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M-001
M-001 is a multivalent recombinant influenza vaccine designed to stimulate broad immune responses against multiple influenza strains.
M-001 is a multivalent recombinant influenza vaccine designed to stimulate broad immune responses against multiple influenza strains. Used for Influenza prevention (universal/broad-spectrum protection).
At a glance
| Generic name | M-001 |
|---|---|
| Also known as | Multimeric-001 |
| Sponsor | BiondVax Pharmaceuticals ltd. |
| Drug class | Recombinant protein vaccine |
| Target | Conserved influenza virus epitopes |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
M-001 (Multimeric-001) is a universal influenza vaccine candidate that uses a recombinant protein platform to present conserved epitopes from multiple influenza virus strains. By targeting conserved regions across different flu strains, it aims to generate cross-protective immunity that extends beyond the specific strains included in seasonal vaccines, potentially providing broader and more durable protection.
Approved indications
- Influenza prevention (universal/broad-spectrum protection)
Common side effects
- Injection site reactions (pain, erythema, swelling)
- Fever
- Myalgia
- Fatigue
Key clinical trials
- A Clinical Study for the Treatment of Pediatric and Adolescent Patients With Type 1 Gaucher Disease (EARLY_PHASE1)
- A Clinical Study Evaluating LY-M001 Injection in the Treatment of Adult Patients With Type I Gaucher Disease (PHASE1, PHASE2)
- SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical Resection (PHASE1)
- A Study of the Safety and Preliminary Efficacy of LY-M001 Injection in the Treatment of Adult Patients with Gaucher Disease Type I (NA)
- A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine (PHASE3)
- Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine (PHASE2)
- Assess the Safety and Immunogenicity of M-001 as A Standalone Influenza Vaccine and as A H5N1 Vaccine Primer in Adults (PHASE2)
- Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- M-001 CI brief — competitive landscape report
- M-001 updates RSS · CI watch RSS
- BiondVax Pharmaceuticals ltd. portfolio CI