FluGen, Inc
FluGen, Inc. is a vaccine development company focused on creating more effective influenza and respiratory disease vaccines. Their flagship product, the M2SR vaccine platform, aims to revolutionize flu prevention with a vaccine that offers consistent efficacy, broad immune response, and protection against virus drift. They are also exploring applications for COVID-19 and other respiratory diseases, with a mission to develop vaccines that are more effective, durable, and easier to distribute globally.
Industries
Nr. of Employees
small (1-50)
FluGen, Inc
Products
Single-replication intranasal influenza vaccine candidate (replication-restricted live-virus platform)
An investigational intranasal vaccine based on a replication-restricted influenza virus designed to induce mucosal, humoral and cellular immunity with cross-reactive protection against drifted strains; intended as a platform for combination respiratory vaccines.
Single-replication intranasal influenza vaccine candidate (replication-restricted live-virus platform)
An investigational intranasal vaccine based on a replication-restricted influenza virus designed to induce mucosal, humoral and cellular immunity with cross-reactive protection against drifted strains; intended as a platform for combination respiratory vaccines.
Services
Clinical development and trial execution
Design and conduct of early-stage clinical studies including Phase 1/1b/2 trials, randomized placebo-controlled studies, dose-escalation and pediatric age de‑escalation protocols, and controlled human challenge studies.
Preclinical vaccine evaluation
In‑house and collaborative animal challenge studies and immunogenicity assessments in small animal models to evaluate sterilizing immunity, cross-lineage protection and translational endpoints.
Formulation and stabilization collaboration
Collaborative R&D projects with formulation specialists to develop stable, distribution-ready vaccine formulations suitable for intranasal and other delivery formats.
Vector engineering for combination vaccines
R&D collaborations to develop viral vector-based platforms capable of delivering multiple antigens for combined protection against different respiratory pathogens.
Manufacturing process development and scale-up
Process development, scale-up and transfer support for mammalian cell–based vaccine and biologics production, including operations, capital project planning and manufacturing oversight.
Quality systems and regulatory support for biologics
Support for quality management systems, manufacturing compliance and regulatory readiness for vaccine production and clinical supply manufacturing.
Clinical development and trial execution
Design and conduct of early-stage clinical studies including Phase 1/1b/2 trials, randomized placebo-controlled studies, dose-escalation and pediatric age de‑escalation protocols, and controlled human challenge studies.
Preclinical vaccine evaluation
In‑house and collaborative animal challenge studies and immunogenicity assessments in small animal models to evaluate sterilizing immunity, cross-lineage protection and translational endpoints.
Formulation and stabilization collaboration
Collaborative R&D projects with formulation specialists to develop stable, distribution-ready vaccine formulations suitable for intranasal and other delivery formats.
Vector engineering for combination vaccines
R&D collaborations to develop viral vector-based platforms capable of delivering multiple antigens for combined protection against different respiratory pathogens.
Manufacturing process development and scale-up
Process development, scale-up and transfer support for mammalian cell–based vaccine and biologics production, including operations, capital project planning and manufacturing oversight.
Quality systems and regulatory support for biologics
Support for quality management systems, manufacturing compliance and regulatory readiness for vaccine production and clinical supply manufacturing.
Expertise Areas
- Replication-restricted live-virus vaccine development
- Intranasal and mucosal vaccine strategies
- Clinical trial management including pediatric de‑escalation and human challenge studies
- Preclinical infectious disease models and challenge studies
Key Technologies
- Single-replication live-virus constructs
- Intranasal (mucosal) vaccine delivery
- Viral vector insertion of heterologous antigens
- Mammalian cell culture bioproduction and scale-up