Pipeline

We are developing a differentiated portfolio of intratumorally and intravenously administered oncolytic virus therapies across our oncolytic Herpes Simplex Virus (oHSV) and Synthetic viral RNA (vRNA) Immunotherapy Platforms. This will enable us to pursue multiple indications with the potential to help transform outcomes for more cancer patients.
Development Stage
Platform
Research
Ind-Enabling
Phase 1
Phase 2
Phase 3

Herpes Simplex Virus

(Intratumoral)

ONCR-177

Herpes Simplex Virus

(Intratumoral)

Indications
Melanoma
SCCHN
TNBC
MSS CRC
Commercial Rights

Herpes Simplex Virus

(Intratumoral)

ONCR-GBM

Herpes Simplex Virus

(Intratumoral)

Indications
Glioblastoma multiforme
Other CNS tumors
Commercial Rights

Synthetic vRNA

(Intravenous)

ONCR-021
Synthetic CVA21

Synthetic vRNA

(Intravenous)

Indications
NSCLC
HCC
ccRCC
Melanoma
Commercial Rights

Synthetic vRNA

(Intravenous)

ONCR-788
Synthetic SVV

Synthetic vRNA

(Intravenous)

Indications
SCLC
Prostate and other neuroendocrine tumors
Commercial Rights
Platform
Therapy
Indications
Research
IND-enabling
Phase 1
Phase 2
Phase 3
Commercial Rights

Herpes Simplex Virus

(Intratumoral)

ONCR-177
Melanoma
SCCHN
TNBC
MSS CRC

Monotherapy and in Combination with

ONCR-177, our lead candidate, is an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) 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 oHSV Platform.

Preclinical Findings

In preclinical studies, we have observed durable virus and immune system-driven anti-tumor activity in injected tumors as well as abscopal activity.  We have also observed that ONCR-177 is well tolerated in a validated animal safety model of oHSV when administered intravenously.

Learn more about our preclinical findings.

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).

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT04348916.

ONCR-GBM
Glioblastoma multiforme
Other CNS tumors

Leveraging our oHSV 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.

Synthetic vRNA

(Intravenous)

ONCR-021
Synthetic CVA21
NSCLC
HCC
ccRCC
Melanoma

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
Synthetic SVV
SCLC
Prostate and other neuroendocrine tumors

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.

ccRCC = clear cell renal cell carcinoma; CNS = central nervous system; GBM = glioblastoma multiforme; HCC = hepatocellular carcinoma; IND = investigational new drug; I/O = immuno-oncology; MSS CRC = microsatellite stable colorectal cancer; NSCLC = non-small cell lung cancer; SCCHN = squamous cell carcinoma of the head and neck; SCLC = small cell lung cancer; TNBC = triple negative breast cancer; vRNA = viral RNA If you are interested in partnering with Oncorus, please contact us.
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