ONCR-177 / Oncorus - LARVOL DELTA

First-in-human phase I trial of oncolytic herpes simplex virus ONCR-177 alone or in combination with pembrolizumab in advanced solid tumors (ESMO 2024) - P1 | "ONCR-177 was safe to administer to surface and visceral lesions either as monotherapy or in combination with Pembrolizumab. Local responses were observed, although sustainable efficacy could not be achieved in a systemic manner in these heavily pretreated pts."

Combination therapy • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • IFNG

KEYNOTE-B73: Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors (clinicaltrials.gov) - P1 | N=66 | Terminated | Sponsor: Oncorus, Inc. | N=132 ➔ 66 | Trial completion date: Jul 2028 ➔ May 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2025 ➔ May 2023; Terminated due to Oncorus portfolio reprioritization

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Head and Neck Cancer • Hepatology • Herpes Simplex • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

KEYNOTE-B73: Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors (clinicaltrials.gov) - P1 | N=132 | Active, not recruiting | Sponsor: Oncorus, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Head and Neck Cancer • Hepatology • Herpes Simplex • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast 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

Oncorus Reports Third Quarter 2022 Financial Results and Provides Business Updates (GlobeNewswire) - "On track to report combination data and additional monotherapy data for ONCR-177 in the fourth quarter of 2022. Oncorus continues to dose patients in its Phase 1 open-label, multi-center clinical trial in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. The company expects to report initial surface lesion combination expansion data for ONCR-177 administered with Merck’s KEYTRUDA and additional surface lesion monotherapy expansion data in the fourth quarter of 2022."

P1 data • Trial status • Oncology • Solid Tumor

Initial results of a Phase 1 study of intratumoral ONCR-177, an oncolytic herpes-simplex virus-1 expressing five immunomodulatory transgenes, in subjects with advanced injectable tumors (SITC 2021) - P1 | "Transgenes elicit potent systemic stimulation of anti-tumor immunity.1 ONCR-177 is being tested in an open-label, multicenter, phase 1 study alone and in combination with pembrolizumab (NCT04348916), for surface lesion injection and intrahepatic injection. Enrollment at the RP2D is underway in monotherapy expansion. Trial Registration NCT04348916"

Clinical • IO biomarker • P1 data • Gastrointestinal Cancer • Melanoma • Oncology • Sarcoma • Solid Tumor • IL12A • PD-L1

Oncorus Reports Second Quarter 2022 Financial Results and Provides Business Updates (GlobeNewswire) - "Second Quarter 2022 and Recent Business Highlights: On track to report combination data and additional monotherapy data for ONCR-177 in the second half of 2022. Oncorus has completed enrollment in the dose expansion portion of its Phase 1 open-label, multi-center clinical trial in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. The company continues to enroll patients in the combination cohort with initial surface lesion combination expansion data for ONCR-177 administered with Merck’s KEYTRUDA and additional surface lesion monotherapy expansion data expected in the second half of 2022."

Enrollment status • P1 data • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

Early results from ONCR-177-101: ONCR-177 alone or in combination with anti-PD-1 blockade (YouTube) - "Jong Chul Park, MD...gives an overview of the results of ONCR-177-101, a first-in-human Phase I study (NCT04348916) of intratumoral ONCR-177 alone or in combination with anti-PD-1 blockade in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors."

Interview • Video

Oncorus Reports Initial Safety, Tolerability, Immune Activation and Positive Clinical Response Data from its Ongoing Phase 1 Clinical Study of ONCR-177, its Lead Viral Immunotherapy Candidate, at SITC 2021 (GlobeNewswire) - "'We are evaluating ONCR-177 in heavily pretreated cancer patients with advanced disease and no available standard of care. I'm impressed by the overall favorable safety and tolerability profile of ONCR-177 observed to date and the clinical responses demonstrated in some patients after only four weeks of monotherapy treatment. I look forward to enrolling patients in the combination cohort with pembrolizumab with the potential for amplification of clinical benefit.'"

