Investigational triple-negative breast cancer vaccine shows safety and immune response in phase 1 trial

Early HumanInvestigationalNot addressed

An investigational alpha-lactalbumin-targeted vaccine, developed by Anixa Biosciences in collaboration with Cleveland Clinic, showed a favorable safety profile and induced a protocol-defined immune response in a majority of participants in a phase 1 trial (ClinicalTrials.gov NCT04674306), according to updated data presented at the Society for Immunotherapy of Cancer (SITC) 39th annual meeting. The trial enrolled 35 participants across three cohorts: triple-negative breast cancer (TNBC) survivors who completed treatment within the prior three years and remain at high recurrence risk; cancer-free carriers of breast-cancer-associated genetic mutations who elected preventive mastectomy; and early-stage TNBC patients who received pre-operative chemoimmunotherapy and were subsequently treated with the vaccine in combination with pembrolizumab. Across all three cohorts, a reported 74% of participants developed a protocol-defined immune response; the vaccine was reported to be well tolerated, with injection-site irritation as the main adverse event and no major systemic adverse events, including in the pembrolizumab-combination cohort. No peer-reviewed efficacy data exists — this is a safety/immunogenicity trial only, and a phase 2 study is reportedly planned. No FDA approval exists for this vaccine.

What This Means

An investigational alpha-lactalbumin-targeted vaccine, developed by Anixa Biosciences with Cleveland Clinic, was reported to be safe and to induce a protocol-defined immune response in 74% of participants across all three trial cohorts in this phase 1 study — this is a safety and immune-response (immunogenicity) trial, not an efficacy trial. NO CLAIM IS MADE OR SHOULD BE INFERRED that this vaccine prevents or treats breast cancer; that question has not yet been studied.

What This Doesn't Mean

This must never be described as a preventive or therapeutic breast-cancer vaccine that works — no efficacy data of any kind exists yet, only safety and immune-response data from 35 total participants across three cohorts. A planned phase 2 study, reportedly intended to evaluate efficacy, has not yet begun as of this review.

Why It Matters

A favorable early safety profile and a meaningful immune response across three distinct at-risk/high-recurrence-risk populations — including in combination with an approved checkpoint inhibitor — supports moving this investigational vaccine into further study, which is itself a genuine, if early, milestone.

Promise & Proof

Proof — strength of the evidence 2 / 5

Base score from evidence stage: Early Human.

Promise — potential significance if later evidence holds up 3 / 5

Baseline — a validly-evidenced story starts here; every further point below is an explicit, checkable reason.
The record includes substantive editorial reasoning about why this discovery matters.
An early-stage finding (preclinical or early human) that already shows at least one concrete signal of significance above.

These two ratings are automatically computed from this story's own structured evidence fields and are shown separately on purpose — they are never combined into one score. They describe this record, not a medical recommendation: they do not establish medical certainty, do not substitute for reading the cited sources, and are recalculated whenever the underlying evidence changes.

Population / Applicability

Studied in: Adults enrolled across three cohorts of a first-in-human phase 1 trial: (1a) triple-negative breast cancer (TNBC) survivors who completed treatment within the prior three years and remain at high recurrence risk; (1b) cancer-free carriers of breast-cancer-associated genetic mutations who elected preventive mastectomy; and (1c) early-stage TNBC patients who received pre-operative chemoimmunotherapy and were subsequently vaccinated in combination with pembrolizumab. (Adults)

This is Phase 1 investigational research only; no treatment or preventive claim of any kind should be made. Injection-site irritation was the primary reported adverse event, with no major systemic adverse events reported even in the pembrolizumab-combination cohort — full safety data should be independently reviewed, not assumed complete from this record alone, before any further characterization.

Full evidence details

Study design: Non-randomized trial
Sample size: 35

Funding & Conflicts

Sponsor/developer: Anixa Biosciences, in collaboration with Cleveland Clinic — not independently confirmed against a primary corporate-disclosure document.

Regulatory status by jurisdiction

Unspecified jurisdiction

Status: Investigational
Last verified: 2026-08-13

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Guideline positions

Guideline

Position: Not addressed
Last verified: 2026-08-13

Primary evidence supporting this story

Phase 1 trial registry (investigational alpha-lactalbumin breast-cancer vaccine) (opens in a new tab) (Clinical-trial registry) NCT04674306 Load-bearing source NCT04674306
Phase 1 trial registry (investigational alpha-lactalbumin breast-cancer vaccine). NCT04674306.

Why Should I Trust This?

1 source at Tier 1 — Government/regulatory authority (FDA, NCI, NIH, ClinicalTrials.gov, CDC, and equivalent)
Last reviewed: 2026-08-13

This panel summarizes real, checkable facts about this record's own sources and review status — it is not a trust score, and reading it is not a substitute for reading the cited sources yourself.

Discovery Timeline

Every recorded change to this record's content or publication status, in order.

2026-08-13 Status change — Status changed from "Legacy / Unverified" to "In editorial review".
2026-08-13 Status change — Status changed from "In editorial review" to "Verified".

Last reviewed 2026-08-13