🧬 This Week in Vaccine Research: Cancer, COVID-19, RSV, Lyme Disease & Alzheimer’s Updates & More
This week’s Vaccine Research roundup highlights pivotal breakthroughs—from a personalized cancer vaccine showing a one hundred percent early tumor response, to a Lyme disease vaccine nearing its first Phase 3 readout in more than two decades.
In Today’s Newsletter
🧬 Russia unveils EnteroMix cancer mRNA vaccine claims [1] [RU • 08 Sep 2025]
Key point: FMBA Russia reported early positive signals for EnteroMix in Phase 1 (endpoint not specified).
Context: Personalized mRNA approach; initial focus colorectal cancer; Phase 1 began June 2025 (n=48); versions for GBM/melanoma noted.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Pfizer/BioNTech: LP.8.1–adapted COVID-19 vaccine topline [2] [08 Sep 2025]
Key point: In adults ≥65 and at-risk 18–64, neutralizing titers vs LP.8.1 rose ≥4× at Day 14 after a 30-µg dose.
Context: Open-label Phase 3 cohort (n=100); prior KP.2-adapted dose ≥6 months earlier; safety consistent; data submitted to FDA.
Implication: May influence prescriber choice and payer reviews pending full data.
⚖️ GSK expands mRNA IP case to Moderna’s next-gen shot [3] [US • 05 Sep 2025]
Key point: Amended Delaware filing seeks royalties on Moderna’s mNexspike, citing lipid/mRNA formulation patents.
Context: Follows prior claims over Spikevax and mResvia; Moderna plans to contest; related suits involve multiple mRNA players.
Implication: Introduces competition that may affect pricing and formulary access.
🫁 RSV vaccine tied to fewer cardiorespiratory admits (60+) [4] [08 Sep 2025]
Key point: Observational analysis linked RSV prefusion-F vaccination to lower all-cause cardiorespiratory hospitalization.
Context: Cardiovascular-only hospitalization reduction not statistically significant; study details not fully specified.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🕷️ Pfizer/Valneva Lyme vaccine nears Phase 3 readout [5] [09 Sep 2025]
https://www.barrons.com/articles/lyme-disease-vaccine-pfizer-valneva-263ba1ba
Key point: Phase 2 showed high antibodies after third annual booster (n=180); no new safety issues reported.
Context: Partners expect Phase 3 results around year-end per report; large U.S./EU burden underscores demand.
Implication: May influence prescriber choice and payer reviews pending full data.
🧠 Alzinova’s ALZ-101 IND cleared; Phase 2 to start [6] [US • 09 Sep 2025]
Key point: FDA approved IND for ALZ-101, an Aβ-oligomer-targeting vaccine, enabling a Phase 2 study in early Alzheimer’s.
Context: Planned multicenter trial (~240 pts) to assess safety, tolerability, and efficacy; builds on Phase Ib immunogenicity/safety.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Variant-adapted COVID boosters continue to show immune-response gains in higher-risk adults.
- Litigation over mRNA IP could reshape economics across COVID/RSV franchises.
- Real-world RSV data support broader value beyond classic efficacy endpoints in older adults.
- Tick-borne disease prevention may finally gain a human vaccine option pending Phase 3.
- Neuro vaccine approaches advance, targeting toxic oligomers in early Alzheimer’s.
- Ambitious oncology vaccine claims warrant cautious interpretation until peer-reviewed readouts.
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FAQ
What is EnteroMix and what stage is it in?
EnteroMix is a Russian mRNA cancer vaccine program with early Phase 1 signals reported; initial target is colorectal cancer, with GBM and melanoma versions mentioned (endpoint not specified) [1].
How strong were the immune responses with Pfizer/BioNTech’s LP.8.1 formula?
In an open-label Phase 3 cohort (n=100), LP.8.1-neutralizing titers increased ≥4× by Day 14 in older and at-risk adults; safety was consistent with prior studies [2].
What exactly did GSK add to its lawsuit against Moderna?
GSK’s amended Delaware complaint seeks royalties on Moderna’s mNexspike, alleging infringement of lipid/mRNA formulation patents already cited against Spikevax and mResvia; Moderna will contest [3].
Does RSV vaccination reduce heart or lung hospitalizations in seniors?
An observational study associated RSV immunization with fewer all-cause cardiorespiratory hospitalizations in adults ≥60; cardiovascular-only outcomes weren’t statistically significant [4].
When could Pfizer/Valneva’s Lyme vaccine have pivotal data?
Barron’s reports Phase 3 results could arrive around year-end; Phase 2 boosters maintained high antibody levels without new safety issues (n=180) [5].
What is ALZ-101 and what will Phase 2 test?
ALZ-101 is a vaccine directed at toxic Aβ oligomers. The FDA-cleared Phase 2 will evaluate safety, tolerability, and efficacy in early Alzheimer’s (~240 patients) [6].
Entities / Keywords
EnteroMix; FMBA Russia; mRNA cancer vaccine; colorectal cancer; glioblastoma; melanoma • Pfizer; BioNTech; COMIRNATY; LP.8.1; KP.2 • GSK; Moderna; mNexspike; Spikevax; mResvia; lipid nanoparticles; patent litigation • RSV vaccine; prefusion F; observational analysis; older adults • Valneva; Pfizer; Lyme vaccine; Phase 3 • Alzinova; ALZ-101; amyloid-beta oligomers; IND; early Alzheimer’s.