Pipeline

We are developing a differentiated portfolio of intratumorally and intravenously administered viral immunotherapies across our Herpes Simplex Virus (HSV) and selectively self-amplifying viral RNA (vRNA) Immunotherapy Platforms. This will enable us to pursue multiple indications with the potential to 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
Commercial Rights

Herpes Simplex Virus

(Intratumoral)

ONCR-GBM

Herpes Simplex Virus

(Intratumoral)

Indications
Glioblastoma multiforme
Other CNS tumors
Commercial Rights

Selectively Self-Amplifying vRNA

(Intravenous)

ONCR-021

Selectively Self-Amplifying vRNA

(Intravenous)

Indications
NSCLC
HCC
ccRCC
Melanoma
Commercial Rights

Selectively Self-Amplifying vRNA

(Intravenous)

ONCR-788

Selectively Self-Amplifying 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

Monotherapy and in Combination with

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.

ONCR-GBM
Glioblastoma multiforme
Other CNS tumors

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.

Selectively Self-Amplifying vRNA

(Intravenous)

ONCR-021
NSCLC
HCC
ccRCC
Melanoma

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
SCLC
Prostate and other neuroendocrine tumors

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.

 

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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