GAITHERSBURG, Md. — Altimmune Inc., a clinical-stage biopharmaceutical company, has retained Summit Biosciences, a world-wide leader in nasal spray pharmaceuticals based in Lexington, Ky., to manufacture a metered nasal spray presentation of AdCOVID, its intranasal COVID-19 vaccine candidate. AdCOVID is an adenovirus-vector vaccine designed to stimulate a broad immune response following a single vaccination that includes both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract.
“As we continue to build our manufacturing consortium and progress the development of AdCOVID, we are pleased to partner with Summit Biosciences to manufacture AdCOVID in a customized multidose nasal spray delivery device. We expect this device may be a convenient and efficient option when vaccinating patients in high-demand settings where our vaccine candidate’s anticipated room temperature stability profile will also be important,” said Vipin K. Garg, president and chief executive officer of Altimmune. “In addition, Altimmune will continue to produce a single dose presentation of AdCOVID to provide alternative forms of administration. Summit Biosciences has expertise in intranasal product innovation, and we are excited to align with their highly experienced team in our fight against COVID-19.”
Summit has been successful in bringing nasal spray medicines from concept to market, said Gregory Plucinski, president and COO of the company.
“Together [with Altimmune], we will combine our respective expertise and capabilities with the goal of ultimately introducing a potentially novel, needle-free, nasal spray vaccine for the SARS-CoV-2 pandemic,” Plucinski said.
AdCOVID is currently being evaluated in a Phase 1 clinical trial. The Phase 1 trial is evaluating the safety and immunogenicity of AdCOVID in healthy adult volunteers between the ages of 18 and 55. Subjects will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses. Altimmune anticipates having a data readout from this Phase 1 trial in the second quarter of 2021.
While traditional vaccines delivered by an intramuscular injection can stimulate systemic immunity as measured in the blood, they have not been shown to induce mucosal immunity in the nasal cavity, which may be critical for blocking transmission of the virus. AdCOVID is designed to deliver vaccine directly to the site of viral entry and replication to stimulate mucosal and cellular immunity in the nasal cavity and respiratory tract, thereby potentially offering an important early defense against the SARS-CoV-2 virus.