ONCR Oncorus Inc

Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapy company focused on driving innovation to transform outcomes for cancer patients, today announced its presentation of preclinical data for both ONCR-021 and ONCR-788 in two e-posters at the American Association for Cancer Research (AACR) Annual Meeting 2022, taking place April 8-13 in New Orleans, Louisiana, supporting the company’s selectively self-amplifying viral RNA (vRNA) Immunotherapy Platform.

“The preclinical data presented on ONCR-021 and ONCR-788 at AACR are an important step forward for Oncorus’ novel approach of selectively self-amplifying vRNA immunotherapies formulated in lipid nanoparticles. We are incredibly pleased to see these vRNA drug candidates’ potent efficacy in preclinical tumor models, after intravenous administration of the nanoparticle formulation even in the presence of neutralizing antibodies,” said Ted Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. “These data further bolster our confidence in our vRNA platform’s ability to deliver the RNA genome of oncolytic viruses to tumors intravenously and to circumvent the common limitation of existing IV-administered oncolytic viral cancer therapies. We look forward to advancing this next-generation approach of selectively self-amplifying vRNA, furthering our goal of realizing the full potential of systemically active viral immunotherapies to transform outcomes for cancer patients.”

Oncorus’ vRNA Immunotherapy Platform encapsulates the genomes of RNA viruses known to kill cancer cells within an LNP, producing a living oncolytic and immunostimulatory viral infection in the tumor to destroy cancer cells and stimulate the immune system. In preclinical studies, Oncorus’ IV-administered vRNA immunotherapies demonstrated efficacy in multiple tumor models, avoiding the challenges seen in previous studies incorporating IV administration of RNA-based oncology therapeutics.

In a poster titled, “ONCR-021 as a systemic intravenous synthetic RNA virus immunotherapy for the repeat treatment of cancer,” Oncorus highlighted:

• ONCR-021, Oncorus’ lead vRNA immunotherapy product candidate, is an LNP formulation of Coxsackievirus A21 (CVA21) vRNA, which encodes an optimized strain of CVA21.
• ONCR-021 demonstrated greater in vitro and in vivo oncolysis compared to previously described CVA21 Kuykendall strain.
• IV administration of ONCR-021 vRNA resulted in rapid initiation of viral replication, oncolysis and potent anti-tumor efficacy driven by CVA21 amplification in situ after delivery to tumor cells.
• Preclinical data support the potential clinical development of ONCR-021 in non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and melanoma based on viral tropism.

Oncorus plans to submit an investigational new drug (IND) application for ONCR-021 with the U.S. Food and Drug Administration (FDA) in mid-2023.

In a poster titled, “Development of ONCR-788, a synthetic oncolytic virus based on Seneca Valley Virus for the treatment of neuroendocrine tumors,” Oncorus highlighted:

• ONCR-788, Oncorus’ second vRNA immunotherapy product candidate, encodes an optimized version of the Seneca Valley Virus (SVV).
• Systemic IV administration of ONCR-788 led to potent anti-tumor efficacy, even in the presence of oncolytic virus neutralizing antibodies within the bloodstream.
• vRNA delivery, viral replication, spread and lysis of tumor cells were observed after administration of ONCR-788.
• Robust anti-tumor efficacy was observed across a diverse set of neuroendocrine tumor models, including tumor CDX and PDX xenografts, lung orthotopic and GEMM-derived models.
• Enhanced T cell recruitment and activation, increased expression of PD-L1 on tumor cells and myeloid cells and M2 to M1 macrophage conversion were observed.
• ONCR-788 in combination with an anti-PD1 resulted in improved anti-tumor activity as compared to ONCR-788 monotherapy.

Oncorus plans to submit an IND for ONCR-788 with the FDA following the IND submission for ONCR-021.

The posters presented at AACR are available on the “Publications & Presentations” section of the Oncorus website at www.oncorus.com.

About Oncorus

At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally (iTu) and intravenously (IV) administered viral immunotherapies for multiple indications with significant unmet need based on our Herpes Simplex Virus (HSV) and selectively self-amplifying viral RNA Immunotherapy Platforms.

Designed to deliver next-generation viral immunotherapy impact, our HSV Platform improves upon key characteristics of this therapeutic class to enhance systemic activity. Our lead HSV program, ONCR-177, is designed to be directly administered into a tumor, resulting in high local concentrations of the therapeutic agent and its five encoded transgenes, as well as low systemic exposure to the therapy, which could limit systemic toxicities. Our pioneering selectively self-amplifying vRNA Immunotherapy Platform, highlighted by our product candidates ONCR-021 and ONCR-788, involves a highly innovative, novel combination of RNA and oncolytic virus-based modalities designed to realize the potential of RNA medicines for cancer.

Please visit www.oncorus.com to learn more.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the timing of IND submissions for ONCR-021 and ONCR-788 and the therapeutic potential of Oncorus’ vRNA Immunotherapy Platform, its ability to deliver potent and sustained tumor efficacy even in the presence of neutralizing antibodies and its ability to address challenges associated with the IV administration of RNA-based oncology therapeutics. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Oncorus’ ability to successfully demonstrate the safety, tolerability and efficacy of ONCR-177, ONCR-021, ONCR-788 and ONCR-GBM and obtain regulatory approval thereof; the impact of COVID-19 on Oncorus’ operations and the timing and anticipated results of its ongoing and planned clinical trials; Oncorus’ ability to obtain the requisite components for its product candidates manufactured in accordance with regulatory requirements; the expansion of Oncorus’ in-house manufacturing capabilities; the adequacy of Oncorus’ existing capital resources and availability of financing on commercially reasonable terms; the accuracy of the Oncorus’ estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and Oncorus’ ability to obtain, maintain and protect its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Oncorus’ Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on March 9, 2022, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the Securities and Exchange Commission from time to time. These documents are available under the “SEC filings” page of the Investors section of Oncorus’ website at http://investors.oncorus.com. Any forward-looking statements represent Oncorus’ views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Oncorus explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.        Investor Contact:Stern Investor Relations Julie SeidelJulie.seidel@sternir.com