Dec. 14 COVID roundup: Phase III miss for Incyte-Novartis JAK inhibitor; Queensland vaccine program axed; plus Sputnik V final efficacy and Phase II starts for CureVac and Inovio
No benefit in Phase III for Incyte, Novartis JAK inhibitor
Jakafi ruxolitinib from Incyte Corp. (NASDAQ:INCY) and Novartis AG (NYSE:NVS; SIX:NOVN) plus standard of care vs. SOC alone did not reduce the proportion of patients with severe complications including death, respiratory failure requiring mechanical ventilation and ICU admission by day 29 (12% vs. 11.8% p=0.769). In the 432-subject Phase III RUXCOVID study to treat patients ages ≥12 with COVID-19-associated cytokine storm, the oral JAK-1/JAK-2 inhibitor also failed to lower mortality and time to recovery.
Olumiant baricitinib, another oral JAK-1/JAK-2 inhibitor from Incyte and licensed to Eli Lilly and Co. (NYSE:LLY), reduced recovery time in hospitalized COVID-19 patients in the Phase III ACTT-2 trial when added to Veklury remdesivir from Gilead Sciences Inc. (NASDAQ:GILD). NIH published the data Friday in The New England Journal of Medicine.
Anti-HIV antibodies nix Queensland vaccine program
CSL Ltd. (ASX:CSL) will not run a Phase II/III trial of the University of Queensland’s v451, nor will the Coalition for Epidemic Preparedness Innovations fund further development of the COVID-19 vaccine, based on the candidate’s induction of anti-HIV antibodies in Queensland’s CEPI-funded Phase I trial. v451 uses Queensland’s “molecular clamp,” an 80-amino acid trimerization motif derived from HIV gp41. Queensland and CSL said in a public statement that while antibodies against HIV were expected, “it was unexpected that the levels induced would interfere with certain HIV tests.”
Sputnik V yields 91% efficacy at final planned analysis
The Russian Direct Investment Fund and the N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology reported 91.4% efficacy for Sputnik V at the final planned analysis at 78 confirmed cases in its Phase III trial. Across the 22,714 volunteers randomized 3:1 to receive the two adenoviral vector components of Sputnik V in a two-dose regimen or placebo, there were 16 cases in the vaccinated group and 62 in the control cohort. No vaccinated volunteers developed severe COVID-19 vs. 20 in the placebo group. Gamaleya will publish the data in a peer-reviewed journal.
CureVac begins pivotal vaccine study
CureVac N.V. (NASDAQ:CVAC) said Monday it enrolled the first volunteer in the Phase IIb/III HERALD trial of CVnCoV. The company expects the study, which will evaluate prime-boost administration of 12 µg of the mRNA vaccine, to enroll over 35,000 subjects ages ≥18 in Europe and Latin America. The two primary efficacy endpoints will evaluate confirmed cases of COVID-19 of any severity and moderate to severe cases in participants who have never been infected with SARS-CoV-2.
Inovio begins Chinese Phase II trial
Inovio Pharmaceuticals Inc. (NASDAQ:INO) and Beijing Advaccine Biotechnology Co. announced Thursday the dosing of the first subject in a Chinese Phase II trial of DNA vaccine INO-4800. The partners aim to enroll 640 volunteers. Three days earlier, Inovio announced it had dosed the first person in the U.S. Phase II/III INNOVATE study, which plans to enroll 400 individuals in the Phase II portion.
JAK-1 – Janus kinase-1
JAK-2 – Janus kinase-2