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Neoantigen × AI
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Brief · 2026-05-30

Neoantigen vaccines accelerate across glioblastoma pancreatic and Lynch indications

Clinical activity in personalized neoantigen vaccines is accelerating across glioblastoma, pancreatic, and Lynch syndrome indications, with ZSky Biotech advancing a DC vaccine into Phase II and Nous-209 targeting cancer interception.

On the methodological front, new AI models like tcrLM and PhysicoGPTCR are improving TCR-antigen binding prediction and generative design, while circRNA platforms demonstrate synergistic potential with checkpoint blockade.

30 items19 Clinical1 Commercial10 AI & Methods
Clinical19
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Clinical

QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers.

NantBioScience has completed a Phase 1 study of YE-NEO-001, a personalized neoepitope yeast-based vaccine, in subjects with previously treated solid cancers. The trial evaluated safety, the Recommended Phase 2 Dose (RP2D), and preliminary efficacy as an adjuvant immunotherapy to induce T-cell responses in patients entering surveillance for recurrent disease.

clinicaltrials · 2026-05-07 · NantBioScience, Inc.
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Clinical

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Nervous System Tumors

Washington University School of Medicine is recruiting for a Phase 1 study assessing the safety and feasibility of a personalized DNA vaccine in pediatric patients with recurrent or treatment-resistant central nervous system tumors. This trial targets a population with limited therapeutic options, focusing on the technical feasibility of delivering personalized DNA constructs in this demographic.

clinicaltrials · 2026-05-07 · Washington University School of Medicine
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Clinical

Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery

A completed Phase 1 randomized trial by Washington University School of Medicine evaluated optimized synthetic long peptide (SLP) neoantigen vaccines co-administered with poly-ICLC in pancreatic cancer patients. The study compared vaccine administration following neoadjuvant chemotherapy and surgery versus a window prior to surgery, aiming to assess safety and immunogenicity in the perioperative setting.

clinicaltrials · 2026-05-06 · Washington University School of Medicine
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Clinical

A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins has launched a Phase 1 trial for a DNAJB1-PRKACA fusion kinase peptide vaccine in advanced fibrolamellar carcinoma. The study tests the safety and antitumor activity of this neoantigen vaccine combined with the glutamine antagonist DRP-104, nivolumab, and ipilimumab, with primary endpoints including objective response rate (ORR).

clinicaltrials · 2026-05-06 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Clinical

GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC

Geneos Therapeutics is conducting a Phase I/IIa single-arm study of GNOS-PV02, a personalized neoantigen DNA vaccine, combined with plasmid-encoded IL-12 (INO-9012) and pembrolizumab in advanced hepatocellular carcinoma (HCC). The trial is currently active but not recruiting, focusing on the combination of DNA-based immunization with immune checkpoint inhibition.

clinicaltrials · 2026-04-22 · Geneos Therapeutics
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Clinical

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM

Dana-Farber Cancer Institute is running a Phase 1 trial of a personalized neoantigen cancer vaccine combined with radiation therapy and pembrolizumab for newly diagnosed glioblastoma. The study aims to determine the safety and appropriate dosing of the vaccine, leveraging patient-specific tumor mutations to generate a targeted immunotherapeutic intervention.

clinicaltrials · 2026-04-17 · Dana-Farber Cancer Institute
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Clinical

KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer

The Affiliated Nanjing Drum Tower Hospital is recruiting for a Phase 1/2 trial of a KRAS neoantigen nanovaccine derived from engineered Lactococcus lactis bacterial membranes. The vaccine is administered as adjuvant therapy to post-operative colorectal and pancreatic cancer patients with KRAS mutations, aiming to assess safety, immunogenicity, and preliminary efficacy in preventing recurrence.

clinicaltrials · 2026-04-15 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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Clinical

Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)

Shanghai Jiao Tong University School of Medicine is recruiting for a trial of mRNA-0523-L001, an individualized mRNA neoantigen vaccine, in advanced endocrine tumors including adrenal corticocarcinoma and medullary thyroid carcinoma. The study evaluates safety, tolerability, and preliminary efficacy, including T-cell responses and objective response rates, in patients with failed or no standard treatments.

clinicaltrials · 2026-04-09 · Shanghai Jiao Tong University School of Medicine
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Clinical

A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor

Fudan University is conducting a clinical study of a personalized self-dendritic cell (self-DC) vaccine targeting neoantigens for advanced solid tumors. The trial focuses on the application of autologous dendritic cells loaded with patient-specific neoantigens, representing a distinct delivery platform within the personalized vaccine landscape.

clinicaltrials · 2026-04-02 · Fudan University
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Clinical

Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy

H. Lee Moffitt Cancer Center and Research Institute is recruiting for a Phase I pilot evaluating a personalized dendritic cell vaccine for high-risk triple-negative breast cancer (TNBC). The study utilizes whole exome sequencing of residual tumors post-neoadjuvant chemotherapy to assess safety, feasibility, and immunogenicity.

clinicaltrials · 2026-04-01 · H. Lee Moffitt Cancer Center and Research Institute
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Clinical

