ONCR Oncorus Inc

Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on developing intravenously administered, self-amplifying RNA to transform outcomes for cancer patients, and Daewoong Pharmaceutical Co., Ltd. (KRX: 069620), a leading South Korean pharmaceutical company, today announced a research collaboration for the discovery and development of novel lipid nanoparticle (LNP) formulations for mRNA drug candidates.

Under the terms of the collaboration, Oncorus and Daewoong will conduct joint research to identify and evaluate formulations of Daewoong’s mRNAs encapsulated in Oncorus’ proprietary LNPs. Oncorus will develop formulated drug candidates at its state-of-the-art manufacturing facility in Andover, Massachusetts. Subject to the parties’ satisfaction with the formulations and the achievement of certain study milestones specified in the research plan, Oncorus and Daewoong have agreed to commence negotiations of a potential future license and supply arrangement for the formulated product.

“This collaboration is important validation for our proprietary LNP platform, which is comprised of both novel ionizable amines and cleavable PEG lipids for both intravenous and intramuscular administration, and we are excited to develop novel LNP formulations for Daewoong’s RNA-based programs,” said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. “With our optimized LNPs and manufacturing capabilities, Oncorus is uniquely positioned to partner with companies like Daewoong that are developing novel, RNA-based therapeutics that would benefit from optimized LNP formulations. We look forward to working closely with the Daewoong team on the first of hopefully many similar partnerships to come.”

“mRNA is now known to be a powerful tool in our ability to fight many diseases,” said Sengho Jeon, Chief Executive Officer of Daewoong. “Oncorus offers a robust solution to enabling mRNA delivery through the pairing of its proprietary LNP technology and in-house process development, with the capacity to manufacture a successful mRNA/LNP formulation on both clinical and commercial scales. We are excited to work with Oncorus to optimize our mRNA drug delivery as we work to improve the quality of life for patients around the world.”

Oncorus’ LNP platform leverages proprietary ionizable and ​polyethylene glycol (PEG) lipids for multiple nucleic acid cargos and possesses other desirable physiochemical properties. In multiple preclinical models involving repeat intravenous (IV) dosing, Oncorus’ formulations have demonstrated improved tolerability, an enhanced therapeutic window and consistent pharmacokinetics compared to approved formulations. Similar studies incorporating Oncorus’ LNP formulations have demonstrated low immunogenicity along with other desirable attributes, including tunable pharmacokinetics with different compositions and stable pharmacokinetics following repeat dosing. The platform is designed to efficiently deliver nucleic acids, including large cargos up to 14 kilobases. This delivery strategy is intended to address many of the complications associated with anti-PEG antibodies interfering with the effective IV delivery of RNA and other nucleic acid-based medicines and can also be leveraged for vaccine applications.

About Oncorus

At Oncorus, we are focused on driving innovation in RNA medicines by developing next-generation immunotherapies to stimulate the immune system and transform outcomes for cancer patients. Our self-amplifying RNA immunotherapy platform improves upon key characteristics of this therapeutic class to enhance systemic activity. ONCR-021, our lead product candidate for non-small cell lung and other cancers, is an IV-administered RNA encoding an optimized Coxsackievirus 21A (CVA21) genome, encapsulated within an LNP for non-small cell lung and other cancers.    

Please visit www.oncorus.com to learn more.            About Daewoong Pharmaceutical

Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on their course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide.

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 Oncorus’ plans to develop formulated drug in accordance with the research collaboration with Daewoong; the parties plans to commence negotiation of a subsequent license and manufacturing and supply arrangement for the formulated drug; the promise of LNP-based delivery mechanisms; and the opportunity for future partnerships relative to Oncorus’ LNP platform. 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 its product candidates and obtain regulatory approval thereof; the adequacy of Oncorus’ existing capital resources and availability of financing on commercially reasonable terms; 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 and its ability to manufacture product at clinical and commercial scales; the impact of COVID-19 on Oncorus’ operations and the timing and anticipated results of its ongoing and planned clinical trials; 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 (“SEC”) on March 9, 2022, and Oncorus’ Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022, June 30, 2022 and September 30, 2022, filed with the SEC on May 4, 2022, August 4, 2022 and November 2, 2022, respectively, as well as discussions of potential risks, uncertainties, and other important factors in the other filings that Oncorus makes with the SEC 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.

Oncorus Investor Contact:Stern Investor Relations Julie SeidelJulie.seidel@sternir.com

Daewoong Pharmaceutical Investor Contact:Thierry Uhthierryur@daewoong.co.kr