Company Product Description Indication Status
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
Dynavax Technologies Corp., of Emeryville, Calif. Heplisav-B Hepatitis B vaccine Hepatitis B virus prophylaxis in patients with end-stage renal disease Interim analysis of a study of 70 patients undergoing hemodialysis showed Heplisav-B produced seroprotection in 86.4% of the first 44 patients; full data expected in the second half of 2020
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
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
United Therapeutics Corp., of Silver Spring, Md. Orenipro (treprostinil diolamine prodrug) PGI2 agonist Pulmonary artery hypertension Enrollment paused due to COVID-19 epidemic
United Therapeutics Corp., of Silver Spring, Md. Treprostinil Technosphere (inhaled) PGI2 agonist Pulmonary artery hypertension Enrollment paused in phase Ib Breeze and pivotal pharmacokinetics studies due to COVID-19 epidemic
Phase II
Cadent Therapeutics Inc., of Cambridge, Mass. CAD-1883 KCNN potassium channel stimulator Spinocerebellar ataxia Trial initiation delayed due to COVID-19 pandemic
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
Corbus Pharmaceuticals Holdings Inc., of Norwood., Mass. Lenabasum  Cannabinoid receptor type 2 agonist Diffuse cutaneous systemic sclerosis  
Data published in Arthritis & Rheumatology showed the drug improved the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score at week 16 to 0.33 compared to 0.00 for placebo (p=0.07)
Destiny Pharma plc, of Brighton, U.K. XF-73 Porphyrin-based compound Prevention of postsurgical infections Phase IIIb study paused due to COVID-19 pandemic
United Therapeutics Corp., of Silver Spring, Md. Treprostinil (inhaled) PGI2 agonist Pulmonary hypertension  Due to COVID-19 pandemic, enrollment paused in Sapphire study in individuals with pulmonary hypertension due to sarcoidosis
Windtree Therapeutics Inc., of Warrington, Pa. Aerosurf Aerosolized KL4 surfactant Respiratory distress syndrome Enrolled first of up to 90 patients in the bridging study to validate the new aerosol delivery system in the neonatal intensive care unit; endpoints include time to nasal continuous positive airway pressure (nCPAP) failure, incidence of nCPAP failure and physiological parameters indicating the effectiveness of lung function
Phase III
Erytech Pharma SA, of Lyon, France Eryaspase  L-asparaginase encapsulated inside donor-derived red blood cells Second-line advanced metastatic pancreatic cancer Trybeca-1 study has enrolled 75% of the roughly 500 patients; independent data monitoring committee recommended continuing the study; interim superiority analysis expected around the end of 2020; final analysis in second half of 2021
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)
United Therapeutics Corp., of Silver Spring, Md. Tyvaso (inhaled sustained-release treprostinil) PGI2 agonist Pulmonary hypertension  Due to COVID-19 pandemic, enrollment paused in Perfect open-label extension study in individuals with pulmonary hypertension due to chronic obstructive pulmonary disease
United Therapeutics Corp., of Silver Spring, Md. Ralinepag PGI2 agonist Pulmonary artery hypertension Due to COVID-19 pandemic, enrollment paused in Advance Outcomes and Advance Capacity studies

Notes

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

No Comments