Company Product Description Indication Status
Phase I
Daiichi Sankyo Co. Ltd., of Tokyo DS-6157 GPR20-directed antibody-drug conjugate Advanced gastrointestinal stromal tumor First patient dosed in study testing drug in patients who have progressed on, or are intolerant to, standard treatment
Incuron Inc., of Buffalo, N.Y. CBL-0137 Targets NOTCH pathway Hematological malignancies Study in previously treated patients suspended due to business reasons
Nektar Therapeutics Inc., of San Francisco Bempegaldesleukin (NKTR-214) CD122-preferential IL-2 pathway agonist Solid tumors Data published in Cancer Discovery showed combination with Opdivo (nivolumab, Bristol Myers Squibb Co.) increased absolute numbers and proliferation of CD8+ T- and NK cells in peripheral blood, and increased expression of genes relating to immune activation in tumor microenvironment, including the genes encoding the interferon gamma inflammatory response to PD-L1; total objective response rate was 59.5%, complete response rate was 18.9% and disease control rate was 83.8%; among 22 patients with confirmed objective responses, median time to response was 1.9 months (range 1.3-7.8) and median duration of response was not reached
Retinset SL, of Barcelona, Spain Bosentan  Competitive antagonist of endothelin-1 at ET-A and ET-B receptors Type 2 diabetes Suspended due to COVID-19 restrictions in Spain
Phase II
Boehringer Ingelheim GmbH, of Ingelheim, Germany BI-1265162 Epithelial sodium channel blocker Cystic fibrosis Study testing different dosing using Respimat inhaler terminated; company said decision not based on safety reasons
Incyte Corp., of Wilmington, Del. Ruxolitinib JAK inhibitor COVID-19 Study withdrawn due to inability to make FDA-required changes
Leo Pharma A/S, of Ballerup, Denmark Delgocitinib cream JAK inhibitor Discoid lupus erythematosus Terminated due to recruitment challenges
Navidea Biopharmaceuticals Inc., of Dublin, Ohio Tc99m tilmanocept Imaging agent Rheumatoid arthritis Preliminary phase IIb results from second interim analysis showed imaging from baseline to week 5 was predictive of clinical outcome at 12 weeks in 7 of 8 subjects with 12-week clinical assessment available; the 1 subject who did not demonstrate concordance of signal quantification and clinical assessment had undergone a change in treatment regime while enrolled in the trial that may have impacted trajectory of clinical response; in subjects with 12-week follow-up data available, global Tc99m tilmanocept signals declined by an average of 58% from baseline to week 5 in those who responded significantly to anti-TNF-alpha treatment by week 12
Samumed LLC, of San Diego Lorecivivint CLK/DYRK1A inhibitor Knee osteoarthritis Phase IIa results published in Arthritis & Rheumatology showed subjects in prespecified subgroup with unilateral symptoms had statistically significant improvements in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, WOMAC Function and medial joint space width (mJSW), as measured by X-ray, at 52 weeks when treated with 0.07 mg lorecivivint vs. placebo; in post-hoc analysis, unilateral symptomatic subjects without widespread pain showed statistically significant improvements in WOMAC Pain, WOMAC Function and mJSW at weeks 26 and 39 vs. placebo; post-hoc analysis of both subgroups showed mJSW improvements in 0.07-mg dose group were concordant with clinical improvements, indicating the potential connection between changes in structural measures and clinical responses that may be due to treatment
Xeris Pharmaceuticals Inc., of Chicago RTU glucagon Metabolic hormone product delivered via ready-to-use formulation Patients at risk of postprandial hypoglycemia following bariatric surgery Findings from outpatient stage of study showed sole use of 300 µg RTU glucagon was adequate to restore or maintain normal blood glucose levels within 15 minutes of administration and maintained up to 120 minutes; during episodes when blood sugar was >70 mg/dL at drug dosing, RTU glucagon and placebo were comparable in maintaining blood sugar within normal levels, and RTU glucagon did not elicit hyperglycemia; during episodes when blood sugar was <70 mg/dL at drug dosing and without the use of glucose tabs, RTU glucagon successfully restored blood glucose levels to normal levels (blood sugar ≥70 mg/dL) within 15 minutes, at a higher frequency when compared to placebo (91% vs. 73%)
Phase III
Geron Corp., of Menlo Park, Calif. Imetelstat Telomerase inhibitor Lower-risk myelodysplastic syndromes Due to effects of COVID-19 pandemic on site initiations and enrollment, patient enrollment now expected to complete by end of first quarter of 2021, with top-line results expected in second half of 2022
Oncopeptides AB, of Stockholm Melflufen Peptide-drug conjugate Relapsed/refractory multiple myeloma Completed enrollment in Ocean study testing melflufen compared to pomalidomide in patients previously treated with immunomodulatory inhibitors and proteasome inhibitors who developed resistance to their last line of therapy and are refractory to lenalidomide; primary endpoint is progression-free survival
Roche Holding AG, of Basel, Switzerland Satralizumab IL-6-targeting monoclonal antibody Neuromyelitis optica spectrum disorder Pooled safety results from pivotal Sakurastar and Sakurasky studies show drug was well-tolerated in broad patient population, including adolescents; rates of adverse events and serious adverse events (SAEs) were comparable between satralizumab and placebo groups (SAEs: 15 vs. 18 events/100 patient years, respectively), as a monotherapy or in combination with baseline therapy
Syndax Pharmaceuticals Inc., of Waltham, Mass. Entinostat HDAC inhibitor HR+/HER2- breast cancer Study conducted by ECOG-ACRIN Cancer Research Group in patients who have progressed on a nonsteroidal aromatase inhibitor did not achieve primary endpoint of demonstrating a statistically significant overall survival benefit over hormone therapy alone

Notes

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