Vaccines Weekly News - October 3rd 2025

Vaccine Research Update: Pneumococcal Advances, Dengue Review, Cancer Data, and More!

From Virometix completing enrollment in a Phase I trial of its synthetic pneumococcal vaccine to India’s CDSCO panel pressing Takeda for full Phase III dengue data, vaccine development remains under close clinical and regulatory watch. Novo Medi Sciences gained CDSCO clearance for a Phase III infant PCV13 booster study, while Evaxion readies two-year data on its AI-driven cancer vaccine EVX-01 for ESMO 2025. With the U.S. Navy testing a first-in-human Staphylococcus aureus vaccine and NIAID backing a fungal vaccine with up to $40 million, innovation continues across critical disease areas.

In Today’s Newsletter

🧬 Virometix completes Phase I enrollment for pneumococcal vaccine V-212 [1] [Switzerland • 01 Oct 2025]

https://www.businesswire.com/news/home/20251001005015/en
Context: First-in-human, randomized, placebo-controlled trial with three dose levels at CEVAC, Ghent University Hospital. Topline safety and immunogenicity data expected Q1 2026.
Key point: Virometix completed enrollment (n=60) in a Phase I trial of V-212, a fully synthetic, serotype-independent vaccine targeting Streptococcus pneumoniae.
Implication: May influence prescriber choice and payer reviews pending full data.

🦟 CDSCO asks Takeda for full Phase III dengue vaccine data [2] [India • 28 Sep 2025]

https://medicaldialogues.in/news/industry/pharma/cdsco-panel-asks-takeda-to-submit-full-phase-iii-data-on-dengue-vaccine
Context: Context: Interim blinded safety data from Indian cohort presented; study includes subjects aged 4–60 years.
Key point: India’s SEC requested Takeda Biopharmaceuticals submit complete Phase III data for its live, attenuated tetravalent dengue vaccine before further review.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 CDSCO clears Novo Medi Sciences Phase III PCV13 booster trial [3] [India • 28 Sep 2025]

https://medicaldialogues.in/news/industry/pharma/cdsco-approves-novo-medi-sciences-phase-iii-booster-trial
Context: Randomized, double-blind, multicenter trial will compare immunogenicity and safety of PCV13.
Key point: SEC approved Novo Medi Sciences’ revised Phase III protocol to evaluate a PCV13 booster in Indian infants.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Evaxion prepares Phase II cancer vaccine results for ESMO [4] [01 Oct 2025]

https://finance.yahoo.com/news/evaxion-readies-two-year-cancer-vaccine-results
Context: Trial tracked long-term durability and progression-free survival; 3-year extension study underway.
Key point: Evaxion confirmed all patients completed treatment in Phase II trial of EVX-01, a personalized neoantigen cancer vaccine. Two-year efficacy results will be presented at ESMO in Oct 2025.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 NMRC begins Phase I human trial of Staphylococcus aureus vaccine [5] [US • 01 Oct 2025]

https://www.med.navy.mil/NMRC/newsroom/staph-vaccine-trial
Context: Designed to reduce risk of skin and soft tissue infections; dosing includes two injections with seven months of follow-up.
Key point: Naval Medical Research Command launched a 129-participant, double-blind, placebo-controlled Phase I trial for a Staph vaccine.
Implication: May influence prescriber choice and payer reviews pending full data.

🍄 Appili & Vitalex win US$40M NIAID contract for fungal vaccine [6] [Canada • 01 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/01/appili-vitalex-vaccine-grant
Context: Funding supports manufacturing, IND filing, and Phase I trials; targets Candida albicans and Candida auris.
Key point: Appili Therapeutics and Vitalex Biosciences awarded up to US$40M by NIAID to develop VXV-01, a dual-antigen vaccine for invasive fungal infections.
Implication: Signals pipeline investment and modality expansion.

Why it Matters

Pneumococcal vaccines remain a global priority; synthetic and conjugate approaches highlight pipeline diversity.
India’s CDSCO continues close oversight of vaccine trials, shaping dengue and pneumococcal strategies.
Cancer vaccine progress (Evaxion) tests AI-driven personalization in oncology.
Military-led Staph vaccine work underscores readiness and public health overlap.
Fungal vaccines (Appili/Vitalex) target a high-mortality space with no approved vaccines.

📢 Stay Ahead in Vaccine Research!

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

FAQ

What is Virometix testing with V-212?

Virometix [1] is conducting a Phase I trial of V-212, a fully synthetic, serotype-independent pneumococcal vaccine candidate designed to protect broadly against Streptococcus pneumoniae.

Why did CDSCO ask Takeda for more dengue vaccine data?

India’s SEC requested [2] Takeda submit the full Phase III report of its tetravalent dengue vaccine before further regulatory consideration, after reviewing interim safety results.

What did Novo Medi Sciences gain approval for?

Novo Medi Sciences [3] received CDSCO clearance to run a Phase III trial evaluating a PCV13 booster in infants, focusing on safety and immunogenicity.

What will Evaxion present at ESMO?

Evaxion [4] will share two-year Phase II efficacy results of EVX-01, its AI-designed personalized cancer vaccine, including durability of response and progression-free survival.

What is the NMRC’s Staph trial about?

NMRC [5] is testing a vaccine against Staphylococcus aureus in a Phase I, first-in-human study with 129 volunteers to assess safety and potential to prevent infections.

What is Appili and Vitalex’s fungal vaccine program?

Appili and Vitalex [6] are advancing VXV-01, a dual-antigen vaccine for Candida infections, under a US$40M NIAID contract covering IND-enabling work and Phase I trials.

Entities / Keywords

Virometix (V-212, pneumococcal vaccine, synthetic SVLP); Takeda Biopharmaceuticals (Dengue tetravalent vaccine, TDV); Novo Medi Sciences (PCV13 booster, pneumococcal conjugate vaccine); Evaxion A/S (EVX-01, personalized cancer vaccine, AI-Immunology platform); Naval Medical Research Command (NMRC) (Staphylococcus aureus vaccine trial); Appili Therapeutics / Vitalex Biosciences (VXV-01, fungal vaccine, Candida albicans, Candida auris); CDSCO / SEC (India regulatory authority for clinical trials); NIAID (NIH) (US government funding body)