Matrix-M
- Generic Name
- Matrix-M
- Drug Type
- Biotech
- Unique Ingredient Identifier
- YZ7P8Y8ECX
- Background
Matrix-M is a saponin-based adjuvant made of nanometer particles, cholesterol, and phospholipid that is developed by Novavax. This compound is administered alongside vaccines to enhance biological functions: creating robust and long-lasting immune responses that may allow for dose-sparing of vaccines.
FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval
• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.
• Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile.
• The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.
Novavax Pivots Business Model, Shifts Focus from Vaccine Development to Technology Licensing
• Novavax reported significant revenue decline with Q4 sales dropping to $88 million from $291 million year-over-year, reflecting diminishing COVID-19 vaccine demand and strategic repositioning.
• The company is transforming from a vaccine manufacturer to a technology platform company, focusing on partnerships and licensing its Matrix-M adjuvant technology to major pharmaceutical firms.
• Strategic cost-cutting measures aim to reduce annual expenses by 80% to $250 million by 2027, while a partnership with Sanofi could yield $175 million upon FDA full authorization of their COVID vaccine.
Dynavax Reports Strong Growth with HEPLISAV-B Revenue Up 26% in 2024, Advances Pipeline Programs
• HEPLISAV-B achieved record net product revenue of $268.4 million in 2024, representing a 26% year-over-year growth, with market share reaching 44% in the U.S. hepatitis B vaccine market.
• Dynavax expects to report top-line results from its Phase 1/2 shingles vaccine trial in Q3 2025 and plans to initiate a Phase 2 plague vaccine trial in collaboration with the U.S. Department of Defense.
• The company projects HEPLISAV-B net product revenue to reach $305-325 million in 2025 and anticipates completing its $200 million share repurchase program by year-end.
Novavax Achieves $50 Million Milestone in Sanofi Partnership Amidst Combination Vaccine Progress
• Novavax has secured a $50 million milestone payment from Sanofi, triggered by progress in the Phase 2/3 clinical trial of its COVID-19 vaccine in children.
• Sanofi's combination vaccine candidates, which include Novavax's COVID-19 vaccine, have entered Phase 1/2 trials and received FDA Fast Track designation.
• The partnership between Novavax and Sanofi includes potential for up to $300 million in additional milestones for the COVID-19 vaccine and tiered royalties.
• Novavax is also eligible for up to $200 million for the first four products created by Sanofi utilizing its Matrix-M adjuvant.
Novavax Launches Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccines
• Novavax has initiated a Phase 3 trial for its COVID-19-Influenza Combination (CIC) vaccine and stand-alone influenza vaccine, evaluating immunogenicity and safety.
• The trial compares the CIC and stand-alone influenza vaccines to Novavax's updated COVID-19 vaccine and a licensed seasonal influenza vaccine in adults aged 65 and older.
• Novavax is collaborating with the FDA to explore potential accelerated approval pathways for both vaccine candidates, aiming for clarity by Q2 2025.
• The Phase 3 trial includes approximately 2,000 participants and builds upon positive Phase 2 data, with initial results expected by mid-2025.
FDA Lifts Clinical Hold on Novavax's COVID-19-Influenza Combination Vaccine
• The FDA has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.
• Novavax is now cleared to begin enrolling participants in the planned Phase 3 trial for the combination vaccine and stand-alone influenza vaccine.
• The clinical hold was initiated due to a serious adverse event reported in a Phase 2 trial participant, which was later determined to be unrelated to the vaccine.
• Novavax plans to collaborate with clinical trial investigators and partners to resume trial activities for the Phase 3 trial as quickly as possible.
FDA Halts Novavax's COVID-19 and Influenza Vaccine Trials Due to Safety Concerns
• The FDA has placed a clinical hold on Novavax's combination COVID-19 and influenza vaccine, along with its standalone influenza vaccine, following a serious adverse event report.
• The adverse event, motor neuropathy, was reported in a Phase 2 trial participant outside the U.S. who received the combination vaccine in January 2023.
• Novavax is collaborating with the FDA to provide necessary information and resolve the clinical hold, aiming to commence Phase 3 trials as soon as possible.
• The clinical hold does not affect Novavax's standalone COVID-19 vaccine, which remains available on the U.S. market.
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