GAITHERSBURG, MD, USA I December 23, 2020 I Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug (IND) application for AdCOVID, a single-dose intranasal COVID-19 vaccine candidate. The Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data. Altimmune has responded to the Agency’s clinical hold letter received on December 22, 2020 and, at this time, does not anticipate a significant impact on the overall clinical development timeline as the Company has agreed to each of the FDA’s requests.
“We appreciate the FDA’s support and guidance as we seek to bring a novel, single-dose intranasal COVID-19 vaccine candidate into the clinic,” said Vipin K. Garg, President and Chief Executive Officer of Altimmune. “We look forward to working with the FDA and will continue preparing to commence our planned Phase 1 clinical trial of AdCOVID.”
About AdCOVID
AdCOVID is a single-dose intranasal COVID-19 vaccine candidate developed by Altimmune based on the Company’s significant experience in the development of intranasal vaccines for respiratory pathogens. In recently published preclinical studies (www.biorxiv.org/content/10.1101/2020.10.10.331348v1) conducted in collaboration with the University of Alabama at Birmingham, AdCOVID induced potent serum neutralizing antibody and T cell responses in mice as well as a robust induction in mucosal immunity against the spike protein of the virus that causes COVID-19. Importantly, the mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both of which are believed to be important in fighting infection and transmission.
Data from Altimmune’s other intranasal platform vaccines (NasoVAX™ and NasoShield™) suggest that AdCOVID likely will have extended stability at room temperature, which would allow for cold chain-free shipment of the vaccine. If such stability is demonstrated, AdCOVID could be stored in the common refrigerators found in community-based doctors’ offices and pharmacies for two years or more. The simple and convenient handling requirements may greatly increase the accessibility of the vaccine, if approved for use.
About Altimmune
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.
SOURCE: Altimmune
Post Views: 28
GAITHERSBURG, MD, USA I December 23, 2020 I Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug (IND) application for AdCOVID, a single-dose intranasal COVID-19 vaccine candidate. The Agency requested certain protocol modifications and the submission of additional Chemistry, Manufacturing and Controls (CMC) data. Altimmune has responded to the Agency’s clinical hold letter received on December 22, 2020 and, at this time, does not anticipate a significant impact on the overall clinical development timeline as the Company has agreed to each of the FDA’s requests.
“We appreciate the FDA’s support and guidance as we seek to bring a novel, single-dose intranasal COVID-19 vaccine candidate into the clinic,” said Vipin K. Garg, President and Chief Executive Officer of Altimmune. “We look forward to working with the FDA and will continue preparing to commence our planned Phase 1 clinical trial of AdCOVID.”
About AdCOVID
AdCOVID is a single-dose intranasal COVID-19 vaccine candidate developed by Altimmune based on the Company’s significant experience in the development of intranasal vaccines for respiratory pathogens. In recently published preclinical studies (www.biorxiv.org/content/10.1101/2020.10.10.331348v1) conducted in collaboration with the University of Alabama at Birmingham, AdCOVID induced potent serum neutralizing antibody and T cell responses in mice as well as a robust induction in mucosal immunity against the spike protein of the virus that causes COVID-19. Importantly, the mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both of which are believed to be important in fighting infection and transmission.
Data from Altimmune’s other intranasal platform vaccines (NasoVAX™ and NasoShield™) suggest that AdCOVID likely will have extended stability at room temperature, which would allow for cold chain-free shipment of the vaccine. If such stability is demonstrated, AdCOVID could be stored in the common refrigerators found in community-based doctors’ offices and pharmacies for two years or more. The simple and convenient handling requirements may greatly increase the accessibility of the vaccine, if approved for use.
About Altimmune
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.
SOURCE: Altimmune
Post Views: 28
