Company Product Description Indication Status
Phase I
Aslan Pharmaceuticals Ltd., of Singapore ASLAN-004 IL-13/IL-4 receptor antagonist Moderate to severe atopic dermatitis Resumed recruitment in the multiple ascending dose study after pause due to the COVID-19 pandemic
Celldex Therapeutics Inc., of Hampton, N.J. CDX-527  Bispecific antibody targeting PD-L1 and CD27 Advanced or metastatic solid tumors that have progressed during or after standard of care therapy Opened enrollment in the 90-patient study designed to determine the maximum tolerated dose; safety, tolerability, pharmacokinetics, immunogenicity, objective response rate, clinical benefit rate, duration of response, progression-free survival and overall survival will also be measured; study includes an expansion phase
Cohbar Inc., of Menlo Park, Calif. CB-4211 Analog of MOTS-c Nonalcoholic steatohepatitis and obesity Treated first subjects in the phase Ib portion of the study testing one dose level for four weeks in 20 patients
Cynata Therapeutics Ltd., of Melbourne, Australia Cymerus MSCs Mesenchymal stem cells COVID-19 with respiratory distress Opened enrollment in the 24-patient Mend study; primary endpoint is improvement in PaO2/FiO2 ratio, as well as safety and tolerability
Geovax Labs Inc., of Atlanta MVA-62B  Boost component HIV infection Started study testing combination of broadly neutralizing antibodies and a Toll-like receptor 9 agonist boosted with MVA-62B
Novavax Inc., of Gaithersburg, Md. NVX-CoV2373  COVID-19 prefusion protein vaccine  plus Matrix-M adjuvant COVID-19 prophylaxis Enrolled first subjects in the phase II portion of the study, which will include approximately 50% older adults 60-84 years of age
PTC Therapeutics Inc., of South Plainfield, N.J. NM21-1480 Tri-specific immuno-oncology product targeting PD-L1, 4-1BB and serum albumin Solid tumors First patient treated in study designed to determine a recommended dose for continued clinical development
Reithera Srl., of Rome GRAd-COV2 Gorilla adenoviral-based vaccine encoding the full-length spike protein of the SARS-CoV-2 COVID-19 prophylaxis Enrolled first of 90 subjects in the study testing 3 escalating doses of the vaccine
Phase II
Adrenomed AG, of Hennigsdorf, Germany Adrecizumab (HAM-8101) Monoclonal antibody targeting adrenomedullin Extreme-critically ill COVID-19 patients Data published in Biomolecules showed 5 of 8 patients had rapid improvement of organ function and subsequent reduction in the disease severity within 12 days after administration
Trevena Inc., of Chesterbrook, PA TRV-027 AT1 receptor agonist Acute lung damage and abnormal blood clotting associated with COVID-19 Started 60-patient study testing abnormal clotting, lung function and other clinical outcomes; top-line data expected in first quarter of 2021
Phase III
Mitsubishi Tanabe Pharma America Inc., of Jersey City, N.J Edaravone (MT-1186) Oral suspension formulation of neuroprotective agent Amyotrophic lateral sclerosis Resumed screening and enrollment in the 150-patient study after pause due to COVID-19 pandemic
Novartis AG, of Basel, Switzerland Spartalizumab (PDR-001) Monoclonal antibody targeting PD-1 Advanced BRAF V600-mutated melanoma The Combi-i study comparing spartalizumab plus Tafinlar (dabrafenib) and Mekinist (trametinib) to Tafinlar and Mekinist alone didn't meet its primary endpoint of investigator-assessed progression-free survival
Odonate Therapeutics Inc., of San Diego Tesetaxel  Taxane Metastatic breast cancer  In the Contessa study, progression-free survival was 9.8 months for tesetaxel plus a reduced dose of capecitabine compared to 6.9 months for the approved dose of capecitabine alone (HR=0.716, p=0.003)
Onconova Therapeutics Inc., of Newtown, Pa. Rigosertib Small-molecule RAS mimetic  Higher-risk myelodysplastic syndromes In the Inspire study, overall survival was 6.4 months for rigosertib compared to 6.3 months for physician's choice (p=0.33)
Protalix Biotherapeutics Inc., of Carmiel, Israel Pegunigalsidase alfa (PRX–102) Modified stabilized version of recombinant alpha-galactosidase-A Fabry disease  Completed treatment period for the Bright study; top-line data expected in the fourth quarter of 2020

Notes

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

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