Company Product Description Indication Status Date

Phase I

Biontech SE, of Mainz, Germany, and Pfizer Inc., of New York BNT-162 mRNA-based COVID-19 vaccine COVID-19 prophylaxis Completed dosing of 12 patients in the first cohort of the study in Germany 4/29/20
Gracell Biotechnologies Co. Ltd., of Suzhou, China GC-027 Off-the-shelf CAR T targeting CD7 Relapsed or refractory T-cell acute lymphoblastic leukemia All 5 patients achieved a complete remission with or without complete blood count recovery; 4 of 5 achieved minimum residual disease-negative complete remission 4/29/20
Inovio Pharmaceuticals Inc., of Plymouth, Pa. INO-4800 DNA vaccine COVID-19 Trial fully enrolled with 40 healthy volunteers; targeting summer start for phase II/III trial 4/28/20
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., and Geneone Life Science Inc., of Seoul, South Korea INO-4700/GLS-5300 MERS-CoV DNA vaccine MERS prophylaxis Of the patients receiving 2 doses at 0 and 8 weeks, 88% seroverted; of the patients receiving a 3 doses at 0, 4 and 12 weeks, 84% seroverted after 2 doses and 100% after 3 doses; 92% of the vaccine recipients in both groups displayed the ability to neutralize the virus 4/29/20
Janssen Pharmaceuticals, a unit of New Brunswick, N.J.-based Johnson & Johnson, and Yuhan Corp., of Seoul, Korea YH-25448 Irreversible EGFR tyrosine kinase inhibitor  EGFR-positive advanced non-small-cell lung cancer Recruitment in phase I/II trial temporarily on hold due to COVID-19 4/30/20

Phase II

Athersys Inc., of Cleveland Multistem Stem cell therapy COVID-19 First clinical site opened for Macovia trial in COVID-19-induced acute respiratory distress syndrome; about 400 subjects will be enrolled; primary endpoint will be number of ventilator-free days through day 28 vs. placebo 5/1/20
Calcimedica Inc., of La Jolla, Calif. CM-4620-IE Ca2+ release activated Ca2+ channel 1 inhibitor  COVID-19-related pneumonia Added an arm to the study to test the drug compared to standard of care in 60 patients using high-flow oxygen therapy; the initial arm of 60 patients is testing the drug or standard of care in patients using low-flow oxygen therapy 5/1/20
Chimerix Inc., of Durham, N.C. Dociparstat sodium Glycosaminoglycan derivative of heparin COVID-19 patients with acute lung injury Started phase II/III study measuring the proportion of patients who survive and do not require mechanical ventilation through day 28; additional endpoints include time to improvement as assessed by the National Institute of Allergy and Infectious Diseases ordinal scale, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality and changes in biomarkers 4/29/20
Eiger Biopharmaceuticals Inc., of Palo Alto, Calif. Peginterferon lambda Type III interferon Mild COVID-19 Dosed first of about 120 patients in the study measuring the duration of viral shedding of SARS-CoV-2 virus and duration of symptoms and hospitalization 5/1/20
Innate Pharma SA, of Marseille, France Avdoralimab Anti-C5aR antibody COVID-19 First patient dosed in placebo-controlled randomized, double-blind trial called Force; expects to enroll 108 patients 4/28/20
Innovent Biologics Inc., of Suzhou, China Parsaclisib Phosphoinositide-3 kinase delta inhibitor Follicle center lymphoma; marginal zone B-cell lymphoma First patient dosed in pivotal China trial 4/28/20
Mesoblast Ltd., of Melbourne, Australia Remestemcel-L Allogeneic mesenchymal stem cell therapy COVID-19 Started enrolling in phase II/III placebo-controlled study to measure whether remestemcel-L provides survival benefit in moderate/severe acute respiratory distress syndrome due to COVID-19 4/30/20
R-Pharm JSC, of Moscow, and Cromos Pharma LLC, of Portland, Ore. Olokizumab and RPH-104 IL-6 receptor antagonist and IL-1 beta ligand inhibitor COVID-19 Randomized first patients in phase II/III trial expected to recruit about 180 patients 4/28/20
Synairgen plc, of Southampton, U.K. SNG-001 (inhaled interferon beta) Interferon-beta ligand COVID-19 Received approvals to extend the study to the home environment so dosing can occur earlier in the infection cycle 5/1/20

Phase III

Aridis Pharmaceuticals Inc., of San Diego AR-301 (tosatoxumab) Human IgG monoclonal antibodies Staphylococcus aureus-induced pneumonia First participant with COVID-19 infection enrolled in ongoing trial assessing study drug's ability to mitigate secondary S. aureus bacterial pneumonia in individuals on mechanical ventilators 5/4/20
Gilead Sciences Inc., of Foster City, Calif. Remdesivir Nucleotide analogue COVID-19 In the Simple study of severe patients, time to clinical improvement for 50% of the patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group; at day 14, 60% of those treated for 5 days and 52.3% of those treated for 10 days were discharged from the hospital (p=0.14); at day 14, 64.5% of those treated for 5 days and 53.8% of those treated for 10 days achieved clinical recovery (p=0.16); separately the National Institute of Allergy and Infectious Diseases said the Adaptive COVID-19 Treatment Trial showed patients treated with remdesivir for 10 days recovered in 11 days compared to 15 days for those who received placebo (p<0.001); mortality rate was 8% for remdesivir and 11.6% for placebo (p=0.059) 4/29/20
I-Mab Biopharma Co. Ltd., of Shanghai, and Morphosys AG, of Martinsried, Germany TJ-202/MOR-202 Monoclonal antibody targeting CD38 Multiple myeloma Dosed first patient in randomized, open-label, parallel-controlled mainland China part of trial evaluating efficacy when combined with lenalidomide/dexamethasone (len/dex) vs. len/dex alone 4/28/20
Lupin Pharmaceuticals Inc., unit of Lupin Ltd., of Mumbai Solosec (secnidazole) 5-nitroimidazole antibiotic Trichomoniasis Pivotal trial showed statistically significant response rate, or microbiological cure, vs. placebo (p<0.001); sNDA filing to FDA expected in second half of 2020 5/4/20
Novartis AG, of Basel, Switzerland Brolucizumab VEGF inhibitor Diabetic macular edema Recruitment in study in Chinese patients with visual impairment due to DME temporarily paused due to safety measure 4/30/20
Novartis AG, of Basel, Switzerland Brolucizumab VEGF inhibitor Neovascular age-related macular degeneration Recruitment in study vs. aflibercept in Chinese patients temporarily paused due to safety measure 4/30/20

Phase IV

Eli Lilly and Co., of Indianapolis LY-2963016 Insulin glargine biosimilar Type 2 diabetes Study in India suspended due to COVID-19 4/30/20

Notes

The date indicated refers to the BioWorld Clinical data table in which the news item can be found.

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