Altimmune and CDMO Vigene Enter COVID-19 Vax Pact

Altimmune has entered into an agreement with Vigene Biosciences to manufacture AdCOVID, Altimmune’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, MD-based contract development and manufacturing organization (CDMO), specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, Altimmune plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.

“Vigene is a fantastic partner to advance AdCOVID into Phase 1 clinical testing and beyond,” said Vipin Garg, president and chief executive officer, Altimmune. “We believe Vigene’s deep experience in viral vector production and their collaborative, client focused approach will help facilitate Altimmune’s timeline for clinical development of AdCOVID.”

Zairen Sun, president and chief executive officer, Vigene, said, “With our new state-of-the-art manufacturing facility and our expertise in viral vector production, we are well positioned to support Altimmune in their COVID-19 vaccine development efforts. In addition to our existing facility, we are in the process of expanding our capacity so that we can support Altimmune beyond clinical development into commercial scale manufacturing.”

Altimmune is also initiating scale up of manufacturing of its AdCOVID vaccine for advanced clinical trials and commercial production. The company is actively engaged in discussions with additional strategic manufacturing partners with the goal of producing at least 100 million doses of AdCOVID in 2021.

AdCOVID is an intranasal vaccine candidate designed to block viral infection and to provide protection against viral spread through stimulation of both mucosal and systemic neutralizing antibodies (IgA and IgG) as well as cell-mediated immunity. By stimulating mucosal immunity in the nasal cavity, a key point of entry and replication for SARS-CoV-2, AdCOVID has the potential to defend against both infection in the recipient as well as spread of the virus to others. Intranasal administration can also be accomplished more simply than an injection and may eliminate the need for highly trained medical personnel. In addition, since it is expected to have extended stability at room temperature, AdCOVID may avoid the need for costly cold chain logistics.

In preclinical studies conducted in collaboration with the University of Alabama at Birmingham (UAB), AdCOVID stimulated both strong serum neutralizing activity and potent mucosal immunity (IgA) in the respiratory tract. Additionally, vaccination of mice with AdCOVID caused the rapid recruitment of immune cells into the respiratory tract, draining lymph nodes and spleen consistent with induction of potent local and systemic immunity. Increases in CD8+ and CD4+ T cells, dendritic cells and NK cells were observed in the respiratory tract, and germinal center and memory B cells as well as T follicular helper cells were observed in regional lymph nodes and the spleen. Importantly, the latter cell types have been associated in prior vaccine development research with long-lived antibody responses.