Oral Neoantigen Therapy in Triple-Negative Breast Cancer

At the ESMO Congress, taking place in Madrid, Spain, from October 23 to 27, 2026, clinical trial findings evaluate an oral individualized neoantigen therapy administered alongside standard checkpoint inhibitors and chemotherapy for triple-negative breast cancer.

Core Technology and System Architecture
NECVAX-NEO1 functions as an orally administered, bacteria-based DNA immunotherapy designed to elicit targeted T-cell responses against patient-specific tumor mutations. The therapeutic architecture integrates an artificial intelligence prediction engine, IMMUNASIGHT, with an oral delivery platform, TORAPRIME. The AI subsystem identifies and selects the most immunogenic neoepitopes unique to an individual tumor profile. The bacterial delivery mechanism then transports the encoded DNA sequences through the gastrointestinal tract, presenting antigens directly to gut-associated lymphoid tissue to stimulate systemic cytotoxic T-cell activation without systemic injection vectors.

Industry Applications
In oncology therapeutics and biopharmaceutical development, solid tumor management requires solutions that address low tumor immunogenicity and high molecular heterogeneity. Triple-negative breast cancer represents a specific technical challenge due to the absence of targeted receptors, necessitating combinations of cytotoxic chemotherapy and checkpoint inhibitors. By deploying individualized neoepitopes, the platform directs immune effector cells to target patient-specific mutational profiles, aiming to improve therapeutic specificity and limit off-target toxicity in solid tumor oncology.

Deployment or Implementation
Clinical deployment was evaluated in an eight-patient cohort within a Phase I/II trial in the neoadjuvant setting. The trial protocol integrated the oral therapy directly into the established clinical regimen. Patients initially completed twelve weeks of two courses of neoadjuvant chemotherapy combined with pembrolizumab prior to planned surgery. NECVAX-NEO1 was subsequently integrated into this regimen, with an optional adjuvant administration phase following surgical resection. Trial operations are expanding to twenty-eight patients, extending into clinical sites across the United States under an approved Investigational New Drug application.

Operational Impact and Performance Metrics
The clinical protocol demonstrated systemic tolerability with no protocol-limiting safety signals observed when adding the oral platform to standard chemotherapy and immunotherapy. Among the eight patients evaluated at surgical resection, five achieved a pathological complete response confirmed by histological analysis and validated by corresponding biomarker shifts. Enzyme-linked immunospot assays detected functional immune reactivity to all selected neoepitopes, confirming biological translation from AI-modeled sequences to in vivo T-cell activation.

Regarding the clinical mechanism and expansion, Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, stated: "Our clinical Phase I/II data are demonstrating promising immune responses in the neoadjuvant treatment of early-stage TNBC patients. We are extending the trial to n=28 patients, including patients in the U.S., as we recently received IND approval to conduct a clinical trial in the country. The additional patients in cohort 2 are being treated with a higher dose of NECVAX-NEO1 on top of Keynote-522 standard of care regimen, which includes pembrolizumab."

Edited by Evgeny Churilov, Induportals Media - Adapted by AI.

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