Altimmune COVID Update, And Other News: The Good, Bad And Ugly Of Biopharma

Summary

  • Altimmune provides positive updates for AdCOVID.
  • Ovid reports positive Phase 2 ELEKTRA study data.
  • Bristol-Myers Squibb faces setback for Phase 3 IDHENTIFY Trial.
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Altimmune provides positive updates for AdCOVID

Altimmune Inc. (ALT) reported positive data from the preclinical studies of its lead vaccine candidate, AdCOVID. The company is carrying out these studies as part of its collaboration with the University of Alabama at Birmingham for developing a vaccine against COVID-19.

The data from the latest study demonstrated potent stimulation of antigen-specific CD4+ and CD8+ T cells in the lungs of CD-1 mice. The impact was visible as early as within 10 days of administering a single intranasal vaccination. The responses were strongly biased toward CD8+ T cells. It is likely that the mucosal T cell response in the respiratory tract depends on the intranasal route of administration.

Earlier this year, the company had reported data from the initial studies for the vaccine. The results demonstrated that the vaccine candidate stimulated a strong systemic neutralizing antibody response. Dr. Frances Lund, Charles H. McCauley Professor and Chair, Department of Microbiology at UAB, and lead investigator for preclinical testing of the AdCOVID vaccine candidates said, “The property that sets AdCOVID apart is that it has been shown preclinically to induce a potent T cell and IgA antibody response in the lungs, in addition to the systemic neutralizing antibody response induced by intramuscular vaccine candidates.”

Additional information from CD-1 mice analysis since the July 13 data reported mean serum neutralization titers 4 weeks after a single intranasal dose above 1:400 in a foci reduction neutralization assay against wild-type SARS-CoV-2 virus. Altimmune is currently producing AdCOVID for a Phase safety and immunogenicity study. The trial will likely begin in the fourth quarter of 2020.

The vaccine candidate is expected to be more user friendly as it does not require any needles or syringes for administration. Its expected room temperature stability also makes it a good candidate for mass distribution without requiring expensive logistics.

Apart from working on developing a COVID-19 vaccine, Altimmune is developing other drug candidates as well. The company is working on ALT-801 for treating NASH. It is a balance and long-acting GLP-1/glucagon receptor dual agonist. In a Gubra mouse model, the drug candidate was administered to animals with biopsy-confirmed NASH for 12 weeks. ALT-801 showed statistically significant better decline in various parameters such as liver weight, body weight and plasma ALT in comparison to semaglutide.

The company plans to carry out the Phase 1 trial in Australia. The study will assess the safety, pharmacokinetics and activity of ALT-801 over 6 weeks treatment in overweight and obese volunteers. It is expected that the readout from the study will be available in the spring of 2021.

ALT-801 is a novel peptide-based dual GLP-1/glucagon receptor agonist. It aims to treat NASH by targeting metabolic dysfunction and obesity. NASH involves various pathways which cause toxic lipid metabolites, inflammation and abnormal buildup of liver fat.

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