Vigil (gemogenovatucel-T)

These results demonstrate OS advantage for maintenance treatment of adult females with newly diagnosed, advanced stage IIIb-IV ovarian cancer with HRP status and cTMB-H profile who are in complete response after debulking surgery and frontline platinum-based doublet chemotherapy.

P2, N=92, Active, not recruiting, Gradalis, Inc. | Trial completion date: Dec 2025 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2028

P2, N=39, Completed, Gradalis, Inc. | N=145 --> 39

Correlation between tumor and Vigil for the cNEO and ITH metrics, showed R2 values of 0.95 and 0.87, respectively. The consistency of the Clonal Neoantigen pipeline results with previously published data as well as the agreement between results for tumor and Vigil for the entire system provide a strong basis of support for utilization of this pipeline for prospective determination of cTMB, cNEO, and ITH values in clinical tumor tissue in order to explore possible correlative relationships with clinical response parameters.

RADD revealed DNA repair proficiency without mutation signatures or expression profiling. High DNA damage levels show improved survival for Vigil maintenance therapies and are correlated with immune evasion proteins. The persistence of DNA lesions in the genomic DNA offers a new biomarker for immunotherapy patient stratification.

Transfected plasmid components contain an expressive human GMCSF DNA segment to enhance anticancer immune functional response and a second component expressing bi-shRNAfurin which reduces TGFβ isomers (TGFβ1 and TGFβ2) thereby reducing cancer inhibition of the targeted immune response. Results generated to date justify advancement to confirmatory clinical trials supporting product regulatory approval.

Vigil is an autologous cellular immunotherapy which is designed to carry the full set of personal clonal neoantigens. Phase 2b results demonstrate a durable recurrence-free survival (RFS) and overall survival (OS) advantage for Vigil in a subset ovarian cancer population with an HRP cancer profile.

We have consolidated information regarding the role of the immune system in both disease progression and disease clearance with the aid of targeted therapies and immunotherapeutic agents. Additionally, we have characterized the treatment modalities currently indicated as the standard of care-such as bevacizumab and the immune CPIs-and those recently approved or in development, including Tivdak, Vigil, and chimeric antigen receptor (CAR) T-cells.

P2, N=92, Active, not recruiting, Gradalis, Inc. | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023

NSA should be considered for application to investigational targeted therapies in order to identify populations most likely to benefit from treatment, in preparation for efficacy conclusive trials.

Results demonstrated safety of combination Vigil/TEM/IRI.

P2, N=25, Completed, Gradalis, Inc. | Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> May 2022