 has been awarded orphan drug designation by the FDA for the skin disorder Netherton syndrome. RVB-003 was previously granted rare pediatric disease designation.
Sun Pharma Advanced Research Co. Ltd. has filed an IND application with the FDA for SBO-154 for the treatment of solid tumors. A global phase I study is planned in advanced solid tumors.
Pleco Therapeutics BV has held a successful pre-IND meeting with the FDA to discuss the continued development of PTX-252, an intravenous formulation designed to treat patients with acute myeloid leukemia (AML).
Palatin Technologies Inc. has obtained U.S. orphan drug designation for PL-7737 for leptin receptor (LEPR) deficiency, including obesity caused by this condition.
Sineugene Therapeutics Co. Ltd. has obtained IND clearance from the FDA for SNUG-01, a first-in-class tripartite motif protein 72 (TRIM72)-targeted gene therapy candidate for amyotrophic lateral sclerosis (ALS). A phase I/IIa trial will evaluate SNUG-01 in adults with ALS.
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