Evaluation of the Safety, Tolerability and Efficacy of iNeo-Vac-R01, an Individualized mRNA Therapeutic Technology Based on Tumor Neoantigens, for Adjuvant Treatment in Patients With Biliary Malignant Tumors After Radical Resection

Yifan Wang is leading a Phase I/II trial for iNeo-Vac-R01, an individualized mRNA therapeutic based on tumor neoantigens. The study evaluates safety for adjuvant treatment in patients with biliary malignant tumors after radical resection, marking a move toward mRNA-based personalization in hepatobiliary cancers.

clinicaltrials · 2026-02-03 · Yifan Wang
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Clinical

Neoantigen-Pulsed Autologous Dendritic Cell Vaccine Combined With Temozolomide for Newly Diagnosed Glioblastoma

ZSky Biotech Inc is conducting a multicenter, randomized Phase II study of ZSNeo-DC1.1, a personalized dendritic cell vaccine, combined with temozolomide for newly diagnosed glioblastoma. The trial’s primary endpoint is progression-free survival (PFS) per RANO 2.0 criteria, with exploratory objectives assessing antigen-specific T-cell responses.

clinicaltrials · 2026-01-26 · ZSky Biotech Inc
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Clinical

Personalized neoantigen cancer vaccines: Why clinical benefit remains inconsistent - ScienceDirect.com

A recent analysis in ScienceDirect examines the reasons behind inconsistent clinical benefit in personalized neoantigen cancer vaccines. This review is critical for the industry as it highlights the persistent challenges in translating neoantigen discovery into reliable patient outcomes, underscoring the need for improved predictive models and trial design.

news · 2026-04-12 · ScienceDirect.com
Commercial01
AI & Methods10
01
AI / Methods

DapPep: Domain Adaptive Peptide-agnostic Learning for Universal T-cell Receptor-antigen Binding Affinity Prediction

Researchers introduced DapPep, a domain-adaptive peptide-agnostic learning framework for universal TCR-antigen binding affinity prediction. Using a lightweight self-attention architecture combined with protein language models, DapPep outperforms existing tools in predicting binding for unseen peptides, addressing a key bottleneck in neoantigen vaccine design for data-scarce settings.

arxiv · 2024-11-26 · Jiangbin Zheng, Qianhui Xu, Ruichen Xia, Stan Z. Li
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AI / Methods

tcrLM: a lightweight protein language model for predicting T cell receptor and epitope binding specificity

Researchers introduce tcrLM, a lightweight masked language model for predicting TCR-antigen binding specificity. Pretrained on over 100 million TCR CDR3 sequences with virtual adversarial training, tcrLM outperforms existing methods in predicting binding, offering a computationally efficient tool for neoantigen vaccine design.

arxiv · 2024-06-24 · Xing Fang, Chenpeng Yu, Shiye Tian, Hui Liu
03
AI / Methods

Contact map dependence of a T cell receptor binding repertoire

This study analyzes the contact map dependence of TCR binding repertoires using an affinity-based model. By weighting pairwise amino acid interactions via crystal structure-derived contact maps, the work provides insights into TCR-pMHC binding energy distributions and their influence on T cell recognition probability during negative selection.

arxiv · 2021-12-30 · Kevin Ng Chau, Jason T. George, José N. Onuchic, Xingcheng Lin, Herbert Levine
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AI / Methods

neoantigens enable selective and potent cross-HLA immunotherapy - Nature

Research published in Nature demonstrates that neoantigens can enable selective and potent cross-HLA immunotherapy. This finding supports the biological rationale for neoantigen-based approaches by highlighting their capacity to trigger robust immune responses across diverse HLA types, a key factor in broadening vaccine applicability.

news · 2025-12-17 · Nature
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AI / Methods

Physicochemically Informed Dual-Conditioned Generative Model of T-Cell Receptor Variable Regions for Cellular Therapy

PhysicoGPTCR, a dual-conditioned generative protein Transformer, is introduced for designing TCR variable regions. Trained on TCR-peptide-HLA triples with physicochemical descriptors, the model improves binding-competent clone generation and sequence space exploration compared to baselines like GPTCR and VAEs, advancing computer-aided cellular therapy.

arxiv · 2025-10-07 · Jiahao Ma, Hongzong Li, Ye-Fan Hu, Jian-Dong Huang
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AI / Methods

A circRNA neoantigen vaccine elicits potent antitumor immunity and synergizes with checkpoint blockade in melanoma.

A new study demonstrates that a circRNA neoantigen vaccine (circRNAMNA) encoding melanoma neoantigens suppresses tumor growth and synergizes with checkpoint blockade. Single-cell RNA sequencing reveals that the vaccine reshapes the immune microenvironment by increasing infiltration of antitumor monocytes/macrophages and eliminating specific tumor subclusters.

europepmc · 2026-03-27 · Wu P, Ge J, Hou X, Qu H, Ouyang J, Wang D, Tong T, Meng Y, Yan Q, Shi L, Gong Z, Chen P, X
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