iNeo-Vac-P01 / Hangzhou Neoantigen Therap - LARVOL DELTA

Neoantigen Vaccine in Esophagus Cancer Patients Following Neoadjuvant Therapy and Surgical Resection (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting ➔ Active, not recruiting | N=40 ➔ 27 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Esophageal Cancer • Oncology

First-in-Human Study of a Personalized Neoantigen Peptide Vaccine (iNeo-Vac-P01) for Postoperative Esophageal Cancer in a Chinese Cohort (SITC 2025) - P1 | "These outcomes compare favorably with historical controls: the 3-year RFS rate of 73.8% in this study exceeds the 43% reported in CheckMate 577 (nivolumab) and 38.5% in a real-world PD-1-based adjuvant cohort. Written informed consent was obtained from the patients before taking part.Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

First-in-human • Late-breaking abstract • P1 data • Tumor-specific neoantigens • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • CSF2

A Clinical Study on iNeo-Vac-P01: A Personalized Neoantigen Immunotherapy for Postoperative Recurrence Prevention in Pancreatic Cancer (SITC 2025) - P1 | "All participants gave informed consent before taking part.Consent Written informed consent was obtained from the patients for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the editor of this journal."

Clinical • IO biomarker • Tumor mutational burden • Tumor-specific neoantigens • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CSF2 • TMB

Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Zhejiang University

New P1/2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Combination treatment of radiofrequency ablation and peptide neoantigen vaccination: Promising modality for future cancer immunotherapy. (ASCO 2022) - P1 | "Background: We previously reported the safety and immunogenicity of a personalized neoantigen-based peptide vaccine, iNeo-Vac-P01, in patients with a variety of cancer types... Neoantigen vaccination after RFA treatment led to an overall increase in clinical response and immune response among patients of different cancer types. Combination treatment of both modalities in mice further validated their synergistic antitumor potentials, which could be further enhanced by the addition of anti-PD-1. The mechanisms of their synergies require further investigation."

Tumor-specific neoantigens • Oncology • CSF2 • IFNG

Combination treatment of radiofrequency ablation and peptide neoantigen vaccination: Promising modality for future cancer immunotherapy. (PubMed, Front Immunol) - P1 | "The safety and immunogenicity of a personalized neoantigen-based peptide vaccine, iNeo-Vac-P01, was reported previously in patients with a variety of cancer types...The mechanisms of their synergies require further investigation. https://clinicaltrials.gov/, identifier NCT03662815."

Journal • Tumor-specific neoantigens • Immune Modulation • Inflammation • Oncology • IFNG

Neoantigen Vaccine in Esophagus Cancer Patients Following Neoadjuvant Therapy and Surgical Resection (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P1 trial • Esophageal Cancer • Gastrointestinal Cancer • Oncology

Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Malignant Tumor (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Sir Run Run Shaw Hospital; Trial completion date: Mar 2021 ➔ Dec 2022

Clinical • Trial completion date • Oncology • Solid Tumor

INEO-P-001: Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1; N=7; Completed; Sponsor: Zhejiang Provincial People's Hospital; Recruiting ➔ Completed; N=20 ➔ 7; Trial completion date: Nov 2020 ➔ Apr 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Zhejiang Provincial People's Hospital; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

[VIRTUAL] A peptide-based neoantigen vaccine for patients with advanced pancreatic cancer refractory to standard treatment. (ASCO 2021) - P1 | "Seven patients with advanced pancreatic cancer refractory to standard treatments were enrolled and treated with personalized peptide neoantigen vaccine, iNeo-Vac-P01... We believed that it was the first tentative study focused in the application of peptide-based neoantigen cancer vaccine in advanced pancreatic cancer . Promisingly, personalized peptide neoantigen vaccine might provide a new strategy to improve the limited clinical efficacy for pancreatic cancer."

Clinical • IO biomarker • Tumor-specific neoantigens • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • IFNG • TMB

A Neoantigen-Based Peptide Vaccine for Patients With Advanced Pancreatic Cancer Refractory to Standard Treatment. (PubMed, Front Immunol) - P1 | "As one of the earliest studies that addressed an issue in treating pancreatic cancer with personalized vaccines, it has been demonstrated that iNeo-Vac-P01, a personalized neoantigen-based peptide vaccine, could improve the currently limited clinical efficacy of pancreatic cancer. ClinicalTrials.gov, identifier (NCT03645148).Registered August 24, 2018 - Retrospectively registered."

Clinical • Journal • Tumor-specific neoantigens • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • IFNG • TMB

Clinical Study of a Personalized Neoantigen Cancer Vaccine Combined With Anti-PD-1 and RFA in Patients With Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Sir Run Run Shaw Hospital

Clinical • IO biomarker • New P1 trial • Oncology • Solid Tumor • CD4 • CD8

Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Zhejiang Provincial People's Hospital

Clinical • New P1 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A pan-cancer clinical study of personalized neoantigen vaccine monotherapy in treating patients with various types of advanced solid tumors. (PubMed, Clin Cancer Res) - P1 | "iNeo-Vac-P01 as monotherapy is feasible and safe for patients with advanced solid tumors. It could elicit T cell-mediated immune response targeting tumor neoantigens, and might have promising antitumor efficacy."

Clinical • IO Biomarker • Journal • Monotherapy • Pan Tumor • Tumor-specific neoantigens • Allergy • Oncology • Solid Tumor