In this biweekly video summary, we spotlight recent progress across the Vaccines field, including clinical advances, regulatory activity, and treatment breakthroughs.
Watch Our Video Summary Capturing Top Vaccine News from the Last Two Weeks
Top Stories Covered in This Video
💉 Alzinova’s Alzheimer’s Vaccine — FDA Fast Track Designation for ALZ-101 [1] [Sweden; 07 Oct 2025]
https://longevity.technology/news/alzinova-gets-fda-fast-track-nod-for-alzheimers-vaccine/
Context: ALZ-101 is designed to target amyloid-beta oligomers, a toxic form believed to cause cognitive decline in Alzheimer’s patients.
Key point: The FDA’s Fast Track designation follows promising Phase 1b results, and Phase 2 trials are set to begin.
Implication: ALZ-101 could represent a breakthrough in Alzheimer’s treatment, offering a more targeted approach than current therapies.
🧬 Bavarian Nordic’s MVA-BN Vaccine — Positive Data in Pediatric Mpox/Smallpox Vaccine Trial [2] [Denmark; 07 Oct 2025]
https://www.globenewswire.com/news-release/2025/10/07/3162738/0/en/Bavarian-Nordic-Reports-Positive-Topline-Data-for-Mpox-Smallpox-Vaccine-in-Pediatric-Population.html
Context: Bavarian Nordic’s MVA-BN vaccine showed non-inferior immune responses in children aged 2-11, compared to adults.
Key point: The vaccine was well-tolerated in children, and the immune response was 2.5 times higher in younger children.
Implication: These results could expand the vaccine’s approval to include children, strengthening global public health responses to mpox.
🦠 University of Maryland & Bharat Biotech’s TSVC — Promising Phase 1 Results for Typhoid and Salmonella Vaccine [3] [US; 08 Oct 2025]
https://www.cidrap.umn.edu/salmonella/vaccine-typhoid-invasive-salmonella-shows-promise-phase-1-trial
Context: TSVC demonstrated strong immune responses in healthy adults, targeting Salmonella Typhi and two invasive non-typhoidal strains.
Key point: The vaccine shows promise for protecting children in sub-Saharan Africa, where Salmonella infections are prevalent.
Implication: TSVC could be a game-changer for global pediatric health, particularly in regions with high Salmonella-related mortality.
💉 TransCode Therapeutics — $25M Funding and Acquisition of Phase 3 Cancer Vaccine [4] [US; 08 Oct 2025]
https://www.fiercebiotech.com/biotech/transcode-rewrites-future-securing-25m-lifeline-and-phase-3-cancer-vaccine
Context: TransCode acquired Polynoma and its Phase 3 melanoma vaccine, seviprotimut-L, alongside a $25 million investment.
Key point: The company now controls Polynoma’s Phase 3 trial for seviprotimut-L, with potential $95M in milestones.
Implication: This acquisition could help TransCode advance in oncology, with a focus on melanoma and other cancers.
🧬 Moderna’s mRNA-4359 Melanoma Data — Phase 1/2 Data Behind Decision to Prioritize Cancer Candidate [5] [US; 13 Oct 2025]
https://www.fiercebiotech.com/biotech/moderna-posts-melanoma-data-behind-decision-say-i-do-ido
Context: Moderna’s Phase 1/2 trial of mRNA-4359, a melanoma vaccine combined with Keytruda, showed a 24% response rate in patients who failed prior treatments.
Key point: The dual mechanism of action may offer more durable immune responses compared to existing therapies.
Implication: Moderna’s approach could address a major unmet need in melanoma treatment.
🧪 Everest Medicines’ EVM14 — First Patient Enrolled in Phase 1 Trial of mRNA Cancer Vaccine [6] [China; 14 Oct 2025]
https://www.manilatimes.net/2025/10/14/tmt-newswire/pr-newswire/everest-medicines-announces-first-patient-enrolled-in-a-global-multi-center-phase-i-clinical-trial-of-tumor-associated-antigen-cancer-vaccine-evm14/2199976
Context: EVM14, an mRNA vaccine targeting five tumor-associated antigens, has entered Phase 1 trials for squamous cell carcinomas.
Key point: The first patient has been enrolled, marking a significant milestone in the global clinical development of EVM14.
Implication: If successful, EVM14 could offer a new treatment for cancers with high unmet need.
