ANDOVER, Mass., Oct. 7, 2022 (GLOBE NEWSWIRE) — Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on stimulating the immune system to transform outcomes for cancer patients, today announced the publication of preclinical data in nature communications highlighting the potential of their synthetic viral RNA (vRNA)/lipid nanoparticles (LNP) platform as a novel approach to treating cancer by enabling repeated intravenous (IV) administration of viral immunotherapy. Data published today demonstrates vRNA/LNP delivery and selective replication, virus assembly, propagation and lysis of tumor cells, leading to potent antitumor efficacy even in the presence of virus-neutralizing antibodies in the bloodstream. sanguine.
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 Coxsackievirus A21 (CVA21), was formulated in LNP. By encapsulating vRNA in LNP, Oncorus was able to recapitulate oncolytic viral therapy in various tumor cells and prevent antibody neutralization. The vRNA/LNP constructs were well tolerated and elicited tumor-specific reactions. in the place production of oncolytic virions, recruitment of immune cells, and tumor destruction. Efficacy was seen in multiple cancer models, including xenograft, PDX, GEMM, and syngeneic models, and a survival benefit was seen in an orthotopic small cell lung cancer (SCLC) tumor model. In general, synthetic RNA viruses were well tolerated after single or multiple IV doses in mice and nonhuman primates. These results support the potential of this modality to expose all tumor lesions within a patient to a potent live drug that can kill tumor cells and stimulate the immune system to fight cancer more effectively.
“Oncorus has made great strides in developing viral RNA encapsulated within LNPs, and this publication is an important first step in harnessing the potential of our platform as we advance this highly innovative approach in the clinic. We are focused on overcoming the neutralizing antibodies seen in previous studies incorporating IV administration of RNA-based oncolytic therapies that have likely limited their effectiveness at present and believe our data support the ability of our self-amplifying vRNA/LNP constructs to overcome these. challenges. said Theodore (Ted) Ashburn, MD, Ph.D., president and chief executive officer of Oncorus. “As demonstrated in the animal models described here, we have established a way to simultaneously cause direct tumor cell death in addition to broad immune stimulation in multiple tumors via an intravenously administered self-amplifying RNA encapsulated within a LNP. We hope to make progress with our first candidate on this platform, ONCR-021, in patients with non-small cell lung cancer, renal cell carcinoma, melanoma, and hepatocellular carcinoma. We plan to file an IND with the US FDA for this program in mid-2023,” said Matthew Kennedy, Ph.D., vice president of research for Oncorus and lead author of this article.
Oncorus has built a pioneering platform that addresses significant unmet needs in cancer immunotherapy treatment. This novel intravenously administered approach involves encapsulating the RNA genomes of viruses known to kill cancer cells in 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 the challenges caused by neutralizing antibodies. Using its platform, Oncorus has developed two vRNA/LNP immunotherapy programs, ONCR-021 and ONCR-788, which are based on CVA21 and SVV, respectively. The company plans to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for ONCR-021 in mid-2023.
At Oncorus, we’re focused on driving innovation to deliver next-generation viral immunotherapies to stimulate the immune system to deliver results for cancer patients. We are advancing a portfolio of intratumoral (iTu) and intravenous (IV) delivered viral immunotherapies for multiple indications with significant unmet need based on our herpes simplex virus (HSV) and self-amplifying viral RNA/LNP immunotherapy platforms.
Designed to deliver next-generation viral immunotherapy impact, our HSV platform enhances key features of this therapeutic class to enhance systemic activity. Our lead HSV program currently in the clinic, ONCR-177, is designed to be delivered directly into a tumor, resulting in high local concentrations of the therapeutic agent and its five encoded transgenes, as well as low systemic exposure to therapy. , which could limit systemic toxicities. Our pioneering self-amplifying vRNA/LNP platform, highlighted by our product candidates ONCR-021 and ONCR-788, involves a novel and highly innovative combination of RNA- and LNP-based modalities designed to harness the potential of RNA drugs for cancer.
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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, but not limited to, express and implied statements regarding expectations regarding the timing of filing an IND for ONCR. -021, as well as the product. the therapeutic potential and clinical benefits of the candidate; and the utility and potential of the Oncorus synthetic viral RNA (vRNA)/lipid nanoparticles (LNP) platform. The words “may”, “could”, “will”, “could”, “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. Search statements contain these identification words. All 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 statement. statements contained in this press release, including, but not limited to, risks associated with: Oncorus’s ability to successfully demonstrate the safety, tolerability and efficacy of its product candidates and obtain regulatory approval thereof; the adequacy of Oncorus’ existing capital resources and the availability of financing on commercially reasonable terms; Oncorus’s ability to obtain the necessary components for its candidate products manufactured in accordance with regulatory requirements; the expansion of Oncorus’ in-house manufacturing capabilities; the impact of COVID-19 on Oncorus’ operations and the timing and anticipated results of its ongoing and planned clinical trials; the accuracy of Oncorus’ estimates regarding expenses, future revenues, capital requirements and additional financing needs; and Oncorus’s 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. Securities (“SEC”) on March 9, 2022, and Oncorus’s subsequent quarterly reports on Form 10-Q, as well as discussions of potential risks, uncertainties and other important factors in Oncorus’ other filings with the SEC from Occasionally. These documents are available on the “SEC Filings” page of the Investors section of the Oncorus website at http://investors.oncorus.com. All forward-looking statements represent the views of Oncorus only as of the date of this press release and should not be relied upon to represent its views as of any later date. Oncorus expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. No representations or warranties (express or implied) are made as to the accuracy of any such forward-looking statements.
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