Herpes Simplex Virus
ONCR-177, our lead product candidate, is an intratumorally administered Herpes Simplex Virus (HSV) viral immunotherapy for the treatment of multiple solid tumor cancers. ONCR-177 fights tumors through multiple mechanisms, including inherent oncolytic activity, immune stimulation elicited by viral infection and the expression of five transgenes (IL-12, CCL4, FLT3LG, anti-PD-1 and anti-CTLA-4).
Learn more about our HSV Platform.
We are currently enrolling patients in a Phase 1, open-label, multi-center, dose-escalation and expansion study designed to evaluate the safety and tolerability and to determine the recommended Phase 2 dose as well as preliminary anti-tumor activity of ONCR-177 alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in adult subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors (ClinicalTrials.gov Identifier: NCT04348916). In addition, we are enrolling and currently dosing separate cohorts of patients with visceral tumors in the liver with the goal of showing additional safety data. We dosed the first patients in the combination arm of the trial in late 2021, with the goal of identifying tumor types that are suitable for dosing in randomized registration-directed trials in combination with KEYTRUDA.
Clinical Findings to Date
In November 2021, at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting, we presented initial findings from the ongoing Phase 1 study, including the fully enrolled and completed surface lesion monotherapy dose escalation part of the study. ONCR-177 was well tolerated with no dose-limiting toxicities or treatment related adverse events exceeding Grade 2. We also reported determination of the recommended Phase 2 dose for the surface lesion monotherapy dose expansion and surface lesion combination dose expansion (ONCR-177 + KEYTRUDA) parts of the study. In addition, as of the relevant cut-off date for the SITC presentation, ONCR-177 demonstrated clinical benefit in three of eight heavily pretreated and evaluable patients across multiple tumor types, and preliminary, biomarker evidence of systemic immune activation.
Link here for the SITC 2021 poster presentation.
Link here for the SITC 2021 press release.
For more information about the ongoing ONCR-177 Phase 1 study, please visit: https://clinicaltrials.gov/ct2/show/NCT04348916.