Company Product Description Indication Status
Phase I
Dynavax Technologies Corp., of Emeryville, Calif. Heplisav-B Hepatitis B vaccine Hepatitis B virus prophylaxis Completed enrollment of 119 participants with end-stage renal disease who are initiating or undergoing hemodialysis; final immunogenicity data expected in the fourth quarter of 2020
Karyopharm Therapeutics Inc., of Newton, Mass. Selinexor Blocks nuclear export of XPO1 Newly diagnosed or recurrent glioblastoma Dosed first of about 400 patients in phase I/II study testing the drug in combination with standard of care for either newly diagnosed GBM or recurrent GBM; primary endpoints are progression-free survival in patients with newly diagnosed GBM and overall survival in patients with recurrent GBM
Nflection Therapeutics Inc., of Wayne, Pa. NFX-179 gel MEK inhibitor Cutaneous neurofibromatosis type-1 Started trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics in adults
Renibus Therapeutics Inc., of Dallas RBT-1 SnPP (tin protoporphyrin) and FeS (iron sucrose) Chronic kidney disease RBT-1 increased HO-1, NQO1, ferritin and hemopexin in patients
Revolution Medicines Inc., of Redwood City, Calif., and Amgen Inc., of Thousand Oaks, Calif. RMC-4630/AMB-510 SHP2 inhibitor/KRAS-G12C inhibitor Advanced solid tumors harboring the KRAS-G12C mutation Dosed first patient in phase Ib dose-escalation and dose-expansion study testing the combination
Soricimed Biopharma Inc., of Toronto SOR-C13 TRP cation channel V6 inhibitor Late-stage pancreatic cancer patients Resuming enrollment in the investigator-initiated phase Ib study after a temporary suspension related to the COVID-19 pandemic
Vedanta Biosciences Inc., of Cambridge, Mass.,  VE-2020 Live biotherapeutic Healthy volunteers (eventually inflammatory bowel disease) The 2 studies showed the drug was generally safe and well-tolerated at all doses and produced durable and dose-dependent colonization that was detected at high abundances 12 weeks after dosing ended for subjects dosed for 14 days; plans to run a phase II study in patients in the next 12 months
Phase II
Beyondspring Inc., of New York Plinabulin Immune and stem cell modulator Chemotherapy-induced neutropenia In the Protective-2 study, 6.3% of patients taking plinabulin plus Neulasta (pegfilgrastim) required a dose reduction compared to 22.7% of patients taking Neulasta alone; none of the patients on the combination had to downgrade their regimen compared to 18.2% of patients on Neulasta alone
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson A3 adenosine receptor agonist Moderate to severe COVID-19 Plans to submit an IND for a phase II study following comments from the FDA on the pre-IND filing
Erytech Pharma SA, of Lyon, France Eryaspase L-asparaginase encapsulated inside donor-derived red blood cells Second-line acute lymphoblastic leukemia Preliminary analysis of data from the investigator-sponsored study showed eryaspase achieved the target level and duration of asparaginase activity
Nanology LLC, of Ft. Worth, Texas Nanopac Submicron particle paclitaxel Non-small-cell and small-cell lung cancers Started study phase Ia testing progression-free survival, overall survival and tumor response of intratumoral injections of the drug
Phase III
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia Voclosporin Calcineurin inhibitor; IL-2 receptor antagonist Lupus nephritis Additional safety data from completed pivotal Aurora trial showed that prespecified confirmed estimated glomerular filtration rate (eGFR) decreases of >30% were 10.1% for study drug and 10.2% in control arm (p=0.971); no clinically meaningful differences between treatment (23.7 mg twice daily) and control groups were seen at any time points on eGFR or in serum creatinine levels
Dermavant Sciences Ltd., subsidiary of Roivant Sciences Ltd., of Basel, Switzerland Tapinarof Aryl hydrocarbon receptor agonist Plaque psoriasis Enrollment completed in long-term safety study for ongoing Psoaring program; top-line results from Psoaring 1 and 2 expected in second half of 2020
Eli Lilly and Co., of Indianapolis Tirzepatide Dual GIP/GLP-1 receptor agonist Type 2 diabetes First participant dosed in Surpass-CVOT cardiovascular outcomes trial assessing noninferiority and superiority vs. Trulicity (dulaglutide, Eli Lilly); primary endpoint measuring time to first occurrence of MACE-3 (composite of CV death, myocardial infarction or stroke)
Fibrogen Inc., of San Francisco Roxadustat HIF prolyl hydroxylase inhibitor Anemia In Dolomites study in nondialysis-dependent stage 3-5 chronic kidney disease, primary endpoint analysis showed noninferiority of study drug vs. darbepoetin alfa in proportion of those who achieved correction of hemoglobin levels during first 24 weeks (89.5% vs. 78%, respectively), with lower bound of 95% CI >0%; roxadustat was superior in decreasing low-density lipoprotein cholesterol with least square mean difference of -0.403 mmol/L (p<0.01) and in time to first intravenous iron use (p=0.004); data from separate phase III study suggested dialysis-dependent CKD patients treated with study drug were not at an increased risk of ophthalmic abnormalities compared with those treated with darbepoetin alfa
Oncosec Medical Inc., of Pennington, N.J. Tavokinogene telseplasmid (Tavo) Plasmid-based interleukin-12 Breast cancer Based on tumor regression and clinical responses in heavily pretreated cohort 1, ongoing Keynote-890 combination trial expanding into first-line inoperable locally advanced or metastatic triple-negative disease by adding study drug to Keytruda (pembrolizumab, Merck & Co. Inc.) plus chemotherapy in second arm, with primary endpoint of overall responder rate
Opko Health Inc., of Miami Somatrogon Growth hormone ligand Growth hormone deficiency Trial in Japan met primary and secondary endpoints, showing comparable efficacy and safety of weekly administration of study drug vs. daily injection of Genotropin (somatropin, Pfizer Inc.), measured by annual height velocity after 12 months (9.65 cm/yr vs. 7.87 cm/yr, respectively) in treatment-naïve pre-pubertal children
Resverlogix Corp., of Calgary, Alberta Apabetalone Bromodomain and extra-terminal inhibitor Chronic kidney disease In CKD subgroup (n=288) from BETonMACE trial, reduction in major cardiovascular events (MACE) seen for study drug (13/124 [10.5%]) vs. placebo (35/164 [21.3%]) with HR of 50% (p=0.03) and 74% (p=0.03) for congestive heart failure (CHF) hospitalizations; for composite endpoint of MACE and hospitalization for CHF, observed hazard reduction for subgroup was 52% (p=0.02)
Soleno Therapeutics Inc., of Redwood City, Calif. Diazoxide choline  Potassium channel stimulator Prader-Willi syndrome Destiny PWS trial did not meet primary endpoint of change from baseline in hyperphagia, measured by total score of Hyperphagia Questionnaire for Clinical Trials, with mean change from baseline of -5.94 (0.879) for study drug vs. -4.27 (1.145) for placebo

Notes

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