Neo Vax (NEO-PV-01) / BioNTech - LARVOL DELTA

Personalized Neoantigen Vaccines Synergize with Immune Checkpoint Therapy and CD8-Targeted Cytokines to Control B-Cell Lymphoma. (PubMed, bioRxiv) - "This vaccine (A20 neoVAX) promoted robust neoAg-specific CD4□ and CD8□ T cell responses in naïve syngeneic BALB/c mice and induced tumor rejection in ∼70% of subcutaneous tumor-bearing mice...In similar experiments in which CD8-IL21 was substituted for CD8-IL2, tumor clearance was also observed in two-thirds of A20-bearing mice but now rejection occurred in the absence of αPD1. Together, these data define a framework for optimal personalized neoAg vaccination in B-lymphoma and demonstrate that neoAg vaccines can safely synergize with CD8 + T cell-selective immunotherapies to prevent T-cell dysfunction and generate durable systemic anti-tumor immunity."

Journal • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD4 • CD8 • IL2 • IL21

DNA, Peptide Vaccines Advance Against GBM. (PubMed, Cancer Discov) - "Phase I trial findings indicate that two different personalized vaccine strategies, DNA-based GNOS-PV01 and peptide-based NeoVax, may be promising strategies for patients with glioblastoma. Notably, the former is effective against MGMT-unmethylated glioblastoma, a subtype for which the prognosis is particularly poor."

Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL. (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Mar 2028 ➔ Jul 2028

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • IGH

Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Pan tumor • Oncology • Solid Tumor

Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: West China Hospital

New P1 trial • Pan tumor • Oncology • Solid Tumor

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Recruiting ➔ Active, not recruiting | N=30 ➔ 10 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment change • Enrollment closed • Trial primary completion date • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Feb 2027 ➔ Feb 2028 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

NeoVax Plus Ipilimumab in Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Patrick Ott, MD, PhD | Trial primary completion date: Jan 2026 ➔ Dec 2027

Trial primary completion date • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Jun 2026 ➔ Feb 2027 | Trial primary completion date: Jun 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL. (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial primary completion date: Mar 2026 ➔ May 2027

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • IGH

SELECTION OF TARGETED NEOANTIGENS FOR ONGOING PERSONALIZED CANCER VACCINE TRIALS AT DANA FARBER CANCER INSTITUTE (IMMUNOLOGY 2025) - P1 | "For the PCV platform (NeoVax), we design up to 24 synthetic long peptides, eighteen to thirty-two amino acids in length...For future iterations, we aim to enhance pipeline by including novel classes of neoantigens, such as those derived from endogenous human retroviruses, fusion epitopes, novel or unannotated open reading frames (nuORFs), and neoantigens identified through immunopeptidome analysis. The neoantigen selection pipeline is currently supporting seven cancer vaccine trials at DFCI.Keywords: Animals Human; Cells T Cells; Molecules Antigens/Peptides/Epitopes MHC; Processes Antigen Presentation/Processing"

Tumor-specific neoantigens • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioblastoma • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Personalized Neoantigen Cancer Vaccine + Pembrolizumab After Rituximab for Follicular Lymphoma (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial primary completion date: Feb 2024 ➔ Dec 2026

Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Jan 2027 ➔ Sep 2030 | Trial primary completion date: Jan 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

NeoVax Plus Ipilimumab in Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Patrick Ott, MD, PhD | Trial primary completion date: Dec 2024 ➔ Jan 2026

Trial primary completion date • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | N=20 ➔ 11

Combination therapy • Enrollment change • Metastases • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

NeoVax Plus Ipilimumab in Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Patrick Ott, MD, PhD | Trial completion date: Sep 2026 ➔ May 2030

Trial completion date • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Jan 2026 ➔ Jun 2026 | Trial primary completion date: Jan 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT

NeoVax With Nivolumab in Patients With Ovarian Cancer (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2024 ➔ Apr 2025

Enrollment closed • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

Integrating multisector molecular characterization into personalized peptide vaccine design for patients with newly diagnosed glioblastoma. (PubMed, Clin Cancer Res) - "Collectively, our findings suggest NeoVax did stimulate expansion of neoantigen-specific effector T cells and provide encouraging results to aid in the development of future neoantigen vaccine-based clinical trials in patients with GBM. Herein, we demonstrate the feasibility of incorporating multisector sampling in cancer vaccine design and provide information on the clinical applicability of clonality, distribution, and immunogenicity of the neoantigen landscape in GBM patients."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IFNG

NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Dana-Farber Cancer Institute | N=20 ➔ 30

Combination therapy • Enrollment change • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

Personalized Neoantigen Cancer Vaccine + Pembrolizumab After Rituximab for Follicular Lymphoma (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Mar 2026 ➔ Dec 2033

Combination therapy • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Melanoma • Oncology • Solid Tumor

Personalized Neoantigen Cancer Vaccine + Pembrolizumab After Rituximab for Follicular Lymphoma (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

NeoVax Plus Ipilimumab in Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Patrick Ott, MD, PhD | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor