Company Product Description Indication Status
Phase I
Bold Therapeutics Inc., of Vancouver, British Columbia BOLD-100 Inhibits stress-induced upregulation of GRP78 and alters the unfolded protein response Advanced gastric, pancreatic, colorectal and bile duct cancers Enrolled first patient in the study testing BOLD-100 plus 5-fluorouracil, leucovorin and oxaliplatin
Caladrius Biosciences Inc., of Basking Ridge, N.J. CLBS-119 Autologous CD34+ cell therapy product COVID-19-induced lung damage Opened enrollment in the 12-patient proof-of-concept study; primary outcome is safety of CLBS-119; secondary endpoint is change in oxygen saturation
Sumitomo Dainippon Pharma Oncology Inc., of Cambridge, Mass. TP-1454  Pyruvate kinase M2 isoform activator Advanced metastatic or progressive solid tumors First patient treated in the study testing TP-1454 alone and in combination with Yervoy (ipilimumab, Bristol Myers Squibb Co.) and Opdivo (nivolumab, BMS); primary endpoint is safety; secondary endpoints include pharmacokinetics and pharmacodynamics 
Phase II
Apellis Pharmaceuticals Inc., of Waltham, Mass. Pegcetacoplan Targeted C3 therapy C3 glomerulopathy In 5 patients, pegcetacoplan produced a mean decrease in 24-hour urine protein-to-creatinine ratio of 73.3%; mean serum albumin increased; mean serum C3 increased; mean serum creatinine stabilized
Rigel Pharmaceuticals Inc., of South San Francisco Fostamatinib Spleen tyrosine kinase inhibitor Hospitalized COVID-19 Enrolled first of approximately 60 patients in the study; primary endpoint is safety of the drug compared to placebo; early efficacy and clinically relevant measures of disease progression will also be assessed
University of Oxford, of Oxford, U.K. Hydroxychloroquine Interferes with lysosomal activity and autophagy Hospitalized COVID-19 In the Recovery study, death within 28 days occurred in 27.0% of patients taking hydroxychloroquine and 25.0% in the standard of care (SOC) group (p=0.15); hospital discharge rate within 28 days was 59.8% for hydroxychloroquine and 62.9% for SOC; of patients who were not undergoing mechanical ventilation at baseline, 30.7% of patients taking hydroxychloroquine went on invasive mechanical ventilation or died, compared to 26.9% of SOC patients
Phase III
Emergent Biosolutions Inc., of Gaithersburg, Md., Grifols SA, of Barcelona; CSL Behring, of King of Prussia, Pa. and Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan COVID-HIG, anti-SARS-CoV-2 hyperimmune globulin, H-Ig Hyperimmune globulin products from plasma of people who have recovered from COVID-19 COVID-19 National Institute of Allergy and Infectious Diseases launched the Insight 013 study comparing the different plasma-derived products to placebo with all patients taking Veklury (remdesivir, Gilead Sciences Inc.); primary endpoint is ordinal outcome scale score on day 7
Gilead Sciences Inc., of Foster City, Calif. Veklury (remdesivir) Antiviral Mild-moderate or severe hospitalized COVID-19 Data from the ACTT-1 study published in The New England Journal of Medicine showed patients treated with Veklury had a median time to recovery of 10 days compared to 15 days with placebo (p<0.001); in patients who required oxygen support at baseline, median time to recovery was 11 days for Veklury and 18 days for placebo; mortality rate was 6.7% for Veklury and 11.9% for placebo at day 15 (HR=0.55) and 11.4% for Veklury and 15.2% for placebo at day 29 (HR=0.73)
Pfizer Inc., of New York Ibrance (palbociclib) Inhibitor of CDKs 4 and 6 Hormone receptor-positive, human epidermal growth factor-negative, early breast cancer with residual invasive disease after completing neoadjuvant chemotherapy Penelope-B study didn't meet its primary endpoint of improved invasive disease-free survival; data to be presented at an upcoming medical congress
Swedish Orphan Biovitrum AB (Sobi), of Stockholm Avatrombopag Thrombopoietin receptor agonist Chemotherapy-induced thrombocytopenia Of patients treated with avatrombopag, 69.5% were responders, defined as avoiding platelet transfusions, chemotherapy dose reductions by 15% or greater and chemotherapy dose delays by 4 days or more, compared to 72.5% of patients taking placebo (p=0.72)

Notes

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