Genprex Inc. announced that the FDA has granted orphan drug designation to the company's lead drug candidate, Reqorsa immunogene therapy (quaratusugene ozeplasmid, GPX-001), for the treatment of small cell lung cancer (SCLC). Reqorsa contains a plasmid that expresses the tumor suppressor gene TUSC2, the expression of which is reduced or not present in SCLC.
Lemonex Inc. announced that the IND application for its mRNA vaccine candidate LEM-mR203 has been approved by the Korean Ministry of Food and Drug Safety (MFDS) on July 21, 2023. The company plans to evaluate LEM-mR203 as potential treatment for COVID-19, with the planned phase I clinical trial being designed to assess its safety and immunogenicity in healthy adults at Seoul National University Hospital, Korea.
Georgiamune Inc. announced that the FDA cleared its IND application for GIM-122, a first-in-class dual-functioning monoclonal antibody designed to target a highly novel mechanism to overcome immunotherapy resistance.
Biocity Biopharma announced that the U.S. FDA has accepted its investigational new drug (IND) application for BC-3448, a bispecific antibody that targets the T cell marker CD3 and epidermal growth factor receptor (EGFR), bringing antitumor T cells in proximity to EGFR-expressing cells. To reduce the risk of cytokine release syndrome (CRS), a known risk of CD3-targeting antibodies, the bispecific has a higher affinity for EGFR than CD3.
Satellos Bioscience Inc. has received orphan drug designation and rare pediatric disease designation from the FDA for SAT-3153 for the potential treatment of Duchenne muscular dystrophy (DMD). The first-in-class oral small-molecule therapeutic is designed to restore the innate muscle regeneration process independent of dystrophin and regardless of exon mutation status.
The FDA has cleared Qualigen Therapeutics Inc.’s IND application for QN-302, a potential best-in-class small molecule G-Quadruplex (G4)-selective transcription inhibitor.
Lexeo Therapeutics Inc. has announced that its IND for LX-2020 has been cleared by the FDA. LX-2020 is an AAVrh10-based gene therapy candidate designed to intravenously deliver a functional PKP2 gene to cardiac muscle for the treatment of arrhythmogenic cardiomyopathy (ACM) caused by variants in PKP2 (PKP2-ACM).
Entrada Therapeutics Inc. has received authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its CTIMP (clinical trial of an investigational medicinal product) application for a phase I clinical trial in healthy volunteers for ENTR-601-44.
Krystal Biotech Inc. has received FDA acceptance of its IND application for lead oncology drug candidate KB-707 for the treatment of locally advanced or metastatic solid tumor malignancies. KB-707 is a modified herpes simplex virus 1 (HSV-1) vector designed to deliver genes encoding both human IL-12 and IL-2 to the tumor microenvironment and promote systemic immune-mediated tumor clearance.
Cessation Therapeutics Inc. has obtained IND clearance from the FDA to initiate a first-in-human trial of CSX-1004 for the prevention of fentanyl overdose. The trial in healthy volunteers is expected to begin next month.
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