Advagene Biopharma
Biopharmaceutical company developing mucosal immunotherapies and nasal-delivered vaccines based on a genetically detoxified enterotoxin-derived immunomodulatory protein platform. Programs include nasal formulations for seasonal influenza, SARS‑CoV‑2 (vaccine and immunotherapy), allergic rhinitis and eosinophilic asthma. The company reports preclinical challenge data, completed and ongoing human clinical trials (Phase I/II and Phase II), international patent coverage, and interactions with national regulatory agencies and advisory programs.
Industries
Nr. of Employees
small (1-50)
Advagene Biopharma
Patents
Method for the prophylaxis or treatment of coronavirus infection using an immunomodulator and vaccine compositions comprising the same
US-11986520-B2
View Details
Method for the prophylaxis or treatment of coronavirus infection using an immunomodulator and vaccine compositions comprising the same
US-11986520-B2
View DetailsProducts
Nasal-spray seasonal influenza vaccine (intranasal)
Intranasal influenza vaccine developed with a detoxified immunomodulatory protein adjuvant intended to induce mucosal IgA and systemic IgG; completed Phase II clinical evaluation with reported durable mucosal neutralizing activity.
Nasal-delivered COVID-19 immunotherapy (intranasal immunomodulatory protein)
Intranasal immunotherapy designed to activate mucosal innate immunity including type I interferon responses to reduce viral replication and transmission; demonstrated improved pathology in animal challenge studies and progressed through human clinical trials.
Nasal immunotherapy for allergic rhinitis
Intranasal immunomodulatory protein administered alone or combined with allergen extracts for treatment of allergic rhinitis; clinical studies reported safety and rapid symptom improvement.
Nasal immunotherapy for severe eosinophilic asthma
Intranasal immunomodulatory therapy under clinical investigation for moderate‑to‑severe eosinophilic asthma with Phase II studies reported and ongoing regulatory interactions.
Nasal-spray seasonal influenza vaccine (intranasal)
Intranasal influenza vaccine developed with a detoxified immunomodulatory protein adjuvant intended to induce mucosal IgA and systemic IgG; completed Phase II clinical evaluation with reported durable mucosal neutralizing activity.
Nasal-delivered COVID-19 immunotherapy (intranasal immunomodulatory protein)
Intranasal immunotherapy designed to activate mucosal innate immunity including type I interferon responses to reduce viral replication and transmission; demonstrated improved pathology in animal challenge studies and progressed through human clinical trials.
Nasal immunotherapy for allergic rhinitis
Intranasal immunomodulatory protein administered alone or combined with allergen extracts for treatment of allergic rhinitis; clinical studies reported safety and rapid symptom improvement.
Nasal immunotherapy for severe eosinophilic asthma
Intranasal immunomodulatory therapy under clinical investigation for moderate‑to‑severe eosinophilic asthma with Phase II studies reported and ongoing regulatory interactions.
Services
Licensing and collaboration agreements for access to a detoxified immunomodulatory protein platform for co-development and distribution of intranasal vaccines and immunotherapies, supported by preclinical and clinical data and IP.
Licensing and collaboration agreements for access to a detoxified immunomodulatory protein platform for co-development and distribution of intranasal vaccines and immunotherapies, supported by preclinical and clinical data and IP.
Expertise Areas
- Mucosal immunotherapy development
- Intranasal vaccine and therapeutic formulation
- Clinical trial management for vaccines and immunotherapies (Phase I–II)
- Recombinant protein therapeutics and microbial expression scale-up
Key Technologies
- Detoxified enterotoxin-derived immunomodulatory protein platform
- Intranasal spray formulation and delivery
- Escherichia coli recombinant protein expression
- Protein–polysaccharide conjugation
News & Updates
Phase II intranasal influenza vaccine results published in Vaccine; Phase IIa intranasal COVID‑19 immunotherapy results published in Human Vaccines & Immunotherapeutics reporting safety, tolerability and accelerated viral clearance.
National regulatory authority approved conduct of a Phase II clinical trial for an intranasal COVID‑19 immunotherapy for treatment of mild COVID‑19 cases.
In a SARS‑CoV‑2 hamster challenge study conducted with a national research institute, intranasal dosing reduced average pathology scores versus control (example: control 2.25 vs treated 1.42; p=0.043), indicating improved lung inflammation outcomes.
Reported Phase IIa clinical trial results for intranasal COVID‑19 immunotherapy showing accelerated viral clearance and acceptable safety, published in an international journal.
Phase II clinical trial results for an intranasal influenza vaccine showing safety, tolerability and durable mucosal IgA responses were published in the journal Vaccine.
Inclusion of the intranasal COVID‑19 immunotherapy development program into national regulatory advisory/guidance mechanisms and engagement with multiple regulatory agencies for clinical trial approvals.
Phase II intranasal influenza vaccine results published in Vaccine; Phase IIa intranasal COVID‑19 immunotherapy results published in Human Vaccines & Immunotherapeutics reporting safety, tolerability and accelerated viral clearance.
National regulatory authority approved conduct of a Phase II clinical trial for an intranasal COVID‑19 immunotherapy for treatment of mild COVID‑19 cases.
In a SARS‑CoV‑2 hamster challenge study conducted with a national research institute, intranasal dosing reduced average pathology scores versus control (example: control 2.25 vs treated 1.42; p=0.043), indicating improved lung inflammation outcomes.
Reported Phase IIa clinical trial results for intranasal COVID‑19 immunotherapy showing accelerated viral clearance and acceptable safety, published in an international journal.
Phase II clinical trial results for an intranasal influenza vaccine showing safety, tolerability and durable mucosal IgA responses were published in the journal Vaccine.
Inclusion of the intranasal COVID‑19 immunotherapy development program into national regulatory advisory/guidance mechanisms and engagement with multiple regulatory agencies for clinical trial approvals.