^
    5d
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Feb 2025 --> Jul 2025 | Trial primary completion date: Feb 2025 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    2ms
    Tumoral and systemic immune modulation with neoadjuvant (NeoAd) intratumoral (IT) TAVO-EP (plasmid IL-12 electro gene transfer) and nivolumab (NIVO) in patients (pts) with operable locoregionally advanced melanoma (AACR 2024)
    At baseline, most patients exhibited low CD8+ TIL, PD-L1 and TIS, with enhanced immune activation following treatment in the TME and blood including increased immune-related gene expression, CD8+ TIL, peritumoral CD8+ T cells and TIS. Four of 5 pts with negative predictive baseline biomarkers [CD8+TIL/PD-L1/TIS]low experienced pCRs supporting activity of IL12/anti-PD1 based regimens in this setting.
    Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • JAK1 (Janus Kinase 1) • IL2 (Interleukin 2)
    |
    CD8 expression
    |
    PD-L1 IHC 22C3 pharmDx • nCounter® PanCancer IO 360™ Panel
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    2ms
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    5ms
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2023 --> Feb 2024 | Trial primary completion date: Nov 2023 --> Feb 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    10ms
    Neoadjuvant (NeoAd) intratumoral (IT) TAVO-EP (plasmid IL-12 electro gene transfer) in combination with nivolumab (NIVO) for patients (pts) with operable locoregionally advanced melanoma (ESMO 2023)
    Conclusions NeoAd IT TAVO-EP and iv NIVO exhibited promising clinical activity and a favorable safety profile. Enhanced immune activation in responding patients supports the proposed immune mechanisms.
    Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CD8 expression
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    11ms
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=33 --> 17
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    12ms
    KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Apr 2024
    Combination therapy • Trial primary completion date • Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • albumin-bound paclitaxel • Tavo (tavokinogene telsaplasmid)
    1year
    KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov)
    P2, N=143, Active, not recruiting, OncoSec Medical Incorporated | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Mar 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    over1year
    KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov)
    P2, N=143, Recruiting, OncoSec Medical Incorporated | Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    over1year
    Neoadjuvant intratumoral TAVO-EP (plasmid IL-12 electro gene transfer) in combination with nivolumab; preliminary clinical and biomarker data in patients with operable locoregionally advanced melanoma (SITC 2022)
    There was evidence of significantly enhanced immune activation supporting the proposed immune mechanisms. Analyses of additional biomaterials are underway.
    Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL7R (Interleukin 7 Receptor) • KLRG1 (Killer Cell Lectin Like Receptor G1)
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    almost2years
    Amplification of the CXCR3/CXCL9 axis via intratumoral electroporation of plasmid CXCL9 synergizes with plasmid IL-12 therapy to elicit robust anti-tumor immunity. (PubMed, Mol Ther Oncolytics)
    Collectively, these data demonstrate that a functional tumoral CXCR3/CXCL9 axis is critical for IL-12 anti-tumor efficacy. Furthermore, restoring or amplifying the CXCL9 gradient in the tumors via intratumoral electroporation of plasmid CXCL9 can not only result in efficient trafficking of cytotoxic CD8 T cells into the tumor but can also reshape the microenvironment to promote systemic immune response.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CXCR3 (C-X-C Motif Chemokine Receptor 3)
    |
    IFNG expression
    |
    Tavo (tavokinogene telsaplasmid)
    over2years
    [VIRTUAL] Updated Clinical Data from KEYNOTE-695 (SITC 2021)
    Sponsored by OncoSec TAVO (IL-12) Intralesional Therapy Durable Responses in PD-1 Progressing Advanced Melanoma: Clinical Significance and Practicality of the Data
    Clinical data
    |
    PD-1 (Programmed cell death 1)
    |
    Tavo (tavokinogene telsaplasmid)
    over2years
