Lexington-based Summit Biosciences has partnered with Altimmune, Inc., a clinical-stage biopharmaceutical company, to manufacture a metered nasal spray of AdCOVID, Altimmune’s intranasal COVID-19 vaccine candidate, the company announced.
The spray is currently being evaluated in a Phase 1 clinical trial. The trial will evaluate the safety and immunogenicity of the drug in healthy adult volunteers between the ages of 18 and 55. As part of the trial, the test subjects will receive one of three dose levels of AdCOVID administered as a nasal spray. Altimmune said it anticipates it will have results of the phase 1 trial in the second quarter of 2021.
“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,” Vipin K. Garg, president and CEO of Altimmune, said in a statement. “We expect this delivery 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.”
Summit, located in the University of Kentucky Coldstream Research Center, is a privately held pharmaceutical company that is focused on developing, manufacturing and commercializing general and innovative nasal spray medicines.
“I am pleased that Altimmune, a recognized leader in intranasal vaccine development, selected Summit in this exciting endeavor,” Gregory Plucinski, president and COO of Summit Biosciences, said in a statement. “Summit has a proven track record in bringing nasal spray medicines from concept to market with its states-of-the-art capabilities that are ideal for this program. 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 SARS-CoV-2 pandemic.”
The companies said that while traditional intramuscular vaccine injections can stimulate immunity as measured in the blood, they have not been shown to create immunity in nasal passages — one of the places where the virus enters the body. AdCOVID, the companies said, is designed to deliver the vaccine directly to the site of entry and stimulate immunity in the nasal cavity and respiratory tract, which could offer an important early defense against the virus.
Altimmune said the AdCOVID nasal spray does not need to be stored at ultra-low temperatures like the Pfizer and Moderna vaccines. This would allow for the spray to be stored in refrigerators in doctors’ offices for up to two years or more, the company said.