Pipeline

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.

Development Status

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.

Leveraging our HSV platform, we are pursuing a viral immunotherapy, ONCR-GBM, to specifically target brain cancer, including glioblastoma multiforme. We are utilizing our knowledge of microRNA expression to engineer a microRNA attenuation strategy to protect healthy brain tissue and select a combination of payloads that address the specific drivers of immune suppression in brain cancer.

Development Status

We continue to conduct preclinical studies of ONCR-GBM and advance this program toward the clinic.

Learn more about our Herpes Simplex Virus platform.

Our lead selectively self-amplifying viral RNA (vRNA) immunotherapy program, ONCR-021, encodes an optimized strain of the coxsackievirus A21 (CVA21). We selected to advance ONCR-021 based on a number of CVA21’s properties, including:

• Demonstrated safety and tolerability after intravenous (IV) administration in patients
• Ability to replicate in solid tumors, including lung tumors
• Inability to insert into host chromosome, eliminating the potential of insertional mutagenesis

Learn more about our selectively self-amplifying vRNA Platform, including our novel lipid nanoparticle (LNP) delivery strategy designed to overcome the challenges caused by neutralizing antibodies that have likely limited the efficacy of prior efforts to treat tumors utilizing IV administration of CVA21. 

Development Status

In preclinical models, we have demonstrated proof of concept that ONCR-021 when administered intravenously, is able to successfully deliver a selectively self-amplifying viral genome to tumors, leading to production of replication-competent virions within tumors that causes tumor growth inhibition.

We plan to file an investigational new drug (IND) application for ONCR-021 with the U.S. Food and Drug Administration in mid-2023.

ONCR-788, our second selectively self-amplifying vRNA immunotherapy product candidate, encodes a modified version of the Seneca Valley Virus (SVV).

We are advancing this program based on the acceptable safety and tolerability demonstrated by the intravenous (IV) administration of SVV in previously conducted early clinical trials.

Learn more about our selectively self-amplifying vRNA Platform.

Development Status

In preclinical models, we have demonstrated proof of concept that ONCR-788, when administered intravenously, is able to successfully deliver a selectively self-amplifying viral genome to tumors leading to production of replication-competent virions within tumors that stimulates the immune system and causes tumor growth inhibition.

We plan to file an investigational new drug application for ONCR-788 with the U.S. Food and Drug Administration following the IND filing of our lead vRNA candidate, ONCR-021.