ONCR-021 / Oncorus - LARVOL DELTA

Oncorus Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates (GlobeNewswire) - "Self-amplifying RNA platform continues to progress. Oncorus remains on track to submit an IND for ONCR-021, the lead product candidate from its self-amplifying RNA platform, in mid-2023. The company plans to evaluate ONCR-021 in patients with non-small cell lung cancer, renal cell carcinoma, melanoma, hepatocellular carcinoma and anaplastic thyroid cancer."

IND • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thoracic Cancer

Oncorus Announces Portfolio Reprioritization to Focus on IV-Administered, Self-Amplifying RNA Medicines for Patients with Cancer (GlobeNewswire) - "Oncorus...announced that it is reprioritizing its pipeline to focus on its lead viral RNA (vRNA) immunotherapy product candidate, ONCR-021. In addition, the company is discontinuing the development of ONCR-177....'We are discontinuing the Phase 1 trial of ONCR-177 to focus our resources on ONCR-021'....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....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)."

Discontinued • IND • P1 data • Clear Cell Renal Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thoracic Cancer

Development of intravenously administered synthetic RNA virus immunotherapy for the treatment of cancer. (PubMed, Nat Commun) - "For two Synthetic RNA virus drug candidates, Seneca Valley virus (SVV) and Coxsackievirus A21, we demonstrate vRNA delivery and replication, virus assembly, spread and lysis of tumor cells leading to potent anti-tumor efficacy, even in the presence of OV neutralizing antibodies in the bloodstream. In mouse and non-human primates, Synthetic-SVV is well tolerated reaching exposure well above the requirement for anti-tumor activity. Altogether, the Synthetic RNA virus platform provides an approach that enables repeat intravenous administration of viral immunotherapy."

Journal • Oncology

Oncorus Announces Publication in Nature Communications Highlighting the Development of its Intravenously Administered Synthetic vRNA/LNP Platform for the Treatment of Cancer (GlobeNewswire) - "Data published today demonstrate vRNA/LNP delivery and 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...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, synthetic RNA viruses were well tolerated after a single or multiple IV dose in mice and non-human primates....'We look forward to progressing our first candidate from this platform, ONCR-021, in patients with non-small cell lung cancer, renal cell carcinoma, melanoma and hepatocellular carcinoma. We plan to submit an IND with the U.S. FDA for this program in mid-2023'"

IND • Pipeline update • Preclinical • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor

Overcoming the Challenge of RNA Therapeutics for the Treatment of Cancer, Development of Lipid Nanoparticle-Formulated RNA Viral Immunotherapy (ASGCT 2022) - "Interestingly, the in vivo efficacy of ONCR-021 and ONCR-788 is maintained even in the presence of neutralizing antibodies against CVA21 and SVV, suggesting that administration of LNP-formulated RNA immunotherapy enables the repeated and systemic exposure of disseminated tumors to potently oncolytic viruses. These data highlight an innovative RNA therapeutic modality for the IV treatment of tumors which overcomes the limitations of other RNA-based therapeutics and supports ONCR-021 and ONCR-788 into IND-enabling studies."

IO biomarker • Infectious Disease • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

Characterization of ONCR-021, a Novel Synthetic Oncolytic Virus (PEGS 2022) - "Oncorus' pioneering synthetic virus approach involves encapsulating viral RNA genomes in lipid nanoparticles to enable intravenous delivery. This talk will provide an overview of analytical methods used to characterize synthetic viral RNA and LNP products."

Oncolytic virus • Oncology

ONCR-021 as a systemic intravenous synthetic RNA virus immunotherapy for the repeat treatment of cancer (AACR 2022) - "Here we present ONCR-021, an LNP formulation of Coxsackievirus A21 (CVA21) vRNA. Consistent with these findings, high doses levels of ONCR-021 were well-tolerated in this model. Altogether, these preclinical data support the development of ONCR-021, a novel synthetic oncolytic virus designed to overcome the challenges of repeat intravenous administration of viral immunotherapy for the treatment of disseminated cancers."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • ICAM1

Oncorus Presents Preclinical Data on ONCR-021 and ONCR-788 Supporting Selectively Self-Amplifying vRNA Immunotherapy Platform at AACR Annual Meeting (GlobeNewswire) - "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."

IND • Preclinical • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma

Oncorus Reports Third Quarter 2021 Financial Results and Provides Business Updates (GlobeNewswire) - "To report initial data from ongoing Phase 1 clinical trial of lead oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy candidate, ONCR-177, in multiple solid tumor indications at the upcoming Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting on November 12th; Completed Pre-IND meeting and initiating GLP IND-enabling safety and tolerability studies for lead intravenously (IV) administered Synthetic viral RNA (vRNA) immunotherapy candidate, ONCR-021 (Synthetic CVA21); plans to submit an IND for ONCR-021 in the first half of 2023; Oncorus will present a poster titled, 'ONCR-GBM: A Novel, Armed Oncolytic HSV-1 Vector Engineered for Efficacy and Safety in Glioblastoma' (Poster #10226), at IOVC 2021, which will take place November 5 – 7 in Sedona, Arizona and virtually."

IND • P1 data • Preclinical • Oncology • Solid Tumor

Oncorus to Host Investor Day Featuring its IV-Administered Synthetic Viral RNA (vRNA) Immunotherapy Platform and Lead Synthetic vRNA Product Candidates (GlobeNewswire) - "Oncorus’ leadership will discuss its Synthetic vRNA Platform and lead Synthetic vRNA candidates, ONCR-021 and ONCR-788, as well as its state-of-the-art process development and GMP manufacturing facility...Oncorus will review preclinical data supporting the ONCR-021 and ONCR-788 candidate nominations and discuss current clinical development plans for each program."

Preclinical • Oncology

Oncorus Announces Nomination of its First IV-Administered Synthetic Viral RNA (vRNA) Immunotherapy Product Candidates, ONCR-021 and ONCR-788 (Businesswire) - "Oncorus...announced the nomination of its first Synthetic viral RNA (vRNA) immunotherapy clinical candidates, ONCR-021 and ONCR-788....Oncorus plans to file an investigational new drug (IND) application for ONCR-021 in the first half of 2023 to enable clinical development for non-small cell lung cancer and other cancers such as hepatocellular carcinoma, clear cell renal cell carcinoma and melanoma, both as a single agent and in combination with immune checkpoint inhibitors. Following the IND filing for ONCR-021, Oncorus plans to file an IND for ONCR-788 to enable its development in small cell lung cancer, neuroendocrine prostate and other neuroendocrine cancers, both as a single agent and in combination with immune checkpoint inhibitors and other cancer treatments."

IND • New molecule • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer