|Celcuity Inc., of Minneapolis||Gedatolisib||PI3K/mTOR inhibitor||ER+/HER2- advanced or metastatic breast cancer||Of the 88 patients in the phase Ib study, gedatolisib plus Ibrance (palbociclib, Pfizer Inc.) and endocrine therapy produced a 60% objective response rate; plans to start a phase II/III study in the first half of 2022|
|Mersana Therapeutics Inc., of Cambridge, Mass.||Upifitamab rilsodotin||Antibody-drug conjugate targeting NaPi2b||Platinum-resistant ovarian cancer||Started dosing in Uplift, the single-arm 100-patient registration part of the phase I/II study in patients who have received up to 4 lines of therapy; primary endpoint is objective response rate in the high NaPi2b population; secondary endpoint is ORR regardless of NaPi2b expression, as well as duration of response and safety|
|Oncoinvent AS, of Oslo, Norway||Radspherin||Alpha-emitting, radium-224 based microsphere suspension||Colorectal cancer with peritoneal carcinomatosis||Safety monitoring committee concluded that the 7MBq dose is safe and approved the start of the repeated injection and expansion cohorts of the ongoing RAD-18-002 study|
|Cytodyn Inc., of Vancouver, Wash.||Vyrologix (leronlimab)||Monoclonal antibody targeting the CCR5 receptor||Post-acute COVID-19 syndrome||Completed enrollment of 56 patients in the CD15 study; results expected in July 2021|
|Redhill Biopharma Ltd., of Tel Aviv, Israel||Yeliva (opaganib)||Sphingosine kinase-2 inhibitor||Hospitalized with severe COVID-19 pneumonia||Based on safety data from the first 255 treated patients, the independent data safety monitoring board recommended the phase II/III study continue; the 464-patient study is over 75% enrolled; completion of enrollment expected in the coming weeks|
|Tenax Therapeutics Inc., of Morrisville, N.C.||Levosimendan||Inhibits PDGF receptors and c-KIT||Pulmonary hypertension and heart failure with preserved ejection fraction||Data from the HELP study published in the Journal of American College of Cardiology: Heart Failure showed 84% of the 44 patients responded during the open-label portion of the study and were randomized to stay on levosimendan or move to placebo; in the blinded portion, levosimendan didn’t significantly reduce the primary endpoint with an exercise-pulmonary capillary wedge (PCWP) pressure of -1.4 mmHg (p=0.65); PCWP measured across all exercise stages was reduced by 3.9±2 mmHg (p=0.047); levosimendan produced a 29.3 meter improvement in the 6-minute walk test compared to placebo (p=0.033)|
|Bristol Myers Squibb Co., of New York||Opdivo (nivolumab)||Monoclonal antibody targeting PD-1||Unresectable advanced or metastatic esophageal squamous cell carcinoma||In the Checkmate-648, Opdivo plus chemotherapy improved overall survival in patients with tumors expressing PD-L1 and in the all-randomized patients at the prespecified interim analysis; the treatment also improved progression-free survival in patients with tumors expressing PD-L1; Opdivo plus Yervoy (ipilimumab) improved OS in patients with tumors expressing PD-L1 and in the all-randomized population; Opdivo plus Yervoy did not meet its other primary endpoint of PFS in patients with tumors expressing PD-L1; data will be shared at an upcoming medical conference, as well as with health authorities|
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