The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Marvax, a heat stable subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for the prevention and post-exposure prophylaxis against MARV infection.
BLR Bio LLC announced that the U.S. FDA has granted orphan drug designation to BLR-200, the company’s investigational therapy for the treatment of systemic sclerosis (SSc).
Lamassu Biotech Inc. has announced that its IND for SA53-OS has been cleared by the FDA in the U.S. The planned phase I/IIa trials will investigate the genetically targeted therapy that blocks the MDM2 protein, a key regulator of the tumor suppressor p53 gene.
The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Suvax, a subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for the prevention and post-exposure prophylaxis against SUDV infection. SUDV is a type of ebolavirus for which there is no current treatment or vaccine.
The U.S. FDA has cleared Tr1x Inc.’s IND application for TRX-103 for the prevention of graft-vs.-host disease (GVHD) in patients undergoing HLA-mismatched hematopoietic stem cell transplantation (HSCT).
Cereno Scientific AB has submitted a clinical trial application (CTA) to the EMA seeking approval for a first-in-human, phase I study of CS-014, a novel histone deacetylase (HDAC) inhibitor drug candidate under development as an antithrombotic treatment.
The U.S. FDA has cleared Biocity Biopharma Co. Ltd.’s IND application for a phase I study of BC-2027. This is the company’s second first-in-class antibody-drug conjugate (ADC) to be approved for clinical trials, following BC-3195, which is directed against placental-cadherin (CDH3).
Verismo Therapeutics Inc. has submitted an IND application to the FDA seeking to initiate a phase I trial this year of Synkir-310 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas (B-cell NHL), including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma.
Context Therapeutics Inc. has submitted an IND application to the FDA to begin a first-in-human phase I study of CTIM-76 in patients with claudin 6 (CLDN6)-positive gynecologic and testicular cancers.
Nested Therapeutics Inc. has obtained FDA clearance of its IND application for NST-628 for the treatment of patients with advanced solid tumors harboring genetic alterations in the RAS-MAPK pathway.
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