LEXINGTON, Ky. — Altimmune Inc., a clinical-stage biopharmaceutical company, announced in March it had retained Lexington-based Summit Biosciences, a manufacturer of nasal spray pharmaceuticals, to develop 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 systemic and local immunity in the nasal cavity and respiratory tract.

Employees at Summit Biosciences in Lexington work on developing a nasal spray mechanism to administer the AdCOVID vaccine candidate. (Photo/Summit Biosciences)

“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,” said Vipin K. Garg, president and CEO of Altimmune. “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.”

In addition, Altimmune will continue to produce a single-dose presentation of AdCOVID to provide alternative forms of administration. 

AdCOVID is currently being evaluated in a phase 1 clinical trial to determine its safety and immunogenicity in healthy adult volunteers between 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 efficacy of AdCOVID will be evaluated through a multi-tiered scientific process. Altimmune anticipates having data from this trial by this coming summer, according to a press release.

Summit Biosciences develops, manufactures, and commercializes generic and innovative nasal spray medicines. (Photo/Summit Biosciences)

Summit Biosciences President and COO Gregory Plucinski said he is pleased Altimmune selected Summit for this endeavor. 

“Summit has a proven track record of bringing nasal spray medicines from concept to market with its state-of-the-art capabilities that are ideal for this program,” Plucinski said. “Together, we will combine our respective expertise and capabilities with the goal of ultimately introducing a potentially novel, needle-free nasal spray vaccine for the COVID-19 pandemic.”

While traditional vaccines delivered by a needle 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 the transmission of the virus. AdCOVID is designed to deliver vaccines directly to the site of viral entry and replication to stimulate mucosal and cellular immunity in the nasal cavity and respiratory tract, potentially offering an important early defense against the virus. The ability to stimulate mucosal and resident T cell immunity in the respiratory tract would be a key differentiator for AdCOVID and may play a critical role in blocking the transmission of the virus, Plucinski said.

Summit Biosciences Inc. was founded in 2009. The private specialized pharmaceutical company develops, manufactures, and commercializes generic and innovative nasal spray medicines. It collaborates on developing products with its clients and manufactures them at an industrial scale, primarily for commercialization in the United States and Europe.