Vaccine Research Update: KRAS Vaccine Progress, Breast Cancer Milestone, Melanoma Late-Breaker, and More!
From Elicio’s KRAS-mutant pancreatic cancer vaccine showing near-universal immune responses to Moderna’s LP.8.1-targeting formula and IO Biotech’s Phase 3 melanoma trial earning an ESMO spotlight, this week’s developments highlight momentum across oncology and infectious disease. With GC Biopharma advancing a domestic COVID-19 mRNA shot, Anixa and Cleveland Clinic approaching final data in breast cancer, and EMA backing HIPRA’s Bimervax booster for adolescents, the landscape underscores clinical progress and regulatory support driving next-generation vaccines.
In Today’s Newsletter
🧬 ELI-002 7P drives ~99% mKRAS-specific T-cell responses in pancreatic cancer [1] [US • 19 Sep 2025]
https://www.curetoday.com/view/vaccine-elicits-immune-responses-in-pancreatic-cancer
Context: Phase 2 AMPLIFY-7P; off-the-shelf KRAS-mutant vaccine; evaluable n=90 (per release cited).
Key point: mKRAS-specific T-cell responses in 89/90 (~99%) of evaluable patients; final DFS analysis anticipated in 4Q25 (per company).
Implication: May influence prescriber choice and payer reviews pending full data.
💉 GC Biopharma files IND for COVID-19 mRNA vaccine GC4006A [2] [KR • 22 Sep 2025]
https://www.mk.co.kr/en/it/11426050
Context: Domestic Phase 1 planned in healthy adults; KDCA-backed pandemic mRNA program; in-house mRNA-LNP platform.
Key point: Aims for Phase 1 approval in 2025 and first dosing early 2026; nonclinical data showed humoral and cellular responses.
Implication: Signals pipeline investment and modality expansion.
🎗️ Anixa/Cleveland Clinic to present Phase 1 breast cancer vaccine final data at SABCS [3] [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:Alpha-lactalbumin vaccine; DoD-funded Phase 1; poster slated for 11 Dec 2025 at SABCS.
Key point: Final safety/immunogenicity readout to inform FDA discussions and Phase 2 planning.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Moderna mNEXSPIKE®: >16× LP.8.1 neutralizing-Ab rise in high-risk 12–64 and ≥65 adults [4] [US • 23 Sep 2025]
https://feeds.issuerdirect.com/news-release.html?newsid=6125971827149873&symbol=MRNA
Context: Ongoing Phase 4; 2025–26 formula targeting LP.8.1; Spikevax® also showed >8× rise in prelim data.
Key point: Preliminary immunogenicity shows strong responses across age groups; safety consistent with prior studies.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🛡️ IO Biotech: Phase 3 IO102-IO103 + pembro late-breaker at ESMO (1L melanoma) [5] [EU/US • 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: Randomized Phase 3 (IOB-013/KN-D18) vs pembrolizumab; plus Phase 2 basket final data in NSCLC and SCCHN via poster.
Key point: Oral late-breaking selection signals pivotal dataset readiness; efficacy/safety details to be presented at ESMO 2025 (Berlin).
Implication: May influence prescriber choice and payer reviews pending full data.
💉 EMA backs LP.8.1-targeted Bimervax booster; expands to ≥12 years [6] [EU • 23 Sep 2025]
https://www.medscape.com/viewarticle/ema-backs-covid-booster-lp-8-1-expands-teens-2025a1000pda
Context: CHMP positive opinion to update HIPRA’s Bimervax composition and lower booster age from 16→12; immunobridging basis.
Key point: Single booster ≥6 months post mRNA primary; higher antibodies vs some variants vs Comirnaty in adults; adequate responses in teens (limited n).
Implication: Introduces competition that may affect pricing and formulary access.
Why it Matters
- KRAS-targeted, off-the-shelf cancer vaccines (ELI-002) could complement adjuvant care in high-relapse tumors.
- Home-grown mRNA platforms (GC Biopharma) enhance regional pandemic readiness and tech sovereignty.
- Late-stage vaccine-immunotherapy combos (IO Biotech) test additive benefit over checkpoint monotherapy.
- Variant-matched COVID boosters (Moderna, HIPRA) aim to sustain protection as LP.8.1 circulates in 2025–26.
📢 Stay Ahead in Vaccine Research!
✅ Contact LucidQuest at info@lqventures.com for strategic guidance on Vaccine innovations and research.
FAQ
What did ELI-002 7P show in pancreatic cancer?
A company-reported Phase 2 update cited mKRAS-specific T-cell responses in ~99% of 90 evaluable patients; DFS analysis is expected in 4Q25 [1].
What is GC4006A and what’s planned?
A COVID-19 mRNA vaccine candidate from GC Biopharma; Korea Phase 1 IND filed to assess safety and immunogenicity in healthy adults, targeting first dosing in early 2026 [2].
When and where will Anixa’s breast cancer vaccine data appear?
Final Phase 1 results will be presented at SABCS on 11 Dec 2025; the aLA vaccine aims to inform Phase 2 and FDA discussions [3].
How strong are Moderna’s LP.8.1 data?
Preliminary Phase 4 results showed >16× neutralizing-antibody increases for mNEXSPIKE and >8× for Spikevax across older and high-risk groups; safety aligned with prior studies [4].
What exactly did IO Biotech announce?
Its randomized Phase 3 melanoma trial of IO102-IO103 + pembrolizumab was accepted as an ESMO 2025 oral late-breaker; detailed efficacy/safety coming at the meeting [5].
What changed for Bimervax in Europe?
CHMP backed updating the protein-based booster to LP.8.1 and extending eligibility to adolescents ≥12 years; decision awaits EC approval [6].
Entities / Keywords
Elicio Therapeutics; ELI-002 7P; KRAS-mutant vaccines; pancreatic cancer; GC Biopharma; GC4006A; mRNA-LNP; Anixa Biosciences; Cleveland Clinic; alpha-lactalbumin vaccine; breast cancer; Moderna; mNEXSPIKE®; Spikevax®; LP.8.1 variant; IO Biotech; IO102-IO103; pembrolizumab; melanoma; ESMO 2025; HIPRA Human Health; Bimervax; CHMP; EMA; adolescents booster; immunobridging.
References
- https://www.curetoday.com/view/vaccine-elicits-immune-responses-in-pancreatic-cancer
- https://www.mk.co.kr/en/it/11426050
- 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
- https://feeds.issuerdirect.com/news-release.html?newsid=6125971827149873&symbol=MRNA
- 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
- https://www.medscape.com/viewarticle/ema-backs-covid-booster-lp-8-1-expands-teens-2025a1000pda