    Durable responses with intratumoral electroporation of plasmid interleukin-12 plus pembrolizumab in patients with advanced triple-negative breast cancer: Cohort 1 update from KEYNOTE-890 (SABCS 2021)
    The combination of TAVO-EP and pembrolizumab in pretreated patients with advanced TNBC resulted in durable RECIST v1.1 responses, including in PD-L1-negative disease, and was well tolerated. This novel immunotherapeutic regimen warrants further evaluation in 2L+ advanced TNBC. Cohort 2 exploring TAVO‑EP + pembrolizumab + chemotherapy in frontline TNBC is currently enrolling.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Tavo (tavokinogene telsaplasmid)
    over2years
    Trial in progress: Phase 2 study of intratumoral plasmid interleukin-12 (tavokinogene telseplasmid; TAVO™) plus electroporation in combination with pembrolizumab with or without chemotherapy in patients with inoperable locally advanced or metastatic triple-negative breast cancer (KEYNOTE-890/OMS-I141) (SABCS 2021)
    Patients will receive pembrolizumab (200 mg IV) every 3 weeks, TAVO-EP (0.5 mg/mL at dose volume of ~1/4 lesion volume) on Days 1, 5, and 8 every 6 weeks, and nab‑paclitaxel (100 mg/m 2 IV) on Days 1, 8, and 15 every 4 weeks. Based on positive efficacy data in Cohort 1, additional cohorts are being planned and will be presented. ClinicalTrials.gov: NCT03567720
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • Tavo (tavokinogene telsaplasmid)
    over3years
    KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov)
    P2, N=125, Recruiting, OncoSec Medical Incorporated | Trial completion date: Dec 2021 --> Jul 2023 | Trial primary completion date: Dec 2020 --> Dec 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    over3years
    KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov)
    P2, N=65, Recruiting, OncoSec Medical Incorporated | Active, not recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    PD-L1 expression • HER-2 negative
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • Tavo (tavokinogene telsaplasmid)
    over3years
    KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, OncoSec Medical Incorporated | Trial completion date: Jan 2024 --> Aug 2024 | Trial primary completion date: Jul 2023 --> Dec 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    PD-L1 expression • HER-2 negative
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • Tavo (tavokinogene telsaplasmid)
    over3years
    KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov)
    P2, N=100, Recruiting, OncoSec Medical Incorporated | Trial completion date: Dec 2020 --> Dec 2021
    Clinical • Trial completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    almost4years
    Trial of pIL-12/MK-3475 in Metastatic Melanoma (clinicaltrials.gov)
    P2, N=24, Completed, University of California, San Francisco | Active, not recruiting --> Completed
    Clinical • Trial completion
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Tavo (tavokinogene telsaplasmid)
    almost4years
    KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, OncoSec Medical Incorporated | Recruiting --> Active, not recruiting | N=25 --> 65 | Trial completion date: Jan 2020 --> Jan 2024 | Trial primary completion date: Jan 2020 --> Jul 2023
    Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    PD-L1 expression • HER-2 negative
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • Tavo (tavokinogene telsaplasmid)
    almost4years
    [VIRTUAL] Intratumoral electroporation of plasmid-encoded IL-12 and membrane-bound anti-CD3 increases tumor immunogenicity and augments the function of T cell subsets (AACR-II 2020)
    Intratumoral (IT) delivery of plasmid IL-12 (tavokinogene telseplasmid; tavo) via electroporation (EP), collectively referred as IT-tavo-EP, generates immunologically-relevant levels of localized IL-12, triggering regression of both treated and distant tumors with minimal toxicity in preclinical and clinical studies...Moreover, functional restoration of TIL isolated from a melanoma patient with active clinical progression on anti-PD-1 therapy, was possible with engagement of membrane-bound αCD3 in the presence of IL-12. Collectively, these data continue to support the utility of IT-tavo-αCD3-EP as a promising therapeutic approach for patients with melanoma and other accessible solid tumors.
    Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • GZMB (Granzyme B)
    |
    CD8 expression
    |
    Tavo (tavokinogene telsaplasmid)