Company Product Description Indication Status
Phase I
Alligator Bioscience AB, of Lund, Sweden  Mitazalimab CD40 antibody Pancreatic cancer Biomarker data showed the study identified a large number of up-regulated genes after treatment, such as PD-L1, and showed RNA sequencing can be successfully used to discover pharmacodynamic biomarkers following CD40 activation with mitazalimab; drug also was found to activate patient-derived tumor-associated macrophages
Amag Pharmaceuticals Inc., of Waltham, Mass. AMAG-432 Ovine antidigoxin polyclonal antibody fragment Severe pre-eclampsia  Phase II/III study terminated following recommendation from data and safety monitoring board, due to futility; no safety concerns raised
Ampio Pharmaceuticals Inc., of Englewood, Colo. Ampion   Stem cell antigen-1 inhibitor  COVID-19 Completed enrollment; data expected with the next week
Biontech SE, of Mainz, Germany NEO-PV-01 Therapeutic vaccine Advanced melanoma Study testing product, either with APX-005M (Apexigen Therapeutics Inc.) or Opdivo (nivolumab, Bristol Myers Squibb Co.), in patients with advanced or metastatic disease closed due to historically slow enrollment compounded by COVID-19 pandemic
Crinetics Pharmaceuticals Inc., of San Diego Paltusotine (CRN-00808) Somatostatin receptor type 2 agonist  Acromegaly Drug provided mean oral bioavailability of 70%
Relay Therapeutics Inc., of Cambridge, Mass. RLY-4008 Fibroblast growth factor receptor 2 (FGFR2) inhibitor Advanced or metastatic solid tumors predominantly with mutations in FGFR2 Treated first of up to 125 patients in study testing the safety, tolerability, pharmacokinetics and antitumor efficacy of RLY-4008
Phase II
Blade Therapeutics Inc., of South San Francisco BLD-2660 Dimeric calpain inhibitor Idiopathic pulmonary fibrosis Suspended due to concerns for patient safety during COVID-19 crisis
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas LX-9211 Adaptor associated kinase 1 inhibitor Diabetic peripheral neuropathic pain Started dosing in the 300-patient Relief-DPN-1 study; primary endpoint is change in Average Daily Pain Score from baseline to week 6
Savara Inc., of Austin, Texas Molgradex  Inhaled recombinant human granulocyte macrophage-colony stimulating factor Nontuberculous mycobacterial lung infection in patients with cystic fibrosis Stopping Encore study due to impact of COVID-19 on recruitment and continued participation as well as the impact of the approval of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor, Vertex Pharmaceuticals Inc.)
Phase III
Ampio Pharmaceuticals Inc., of Englewood, Colo. Ampion   Stem cell antigen-1 inhibitor  Severe osteoarthritis of the knee Early in the fourth quarter of 2020, company plans to submit a proposal to the FDA for dealing with study, which was paused due to the COVID-19 pandemic
Hutchison China Meditech Ltd., of Hong Kong Fruquintinib Vascular endothelial growth factor receptor 1/2/3 inhibitor Metastatic colorectal cancer First patient dosed in the 522-patient Fresco-2 study; primary endpoint is overall survival
Mesoblast Ltd., of New York Remestemcel-L Allogeneic culture-expanded mesenchymal stem cells Moderate to severe acute respiratory distress syndrome due to COVID-19  Data safety monitoring board recommended continuation of the study after reviewing data from the first 30% of total target patient enrollment
Oncopeptides AB, of Stockholm Melflufen (melphalan flufenamide) Peptide-drug conjugate targeting aminopeptidases Relapsed refractory multiple myeloma  Completed enrollment of 495 patients; top-line data expected in the first half of 2021


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