Neo Vax (NEO-PV-01)

P1, N=11, Active, not recruiting, Dana-Farber Cancer Institute | N=20 --> 11

P1, N=19, Active, not recruiting, Patrick Ott, MD, PhD | Trial completion date: Sep 2026 --> May 2030

P1, N=56, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Jan 2026 --> Jun 2026 | Trial primary completion date: Jan 2025 --> Jun 2025

P1, N=22, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2024 --> Apr 2025

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.

P1, N=30, Recruiting, Dana-Farber Cancer Institute | N=20 --> 30

P1, N=20, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Mar 2026 --> Dec 2033

P1, N=20, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting

P1, N=20, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting

P1, N=19, Active, not recruiting, Patrick Ott, MD, PhD | Recruiting --> Active, not recruiting

P1, N=15, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Mar 2025 --> Mar 2028 | Trial primary completion date: Mar 2023 --> Mar 2026

Here, we report the clinical and immune data from a Phase Ib clinical trial of a personalized neoantigen-vaccine NEO-PV-01 in combination with pemetrexed, carboplatin, and pembrolizumab as first-line therapy for advanced non-squamous non-small cell lung cancer (NSCLC). Neoantigen-specific CD4 T cells generated post-vaccination revealed effector and cytotoxic phenotypes with increased CD4 T cell infiltration in the post-vaccine tumor biopsy. Collectively, these data support the safety and immunogenicity of this regimen in advanced non-squamous NSCLC.

report a phase 1b clinical trial combining a personalized vaccine NEO-PV-01 with chemotherapy and anti-PD-1 pembrolizumab in first-line metastatic non-squamous NSCLC. They demonstrate that this treatment regimen was well tolerated and induced neoantigen-specific CD4 T cell responses with effector phenotype.

P1, N=20, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting

P1, N=20, Not yet recruiting, Dana-Farber Cancer Institute | Trial completion date: Mar 2025 --> Feb 2026 | Trial primary completion date: Mar 2023 --> Feb 2024

P1, N=20, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Sep 2026 --> Sep 2028 | Trial primary completion date: Dec 2021 --> Dec 2023

P1, N=56, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Aug 2022 --> Jan 2026 | Trial primary completion date: Dec 2021 --> Jan 2025

P1, N=15, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting

P1, N=15, Not yet recruiting, Dana-Farber Cancer Institute | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2021 --> Mar 2023

NEO-PV-01 in combination with pembrolizumab and carboplatin/pemetrexed has a good safety profile and induces de novo immune responses in first-line non-squamous NSCLC. The association of baseline disease characteristics to prolonged PFS suggests future patient enrichment strategies for evaluation of this novel regimen in a phase 2 trial.

P1, N=34, Completed, BioNTech US Inc. | N=55 --> 34

P1, N=15, Not yet recruiting, Dana-Farber Cancer Institute | N=10 --> 15

P1, N=56, Recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Aug 2021 --> Dec 2021

Here, we report the first open-label, phase Ib clinical trial of a personalized neoantigen-based vaccine, NEO-PV-01, in combination with PD-1 blockade in patients with advanced melanoma, non-small cell lung cancer, or bladder cancer...In addition, epitope spread to neoantigens not included in the vaccine was detected post-vaccination. These data support the safety and immunogenicity of this regimen in patients with advanced solid tumors (Clinicaltrials.gov: NCT02897765).

P1, N=10, Not yet recruiting, Dana-Farber Cancer Institute | Trial completion date: Dec 2024 --> Jan 2024 | Trial primary completion date: Dec 2021 --> Jan 2021

P1, N=10, Not yet recruiting, Dana-Farber Cancer Institute | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2021 --> Dec 2021

P1, N=55, Completed, Neon Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> May 2020 | Trial primary completion date: Dec 2020 --> Feb 2020

P1, N=3, Active, not recruiting, Washington University School of Medicine | Suspended --> Active, not recruiting | N=30 --> 3 | Trial completion date: Nov 2023 --> Feb 2021 | Trial primary completion date: Jul 2021 --> May 2020

P1, N=30, Suspended, Washington University School of Medicine | Recruiting --> Suspended