Vaccines Weekly News – October 9th 2025

LucidQuest

1 month ago

Vaccine Research Update: COVID Prevention, Malaria Rollout, Cancer Progress, and More!

From Invivyd’s FDA-cleared IND for its pivotal COVID prevention antibody to Liberia’s nationwide rollout of the RTS,S malaria vaccine, vaccine development is advancing on multiple fronts. Anixa and Cleveland Clinic completed their Phase 1 breast cancer vaccine trial, while Alzinova gained FDA Fast Track and IND clearance for its Alzheimer’s candidate ALZ-101. Bavarian Nordic posted positive pediatric mpox/smallpox data ahead of an EMA filing, Bharat Biotech’s trivalent Salmonella vaccine showed strong immunogenicity, and TransCode expanded into oncology vaccines with its Polynoma acquisition.

In Today’s Newsletter

💉 Invivyd’s VYD2311 COVID prevention antibody: US IND cleared, pivotal plan aligned [1] [US; 06 Oct 2025]

https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-us-ind-clearance-and-alignment-us-fda-pivotal
Context: REVOLUTION program includes DECLARATION (Phase 3, placebo-controlled) and LIBERTY (active-controlled vs mRNA vaccine, with co-administration arm).
Key point: FDA cleared IND and provided feedback to advance pivotal plans for VYD2311, a vaccine-alternative monoclonal antibody to prevent COVID (endpoints and sizes described; start targeted around end-2025).
Implication: May influence prescriber choice and payer reviews pending full data.

🦟 Liberia launches national Phase 2 of RTS,S malaria vaccination for infants [2] [Liberia; 06 Oct 2025]

https://www.liberianobserver.com/news/liberia-begins-2nd-phase-of-malaria-vaccine/article_b7804729-3761-45ab-9e41-7564b6eca7eb.html
Context: Expansion from 6 southern counties in 2024 to remaining 9 counties; targets children 5–15 months; administered at 5, 6, 7, and 15 months.
Key point: MoH began nationwide rollout of RTS,S to young children, citing high malaria burden and prior uptake in pilot counties.
Implication: May expand screening, initiation, and follow-up at scale.

🧪 Anixa breast cancer vaccine hits Phase 1 visit completion, readout set for SABCS [3] [US; 07 Oct 2025]

https://www.prnewswire.com/news-releases/anixa-biosciences-announces-completion-of-final-patient-visit-in-breast-cancer-vaccine-clinical-trial-302576465.html
Context: First-in-human trial at Cleveland Clinic in three cohorts (TNBC post-treatment, prevention, pembrolizumab combo) with 35 participants.
Key point: Final patient visit completed; company cites tolerability and >70% protocol-defined immune responses in preliminary look, with full data planned for 11 Dec 2025.
Implication: May influence prescriber choice and payer reviews pending full data.

🧠 Alzinova’s ALZ-101 gets FDA Fast Track after US IND clearance [4] [07 Oct 2025]

https://longevity.technology/news/alzinova-gets-fda-fast-track-nod-for-alzheimers-vaccine/
Context: Oligomer-selective amyloid-beta vaccine; Phase 1b showed tolerability and high immune response rate per company; Phase 2 to enroll ~240 early AD participants.
Key point: FDA granted Fast Track and IND clearance to proceed with a US Phase 2 study using ADCOMS as primary cognitive endpoint.
Implication: Signals pipeline investment and modality expansion.

🧫 Bavarian Nordic pediatric MVA-BN mpox/smallpox data positive, supports EU label expansion [5] [Denmark; 07 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/07/3162738/0/en/Bavarian-Nordic-Reports-Positive-Topline-Data-for-Mpox-Smallpox-Vaccine-in-Pediatric-Population.html
Context: NCT06549530 in DRC and Uganda, 2–11 years vs 18–50 years; co-funded by CEPI.
Key point: Primary endpoint met, showing non-inferior pediatric immune response vs adults and comparable safety; EMA filing planned in 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Trivalent Salmonella conjugate vaccine shows promise in Phase 1 adults [6] [US; 08 Oct 2025]

