This week’s vaccines update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.
In Today’s Newsletter
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In Today’s Newsletter
🧬 GC Biopharma enters Phase 1 COVID-19 mRNA program [1] [KR • 15 Dec 2025]
https://www.koreabiomed.com/news/articleView.html?idxno=29973
Context: KDCA “Pandemic Preparedness mRNA Vaccine Development Support Project.”
Key point: GC Biopharma advanced a COVID-19 mRNA candidate from nonclinical studies into Phase 1 and plans an IND filing by year-end (endpoint not specified).
Implication: Signals pipeline investment and modality expansion.
👃 Intranasal BPZE1 shows promise against whooping cough [2] [13 Dec 2025]
https://www.emjreviews.com/microbiology-infectious-diseases/news/novel-intranasal-vaccine-shows-promise-against-whooping-cough/
Context: Phase 2b randomized, placebo-controlled human challenge trial in 53 healthy adults.
Key point: BPZE1 reduced or prevented Bordetella pertussis colonisation versus placebo and was well tolerated.
Implication: May influence prescriber choice and payer reviews pending full data.
🎗️ Anixa assumes IND for breast cancer vaccine [3] [US • 16 Dec 2025]
https://www.biospace.com/press-releases/anixa-biosciences-announces-transfer-of-ind-for-breast-cancer-vaccine-from-cleveland-clinic
Context: Vaccine targets α-lactalbumin, a protein re-expressed in many breast cancers.
Key point: Anixa Biosciences completed the IND transfer from Cleveland Clinic and plans to initiate Phase 2 following encouraging Phase 1 safety and immunogenicity.
Implication: Signals pipeline investment and modality expansion.
🧪 IO Biotech reports five-year melanoma outcomes [4] [15 Dec 2025]
https://iobiotech.com/press-releases/?workflow=3022a6c1-f79b-4a79-95d0-14f6f8f60440
Context: Phase 1/2 trial (MM1636) of IO102–IO103 plus nivolumab in first-line metastatic melanoma.
Key point: Five-year follow-up showed durable efficacy and long survival, supporting FDA Breakthrough Therapy Designation and Phase 3 initiation.
Implication: May influence prescriber choice and payer reviews pending full data.
🧾 GeoVax secures US patent for multi-antigen COVID-19 vaccine [5] [US • 16 Dec 2025]
https://www.geovax.com/investors/press-releases/geovax-receives-u-s-patent-office-notice-of-allowance-for-broad-spectrum-covid-19-vaccine-design
Context: rMVA-based vaccine expressing Spike, Membrane, and Envelope proteins.
Key point: The USPTO issued a Notice of Allowance covering GeoVax’s multi-antigen COVID-19 vaccine design.
Implication: Signals pipeline investment and modality expansion.
🇪🇺 EMA backs Moderna’s mNEXSPIKE [6] [EU • 15 Dec 2025]
https://feeds.issuerdirect.com/news-release.html?newsid=5545676968563476&symbol=MRNA
Context: Phase 3 trial in 11,400 participants aged 12+.
Key point: EMA CHMP issued a positive opinion recommending authorization of Moderna’s mNEXSPIKE vaccine.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Cleveland Clinic reports early breast cancer vaccine data [7] [US • 18 Dec 2025]
https://newsroom.clevelandclinic.org/2025/12/18/early-findings-show-breast-cancer-vaccine-produces-immune-response
Context: First-in-human Phase 1 study in 35 participants with or at high risk of triple-negative breast cancer.
Key point: The investigational vaccine induced a predefined immune response in most participants and was well tolerated (clinical efficacy not assessed).
Implication: Signals pipeline investment and modality expansion.
🌍 CEPI funds Phase 3 pandemic flu mRNA vaccine [8] [UK–US • 18 Dec 2025]
https://feeds.issuerdirect.com/news-release.html?newsid=6130297639445566&symbol=MRNA
Context: CEPI–Moderna partnership aligned with the 100 Days Mission.
Key point: CEPI committed up to $54.3 million to support a pivotal Phase 3 trial of Moderna’s H5 influenza mRNA vaccine.
Implication: Signals pipeline investment and modality expansion.
Why it matters
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Governments are backing domestic mRNA platforms to strengthen pandemic readiness.
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Mucosal vaccines like BPZE1 could address transmission gaps left by existing injectables.
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Cancer vaccines continue to progress from proof of concept into later-stage trials.
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Regulators are signaling sustained demand for next-generation COVID-19 vaccines.
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Global partnerships aim to accelerate equitable access in future pandemics.
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FAQ
What is GC Biopharma developing with KDCA support?
GC Biopharma is advancing a COVID-19 mRNA vaccine into Phase 1 as part of a KDCA-backed pandemic preparedness program, aiming for an end-to-end domestic mRNA platform [1].
How does BPZE1 differ from current pertussis vaccines?
BPZE1 is an intranasal vaccine designed to prevent bacterial colonisation, a limitation of current injectable vaccines, and showed reduced colonisation in a Phase 2b study [2].
What is the target of Anixa’s breast cancer vaccine?
The vaccine targets α-lactalbumin, a protein re-expressed in many breast cancers, with Phase 1 data showing safety and immune activation [3].
Why are IO Biotech’s results notable?
Five-year outcomes suggest durable benefit of IO102-IO103 plus nivolumab in metastatic melanoma, supporting ongoing Phase 3 development [4].
What differentiates Moderna’s mNEXSPIKE?
mNEXSPIKE uses a lower-dose formulation and showed non-inferior to slightly superior efficacy versus Spikevax in Phase 3 data reviewed by EMA [6].
Entities / Keywords
GC Biopharma, KDCA, mRNA vaccines, BPZE1, Bordetella pertussis, Anixa Biosciences, Cleveland Clinic, α-lactalbumin, IO Biotech, IO102-IO103, nivolumab, GeoVax, rMVA platform, Moderna, mNEXSPIKE, CEPI, pandemic influenza.
References
- https://www.koreabiomed.com/news/articleView.html?idxno=29973
- https://www.emjreviews.com/microbiology-infectious-diseases/news/novel-intranasal-vaccine-shows-promise-against-whooping-cough/
- https://www.biospace.com/press-releases/anixa-biosciences-announces-transfer-of-ind-for-breast-cancer-vaccine-from-cleveland-clinic
- https://iobiotech.com/press-releases/?workflow=3022a6c1-f79b-4a79-95d0-14f6f8f60440
- https://www.geovax.com/investors/press-releases/geovax-receives-u-s-patent-office-notice-of-allowance-for-broad-spectrum-covid-19-vaccine-design
- https://feeds.issuerdirect.com/news-release.html?newsid=5545676968563476&symbol=MRNA
- https://newsroom.clevelandclinic.org/2025/12/18/early-findings-show-breast-cancer-vaccine-produces-immune-response
- https://feeds.issuerdirect.com/news-release.html?newsid=6130297639445566&symbol=MRNA