Company Product Description Indication Status
Phase I
Aptevo Therapeutics Inc., of Seattle APVO-436 Anti-CD123 x anti-CD3 bispecific antibody Acute myeloid leukemia and myelodysplastic syndrome Dosing in cohorts 1-6 completed in phase I/Ib trial, with 2 patients dosed in cohort 7; no evidence of dose-limiting toxicities observed at cohort 6 and no evidence of drug-induced antibodies observed in 20 patient blood samples analyzed to date
Cartesian Therapeutics Inc., of Gaithersburg, Md. Descartes-30 RNA-engineered mesenchymal stem cell therapy Moderate to severe acute respiratory distress syndrome Started phase I/II trial, including patients with ARDS caused by COVID-19
Clear Creek Bio Inc., of Cambridge, Mass. Brequinar Small-molecule DHODH inhibitor COVID-19 Dosed first of about 24 hospitalized patients 
Hepion Pharmaceuticals Inc., of Edison, N.J. CRV-431 Peptidyl-prolyl cis-trans isomerase A inhibitor; hepatitis B structural protein inhibitor Nonalcoholic steatohepatitis  Dosing completed in all subjects in phase Ib multiple ascending-dose study in healthy volunteers
Innovent Biologics Inc., of San Francisco IBI-112 Recombinant anti-interleukin 23p19 subunit antibody Autoimmune disease Dosed first healthy subject in China
Orchard Therapeutics Inc., of Boston and London OTL-203 Ex vivo autologous hematopoietic stem cell gene therapy Mucopolysaccharidosis type I  Additional interim data from ongoing study based on 8 patients followed for minimum of 6 months showed treatment continued to demonstrate rapid hematologic reconstitution, with neutrophil and platelet engraftment within 21 days following treatment; efficacy established by sustained supranormal alpha-L-iduronidase enzyme expression in peripheral blood for all patients within 3 months post-gene therapy and up to 18 months in first treated patient; metabolic correction as measured by reduction in glycosaminoglycan levels in urine achieved in all patients by 6 months post-gene therapy, with sustained correction out to 18 months in first treated patient
Transcenta Holding Ltd., of Suzhou, China TST-001 Humanized Claudin 18.2 monoclonal antibody Metastatic solid tumors Dosed first subject in China trial
Phase II
Annovis Bio Inc., of Berwyn, Pa. ANVS-401 Inhibits neurotoxic proteins Early Alzheimer’s disease and Parkinson’s disease Dosed first of 3 patients in phase IIa study; data readout expected by late summer 2021
Arena Pharmaceuticals Inc., of San Diego Etrasimod Once-daily, oral, selective S1P receptor modulator Moderate to severe alopecia areata Dosed first subject in 24-week study; data expected in 2021
Biophytis SA, of Paris Sarconeos (BIO-101) Proto-oncogene Mas agonist COVID-19-related respiratory failure First patient dosed at AZ Sint Maarten hospital in Mechelen, Belgium, in Cova phase II/III trial; primary endpoint is proportion of all-cause mortality and respiratory deterioration within up to a 28-day period
Genfit SA, of Lille, France Elafibranor Dual PPAR alpha/PPAR delta agonist Nonalcoholic fatty liver disease Study terminated; company said continuation of trial cannot serve a scientific purpose
Immunomic Therapeutics Inc., of Rockville, Md. ITI-1000 Dendritic cell vaccine Glioblastoma Data from the Attac studies, published in the American Association for Cancer Research, showed overall 5-year survival increased from historical low of 5% to 25%; in 2 of the studies, vaccination site pre-conditioning with either Td or GM-CSF resulted in enhanced immune response by increasing migration of DCs to regional lymph nodes to "present" the pp65 CMV antigen to immune cells, and increased percentage of long-term, 5-year survivors to nearly 35% in subset of treated patients who received vaccination site pre-conditioning with either Td or GM-CSF
Kuros Biosciences Inc., of Schlieren, Switzerland Fibrin-PTH (KUR-113) Drug-biologic bone graft Degenerative disc disease First patient treated in Structure trial in transforaminal lumbar interbody fusion procedures
Oxurion NV, of Leuven, Belgium THR-149 Inhibits plasma kallikrein-kinin system Diabetic macular edema Dosed first patient in 2-part study
Phase III
Astrazeneca plc, of Cambridge, U.K. AZD-1222 Vaccine COVID-19 Testing begun in U.S.; study to enroll about 30,000 adult volunteers at 80 sites
Bristol Myers Squibb Co., of New York Zeposia (ozanimod) Oral S1P receptor modulator Relapsing multiple sclerosis Interim results from Daybreak extension trial found no new safety concerns with long-term use; at months 24 and 36, 79% and 75% of participants, respectively, were relapse-free, and 3- and 6-month confirmed disability progression was observed in 10.8% and 8.6% of participants in the trial, respectively
Iveric Bio Inc., of New York Zimura (avacincaptad pegol) Complement C5 inhibitor Geographic atrophy secondary to age-related macular degeneration Results from Gather1 study, published in the Journal of the American Academy of Ophthalmology, showed drug met prespecified primary efficacy endpoint at 12 months and reached statistical significance; reduction in mean rate of GA growth over 12 months was 27.38% (p=0.0072) for the 2-mg group vs. corresponding sham control group and 27.81% (p=0.0051) for the 4-mg group vs. corresponding sham control group
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Kevzara (sarilumab) Inhibits IL-6-mediated signaling COVID-19 Study in severely or critically ill hospitalized patients did not meet primary and key secondary endpoints vs. placebo added to usual hospital care
Phase IV
Alimera Sciences Inc., of Atlanta Iluvien (fluocinolone acetonide intravitreal implant) Glucocorticoid receptor agonist Diabetic macular edema Enrolled first patient in New Day trial designed to generate prospective data for Iluvien as baseline therapy in patients diagnosed with DME

Notes

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