🦠 GC Biopharma’s Shingles Vaccine — Secures CMO Rights for Amezosvatein [7] [South Korea; 13 Oct 2025]
https://www.biospace.com/press-releases/gc-biopharma-secures-cmo-rights-for-shingles-vaccine-from-curevo-vaccine
Context: GC Biopharma will manufacture Curevo’s shingles vaccine, amezosvatein, which showed favorable results in Phase 2 trials.
Key point: Amezosvatein could compete with Shingrix, offering a more tolerable option for patients.
Implication: The addition of amezosvatein to the market could provide a valuable alternative to the dominant shingles vaccine.
🌍 SK Bioscience’s GBP511 — First-In-Human Trial of Universal Coronavirus Vaccine [8] [South Korea; 14 Oct 2025]
https://www.skbioscience.com/en/news/news_01_01?mode=view&id=322
Context: GBP511, designed to protect against COVID-19 variants and related coronaviruses, enters Phase 1/2 trials in Australia.
Key point: The universal approach aims to provide broad protection across the entire sarbecovirus family.
Implication: If successful, GBP511 could be a vital tool in pandemic preparedness and future coronavirus outbreaks.
Why it Matters
- Cancer vaccines: Moderna’s mRNA approach and Everest’s EVM14 highlight the growing role of immuno-oncology, targeting tumor-specific antigens to improve immune responses in difficult-to-treat cancers.
- Infectious disease vaccines: GC Biopharma and Clover Biopharma’s trials may transform the shingles and RSV vaccination landscapes, offering better-tolerated and combination vaccine options for older adults.
- Pandemic preparedness: SK Bioscience’s universal coronavirus vaccine could change the way we approach future virus outbreaks, providing broad protection against diverse strains and ensuring preparedness for potential pandemics.
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FAQ
What is the focus of Moderna’s mRNA-4359 in melanoma treatment?
Moderna’s mRNA-4359 targets both PD-L1 and IDO pathways to boost immune responses in patients who have failed previous checkpoint inhibitor therapies, showing a 24% response rate in Phase 1/2 trials. [5]
What are the clinical goals of Everest’s EVM14 vaccine?
EVM14 targets squamous cell carcinomas by activating the immune system through a combination of five tumor-associated antigens, aiming to offer new treatment options for patients with limited existing therapies. [6]
How does amezosvatein compare to Shingrix in early trials?
Amezosvatein has shown favorable tolerability and immune activity, with potential advantages over Shingrix in terms of reduced side effects, though more data are needed. [7]
What do Clover’s Phase 1 RSV+hMPV±PIV3 data suggest for future vaccine strategies?
Clover’s combination vaccines may offer enhanced protection against RSV, hMPV, and PIV3, with Phase 2 trials planned to confirm the potential for broader protection in older adults. [4]
What is SK Bioscience’s GBP511 aiming to achieve?
GBP511 is designed to provide universal protection against sarbecoviruses, including SARS-CoV-2 variants, by targeting multiple strains within the coronavirus family. [8]
Entities / Keywords
Moderna (mRNA-4359; melanoma; PD-L1; IDO; cancer vaccines); Everest Medicines (EVM14; mRNA cancer vaccine; tumor-associated antigens); GC Biopharma (shingles vaccine; amezosvatein; CMO); Clover Biopharma (RSV+hMPV±PIV3; combination vaccines); SK Bioscience (GBP511; universal coronavirus vaccine; sarbecoviruses)
References
- https://longevity.technology/news/alzinova-gets-fda-fast-track-nod-for-alzheimers-vaccine/
- https://www.globenewswire.com/news-release/2025/10/07/3162738/0/en/Bavarian-Nordic-Reports-Positive-Topline-Data-for-Mpox-Smallpox-Vaccine-in-Pediatric-Population.html
- https://www.cidrap.umn.edu/salmonella/vaccine-typhoid-invasive-salmonella-shows-promise-phase-1-trial
- https://www.fiercebiotech.com/biotech/transcode-rewrites-future-securing-25m-lifeline-and-phase-3-cancer-vaccine
- https://www.fiercebiotech.com/biotech/moderna-posts-melanoma-data-behind-decision-say-i-do-ido
- https://www.manilatimes.net/2025/10/14/tmt-newswire/pr-newswire/everest-medicines-announces-first-patient-enrolled-in-a-global-multi-center-phase-i-clinical-trial-of-tumor-associated-antigen-cancer-vaccine-evm14/2199976
- https://www.biospace.com/press-releases/gc-biopharma-secures-cmo-rights-for-shingles-vaccine-from-curevo-vaccine
- https://www.skbioscience.com/en/news/news_01_01?mode=view&id=322