Latest Vaccine Research News - Sept 19th - Oct 2nd 2025

Watch Our Video Summary Capturing Top Vaccine News from the Last Two Weeks

From ELI-002’s near-universal KRAS-targeted responses and IO Biotech’s Phase 3 melanoma vaccine debut to NIAID’s $40 million fungal vaccine funding—this episode’s highlights are compelling. We cover oncology, infectious disease, immunotherapy, and pandemic preparedness, with regulatory progress and trial readouts across areas, underscoring accelerating innovation and expanding vaccine frontiers.

🧬 Pancreatic cancer vaccine ELI-002 7P elicits 99% T-cell responses [1]

https://www.curetoday.com/view/vaccine-elicits-immune-responses-in-pancreatic-cancer
Context: Vaccine targets seven KRAS mutations; data consistent with earlier Phase 1. Disease-free survival readout expected Q4 2025.
Key point: Elicio Therapeutics reported 89/90 evaluable patients in Phase 2 AMPLIFY-7P trial had KRAS-specific T-cell responses (~99%).
Implication: May influence prescriber choice and payer reviews pending full data.

🎗️ Anixa breast cancer vaccine Phase 1 results headed to SABCS [2] [US – 22 Sep 2025]

https://www.prnewswire.com/news-releases/cleveland-clinic-to-present-final-results-of-phase-1-clinical-trial-for-anixa-biosciences-breast-cancer-vaccine-at-2025-san-antonio-breast-cancer-symposium-302562079.html
Context: Trial at Cleveland Clinic, funded by US DoD, assessed safety and immunogenicity; FDA discussions to follow.
Key point: Final Phase 1 trial data of alpha-lactalbumin vaccine to be presented Dec 11, 2025 at SABCS.
Implication: May influence prescriber choice and payer reviews pending full data.

🌍 IO Biotech Phase 3 melanoma vaccine data at ESMO [3] [EU – 23 Sep 2025]

https://www.globenewswire.com/news-release/2025/09/23/3154660/0/en/IO-Biotech-Announces-Late-Breaking-Abstract-in-Advanced-Melanoma-Selected-for-Oral-Presentation-at-ESMO-Congress-2025.html
Context: Phase 2 basket trial data in NSCLC and SCCHN also to be presented (efficacy, PFS, OS, biomarkers).
Key point: Oral presentation at ESMO 2025 to highlight Phase 3 trial of IO102-IO103 + pembrolizumab in 1L advanced melanoma.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 EMA backs LP.8.1 booster (Bimervax; HIPRA), extends to teens [4] [EU – 23 Sep 2025]

https://www.medscape.com/viewarticle/ema-backs-covid-booster-lp-8-1-expands-teens-2025a1000pda
Context: Immunobridging study showed higher antibodies vs Omicron/variants; mild-moderate adverse events common.
Key point: EMA CHMP issued positive opinion on updated protein-based COVID-19 booster for LP.8.1, expanding eligibility from ≥16 to ≥12 years.
Implication: Introduces competition that may affect pricing and formulary access.

🦠 Virometix completes Phase 1 enrollment for pneumococcal vaccine [5] [EU – 30 Sep 2025]

https://www.biospace.com/press-releases/virometix-announces-completion-of-enrollment-in-phase-i-trial-of-v-212-a-fully-synthetic-serotype-independent-vaccine-candidate-against-streptococcus-pneumoniae
Context: Conducted with CEVAC at Ghent; topline safety and immunogenicity data expected Q1 2026.
Key point: 60-subject Phase 1 trial of fully synthetic serotype-independent vaccine V-212 fully enrolled.
Implication: May influence prescriber choice and payer reviews pending full data.

🔬 Evaxion prepares EVX-01 two-year cancer vaccine data for ESMO [6] [EU – Oct 2025]

https://www.rttnews.com/amp/3577812/evaxion-readies-two-year-cancer-vaccine-results-for-esmo.aspx
Context: AI-driven, patient-specific vaccine approach; trial extension to 3 years ongoing.
Key point: Phase 2 EVX-01 trial completed treatment; two-year efficacy results (durability, PFS) to be presented at ESMO 2025.
Implication: May influence prescriber choice and payer reviews pending full data.

⚓ NMRC runs first-in-human Staphylococcus aureus vaccine trial [7] [US – Sep 2025]

https://www.dvidshub.net/news/549709/nmrc-researchers-conduct-first-human-clinical-trials-staph-treatment
Context: Double-blind, placebo-controlled design; two doses given 1 month apart with 7-month safety follow-up.
Key point: 129 participants enrolled in Phase 1 trial of vaccine aimed at reducing Staph infections in service members.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💵 NIAID funds Appili & Vitalex up to $40M for fungal vaccine [8] [US – 01 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/01/3159377/0/en/Appili-Therapeutics-and-its-Partner-Vitalex-Biosciences-Awarded-Contract-from-NIAID-Valued-at-up-to-US-40-Million-to-Develop-Fungal-Vaccine-VXV-01.html
Context: Dual-antigen design aims for broad protection; no fungal vaccines currently approved.
Key point: NIAID awarded up to $40M for VXV-01 vaccine against invasive Candida infections. Phase 1 planned post-IND.
Implication: Signals pipeline investment and modality expansion.

Why it Matters

KRAS-targeted immunotherapy [1] could address high recurrence in pancreatic cancer.
Breast cancer vaccine [2] may pioneer preventive immunization approaches.
IO Biotech and Evaxion [3,6] highlight immunotherapy’s diversification into melanoma and personalized cancer vaccines.
EMA’s LP.8.1 decision [4] reshapes Europe’s 2025–26 COVID strategy.
Synthetic approaches (Virometix [5], Appili/Vitalex [8]) signal innovation in vaccine platforms.

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FAQ

What did Elicio report in pancreatic cancer?

ELI-002 7P triggered KRAS-specific T-cell responses in ~99% of evaluable patients in Phase 2 AMPLIFY-7P [1].

When will Anixa release its breast cancer vaccine data?

Final Phase 1 results will be presented Dec 11, 2025 at SABCS, Cleveland Clinic-led, DoD-funded [2].

What is IO Biotech presenting at ESMO?

Phase 3 trial of IO102-IO103 plus pembrolizumab in melanoma, plus Phase 2 basket trial updates in NSCLC and SCCHN [3].

What change did EMA make on COVID-19 vaccination?

Approved LP.8.1-updated Bimervax booster, lowering eligibility from age 16 to 12 years [4].

What milestone did Virometix reach?

Completed Phase 1 enrollment for synthetic pneumococcal vaccine V-212, topline Q1 2026 [5].

How is NIAID supporting fungal vaccines?

Funding up to $40M for Appili/Vitalex’s VXV-01, aiming to protect against invasive Candida infections [8].

Entities / Keywords

Elicio Therapeutics; ELI-002 7P; AMPLIFY-7P; KRAS vaccine; Anixa Biosciences; alpha-lactalbumin (aLA) vaccine; Cleveland Clinic; SABCS; IO Biotech; IO102-IO103; pembrolizumab; ESMO Congress 2025; EMA; CHMP; Bimervax; HIPRA; LP.8.1 variant booster; Virometix; V-212; pneumococcal vaccine; CEVAC; Evaxion A/S; EVX-01; AI-Immunology; personalized neoantigen vaccine; NMRC; Naval Medical Research Command; Staphylococcus aureus vaccine; Appili Therapeutics; Vitalex Biosciences; VXV-01; fungal vaccine; NIAID.