Vaccines Today - October 17, 2025

This week Vaccines update features the latest updates, industry progress, and developments from leading biopharma companies.

In Today’s Newsletter

💉 Moderna’s mRNA-4359 Melanoma Data — Phase 1/2 data behind decision to prioritize cancer candidate [1] [US • 13 Oct 2025]

https://www.fiercebiotech.com/biotech/moderna-posts-melanoma-data-behind-decision-say-i-do-ido
Context: Moderna’s combination of mRNA-4359 (encoding PD-L1 and IDO) with Keytruda showed a 24% response rate in melanoma patients after prior PD-1/L1 inhibitor failure.
Key point: The promising data from 29 patients in the Phase 1/2 trial suggests the potential for broader immune responses in hard-to-treat melanoma populations.
Implication: This dual mechanism may address a significant unmet need in melanoma, with mRNA-4359 positioned for further development.

🧬 Everest Medicines’ EVM14 Cancer Vaccine — First patient enrolled in global Phase 1 trial [2] [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 cancer vaccine, targets five tumor-associated antigens and aims to treat squamous cell carcinomas.
Key point: The first patient enrolled in the Phase 1 trial in the US marks a major milestone for Everest, highlighting the potential of mRNA vaccines in cancer immunotherapy.
Implication: If successful, EVM14 could complement existing treatments and enhance long-term cancer survival rates.

🦠 GC Biopharma’s Shingles Vaccine — Secures CMO rights for amezosvatein [3] [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 help manufacture amezosvatein, a recombinant shingles vaccine currently in clinical development.
Key point: Amezosvatein demonstrated favorable tolerability in early trials and could challenge Shingrix’s market dominance.
Implication: The global shingles vaccine market may become more competitive, offering patients a new, potentially better-tolerated option.

💉 Clover Biopharma’s RSV+hMPV±PIV3 Vaccine — Phase 1 clinical data shows promise for combination vaccines [4] [China • 14 Oct 2025]

https://www.cloverbiopharma.com/media/185.html
Context: Clover’s combination RSV, hMPV, and PIV3 vaccines demonstrated strong immune responses and tolerability in older adults.
Key point: Positive data indicates potential for broadening protection against respiratory diseases and re-vaccinating individuals with waning immunity.
Implication: Clover’s vaccines may address critical gaps in RSV prevention, particularly for older adults, with Phase 2 trials planned for 2026.

🌍 SK Bioscience’s Universal Coronavirus Vaccine — GBP511 enters clinical trial phase [5] [South Korea • 13 Oct 2025]

https://www.skbioscience.com/en/news/news_01_01?mode=view&id=322
Context: GBP511, a universal vaccine targeting sarbecoviruses, enters Phase 1/2 trials in Australia.
Key point: The vaccine aims to provide broad protection against various coronaviruses, including SARS-CoV-2 variants.
Implication: If successful, GBP511 could become a cornerstone for future pandemic preparedness and cross-variant COVID-19 protection.

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. [1]

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. [2]

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. [3]

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. [5]

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)