Altimmune Submits Investigational New Drug Application for NasoVAX in Preparation for Phase 2 Trial
- Category: Vaccines
- Published on Monday, 21 August 2017 18:25
- Hits: 552
60 volunteers to be enrolled
Data expected in the first quarter of 2018
GAITHERSBURG, MD, USA I August 21, 2017 I Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced the Company has submitted an Investigational New Drug (IND) application to the U.S Food and Drug Administration (FDA) for NasoVAX, the Company’s intranasally administered recombinant flu vaccine. NasoVAX uses an adenovector to achieve expression of the influenza antigen in the target cell, thereby potentially stimulating a broader and more rapid immune response than traditional flu vaccines. Previous versions of NasoVAX evaluated in two Phase 1 studies under earlier INDs were immunogenic and well tolerated.
“Our IND filing is an important milestone for our development program that we hope will eventually lead to the availability of NasoVAX for patients in the US who are at risk for developing the flu,” said Dr. Sybil Tasker, Chief Medical Officer at Altimmune. “The risks from flu and flu-related complications are well-known, particularly in populations with weakened immune systems. Current vaccines leave significant room for improvement, and according to the CDC, have about a 40% efficacy rate over the ten year period 2005-2015. In pre-clinical studies, NasoVAX generated cross protection against divergent strains. If this is confirmed in the clinic, it will be a very promising sign that the vaccine has the potential to be more efficacious than currently licensed vaccines.”
The Phase 2 NasoVAX study will evaluate the safety and immunogenicity of a single administration of an intranasal dose at three dose levels of a single flu strain. The Company will evaluate the antibody response to both matched and divergent strains, along with cellular and mucosal immunity. The study will enroll 60 volunteers, who will receive a single intranasal dose of vaccine or placebo. Data is expected sometime in the first quarter of 2018.
Following this study, Altimmune intends to confirm the dose in a larger trial evaluating immunogenicity of a quadrivalent vaccine formulation and may also conduct a challenge study to confirm the protection within days of vaccination demonstrated in preclinical studies. Both of these studies could commence as soon as the second half 2018.
NasoVAX, Altimmune’s next generation rapid response influenza vaccine candidate, uses Altimmune’s RespirVec technology to mobilize multiple components of the immune system, with the aim to rapidly establish immunity against influenza infections. NasoVAX uses an easy and painless intranasal administration, which Altimmune expects will activate mucosal and innate immunities, and may provide a first line of defense against influenza infections while the antibody response is being developed. Protection against a lethal challenge of influenza has been demonstrated in preclinical models in days instead of weeks and against broad and divergent strains of influenza. NasoVAX is produced in cell culture instead of chicken eggs. This is a more efficient, scalable process where product can be produced in less than half the time as traditional influenza vaccines.
Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease and on the development of two next-generation anthrax vaccines that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines. The company has two proprietary platform technologies, RespirVec and Densigen, each of which has been shown to activate the immune system in distinctly different ways than traditional vaccines.