Company Product Description Indication Status
Amgen Inc., of Thousand Oaks, Calif., and Cytokinetics Inc., of South San Francisco Omecamtiv mecarbil Cardiac myosin activator Chronic heart failure with reduced ejection fraction FDA granted fast track designation
Arch Biopartners Inc., of Toronto Metablok  LSALT peptide that inhibits DPEP-1 Organ inflammation in COVID-19 patients Health Canada issued a no objection letter to the start of a 60-patient phase II study with the primary endpoint of frequency of acute respiratory distress syndrome; secondary endpoint is frequency of kidney inflammation and injury
Bridge Biotherapeutics Inc., of Seongnam, South Korea BBT-176 Epidermal growth factor receptor tyrosine kinase inhibitor Advanced non-small-cell lung cancer Korea's Ministry of Food and Drug Safety cleared the IND for a 90-patient phase I/II study designed to find the maximum tolerable dose, recommended phase II dose and to observe safety, tolerability and the antitumor efficacy in the phase I portion; phase II includes an expansion cohort measuring safety and efficacy
Cynata Therapeutics Ltd., of Melbourne, Australia Cymerus Mesenchymal stem cells COVID-19 patients in intensive care Received ethics approval for the 12-patient Mend study; recruitment expected to begin once agreements with study centers are finalized
Junshi Biosciences Co. Ltd., of Shanghai Toripalimab  Monoclonal antibody targeting PD-1 Second-line, locally advanced or metastatic urothelial carcinoma China National Medical Products Administration accepted the supplemental NDA
Pluristem Therapeutics Inc., of Haifa, Israel PLX-PAD  Placental expanded cells Acute respiratory distress syndrome caused by COVID-19 FDA cleared IND for 140-patient phase II study; primary endpoint is ventilator-free days during the main 28-day study period; secondary endpoints include survival rate and days outside the intensive care unit
Redhill Biopharma Ltd., of Tel Aviv, Israel Opaganib Sphingosine kinase-2 inhibitor Moderate to severe COVID-19 with pneumonia FDA approved the IND for a 40-patient phase IIa study; primary endpoint is reduction in total oxygen requirement over the course of treatment for up to 14 days; secondary endpoints include time to 50% reduction in oxygen requirements, proportion of patients without fever at day 14 and proportion with negative nasal swabs at day 14
Sesen Bio Inc., of Cambridge, Mass. Vicinium (VB4-845) Recombinant fusion protein targeting epithelial cell adhesion molecule antigens to deliver Pseudomonas exotoxin A High-risk, BCG-unresponsive non-muscle invasive bladder cancer Scientific advice from EMA's Committee for Medicinal Products for Human Use suggests the data required for approval can be addressed with the completed phase III data; plans to file an MAA in early 2021
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Entyvio (vedolizumab) Monoclonal antibody targeting alpha4beta7 integrin Moderately to severely active ulcerative colitis or Crohn’s disease  European Commission granted marketing authorization for the subcutaneous formulation

Notes

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

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