Contrafect Corp. has submitted an IND application to the FDA for its intravenous antibacterial agent, CF-370, for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

The FDA has cleared an IND application for ADEL-Y01, being jointly developed by Oscotec Inc. and Adel Inc., for the treatment of Alzheimer’s disease. A phase Ia/b study will include healthy volunteers, and participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.

Eikon Therapeutics Inc. has received IND clearance from the FDA to initiate phase I studies with IMP-1734, a highly selective poly(ADP-ribose) polymerase 1 (PARP-1) inhibitor developed in partnership with Impact Therapeutics Inc.

Carrick Therapeutics Ltd. has received FDA clearance of its IND application for CT-7439, a novel cyclin dependent kinase 12/13 (CDK12/13) inhibitor.

Pepgen Inc. has received a no objection letter from Health Canada for its clinical trial application (CTA) to initiate a phase I study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). Initial data from the study are expected next year.

Uniqure NV has received FDA clearance of its IND application for AMT-260, the company’s gene therapy candidate that represents a potential one-time administered approach to treating refractory mesial temporal lobe epilepsy (MTLE).

Tscan Therapeutics Inc. has received FDA clearance of its IND application for TSC-203-A0201, a T-cell receptor (TCR)-engineered T-cell therapy (TCR-T) targeting preferentially expressed antigen in melanoma (PRAME). PRAME is expressed in melanoma and other solid tumors, including head and neck cancers and non-small-cell lung cancers. TSC-203-A0201 is specific for patients with HLA type A*02:01.

Harbour Biomed Ltd. has received FDA clearance of its IND application to commence a phase I trial of HBM-9033 in advanced solid tumors. Developed in collaboration with Medilink Therapeutics (Suzhou) Co. Ltd., HBM-9033 is an antibody-drug conjugate that specifically targets human mesothelin (MSLN), an upregulated tumor-associated antigen in various solid tumors, including mesothelioma, ovarian cancer, lung cancer, breast cancer and pancreatic cancers. The fully human monoclonal antibody in HBM-9033, generated from the Harbour Mice platform, binds preferably to membrane bond MSLN over soluble MSLN, which minimizes the interference of the shedding MSLN on the binding and internalization of the membrane bond MSLN.

Akava Therapeutics Inc. has announced FDA clearance of its IND application for AKV-9 (formerly NU-9) for the treatment of amyotrophic lateral sclerosis (ALS). The company is planning a first-in-human phase I study in healthy subjects.