https://www.cidrap.umn.edu/salmonella/vaccine-typhoid-invasive-salmonella-shows-promise-phase-1-trial
Context: UM School of Medicine CVD with Bharat Biotech; TSVC targets S. Typhi and iNTS (Typhimurium, Enteritidis); Nature Medicine report.
Key point: In 22 healthy adults, TSVC was well tolerated with strong IgG responses to all three polysaccharides and flagellins; durability signals observed.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💊 TransCode to acquire Polynoma and phase 3 melanoma vaccine, secures US$25M [7] [US; 08 Oct 2025]

https://www.fiercebiotech.com/biotech/transcode-rewrites-future-securing-25m-lifeline-and-phase-3-cancer-vaccine
Context: All-stock buy of Polynoma from CK Life Sciences affiliate; concurrent US$25M investment; seviprotimut-L previously ran a Phase 3 with mixed results.
Key point: Post-deal, CK will own ~91% of TransCode; plans for confirmatory Phase 3 of seviprotimut-L noted, while internal program TTX-MC138 aims for Phase 2a next year.
Implication: Signals pipeline investment and modality expansion.

Why it Matters

Antibody-based COVID prevention (Invivyd) offers an option for at-risk groups that may not respond to, or prefer, vaccination.
RTS,S national rollout illustrates operational scaling of malaria immunization in high-burden settings.
Oncology vaccines continue to mature across prevention and adjuvant settings, with diversified antigens and combinations.
Neurodegeneration vaccine strategies are advancing beyond plaques toward oligomer-selective targets.
Pediatric mpox/smallpox data could broaden outbreak-response tools in Africa and beyond.

📢 Stay Ahead in Vaccine Research!

✅ Contact LucidQuest at info@lqventures.com for strategic guidance on Vaccine innovations and research.

FAQ

What trials are in Invivyd’s REVOLUTION program for VYD2311?

DECLARATION is a BLA-enabling Phase 3 placebo-controlled prevention study with single-dose and monthly IM dosing. LIBERTY is an active-controlled safety and tolerability study versus mRNA vaccine with a co-administration arm [1].

Who is eligible in Liberia’s RTS,S rollout and how is it given?

Liberia targets children 5–15 months with four doses at 5, 6, 7, and 15 months, expanding beyond the 2024 regional launch to nine additional counties in 2025 [2].

What did Anixa’s Phase 1 breast cancer vaccine trial include?

Three cohorts, totaling 35 women: TNBC post-treatment, prevention in high-risk mutation carriers planning prophylactic mastectomy, and a pembrolizumab combination group. Final data are planned for SABCS on 11 Dec 2025 [3].

What does FDA Fast Track for ALZ-101 cover?

Fast Track and IND clearance enable Alzinova to run a US Phase 2 in early Alzheimer’s disease, using ADCOMS as primary endpoint, following Phase 1b tolerability and immune response signals [4].

What are the key pediatric findings for MVA-BN?

In children 2–11 years, immune responses were non-inferior to adults, with highest neutralizing titers in ages 2–5, and a safety profile similar to adults, supporting a 2026 EMA filing plan [5].

What pathogens does the trivalent Salmonella vaccine target?

S. Typhi plus iNTS serovars Typhimurium and Enteritidis, combining Typbar TCV Vi polysaccharide with two iNTS conjugates. Phase 1 adult data showed strong immunogenicity and tolerability [6].

Entities / Keywords

Invivyd (VYD2311; monoclonal antibody; COVID prevention; DECLARATION; LIBERTY; REVOLUTION); Liberia Ministry of Health (RTS,S; malaria vaccine; Gavi); Anixa Biosciences / Cleveland Clinic (breast cancer vaccine; TNBC; pembrolizumab); Alzinova (ALZ-101; amyloid-beta oligomers; Fast Track; IND; ADCOMS); Bavarian Nordic (MVA-BN; mpox; smallpox; CEPI; EMA label extension); University of Maryland School of Medicine CVD / Bharat Biotech (TSVC; typhoid; iNTS; Typhimurium; Enteritidis); TransCode Therapeutics / Polynoma / CK Life Sciences (seviprotimut-L; melanoma vaccine; TTX-MC138)