Media quote

Oncorus Reports Initial Safety, Tolerability, Immune Activation and Positive Clinical Response Data from its Ongoing Phase 1 Clinical Study of ONCR-177, its Lead Viral Immunotherapy Candidate, at SITC 2021 (GlobeNewswire) - P1, N=132; NCT04348916; Sponsor: Oncorus, Inc; "After four weeks of ONCR-177 monotherapy treatment (two doses) at RP2D, three of these eight evaluable patients (all in the surface lesion monotherapy expansion cohorts) demonstrated clinical benefit as follows: Partial response in a patient with cutaneous melanoma as measured by calipers per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1...Investigator-reported clinical response in a squamous cell carcinoma of the head and neck (SCCHN) patient in injected lymph node after four weeks; Stable disease in a patient with mucosal melanoma as measured by RECIST 1.1 with improvement in cancer-related symptoms; Several findings from the study thus far suggest immune stimulation of the tumor microenvironment, including mild, dose-dependent CRS in association with increased interferon-γ (IFN-γ) and T cell proliferation in blood, as well evidence of tumor PD-L1 expression and immune cell infiltration."

P1 data • Oncology • Solid Tumor

Oncorus Reports Initial Safety, Tolerability, Immune Activation and Positive Clinical Response Data from its Ongoing Phase 1 Clinical Study of ONCR-177, its Lead Viral Immunotherapy Candidate, at SITC 2021 (GlobeNewswire) - "Oncorus plans to initiate enrollment in the surface lesion dose combination expansion (Part 2) and the visceral lesion dose monotherapy escalation (Part 3) by the end of 2021. The company plans to report additional surface lesion monotherapy expansion data in mid-2022, and initial surface lesion combination expansion data (ONCR-177 + KEYTRUDA®) and visceral lesion monotherapy dose escalation data in late 2022."

Enrollment status • P1 data • Oncology • Solid Tumor

Oncorus Announces Exclusive Licensing Agreement with Gaeta Therapeutics Ltd. for Use of Locally Delivered Interleukin-12 (IL-12) via Oncolytic Viral Expression in Combination with Immune Checkpoint Inhibitors (GlobeNewswire) - "Oncorus, Inc...announced that it has signed an exclusive licensing agreement with Gaeta Therapeutics Ltd., related to the use of locally delivered Interleukin-12 (IL-12) via oncolytic viral expression in combination with immune checkpoint inhibitors, including CTLA-4, PD-1 or PD-L1 checkpoint blockade...Under the terms of the agreement, Gaeta will receive an upfront payment of $0.2M and is eligible to receive up to $7.5M in potential clinical and regulatory milestone payments on a product-by-product and indication-by-indication basis...Oncorus will present initial data from its ongoing Phase 1 clinical trial of ONCR-177 at the upcoming Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting, taking place November 12–14, 2021 in Washington, D.C. and virtually."

Licensing / partnership • P1 data • Oncology

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 Present Initial Data from its Ongoing Phase 1 Clinical Trial of ONCR-177 at the Upcoming Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting (GlobeNewswire) - "The details for Oncorus' SITC poster are as follows:...Title: Initial results of a Phase 1 study of intratumoral ONCR-177, an oncolytic herpes-simplex virus-1 expressing five immunomodulatory transgenes, in subjects with advanced injectable tumors. Abstract #: 511. Primary Author/Presenter: Jong Chul Park, M.D..."

Oncorus to Present Initial Data from its Ongoing Phase 1 Clinical Trial of ONCR-177 at the Upcoming Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting (GlobeNewswire) - "Oncorus, Inc...announced it will present initial data from its ongoing Phase 1 clinical trial of ONCR-177 at the upcoming Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting, taking place November 12–14, 2021 in Washington, D.C. and virtually."

P1 data • Oncology • Solid Tumor

Oncorus Reports Second Quarter 2021 Financial Results and Provides Business Highlights (GlobeNewswire) - "Continues to progress Phase 1 clinical trial of ONCR-177, company’s lead oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy candidate; on track to report initial interim data in 4Q’21...Anticipates first phase of GMP clinical manufacturing facility, including process development and quality control, to be completed in 2021, as previously guided."

Commercial • P1 data • Oncology • Solid Tumor

Oncorus Reports First Quarter 2021 Financial Results and Provides Business Highlights (GlobeNewswire) - "Enrolling Phase 1 clinical trial of ONCR-177...Oncorus has an ongoing clinical trial collaboration with Merck involving KEYTRUDA and anticipates reporting interim data from the Phase 1 trial in the second half of 2021 through the second half of 2022...Oncorus continues to advance its lead synthetic, IV administered vRNA immunotherapy programs based on the Coxsackievirus A21 (CVA21) and the Seneca Valley Virus (SVV). The company expects to nominate clinical candidates for both programs in the first half of 2021."

