INO-5150 / Inovio - LARVOL DELTA

INO-5150 (PSA and PSMA) +/- INO-9012 (IL-12) immunotherapy in biochemically relapsed prostate cancer (ESMO-IO 2017) - P1; "Data demonstrated both PSA and PSMA are immunogenic and INO-5150 induced cellular immune responses. Additional analyses and follow-up are ongoing to further elucidate the correlation of immunologic efficacy and clinical benefit that has been initially observed."

Adverse events • Clinical • Prostate Cancer

Synthetic DNA Immunotherapy in Biochemically Relapsed Prostate Cancer (ESMO 2018) - P1; "INO-5150 +/- INO-9012 was safe, well tolerated and immunogenic. Clinical efficacy was observed in the patients with D0 PSADT≤ 12 mos as evidenced by a significant dampening of log2PSA change over time and increased PSADT up to 72 weeks FU. Additional genomic analyses are ongoing to further elucidate the correlation of immunologic efficacy and clinical benefit."

Prostate Cancer

Safety and immunogenicity of a DNA-vaccine immunotherapy in men with biochemically (PSA) relapsed prostate cancer (ESMO 2017) - P1; "INO-5150 +/- INO-9012 was safe at dosages examined. Data demonstrated both PSA and PSMA are immunogenic and INO-5150 induced cellular immune responses. Higher proportion of arm A pts showed immunological responses as well as improvements in PSA DT, specifically pts with DT ≤ 12 mos suggesting correlation of immunological efficacy and clinical benefit."

Adverse events • Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

A clinical trial for the safety and immunogenicity of a DNA-based immunotherapy in men with biochemically (PSA) relapsed prostate cancer. (ASCO-GU 2017) - P1; "Background: Introducing amino acid sequence changes in highly expressed self-antigens for androgen sensitive prostate cancer pts might be sufficient to break tolerance, thus a DNA vaccine was developed using SynCon PSA and PSMA (INO-5150) that share 96.8 and 91.6% sequence identities to these native antigens, respectively. INO-5150 (+) or (-) INO-9012 is generally safe and well-tolerable at all 4 dose levels in a biochemically relapsed prostate cancer patient population."

Adverse events • Clinical • Pain • Prostate Cancer

A clinical trial for the safety and immunogenicity of a DNA-based immunotherapy in men with biochemically (PSA) relapsed prostate cancer. (ASCO 2017) - P1; "We evaluated a DNA vaccine (INO-5150) including SynCon PSA and PSMA. INO-5150 (+) and (-) INO-9012 was generally safe and well-tolerated at all 4 dose levels in this patient population. Preliminary data suggest PSA stabilization in some patients. Immune analyses are ongoing."

Adverse events • Clinical • Biosimilar • Pain • Prostate Cancer

[VIRTUAL] Immunotherapy targeting PSA and PSMA in patients with biochemically recurrent prostate cancer expands antigen-specific T cell receptor repertoire in a PhI/II trial (AACR-II 2020) - "Treatment with INO-5150 +/- INO-9012 in PCa patients drove the expansion of a diverse pool of antigen specific T cells with a high Shannon’s Entropy value suggesting high TCR diversity. Patients with immune reactivity by flow cytometry were more likely to have a higher frequency of PSA/PSMA specific TCRs that expanded >10 fold over their pre-treatment value; however patients without immune reactivity also demonstrated expansion in TCRs. These data suggest that INO-5150 induced PSA/PSMA specific T cells and that TCR sequencing is a valuable tool for assessment of immune responses induced by immunotherapy that does not bias towards a specific T cell function."

Clinical • Late-breaking abstract • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • IL12A • KLK3 • PD-1

Evaluation of an immunotherapeutic DNA-vaccine in biochemically relapsed prostate cancer. (ASCO 2018) - P1; "INO-5150 +/- INO-9012 was safe, well tolerated and immunogenic. A clinical effect was demonstrated by evidence of dampening % rise in PSA and increased PSADT in the majority of patients. In patients with no known disease progression during the study, a significant PSA stabilizing effect of the immunotherapy was observed."

Prostate Cancer

Dr. Shore on Challenges with ADT in Recurrent Prostate Cancer (OncLive) - "Neal D. Shore, MD, FACS...discusses challenges with androgen deprivation therapy (ADT) in recurrent prostate cancer....This unmet need served as the basis for a phase 1/2, open-label, multicenter study that assessed INO-5150, a DNA-based immune therapy, with or without INO-9012, in patients with biochemically recurrent prostate cancer, Shore concludes."

Video

Dr. Shore on Benefits of Immunotherapy INO-5150 in Recurrent Prostate Cancer (YouTube) - "​Neal D. Shore, MD, FACS, discusses the potential benefits of the immunotherapy INO-5150 for patients with biochemically recurrent prostate cancer."

Video

Dr. Shore on Immunotherapy Targeting PSA and PSMA in Biochemically Recurrent Prostate Cancer (OncLive) - P=NA, N=19; "Neal D. Shore, MD, FACS...discusses immunotherapy targeting prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA) in biochemically recurrent prostate cancer....Peripheral blood mononuclear cells were collected before and after treatment from a subset of patients (n=19) and stimulated with PSA or PSMA peptides, negative or positive controls.....Although the approach may not be a full-proof way to avoid T-cell suppression, it could help delay the time to androgen deprivation therapy, concludes Shore."

Clinical data • Video

Inovio’s cancer immunotherapy (INO-5150) slowed PSA rise and significantly increased PSA doubling times in patients with recurrent prostate cancer - "Dr. Neil Shore, MD...said, 'Immunotherapy is an exciting new approach being evaluated for the treatment of many cancers including prostate cancer, where a small subset of patients have been shown to demonstrate clinical benefit from such therapy in the form of checkpoint inhibitors....Our results suggest that further evaluation of this product in prostate cancer patients should be explored.'"

Media quote • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

CD8 T Cells Impact Rising PSA in Biochemically Relapsed Cancer Patients Using Immunotherapy Targeting Tumor-Associated Antigens. (PubMed, Mol Ther) - "INO-5150 is a synthetic DNA therapy that includes plasmids encoding for prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA), and INO-9012 is a synthetic DNA plasmid encoding for interleukin-12 (IL-12). Immunogenicity was observed in 76% (47/62) of patients by multiple assessments. Analysis indicated that CD38 and perforin co-positive CD8 T cell frequency correlated with attenuated PSA rise (p = 0.05, n = 50)."

Clinical • Journal