Company Product Description Indication Status
Agenus Inc., of Lexington, Mass. AgenT-797 Allogeneic invariant natural killer T cell-based immunotherapy COVID-19 infection FDA cleared IND to assess study drug in infected individuals with moderate to severe respiratory distress 
Braeburn Inc., of Plymouth Meeting, Pa. Brixadi (buprenorphine)  ORL1 receptor agonist; opioid receptor mu modulator Opioid use disorder Final approval requested from FDA of NDA covering weekly and monthly extended-release formulations of drug; 6-month review cycle expected
Cellenkos Inc., of Houston CK-0802 Cryopreserved cord blood-derived T regulatory cells COVID-19 infection FDA cleared IND to initiate phase I study in intubated individuals with acute respiratory distress syndrome; co-primary endpoints are toxicity and 28-day treatment success
Citius Pharmaceuticals Inc., of Cranford, N.J. Mino-Lok (minocycline + edetate + ethyl alcohol)
30S ribosomal protein inhibitor
Bloodstream infections FDA provided positive guidance on proposed catheter compatibility studies to treat central line-associated and catheter-related infections
Helsinn Healthcare SA, of Lugano, Switzerland Akynzeo (fosnetupitant + palonosetron) 5-HT 3 receptor antagonist; NK1 receptor antagonist Chemotherapy-induced nausea and vomiting FDA approved ready-to-dilute liquid formulation 
Nkmax America Inc., of Santa Ana, Calif. SNK-01 Autologous natural killer cell immunotherapy Solid tumors FDA cleared IND for phase I/IIa trial in combination with trastuzumab or cetuximab to treat advanced/metastatic HER2- or EGFR-expressing cancer; trial expected to begin in third quarter of 2020
Renovorx Inc., of Los Altos, Calif. Renovocath + gemcitabine  Drug/device Cholangiocarcinoma FDA granted orphan drug designation in indication
Rigenerand SRL, of Modena, Italy RR-001 TNFSF10 gene stimulator Pancreatic cancer Italian Medicine Authority granted authority to produce gene therapy products for clinical purposes, including RR-001 for use in phase I trial expected to start in first quarter of 2021
Sapience Therapeutics Inc., of Harrison, N.Y. ST-101 CCAAT enhancer binding protein beta inhibitor Advanced solid tumors FDA accepted IND application for phase I/II trial in adults and granted orphan drug designation to treat glioma
Tetra Bio-Pharma Inc., of Ottawa, Ontario HCC-011 Inhaled THC Hepatocellular carcinoma During type B meeting, FDA provided guidance on nonclinical safety and human clinical pharmacology, safety and efficacy requirements and agreed with proposed nonclinical safety program to support development; agency also agreed that food effect study not required
Y-Mabs Therapeutics Inc., of New York Danyelza (naxitamab)  3F8 IgG1 monoclonal antibody Neuroblastoma FDA accepted BLA and granted priority review, setting PDUFA date of Nov. 30, 2020; no advisory committee meeting expected

Notes

For more information about individual companies and/or products, see Cortellis.

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