Vaxart | MedPath

HHS and NIH Launch "Generation Gold Standard" Universal Vaccine Platform to Combat Pandemic Threats

21 days ago

• The U.S. Department of Health and Human Services and NIH have announced "Generation Gold Standard," a next-generation universal vaccine platform using beta-propiolactone-inactivated whole-virus technology. • The government-owned platform aims to develop universal vaccines against multiple strains of influenza and coronaviruses, with clinical trials for universal influenza vaccines scheduled to begin in 2026. • The BPL-1357 intranasal flu vaccine is currently in advanced trials and designed to block virus transmission—a capability absent in current vaccines—with FDA approval targeted for 2029.

HHS Terminates Funding for GeoVax's Next-Generation COVID-19 Vaccine Amid Ongoing Clinical Trials

a month ago

• The Department of Health and Human Services has issued a Stop Work Order for GeoVax's investigational COVID-19 vaccine GEO-CM04S1, withdrawing funding previously granted under Project NextGen. • GeoVax's vaccine candidate was designed to provide broader and more durable COVID-19 protection, showing promise in both primary vaccination and as a booster, particularly for immunocompromised patients. • This termination follows similar funding cuts to other biotechs including Vaxart and CastleVax, raising questions about shifting priorities in vaccine development under the current HHS leadership.

Vaxart's Oral Norovirus Vaccine Shows Promising Immune Response in Elderly Phase 1b Trial

3 months ago

• Phase 1b trial results published in Science Translational Medicine demonstrate strong and durable antibody responses to Vaxart's oral norovirus vaccine in elderly adults, despite age-related immune challenges. • The vaccine candidate generated significant serum antibody responses across all dose cohorts, with increases in anti-VP1 IgA and IgG levels observed at days 29 and 57 post-vaccination. • The oral vaccine demonstrated excellent safety profile with only mild to moderate side effects, while successfully inducing both mucosal-homing B cells and T cells, suggesting potential for robust protection against infection.

FDA Cancels Critical Flu Vaccine Advisory Meeting, Raising Production Timeline Concerns

3 months ago

• The FDA has unexpectedly canceled the March 13 meeting of its Vaccines and Related Biological Products Advisory Committee, which was scheduled to discuss next year's flu vaccine composition. • The cancellation could significantly impact the six-month flu vaccine production cycle, potentially disrupting the traditional June manufacturing start date. • Health experts and vaccine manufacturers express concern over the disruption to the established regulatory process for seasonal flu vaccine strain selection.

Five Novel 9-Month Oral Regimens Show Promise in Phase 3 Trial for Drug-Resistant TB

3 months ago

• Phase 3 endTB trial demonstrates that five all-oral 9-month regimens are as effective as standard 18-24 month treatment for rifampin-resistant tuberculosis, with four regimens proving noninferior. • New treatment combinations incorporating bedaquiline, clofazimine, levofloxacin, and pyrazinamide show favorable outcomes, though concerns about hepatotoxicity and peripheral neuropathy persist. • The successful trial highlights the importance of community-researcher trust, while emphasizing the need to address ongoing toxicity concerns in future treatment developments.

Akero's Efruxifermin Shows Promise in Reversing Cirrhosis Due to MASH in Phase 2b Trial

4 months ago

• Akero Therapeutics' Efruxifermin (EFX) demonstrated statistically significant cirrhosis reversal in patients with MASH in a Phase 2b trial. • In patients with baseline and week 96 biopsies, 39% treated with 50mg EFX showed cirrhosis reversal without worsening MASH, compared to 15% with placebo. • The SYMMETRY study underscores the benefit of longer EFX treatment, showing a doubling of effect size from weeks 36 to 96 in the 50mg group. • Akero is continuing to evaluate 50mg EFX in the Phase 3 SYNCHRONY Outcomes study for patients with compensated cirrhosis due to MASH.

Vaxart's Oral COVID-19 Vaccine Candidate Receives Positive DSMB Review, Advancing Phase 2b Trial

4 months ago

• Vaxart's Phase 2b trial of its oral COVID-19 vaccine candidate received a favorable review from the independent Data Safety Monitoring Board (DSMB). • The DSMB recommended the trial proceed without modifications after assessing 30-day safety data from a sentinel cohort of 400 participants. • Vaxart plans to enroll approximately 10,000 participants upon favorable review from the FDA and approval from BARDA. • The Phase 2b trial compares Vaxart's oral vaccine to an approved mRNA injectable vaccine in previously immunized adults.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Vaxart Advances Oral Vaccine Programs for COVID-19, Norovirus, and Influenza

5 months ago

• Vaxart's Phase 2b COVID-19 oral vaccine trial is set to expand to 10,000 participants, pending FDA review of safety data and BARDA approval. • A Phase 1 trial for Vaxart's second-generation oral norovirus vaccine constructs is planned for the first half of 2025, with initial data expected by mid-2025. • Preclinical studies are underway for a new avian influenza vaccine candidate, designed to address the latest clade 2.3.4.4b strains. • Vaxart's existing funding, including a Project NextGen award, is expected to sustain operations into 2026, supporting key clinical and regulatory milestones.

Moderna's mRNA Norovirus Vaccine Enters Phase 3 Trial Amidst Surging Cases

5 months ago

• Moderna is conducting a Phase 3 trial for an mRNA vaccine targeting norovirus, a highly contagious virus causing gastroenteritis. • The vaccine candidate includes three different norovirus types to improve protection against prevalent strains, using a multivalent approach. • The trial involves 25,000 participants globally and aims to reduce severe illness and hospitalization, especially among the elderly and young. • A new norovirus strain has emerged, potentially complicating the trial, as it may not be targeted by the current vaccine.