Tavo (tavokinogene telsaplasmid)

P1, N=16, Terminated, Providence Health & Services | Completed --> Terminated; Study was ended prematurely due to lack of efficacy. As per FDA guidance, our site continued to follow enrolled subjects through the 180 day safety visit.

The clinical efficacy of neoadjuvant IT TAVO-EP + nivolumab is promising with 80% of patients achieving an MPR. Evidence of potent immune activation both systemically and within the TME along with a favorable safety profile supports the activity of local IL-12 and anti-PD1 based regimens.

P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2025 --> Jun 2028 | Trial primary completion date: Jul 2023 --> Jun 2028

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

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.

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

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

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.

P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=33 --> 17

P2; Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Apr 2024

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

P2, N=143, Recruiting, OncoSec Medical Incorporated | Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2023

There was evidence of significantly enhanced immune activation supporting the proposed immune mechanisms. Analyses of additional biomaterials are underway.

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.

Sponsored by OncoSec TAVO (IL-12) Intralesional Therapy Durable Responses in PD-1 Progressing Advanced Melanoma: Clinical Significance and Practicality of the Data

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.

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

P2, N=125, Recruiting, OncoSec Medical Incorporated | Trial completion date: Dec 2021 --> Jul 2023 | Trial primary completion date: Dec 2020 --> Dec 2022

P2, N=65, Recruiting, OncoSec Medical Incorporated | Active, not recruiting --> Recruiting

P2, N=65, Active, not recruiting, OncoSec Medical Incorporated | Trial completion date: Jan 2024 --> Aug 2024 | Trial primary completion date: Jul 2023 --> Dec 2023

P2, N=100, Recruiting, OncoSec Medical Incorporated | Trial completion date: Dec 2020 --> Dec 2021

P2, N=24, Completed, University of California, San Francisco | Active, not recruiting --> Completed

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

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.