Plague Pipeline

Dynavax; rF1V originated at USAMRIID, Fort Detrick

The US Department of Defense antigen is an F1–V fusion first made at USAMRIID. Dynavax mixed it with CpG 1018, a TLR9 adjuvant also used in the licensed hepatitis B vaccine Heplisav-B, under a DoD award of about $22 million announced in 2021. Dynavax is the sponsor of the Phase 2 records NCT05506969 and NCT07207408. The later trial started enrollment on 11 September 2025 in adults 18 to 55, aimed at pneumonic plague after aerosol exposure. Sanofi bought Dynavax for $15.50 a share; the deal closed in February 2026 and DVAX was delisted. DoD still funds the work.

Stage chart

Preclinical

Phase 1

Phase 2

Phase 3

Licensed

Phase 2 · enrolled Q3 2025. Phase 3 is empty here, as it is for every programme in the set.

Years on the record

2021–2026. Labelled “2021–now” on the briefing. Not a forecast.

Analyst card

Challenge: The indication is pneumonic plague after aerosol exposure. The Phase 2 studies immune response and safety in adults. They do not challenge volunteers.
F1-negative strains: Not reported. F1 and V are both in the fusion.
Adjuvant: CpG 1018, a TLR9 agonist. Same adjuvant family as Heplisav-B.
Route: Parenteral. The muscle is not restated in this briefing.
Stability: Formulation and cold-chain requirement are not stated.
Time to protection: Not reported. No time-to-protection figure is in the briefing.
Other threats: Plague only. Anthrax is not part of this candidate.
Survival figure: No survival figure in the briefing. Earlier alum-adjuvanted rF1V work sat with DynPort; this entry is the CpG version.
Animal Rule: No FDA Animal Rule designation is recorded. Human plague challenge is not done; a US licence would need animal efficacy under 21 CFR 601 Subpart H, plus a correlate of protection. Neither is established here.

Pipeline record

Antigen: DoD rF1V fusion, first made at USAMRIID, Fort Detrick.
Adjuvant: CpG 1018, a TLR9 agonist. The same adjuvant family is in the licensed hepatitis B vaccine Heplisav-B.
Contract: About $22 million from the US Department of Defense, announced 4 October 2021, to run a Phase 2.
Trials: NCT05506969, then NCT07207408. Protocol DV2-DC02-02. Sanofi identifier VCG26632. Enrollment on the later trial started 11 September 2025.
Who is in it: Adults 18 to 55. The stated aim is pneumonic plague after aerosol exposure.
Company: Dynavax sponsored the trials. Sanofi bought Dynavax for $15.50 a share; the deal closed in February 2026 and DVAX was delisted. DoD still funds the work.

Registries

NCT05506969 · ClinicalTrials.gov · rF1V with CpG 1018Phase 2. Dynavax with the US Department of Defense. Adults 18 to 55. Immunogenicity and safety. Not a challenge study.
NCT07207408 · ClinicalTrials.gov · rF1V-1018Phase 2. Protocol DV2-DC02-02. Sanofi identifier VCG26632. Enrollment started 11 September 2025. Estimated primary completion 29 January 2027. About 148 adults aged 18 to 55.

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Platform

Subunit

Purified pieces of the bacterium — here, usually capsule antigen F1 and the V antigen, LcrV — instead of a living organism. This is the only platform in the set with a new marketing authorisation.

Who is paying

US Department of Defense — fully funded

Listed company

Sanofi Nasdaq:SNY

$40.20+0.64 (+1.62%)

Last close on file · 7 Oct 2026, 16:00 EDT

Sanofi bought Dynavax in February 2026. Dynavax supplied CpG 1018 and this rF1V candidate, then left the Nasdaq. Its last print was $15.50 on 9 February 2026. The US Department of Defense still funds the trial.

Country

United States

What was tested

Human · Phase 2

Stage

Phase 2 · enrolled Q3 2025

Date

2021–now

Antigens named

F1V / LcrV