On November 30, 2022 Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on developing IV administered, self-amplifying RNA to transform outcomes for cancer patients, reported that it is reprioritizing its pipeline to focus on its lead viral RNA (vRNA) immunotherapy product candidate, ONCR-021 (Press release, Oncorus, NOV 30, 2022, View Source [SID1234624601]). In addition, the company is discontinuing the development of ONCR-177, reducing its workforce and burn rate and reiterating guidance for its cash runway into early 2024.

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"Oncorus’ mission is now focused on realizing the full promise of IV-administered, self-amplifying RNA medicines to transform outcomes for cancer patients through our lead program, ONCR-021, which we plan to evaluate in patients with non-small cell lung and other cancers," said Theodore (Ted) Ashburn, M.D., Ph.D., President, and Chief Executive Officer of Oncorus. "As part of this reprioritization, we are discontinuing the Phase 1 trial of ONCR-177 to focus our resources on ONCR-021. We would like to express our deep gratitude to all the patients and their families, investigators and collaborators who participated in the ONCR-177 study. We believe that we are now well positioned to execute on our goals and progress our novel, first-of-its-kind self-amplifying vRNA immunotherapy candidate, ONCR-021, into the clinic for cancer patients."

Oncorus will present the results of the Phase 1 study of ONCR-177 in patients with advanced disease in conjunction with a scientific congress in 2023. In addition, Oncorus has reduced its workforce by 20%, with its remaining workforce solely focused on the clinical development of ONCR-021, its first self-amplifying RNA product candidate. With this re-prioritization and workforce realignment, Oncorus has reduced its burn rate and continues to expect its current cash, cash equivalents and investments will be sufficient to fund its operating expenses into early 2024.

ONCR-021 Program Highlights and Upcoming Milestones

ONCR-021 is Oncorus’ lead candidate from its self-amplifying RNA platform intended to allow for intravenous (IV) administration. ONCR-021 is comprised of vRNA encoding for the genome of an optimized strain of the Coxsackievirus A21 (CVA21) formulated in a proprietary lipid nanoparticle (LNP). This technology enables RNA self-amplification via multiple transcription cycles in tumor cells and further amplification via viral spread to neighboring tumor cells. The company is planning to submit an investigational new drug application (IND) for this program in mid-2023 to evaluate ONCR-021 in patients with non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), melanoma and hepatocellular carcinoma (HCC).

In October 2022, Oncorus published preclinical data in Nature Communications highlighting the potential of its self-amplifying RNA platform as a novel approach to treating cancer by enabling repeat IV administration. The data demonstrate that the delivery of RNA encoding for the genome of a replication competent virus encapsulated in an LNP enables selective replication, virus assembly, spread and lysis of tumor cells, leading to potent anti-tumor efficacy even in the presence of virus neutralizing antibodies in the bloodstream. These RNA constructs were well-tolerated in preclinical models and elicited tumor-specific in situ production of oncolytic virions, broad immune cell recruitment and tumor destruction. Efficacy was observed across multiple cancer models, including xenografts, PDX, GEMM and syngeneic models, with survival benefit observed in an orthotopic small cell lung cancer (SCLC) tumor model. Overall, these constructs were well-tolerated after a single or multiple IV doses in both mice and non-human primates. These results support the potential of this modality to safely and effectively kill tumor cells while stimulating multiple arms of the immune system to better fight cancer.

Additional Development Programs

Further development of ONCR-788, the company’s second self-amplifying RNA product candidate, which encodes for a modified genome of the Seneca Valley Virus (SVV) for the treatment of small cell lung cancer (SCLC), neuroendocrine prostate cancer and other neuroendocrine tumors, and ONCR-719, an armed HSV-1 engineered for viral entry via the EGFR receptor for the treatment of glioblastoma multiforme, is dependent on additional financing.

Conference Call and Webcast Information

Oncorus will host a live conference and webcast today, November 30, 2022, at 8:00 a.m. ET to discuss these company updates. To access the conference call, please register here. The live webcast can be accessed under the "Events & Presentations" section of Oncorus’ website at www.oncorus.com. A webcast replay will also be available on the corporate website at the conclusion of the call.