Company Product Description Indication Status
Phase I
Genprex Inc., of Austin, Texas Reqorsa TUSC2 immunogene therapy Non-small-cell lung cancer Started recruiting clinical trial sites for the upcoming phase I/II Acclaim-2 study testing Reqorsa plus Keytruda (pembrolizumab, Merck & Co. Inc.) in patients who are low expressors (1% to 49%) of PD-L1; plans to conduct the study at 15 sites with about 150 patients
HDT Bio Corp., of Seattle, and Gennova Biopharmaceuticals Ltd., of Pune, India RNA vaccine COVID-19 spike glycoprotein inhibitor COVID-19 First volunteers dosed in India in phase I/II trial
Immunitybio Inc., of Culver City, Calif. Anktiva (nogapendekin alfa) IL-15 receptor agonist/modulator Non-Hodgkin lymphoma In combination trial with anti-CD20 monoclonal antibody Rituxan (rituximab) in people with relapsed/refractory disease, overall response rate was 78% (7 of 9) in CD20-sensitive people; 7 of 7 responses in these cohorts were complete remissions
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda KPL-404 CD40 ligand receptor antagonist Autoimmune disease Efficacy data showed 10-mg/kg I.V. dose achieved full CD40 receptor occupancy (RO) through at least day 71 and complete suppression of T-cell-dependent antibody response (TDAR) after keyhole limpet hemocyanin (KLH) challenge and re-challenge through at least day 57; 5-mg/kg SC dose achieved full RO through day 43 and suppression of TDAR after KLH challenge through at least day 29
Merus NV, of Utrecht, the Netherlands MCLA-129 Biclonics targeting EGFR and c-MET Advanced non-small-cell lung cancer and other solid tumors First patient enrolled in the phase I/II study; phase I will determine the maximum tolerated dose and/or the recommended phase II dose; phase II will evaluate safety, tolerability and potential clinical activity
Revolo Biotherapeutics, of New Orleans ‘1104  Peptide derived from mTB Chaperonin 60.1 Allergic diseases Study in healthy volunteers showed the drug was safe and well-tolerated at the 2 doses evaluated, 4 mg and 8 mg; there were no serious adverse events
Rezolute Inc., of Redwood City, Calif. RZ-402 Plasma kallikrein inhibitor Diabetic macular edema Drug was safe and well-tolerated at all doses tested, without dose-limiting toxicities; plasma concentrations support the potential for once-daily dosing
Vaxart Inc., of South San Francisco VXA-CoV2-1 Oral recombinant vaccine COVID-19 prophylaxis Vaccine produced CD8+ T-cell responses, as measured by IFN-g and TNF-a induction that were stronger than responses induced by mRNA-based vaccines
Vaxart Inc., of South San Francisco VXA-GI.1.NN Oral norovirus vaccine expressing GI.1 VP1 Norovirus infection prophylaxis Enrolled first of 30 volunteers in a phase Ib boosting regimen trial testing 3 different regimens for timing of the booster; endpoints are safety and immunogenicity
Phase II
Arch Biopartners Inc., of Toronto Metablok  LSALT peptide COVID-19 with acute lung injury and acute kidney injury Completed enrollment of 65 patients with 61 of those having received at least 1 treatment dose; data expected in July 2021
Checkmate Pharmaceuticals Inc., of Cambridge, Mass. Vidutolimod (CMP-001) Toll-like receptor 9 agonist Anti-PD-1-refractory advanced melanoma Started dosing patients in the study testing vidutolimod plus Opdivo (nivolumab, Bristol Myers Squibb Co.); primary endpoint is objective response rate
Cytokinetics Inc., of South San Francisco CK-3773274 Cardiac myosin inhibitor Hypertrophic cardiomyopathy Opened enrollment in cohort 3 of the Redwood-HCM study; cohort will assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of CK-274 in 8 to 12 patients whose background therapy includes disopyramide; results from cohorts 1 and 2 are expected in mid-2021
Cyxone AB, of Stockholm Rabeximod Immunomodulator Rheumatoid arthritis Collaborating with Costantino Pitzalis at the William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London on the design of the phase IIb study
Ichnos Sciences Inc., of New York Telazorlimab OX40 antagonist Atopic dermatitis The 300-mg and 600-mg doses were statistically superior to placebo for percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16 (p<0.05 for both); percent of patients reaching EASI-75 was statistically significant for the 300-mg dose; preliminary data suggest the improvement continued after week 16
Tarsus Pharmaceuticals Inc., of Irvine, Calif. TP-03 Non-competitive antagonist of insect and arachnid GABA-Cl channels Demodex blepharitis In the Europa study, collarette cure at 42 days was achieved in 80% of patients taking TP-03 and 16% of patients taking vehicle (p<0.001); mites were eradicated in 73% of patients treated with TP-03 compared to 21% of patients given vehicle (p=0.003); composite collarette and erythema cure at 42 days occurred in 73% of patients treated with TP-03 compared to 11% of patients given vehicle (p<0.001)
Verona Pharma plc, of London Ensifentrine Phosphodiesterase 3 and 4 inhibitor Chronic obstructive pulmonary disease Subgroup analysis of the phase IIb study of ensifentrine plus Spiriva Respimat (tiotropium, Boehringer Ingelheim Pharmaceuticals Inc.) showed the combination improved lung function and quality of life in both severe and moderate COPD subgroups
Phase III
Biolinerx Ltd., of Tel Aviv Motixafortide CXCR4 inhibitor Hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma In the Genesis study, 70% of patients taking motixafortide plus G-CSF mobilized ≥ 6 million CD34+ cells/kg in up to 2 apheresis sessions compared to 14.3% of patients taking G-CSF alone; 67.5% of patients taking motixafortide plus G-CSF mobilized ≥ 6 million CD34+ cells/kg in just 1 apheresis session compared to 4.8% of patients taking G-CSF alone
Obseva SA, of Geneva Yselty GnRH receptor antagonist Moderate to severe endometriosis-associated pain Completed enrollment of 486 women in the Edelweiss 3 study; data from the primary endpoint expected in the fourth quarter of 2021

Notes

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