Company Product Description Indication Status
Phase I
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 
Phase II
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)
Phase III
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

Notes

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