ONCR-788 / Oncorus - LARVOL DELTA

Oncorus Announces Portfolio Reprioritization to Focus on IV-Administered, Self-Amplifying RNA Medicines for Patients with Cancer (GlobeNewswire) - "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."

Commercial • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioblastoma • Glioma • Lung Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

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

Development of ONCR-788, a synthetic oncolytic virus based on Seneca Valley virus for the treatment of neuroendocrine tumors (AACR 2022) - "Combination of ONCR-788 with anti-PD-1 resulted in improved anti-tumor activity versus the monotherapy arms. Altogether, ONCR-788 provides an innovative approach that enables repeat intravenous administration of viral immunotherapy."

IO biomarker • Oncolytic virus • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • PD-L1

Oncorus Presents Preclinical Data on ONCR-021 and ONCR-788 Supporting Selectively Self-Amplifying vRNA Immunotherapy Platform at AACR Annual Meeting (GlobeNewswire) - "Systemic IV administration of ONCR-788 led to potent anti-tumor efficacy, even in the presence of oncolytic virus neutralizing antibodies within the bloodstream. vRNA delivery, viral replication, spread and lysis of tumor cells were observed after administration of ONCR-788. Robust anti-tumor efficacy was observed across a diverse set of neuroendocrine tumor models, including tumor CDX and PDX xenografts, lung orthotopic and GEMM-derived models. Enhanced T cell recruitment and activation, increased expression of PD-L1 on tumor cells and myeloid cells and M2 to M1 macrophage conversion were observed. ONCR-788 in combination with an anti-PD1 resulted in improved anti-tumor activity as compared to ONCR-788 monotherapy. Oncorus plans to submit an IND for ONCR-788 with the FDA following the IND submission for ONCR-021."

IND • Preclinical • Neuroendocrine Tumor • Oncology

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