Company Product Description Indication Status
Phase I
Gilead Sciences Inc., of Foster City, Calif. Vesatolimod Toll-like receptor 7 agonist  HIV infection Phase Ib data showed TLR7 stimulation by study drug was associated with modestly increased time to viral rebound vs. placebo with median time to viral rebound (>50 copies/mL) of 4.1 weeks for vesatolimod vs. 3.9 weeks for placebo (p=0.036); for rebound to >200 copies/mL, median time was 5 weeks vs. 4 weeks, respectively (p=0.024); 4 in vesatolimod group had no virologic rebound (>50 c/mL) for 6 or more weeks; enhanced immune function and decreased levels of intact HIV DNA also seen with study drug
Oncternal Therapeutics Inc., of San Diego Cirmtuzumab Receptor tyrosine kinase-like orphan receptor 1 inhibitor Mantle cell lymphoma Interim data from ongoing phase I/II Cirll combination trial with ibrutinib (Imbruvica, Johnson & Johnson/Pharmacyclics LLC) in relapsed/refractory disease showed 50% complete response (CR) rate in 6 of 12 evaluable patients, including 1 complete metabolic response by PET scan; CRs are ongoing, including 1 at > 21 months on study; data also showed 33% partial response (PR) rate (4 of 12), 17% stable disease rate (2 of 12) and 83% best objective response (CR or PR) rate
Redhill Biopharma Ltd., of Tel Aviv, Israel Yeliva (opaganib) Sphingosine kinase 2 inhibitor Cholangiocarcinoma Following full enrollment of 39 people with advanced, unresectable intrahepatic, perihilar and extrahepatic disease evaluable for efficacy, preliminary phase I/IIa data showed signal of activity in multiple participants, leading to opening of second arm evaluating study drug in combination with hydroxychloroquine; third arm evaluating combination with Redhill's serine protease inhibitor, RHB-107 (upamostat), is subject to discussions with FDA
Phase II
Redhill Biopharma Ltd., of Tel Aviv, Israel Yeliva (opaganib) Sphingosine kinase 2 inhibitor Prostate cancer Investigator-sponsored study initiated at Medical University of South Carolina evaluating study drug in up to 60 participants with metastatic castration-resistant disease progressing during treatment with androgen-signaling blockers
Phase III
Medday Pharmaceuticals SA, of Paris MD-1003 (biotin) Dual acetyl CoA carboxylase-1/2 stimulator Progressive multiple sclerosis Second pivotal and confirmatory trial (SP12) missed primary endpoint of reversing functional disability; study also failed to meet secondary endpoints


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

No Comments