Company Product Description Indication Status
Phase I
Bio-Thera Solutions Ltd., of Guangzhou, China BAT-1308 PD-1-targeting monoclonal antibody Advanced solid tumors Study initiated to determine maximum tolerated dose, pharmacokinetics and preliminary antitumor activity; disease-specific expansion cohorts planned at maximally tolerated or biologically relevant dose
Inmune Bio Inc., of La Jolla, Calif. Xpro-1595 TNF alpha ligand inhibitor Alzheimer's disease Interim data from ongoing phase Ib trial showed cytokine/chemokine CSF levels decreased after 12 weeks of therapy, including statistically significant reductions of c-reactive protein and YKL-40, (p<0.0001); correlation seen between neuroinflammation, measured by CSF, and neuroimaging biomarker of MRI white matter free water (R2=0.75; p<0.01)
Kuur Therapeutics Ltd., of Houston KUR-501  Autologous GD2 CAR-NKT cells Neuroblastoma Ginakit2 study in relapsed/refractory disease with 10 evaluable participants and escalation to dose of 1x108 cells/m2 showed 1 complete and 1 partial response, with stable disease in 3 additional people
Kuur Therapeutics Ltd., of Houston KUR-502 Off-the-shelf CD19 CAR-NKT cells CD19-positive cancer Anchor study in relapsed/refractory disease with 2 evaluable participants with lymphoma treated to date at starting dose of 1x107 cells/m2 showed 1 complete and 1 partial response
Lyndra Therapeutics Inc., of Watertown, Mass. LYN-047 (rosuvastatin, extended release) HMG CoA reductase inhibitor Dyslipidemia First of 16 healthy participants dosed in trial in Australia assessing weekly oral treatment; following run-in of immediate-release drug, participants receive 140-mg capsule (equivalent to 20-mg daily dose) in 2 administrations 1 week apart
Moderna Inc., of Cambridge, Mass. mRNA-1273 (TAK-919) COVID-19 spike glycoprotein modulator COVID-19 infection Partner Takeda Pharmaceutical Co. Ltd. dosed first of 200 healthy adults in phase I/II study in Japan
Sutro Biopharma Inc., of South San Francisco STRO-002 Folate receptor alpha-targeting antibody-drug conjugate  Ovarian cancer First participant dosed in dose-expansion cohort of 4.3 or 5.2 mg/kg every 3 weeks
Transgene SA, of Strasbourg, France TG-4050 Virus-based immunotherapy Head and neck cancer First of up to 30 participants with HPV-negative disease dosed; initial data expected in second half of 2021
Phase II
Aribio Co. Ltd., of Seongnam, South Korea AR-1001 Inhibits neuron apoptosis, restores synaptic plasticity and activates autophagy removal of amyloid plaques and tau proteins Mild to moderate Alzheimer’s disease Completed last patient visit in the 210-patient study in which 171 patients completed the 6-month treatment; top-line data expected by the end of the first quarter of 2021
Azurrx Biopharma Inc., of Delray Beach, Fla. MS-1819   Recombinant lipase enzyme Exocrine pancreatic insufficiency in patients with cystic fibrosis First 2 patients treated in the Option 2 extension study; top-line data expected in the first quarter of 2021
Cardiol Therapeutics Inc., of Oakville, Ontario Cardiolrx Cannabidiol  Hospitalized COVID-19 with a history of, or risk factors for, cardiovascular disease Formed a data safety monitoring committee and a clinical endpoints committee for the 422-patient phase II/III study
Dermata Therapeutics LLC, of San Diego DMT-310  Natural product from a freshwater sponge Moderate to severe acne Once-weekly treatment significantly reduced inflammatory and noninflammatory lesions and had a greater proportion of Investigator Global Assessment treatment success
Heron Therapeutics Inc., of San Diego HTX-011  Anesthetic bupivacaine and nonsteroidal anti-inflammatory drug meloxicam Postoperative pain following bunionectomy Data published in the Journal of the American Podiatric Medical Association showed 77% of patients taking HTX-011 plus over-the-counter oral acetaminophen and ibuprofen were opioid-free through the 72-hour period following surgery and continued to be opioid-free through 28 days of recovery
Meissa Vaccines Inc., of Redwood City, Calif. MV-012-968 Intranasal live attenuated respiratory syncytial virus vaccine Respiratory syncytial virus infection prophylaxis First of up to 70 participants treated in the study; primary endpoint is frequency of symptomatic respiratory syncytial virus infection
Newron Pharmaceuticals SpA, of Milan Evenamide Sodium channel inhibitor Schizophrenia Last of 138 participants enrolled in 4-week explanatory study 008 assessing 2 fixed doses (7.5 mg and 15 mg) twice daily in people with chronic disease receiving treatment with second-generation atypical antipsychotic to address FDA questions on preclinical data before submitting IND for pivotal phase III trial
Surface Ophthalmics Inc., of Pleasanton, Calif. SURF-201 Ophthalmic formulation of the corticosteroid betamethasone Post-cataract surgery pain and inflammation Twice-daily dosing produced complete clearance of anterior chamber cells at day 8 (p=0.01) and day 15 (p=0.001); almost 90% of patients were pain free at day 15
Phase III
Calliditas Therapeutics AB, of Stockholm Nefecon Targeted release formulation of the corticosteroid budesonide  Primary IgA nephropathy Completed enrollment in part B of the 360-patient Neflgard study
Eli Lilly and Co., of Indianapolis, and Abcellera Biologics Inc., of Vancouver, British Columbia Bamlanivimab (LY-CoV555) Monoclonal antibody targeting SARS-CoV-2 COVID-19 prophylaxis In the Blaze-2 study, treatment with bamlanivimab reduced the risk of developing symptomatic COVID-19 compared to placebo (p=0.00026) 
Intra-Cellular Therapies Inc., of New York Caplyta (lumateperone) Serotonin 5-HT2A receptor/dopamine D2 receptor antagonist Schizophrenia Data from 6-week switching study in people with stable disease that showed drug was well-tolerated with stable symptom control published online in Schizophrenia Research
Merck KGaA, of Darmstadt, Germany, and Glaxosmithkline plc, of London Bintrafusp alfa Bifunctional immunotherapy blocking TGF-beta and PD-L1 pathways Stage IV non-small-cell lung cancer Independent data monitoring committee recommended discontinuing the INTR@PID Lung 037 study because it's unlikely to meet the co-primary endpoint of progression-free survival
Oramed Pharmaceuticals Inc., of New York ORMD-0801 Oral insulin Type 2 diabetes Started randomization of the 675-patient study comparing once-daily and twice-daily treatment to placebo; primary endpoint is A1c levels; secondary endpoint is change in fasting plasma glucose

Notes

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