Company Product Description Indication Status
Phase I
India Globalization Capital Inc., of IGC-AD1 Cannabinoid-based drug Alzheimer's disease First 3 levels of dosing completed
Mediwound Ltd., of Yavne, Israel MWPC-005 Concentrate of proteolytic enzymes enriched in bromelain Non-melanoma skin cancer Clinical program launched
Phase II
Bionomics Ltd., of Adelaide, Australia BNC-210 Negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor Post-traumatic stress disorder Oral tablet formulation (900 mg given twice daily) exceeded blood exposure projected for upcoming phase II study
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Namodenoson A3 adenosine receptor binder Liver cancer Overall survival of nearly 4 years in 2 patients with disappearance of ascites, normal liver function and good quality of life
Cartesian Therapeutics Inc., of Gaithersburg, Md. Descartes-11 MRNA CAR T-cell therapy Multiple myeloma Trial initiated
Gannex, a wholly owned subsidiary of Shanghai-based Ascletis Pharma Inc. ASC-41 Selective thyroid hormone receptor beta agonist Nonalcoholic steatohepatitis Results in overweight and obese subjects with elevated LDL-C suggest that, over 28 days of oral doses, subjects demonstrated sustainable, clinically meaningful and statistically significant reduction in LDL-C, triglyceride and total cholesterol vs. placebo; HDL-C remained relatively unchanged
Immunicum AB, of Stockholm Ilixadencel Off-the-shelf cell-based cancer immunotherapy Metastatic renal cell carcinoma Updated survival data from Mereca trial testing combination with sunitinib in first-line treatment of newly diagnosed patients showed median overall survival not reached at 35.6 months for the combo group vs. 25.3 months for the sunitinib control group; proportion of patients alive was 41% (23/56) in combo group, compared to 30% (9/30) in control group
Ipsen SA, of Paris Lanreotide autogel Long-acting somatostatin analogue Neuroendocrine tumors Quality of life (QoL) data from Clarinet Forte study showed no deterioration of QoL with no substantial deviation from baseline prior to treatment; additional pharmacokinetic (PK) analyses of increased dosing regimen showed PK increased in proportional manner and no increase in rates of glycoregulation, cholelithiasis or hypertension in patients with increased lanreotide autogel exposure was observed
Sanofi SA, of Paris, and Glaxosmithkline plc, of London COVID-19 vaccine Adjuvanted recombinant protein COVID-19 vaccine COVID-19 Initiated new study of 720 volunteers, 18 and older, to select appropriate antigen dosage for phase III evaluation
Phase III
Abbvie Inc., of North Chicago Upadacitinib Oral JAK inhibitor Ulcerative colitis U-Accomplish induction study met primary endpoint of clinical remission, per Adapted Mayo Score and all ranked secondary endpoint; 33% of patients on upadacitinib achieved clinical remission at week 8 vs. 4% of patients on placebo (p<0.001)
Italfarmaco Group, of Milan, Italy Givinostat HDAC inhibitor Duchenne muscular dystrophy Ongoing, long-term phase II extension study continue to show delay in disease progression in boys at 7-year follow-up period; yearly rate of change of respiratory parameters such as Forced Vital Capacity % Predicted and Peak Expiratory Flow % predicted is -1.7% and 0% in contrast to the 4 to 6% yearly rate of decline in those parameters as demonstrated in natural history studies
Kintor Pharmaceutical Ltd., of Suzhou, China Proxalutamide Androgen receptor antagonist COVID-19 Completed recruitment of 588 hospitalized patients in Brazil; data expected to be available in March 2021
Novavax Inc., of Gaithersburg, Md. NVX-CoV2373 Recombinant protein-based vaccine COVID-19 Completed enrollment in Prevent-19 pivotal study in U.S. and Mexico
Otonomy Inc., of San Diego Otividex Glucocorticoid receptor agonist Ménière’s disease Trial did not achieve primary endpoint, defined as count of definitive vertigo days in month 3 vs. placebo for intent-to-treat population (p=0.312) using Negative Binomial Model; analysis did achieve statistical significance for per-protocol population (p=0.031)
Valneva SE, of Saint-Herblain, France VLA-1553 Live-attenuated, single-dose vaccine Chikungunya Initiated clinical lot-to-lot consistency trial to run in parallel to ongoing pivotal phase III study
VBL Therapeutics Ltd., of Tel Aviv, Israel VB-111 Anticancer gene therapy agent Recurrent ovarian cancer Independent data safety monitoring board found no safety issues in its preplanned review of the ongoing Oval study and recommended its continuation as planned

Notes

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