ONCR-177, our lead candidate, is an intratumorally administered oncolytic 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).

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 > 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, ONCR-177 demonstrated clinical benefit in several heavily pretreated 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 an oncolytic virus 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 oncolytic Herpes Simplex Virus platform.

Our lead synthetic 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 Synthetic vRNA Platform, including our novel liquid 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 synthetic viral genome to tumors, leading to production of a replication-competent virus within the 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 the first half of 2023.

ONCR-788, our second synthetic 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 Synthetic vRNA Platform.

ONCR-788 will utilize shared formulation and manufacturing strategies with our lead synthetic viral immunotherapy candidate, ONCR-021, enabling efficiencies in product candidate development.

Development Status

In preclinical models, we have demonstrated proof of concept that ONCR-788, when administered intravenously, is able to successfully deliver a synthetic viral genome to tumors leading to production of a replication-competent virus within the tumors that causes tumor growth inhibition.

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