Lantern Pharma Inc. has received FDA clearance of its IND application for LP-284, being developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL), including mantle cell lymphoma, double hit lymphoma and other high-grade B-cell lymphomas. Enrollment in a first-in-human phase I trial is expected to begin during the fourth quarter of this year.
Lapix Therapeutics Inc. has received IND clearance from the FDA to initiate a phase I trial of its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS).
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.
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.
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