Clinical • Enrollment status • P1 data • Oncology • Solid Tumor

Oncorus Reports Third Quarter 2020 Financial Results and Provides Business Highlights (GlobeNewswire) - “Initiated Phase 1 clinical trial of ONCR-177…Oncorus anticipates reporting interim data from the Phase 1 clinical trial in the second half of 2021 through the second half of 2022…Continued to advance second oHSV viral immunotherapy candidate, ONCR-GBM…Oncorus plans to nominate its ONCR-GBM clinical candidate in the second half of 2021.”

New trial • P1 data • Oncology • Solid Tumor

Oncorus Announces Publication of Preclinical Data Demonstrating Potent Systemic Antitumor Activity of its Clinical Stage Oncolytic Herpes Simplex Viral Immunotherapy Product Candidate ONCR-177 (GlobeNewswire) - "Oncorus...announced today the recent publication of preclinical data supporting the clinical development of its lead oncolytic Herpes Simplex Virus (oHSV) clinical candidate, ONCR-177. In the paper, entitled, 'ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity' (Haines, et al., 2020), published online in the journal Cancer Immunology Research, ONCR-177 demonstrated potent and durable antitumor activity in multiple immune-competent tumor models....Oncorus expects to report initial interim data from the monotherapy dose escalation part of this trial in the second half of 2021 with addition data readouts through the second half of 2022."

P1 data • Preclinical • Oncology

Oncorus Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Highlights (GlobeNewswire) - “The Phase 1 open-label, multi-center, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177 and to determine the recommended Phase 2 dose, as well as its preliminary anti-tumor activity, alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. Oncorus anticipates reporting interim data from the Phase 1 clinical trial in the second half of 2021 through the second half of 2022.”

P1 data • Oncology • Solid Tumor

Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors (clinicaltrials.gov) - P1; N=132; Recruiting; Sponsor: Oncorus, Inc.; N=71 ➔ 132; Trial completion date: Oct 2027 ➔ Jul 2028; Trial primary completion date: Jun 2023 ➔ Jan 2025

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Head and Neck Cancer • Hepatology • Herpes Simplex • Liver Cancer • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Oncorus to Build GMP Viral Immunotherapy Clinical Manufacturing Facility in Andover, Mass. (GlobeNewswire) - "The company is currently conducting a Phase 1 clinical trial of its lead product candidate, ONCR-177...The company anticipates reporting interim data from this Phase 1 trial in the second half of 2021 through the second half of 2022. Oncorus plans to nominate its first intravenously administered synthetic virus clinical candidates (coxsackievirus A21 and Seneca Valley Virus programs) in the first half of 2021 and its second intratumorally administered oHSV clinical candidate, which will specifically target brain cancer, including glioblastoma multiforme, in the second half of 2021...Oncorus anticipates the first phase of the facility’s buildout will be completed in late 2021...and full operation commencing in early 2023."

Clinical • Commercial • P1 data • Brain Cancer • Glioblastoma • Oncology

ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity. (PubMed, Cancer Immunol Res) - P1 | "In vitro assays demonstrated that targeted miRs could efficiently suppress ONCR-177 replication and transgene expression, as could the HSV-1 standard-of-care therapy acyclovir. The addition of systemic anti-PD-1 augmented the efficacy of mONCR-171, particularly for abscopal tumors. Based in part upon these preclinical results, ONCR-177 is being evaluated in patients with metastatic cancer (ONCR-177-101, NCT04348916)."

IO biomarker • Journal • Herpes Simplex • Immune Modulation • Inflammation • Oncology • CD8 • IL12A

[VIRTUAL] ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity (IOS 2020) - "ONCR-177 is armed with five transgenes selected for activation of antitumor immunity. Significant efficacy, survival benefit, and the elicitation of protective immunity were demonstrated in multiple syngeneic tumor models and warrant the clinical investigation of ONCR-177 in patients with metastatic cancer."

Herpes Simplex • Oncology • Solid Tumor

Oncorus Initiates First-in-Human Phase 1 Study of ONCR-177 for the Treatment of Adult Subjects with Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors (Businesswire) - "Oncorus, Inc…announced that it has initiated a Phase 1 study of its lead product candidate, ONCR-177…The Phase 1 open-label, multi-center, dose escalation and expansion study is designed to evaluate the safety and tolerability and to determine the recommended Phase 2 dose as well as preliminary anti-tumor activity of ONCR-177 alone and in combination with Merck’s anti-PD1-1, KEYTRUDA® (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors…The expansion cohorts will enroll patients with solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or have a disease for which no standard of care exists, including patients with breast cancer, squamous cell carcinoma of the head and neck (SCCHN), and melanoma."

Enrollment status • Trial status • Breast Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck