Company Product Description Indication Status
Phase I
Compugen Ltd., of Holon, Israel COM-701  Antibody targeting PVRIG Advanced solid tumors Updated data from dose-escalation study in patients who have exhausted all available standard therapies show treatment tolerated in 8th cohort, given 20 mg/kg on Q4 weekly dosing schedule, with preliminary antitumor activity in 2 patients, including a partial response in a patient with microsatellite stable primary peritoneal cancer on monotherapy and a confirmed partial response in a patient with microsatellite stable colorectal cancer treated in combination with Opdivo (nivolumab, Bristol Myers Squibb Co.)
Dare Bioscience Inc., of San Diego Sildenafil cream, 3.6%  Phosphodiesterase type 5 inhibitor  Healthy women (eventually female sexual arousal disorder)  In first 6 subjects, there were statistically meaningful differences in genital temperature changes after treatment with active cream compared to placebo
FSD Pharma Inc., of Toronto Ultra-micronized-PEA Fatty acid amide palmitoylethanolamide Healthy volunteers (eventually pain) Started study testing the safety, tolerability and pharmacokinetics of single and multiple ascending doses of the drug
Gemoab GmbH, of Dresden, Germany UniCAR-T-CD123 Switchable CAR T targeting CD123 Late-stage, relapsed/refractory acute leukemia expressing CD123 antigen First patient apheresed in study testing the feasibility, safety and potential efficacy of CAR T with continuous infusion of the CD123-specific targeting module TM123
Revolution Medicines Inc., of Redwood City, Calif. RMC-4630 SHP2 inhibitor  Solid tumors with RAS mutations focusing on pancreatic cancer Netherlands Cancer Institute, with financial support from the American Association for Cancer Research, plans to start the Sherpa study testing the drug plus an ERK inhibitor in the second half of 2020
Terns Pharmaceuticals Inc., of Foster City, Calif. TERN- 201  Semicarbazide-sensitive amine oxidase Healthy volunteers (eventually nonalcoholic steatohepatitis) Drug was safe, well-tolerated and reduced plasma semicarbazide-sensitive amine oxidase activity
Phase II
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist COVID-19 Submitted an IND to the FDA to test the drug in patients with mild to moderate respiratory illness after contracting the novel coronavirus; study will measure combined total symptom score for fever, myalgia, dyspnea and cough, as the primary endpoint
Faron Pharmaceuticals Oy, of Turku, Finland Traumakine   CD73 agonist; interferon-beta ligand Acute respiratory distress syndrome FDA accepted the protocol design for the next study, which will exclude the concomitant use of glucocorticoids; pilot study will enroll 60 patients with data used to adjust size of pivotal study
Phase III
Bristol Myers Squibb Co., of New York, and Abbvie Inc., of North Chicago Empliciti (elotuzumab)  Monoclonal antibody targeting signaling lymphocyte activation molecule family member 7 First-line multiple myeloma In the Eloquent-1 study, Empliciti plus Revlimid (lenalidomide) and dexamethasone didn't improve progression-free survival compared to Revlimid plus dexamethasone; data to be presented at a future medical meeting
Kala Pharmaceuticals Inc., of Watertown, Mass. Eysuvis (loteprednol etabonate, KPI-121) Steroid delivered via a mucus-penetrating particle Dry eye disease Drug improved ocular discomfort severity (ODS) at day 15 compared to placebo in the overall intent-to-treat (ITT) population (p=0.0002) and in the predefined subgroup of ITT patients with more severe ocular discomfort at baseline (p=0.0007); in the ITT population, compared to placebo, drug also improved conjunctival hyperemia at day 15 (p<0.0001), ODS at day 8 (p=0.0282) and total corneal staining at day 15 (p=0.0042)
Retrophin Inc., of San Diego Sparsentan Blocks endothelin receptor type A and angiotensin receptor Focal segmental glomerulosclerosis Duplex study enrolled first 190 patients; interim data after completion of 36 weeks of treatment expected in the first quarter of 2021
Viiv Healthcare Ltd., of London Cabotegravir Integrase inhibitor HIV 48-week data from Atlas-2M study in combination with rilpivirine met primary endpoint, showing administration every 8 weeks was noninferior when compared to administration every 4 weeks

Notes

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

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