Company Product Description Indication Status
Phase I
Aridis Pharmaceuticals Inc., of San Jose AR-501 Inhaled gallium citrate Chronic lung infections in cystic fibrosis Results from phase I portion of phase I/II trial showed aerosols were well-tolerated; transient incremental changes in airflow as measured by spirometry were observed in both AR-501 and placebo recipients that were not dose related; all doses to proceed to phase IIa portion
FSD Pharma Inc., of Toronto FDS-201 (ultramicronized palmitoylethanolamide) Anti-inflammatory COVID-19 Top-line results in healthy volunteer trial showed drug safe and well-tolerated, with no abnormal lab findings or ECGs observed and no serious adverse events reported; pharmacokinetic profile still being analyzed
Heat Biologics Inc., of Durham, N.C. PTX-35 Antibody T-cell co-stimulator targeting TNFRSF25 Advanced solid tumors Treated first patient; study expected to enroll up to 30 patients whose tumors are refractory to standard of care; objectives include safety, determination of recommended phase II dose and exploratory analyses of clinical benefit and immunological effect 
Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson Loperamide Opioid receptor agonist Antidiarrheal Study testing effects on electrocardiogram intervals in healthy adults put on hold due to COVID-19
Onconova Therapeutics Inc., of Newtown, Pa. Rigosertib Targets RAS effector pathways Lung adenocarcinoma Investigator-initiated phase I/IIa trial testing combination with Opdivo (nivolumab, Bristol Myers Squibb Co.) in patients with advanced metastatic KRAS-mutated disease began enrollment
Revolution Medicines Inc., of Redwood City, Calif. RMC-4630 SHP2 inhibitor Advanced malignancies Dosed first patient in study testing combination with Keytruda (pembrolizumab, Merck & Co. Inc.); study will include patients with non-small-cell lung cancer who have progressed on or after platinum-based chemotherapy and patients with colorectal cancer who have progressed on or after standard of care 
Springworks Therapeutics Inc., of Stamford, Conn. Nirogacestat Gamma-secretase inhibitor Relapsed or refractory multiple myeloma First patient dosed in phase Ib trial testing combination with antibody-drug conjugate belantamab mafodotin (Glaxosmithkline plc)
Tarsius Pharma Ltd., of Tel Aviv, Israel TRS-01 Topical immune-modulator agent Active anterior non-infectious uveitis Completed patient enrollment in phase I/II trial; top-line data expected in second half of 2020
Phase II
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. Roflumilast foam Topical formulation of PDE4 inhibitor Seborrheic dermatitis Completed enrollment; top-line data expected early in fourth quarter of 2020
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia Voclosporin ophthalmic solution Nanomicellar solution formulation of calcineurin inhibitor Dry eye syndrome Completed enrollment in phase II/III Audrey trial; data expected in fourth quarter of 2020
Evelo Biosciences Inc., of Cambridge, Mass. EDP-1815 Monoclonal microbial candidate COVID-19 Drug will be included in phase II/III Tactic-E trial testing experimental therapies in prevention and treatment of life-threatening complications associated with COVID-19 in hospitalized patients at early stages of disease
Hookipa Pharma Inc., of New York HB-101 Vaccine Cytomegalovirus Interim results showed drug well-tolerated; all 5 patients who received 3 doses mounted CMV-neutralizing antibodies, while 3 of 14 patients (21%) who received only 2 doses also mounted CMV-neutralizing antibodies; all 3 (100%) who received 3 doses and 1 of 2 who received only 2 doses (50%) mounted a CMV-specific cellular immune response
Myokardia Inc., of Brisbane, Calif. Danicamtiv (MYK-491) Small-molecule selective cardiac myosin activator Heart failure Phase IIa data published in the European Journal of Heart Failure showed drug, administered orally for 7 days in patients with stable chronic heart failure, was generally well-tolerated and was associated with clinically meaningful improvements in left ventricular (LV) contractility, including statistically significant increases in LV stroke volume, without impairing the heart’s ability to relax and fill; treatment also improved left atrial volume and function; nonclinical studies indicated danicamtiv directly activates the left ventricle and left atrium
Ziopharm Oncology Inc., of Boston Ad-RTS-hIL-12 with veledimex  Inducible adenoviral vector encoding human pro-inflammatory cytokine interleukin-12 and activator ligand Recurrent or progressive glioblastoma 26 subjects enrolled in trial testing combination with PD-1 inhibitor Libtayo (cemiplimab-rwlc, Regeneron Pharmaceuticals Inc./Sanofi SA)
Phase III
Merck & Co. Inc., of Kenilworth, N.J. V-114 15-valent pneumococcal conjugate vaccine Pneumococcal disease Results from Pneu-Way study in adults 18 and older with HIV showed vaccine elicited an immune response to all 15 serotypes included in the vaccine, including serotypes 22F and 33F; results from Pneu-Flu study in healthy adults 50 and older showed vaccine can be given concomitantly with the quadrivalent influenza vaccine
Pfizer Inc., of New York 20vPnC 20-valent pneumococcal polysaccharide conjugate vaccine candidate Pneumococcal disease Started 2 trials to test 4-dose series in infants starting at 2 months of age
Pfizer Inc., of New York RSVpreF Vaccine Respiratory syncytial virus  Started study in pregnant women to evaluate the safety and efficacy of RSVpreF in infants born to immunized pregnant women as compared to placebo
Pfizer Inc., of New York MenABCWY Pentavalent meningococcal vaccine candidate Meningococcal disease Started study in adolescents and young adults to test safety, tolerability and immunogenicity vs. licensed vaccines, with goal of determining immunologic noninferiority

Notes

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

No Comments