Oncorus Announces Publication in Nature Communications Highlighting the Development of its Synthetic IVRNA/LNP Platform for the Treatment of Cancer


Oncorus, Inc.

New Preclinical Results Support Self-Amplified vRNA/LNP Immunotherapy Platform and Ongoing Studies Enabling IND of ONCR-021

ANDOVER, Mass., Oct. 07, 2022 (GLOBE NEWSWIRE) — Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on boosting the immune system to transform cancer patient outcomes, announced today the publication of preclinical data in Nature Communication highlighting the potential of its synthetic viral RNA (vRNA)/lipid nanoparticle (LNP) platform as a novel approach to cancer treatment by enabling repeated intravenous (IV) delivery of viral immunotherapy. Data released today demonstrate selective vRNA/LNP delivery and replication, virus assembly, tumor cell propagation and lysis, leading to potent anti-tumor efficacy even in the presence of antibodies neutralizing the virus in the blood.

The article describes the design and development of Oncorus’ synthetic RNA viruses for the systemic treatment of cancer. IV delivery of viral RNA genomes for two picornaviruses, Seneca Valley virus (SVV) and Coxsackie virus A21 (CVA21), has been formulated into LNPs. By encapsulating vRNA in LNPs, Oncorus was able to recapitulate viral oncolytic therapy in various tumor cells and avoid neutralizing antibodies. The vRNA/LNP constructs were well tolerated and elicited tumor-specific responses. on the spot production of oncolytic virions, recruitment of immune cells and tumor destruction. Efficacy was observed in several cancer models, including xenografts, PDX, GEMM, and syngeneic models, with survival benefit observed in an orthotopic tumor model of small cell lung cancer (SCLC). Overall, synthetic RNA viruses were well tolerated after one or more intravenous doses in mice and non-human primates. These results support the potential of this modality to expose all tumor lesions in a patient to a potent live drug that can both kill tumor cells and stimulate the immune system to fight cancer more effectively.

“Oncorus has made great strides in the development of LNP-encapsulated viral RNA, and this publication is an important first step in realizing the potential of our platform as we advance this highly innovative approach into the clinic. We focus on overcoming neutralizing antibodies observed in previous studies incorporating IV administration of RNA-based oncolytic therapeutics, which likely limited their efficacy today and believe that our data supports the ability of our constructs to ‘self-amplified vRNA/LNP overcome these challenges,’” said Theodore (Ted) Ashburn, MD, Ph.D., President and CEO of Oncorus. “As demonstrated in the animal models described here, we have established a means to simultaneously induce direct tumor cell killing in addition to broad immune stimulation in multiple tumors through an intravenously administered self-amplifying RNA encapsulated in an LNP We look forward to advancing our first candidate from this platform, ONCR-021, in patients with non-small cell lung cancer, renal cell carcinoma, melanoma and hepatocellular carcinoma. an IND to the U.S. FDA for this program in mid-2023,” said Matthew Kennedy, Ph.D., vice president of research at Oncorus and lead author of this paper.

Oncorus has built a pioneering platform addressing significant unmet needs in cancer immunotherapy treatment. This new intravenously administered approach encapsulates the RNA genomes of viruses known to kill cancer cells into an LNP, resulting in vRNA/LNP immunotherapy. Oncorus’ LNP delivery strategy is intended to be less immunogenic than a natural viral capsid and is designed to overcome challenges caused by neutralizing antibodies. Using its platform, Oncorus has developed two vRNA/LNP immunotherapy programs, ONCR-021 and ONCR-788, based on CVA21 and SVV respectively. The company expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ONCR-021 in mid-2023.

About Oncorus

At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to boost the immune system to achieve results for cancer patients. We are developing a portfolio of viral immunotherapies delivered intratumorally (iTu) and intravenously (IV) for multiple indications with significant unmet need based on our herpes simplex virus (HSV) immunotherapy platforms and self-amplified viral RNA/LNP.

Designed to deliver next-generation viral immunotherapy impact, our HSV platform enhances key features of this therapeutic class to improve systemic activity. Our main HSV program currently in the clinic, 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 self-amplified vRNA/LNP platform, evidenced by our ONCR-021 and ONCR-788 product candidates, involves a highly innovative new combination of RNA and LNP-based modalities designed to realize the potential RNA drugs against cancer.

Please visit www.oncorus.com to learn more.

Caution 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 expectations regarding the timing of the submission of a IND for ONCR-021, as well as the product, the therapeutic potential and clinical benefits of the candidate and the utility and potential of Oncorus’ synthetic viral RNA (vRNA)/lipid nanoparticle (LNP) platform. The words “may”, “could”, “will”, “could”, “should”, “should”, “expect”, “plan”, “anticipate”, “intend”, ” believes”, “expects”, “estimates”, “seeks”, “predicts”, “future”, “projects”, “potential”, “continues”, “targets” and similar words or expressions are intended to identify forward-looking statements, although not all looking statements contain these identifying words. All forward-looking statements contained in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and factors that may cause actual events or results to differ. differ materially from those expressed or implied by any forward-looking statement. the statements contained in this press release, including, but not limited to, risks associated with: Oncorus’ ability to successfully demonstrate the safety, tolerability and efficacy of its product candidates and to obtain the regulatory approval thereof; the adequacy of Oncorus’ existing capital resources and the availability of financing on commercially reasonable terms; Oncorus’s ability to obtain components required for its product candidates manufactured in accordance with regulatory requirements; expansion of Oncorus’ in-house manufacturing capabilities; the impact of COVID-19 on Oncorus’ operations and the timing and expected results of its ongoing and planned clinical trials; the accuracy of Oncorus’ estimates of expenses, future revenues, capital requirements and additional funding requirements; and Oncorus’ ability to obtain, retain and protect its intellectual property. These and other risks and uncertainties are described in more detail in the section entitled “Risk Factors” of Oncorus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”). March 9, 2022, and Oncorus’ subsequent quarterly reports on Form 10-Q, as well as discussions of potential risks, uncertainties and other important factors in other filings Oncorus makes from time to time with the SEC. These documents are available on the “SEC filings” page of the Investors section of the Oncorus website at http://investors.oncorus.com. Any forward-looking statements represent the views of Oncorus 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 expressly 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 representation or warranty (express or implied) is made as to the accuracy of these forward-looking statements.

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