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.

A personalized cancer vaccine (PCV), built to target each patient’s own tumor-specific mutations (neoantigens) and given with or without the immunotherapy drug ipilimumab, produced no recurrence in any of 9 patients with high-risk, fully resected clear cell renal cell carcinoma (kidney cancer) at a median follow-up of about 40 months after surgery, in a phase 1, first-in-human trial (ClinicalTrials.gov NCT02950766; primary publication in Nature, DOI 10.1038/s41586-024-08507-5) led by researchers at Yale School of Medicine and the Dana-Farber Cancer Institute. All 9 participants developed T-cell immune responses against the vaccine’s target mutations, including against known kidney-cancer driver-gene mutations (in genes called VHL, PBRM1, BAP1, KDM5C, and PIK3CA), and no dose-limiting toxicities were reported. This is an early-phase, adjuvant (post-surgery, no visible cancer remaining) safety and immunogenicity trial in a very small number of patients, not a treatment for active/measurable kidney cancer and not yet compared against standard follow-up care in a randomized trial.

The randomized, open-label, phase 2b KEYNOTE-942 trial tested an individualized neoantigen therapy — mRNA-4157/V940, a personalized mRNA cancer vaccine manufactured for each individual patient’s own tumor mutations — combined with pembrolizumab, against pembrolizumab alone, as adjuvant (after-surgery) treatment in patients with resected, high-risk (stage IIIB-IV) melanoma. Patients were randomized 2:1 to the combination (107 patients) or pembrolizumab alone (50 patients); after 18 months, recurrence-free survival was 78.6% in the combination arm versus 62.2% with pembrolizumab alone, a 44% reduction in the risk of recurrence or death, published in The Lancet (DOI 10.1016/S0140-6736(23)02268-7). A 3-year update presented at ASCO 2024 (Journal of Clinical Oncology, DOI 10.1200/JCO.2024.42.17_suppl.LBA9512) reported the benefit was sustained. The therapy has received FDA Breakthrough Therapy Designation but is NOT yet FDA-approved for any indication — it remains investigational, currently being tested in the larger, confirmatory phase 3 V940-001/INTerpath-001 trial.

BNT116, an investigational NSCLC (non-small-cell lung cancer) vaccine, is under study in the LuCa-MERIT-1 first-in-human trial. Trial registry: https://clinicaltrials.gov/study/NCT05142189. The registry describes the trial as first-in-human and recruiting, with multiple treatment cohorts, as of the current source record — the cohorts must not be reduced to a single universal regimen in any summary. This is a Phase I, investigational, ongoing clinical trial: no efficacy claim is made or should be made here, since no primary posted trial result was supplied by the governing directive. This story is primarily ABOUT an ongoing trial, not about a proven result. [Identifiers as supplied, attributed to independent verification outside this environment — not independently re-verified live here.]

A personalized RNA (neoantigen) vaccine study in pancreatic ductal adenocarcinoma reports durable T-cell responses. Primary publication: PMID 39972124, https://pubmed.ncbi.nlm.nih.gov/39972124/, DOI https://doi.org/10.1038/s41586-024-08508-4. Earlier Phase I publication: PMID 37165196, https://pubmed.ncbi.nlm.nih.gov/37165196/, DOI https://doi.org/10.1038/s41586-023-06063-y. A follow-on randomized Phase II trial is registered: https://clinicaltrials.gov/study/NCT05968326 — described as Phase II/recruiting as of the current source record (an exact recruitment/enrollment count is [NOT SPECIFIED] by the governing directive and is not invented here). This is investigational: this vaccine is NOT proven to prevent pancreatic cancer recurrence and is not an established treatment. [Identifiers as supplied, attributed to independent verification outside this environment — not independently re-verified live here.]