This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment.

Start Date24 Apr 2020

Sponsor / Collaborator

Vyriad, Inc.Startup

[+1]

NCT03647163

/ RecruitingPhase 1/2

Phase 1-2 Trial of Systemically Administered VSV-IFNβ-NIS in Combination with Checkpoint Inhibitor Therapy in Patients with Selected Solid Tumors

The safety run-in portion of this study is designed to identify the optimal dose of VSV-IFNβ-NIS in combination with pembrolizumab in patients with solid tumors and follows the 3+3 design. The expansion portion will use one-sample binomial designs to assess the efficacy of the combination in patients with refractory NSCLC or NEC. The optimal dose (RP2D) determined in the dose escalation portion of the trial will be used for the expansion portion. The study has been conducted with a dose of 1.7 × 1010 as the recommended phase II dose in an expansion cohort of 10 patients with NSCLC. However, current data suggests that VSV-IFNβ-NIS doses of up to 1.7 × 1011 is safe and likely more efficacious. Thus, this study will test a second VSV-IFNβ-NIS dose level, 1.0x1011 TCID50. A safety assessment will be carried out after 3 patients are enrolled. If this dose schedule is well tolerated and virus PK are not negatively impacted, both the NSCLC and NEC expansion cohorts will open using this dose schedule. If 2 of the first 3 patients or 2 of the first 6 patients experience a DLT, the dose will be de-escalated to 5 x 1010. The safety run-in/dose escalation portion of this study is expected to require a minimum of 3 patients and a maximum of 18 patients (6 patients per dose level). The expansion portion of this study is expected to require a minimum of 10 per cohort. The NSCLC and NEC patients enrolled at the identified optimal dose in the dose escalation cohort would be included in the dose expansion cohort if they are evaluable for the primary endpoint in the expansion portion (4 dose escalation patients at the optimal dose are expected to roll over to the expansion). Additionally, up to 16 Renal Cell Carcinoma (RCC) patients will be treated in the expansion cohort. This will permit up to 86 treated patients.

Start Date09 Apr 2019

Sponsor / Collaborator

Vyriad, Inc.Startup

[+1]

NCT03120624

/ Active, not recruitingPhase 1IIT

Phase I Trial of Intravenous Administration of Vesicular Stomatitis Virus Genetically Engineered to Express Thyroidal Sodium Iodide Symporter (NIS) and Human Interferon Beta (hIFNb), in Patients With Metastatic or Recurrent Endometrial Cancer

This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving VSV-hIFNbeta-NIS with ruxolitinib phosphate may work better in treating patients with endometrial cancer compared to VSV-hIFNbeta-NIS alone.

Start Date15 Sep 2017

Sponsor / Collaborator

Mayo Clinic

[+1]

100 Clinical Results associated with VSV-IFNbeta-NIS

100 Translational Medicine associated with VSV-IFNbeta-NIS

100 Patents (Medical) associated with VSV-IFNbeta-NIS

Literatures (Medical) associated with VSV-IFNbeta-NIS

01 Dec 2023·Molecular therapy oncolytics

Neoadjuvant systemic oncolytic vesicular stomatitis virus is safe and may enhance long-term survivorship in dogs with naturally occurring osteosarcoma

Article

Author: Modiano, Jaime F ; Chehadeh, Andrea ; Henson, Michael S ; Suksanpaisan, Lukkana ; Cornax, Ingrid ; Makielski, Kelly M ; Borgatti, Antonella ; Tabaran, Alexandru-Flaviu ; Koopmeiners, Joseph S ; Pracht, Sara ; Stuebner, Kathleen M ; O'Sullivan, M Gerard ; Groschen, Donna ; Preusser, Caitlin ; Bergsrud, Kelly ; Winter, Amber ; Farrar, Michael A ; Sarver, Aaron L ; Cutter, Gary R ; Russell, Stephen J ; Mills, Lauren J ; Wolfe, Melissa ; Schwabenlander, Marc D ; Naik, Shruthi

Osteosarcoma is a devastating bone cancer that disproportionally afflicts children, adolescents, and young adults. Standard therapy includes surgical tumor resection combined with multiagent chemotherapy, but many patients still suffer from metastatic disease progression. Neoadjuvant systemic oncolytic virus (OV) therapy has the potential to improve clinical outcomes by targeting primary and metastatic tumor sites and inducing durable antitumor immune responses. Here we describe the first evaluation of neoadjuvant systemic therapy with a clinical-stage recombinant oncolytic vesicular stomatitis virus (VSV), VSV-IFNβ-NIS, in naturally occurring cancer, specifically appendicular osteosarcoma in companion dogs. Canine osteosarcoma has a similar natural disease history as its human counterpart. VSV-IFNβ-NIS was administered prior to standard of care surgical resection, permitting microscopic and genomic analysis of tumors. Treatment was well-tolerated and a "tail" of long-term survivors (∼35%) was apparent in the VSV-treated group, a greater proportion than observed in two contemporary control cohorts. An increase in tumor inflammation was observed in VSV-treated tumors and RNA-seq analysis showed that all the long-term responders had increased expression of a T cell anchored immune gene cluster. We conclude that neoadjuvant VSV-IFNβ-NIS is safe and may increase long-term survivorship in dogs with naturally occurring osteosarcoma, particularly those that exhibit pre-existing antitumor immunity.

01 Oct 2018·ANNALS OF ONCOLOGY

Tracking VSV-IFNβ-NIS oncolytic virus (OV) activity in patients (pts) with advanced solid tumors: The iodide symporter gene (NIS) as a pharmacodynamic (PD) marker using SPECT/CT imaging of OV therapy

Article

Author: Patel, M R ; Diaz, R M ; Peng, K W ; Russell, S J ; Bexon, A S ; Powell, S F ; Merchan, J ; Strauss, J ; Cripe, T P ; O'Connor, M K ; Old, M O ; Suksanpaisan, L

01 Jan 2018·MOLECULAR CANCER THERAPEUTICS

Comparative Oncology Evaluation of Intravenous Recombinant Oncolytic Vesicular Stomatitis Virus Therapy in Spontaneous Canine Cancer

Article

Author: Russell, Stephen J. ; Federspiel, Mark J. ; LeBlanc, Amy K. ; Suksanpaisan, Lukkana ; Steele, Michael B. ; Miller, Amber C. ; Galyon, Gina D. ; Peng, Kah Whye ; Jenks, Nathan J. ; Naik, Shruthi ; Allstadt, Sara D.

Abstract:

Clinical translation of intravenous therapies to treat disseminated or metastatic cancer is imperative. Comparative oncology, the evaluation of novel cancer therapies in animals with spontaneous cancer, can be utilized to inform and accelerate clinical translation. Preclinical murine studies demonstrate that single-shot systemic therapy with a vesicular stomatitis virus (VSV)-IFNβ-NIS, a novel recombinant oncolytic VSV, can induce curative remission in tumor-bearing mice. Clinical translation of VSV-IFNβ-NIS therapy is dependent on comprehensive assessment of clinical toxicities, virus shedding, pharmacokinetics, and efficacy in clinically relevant models. Dogs spontaneously develop cancer with comparable etiology, clinical progression, and response to therapy as human malignancies. A comparative oncology study was carried out to investigate feasibility and tolerability of intravenous oncolytic VSV-IFNβ-NIS therapy in pet dogs with spontaneous cancer. Nine dogs with various malignancies were treated with a single intravenous dose of VSV-IFNβ-NIS. Two dogs with high-grade peripheral T-cell lymphoma had rapid but transient remission of disseminated disease and transient hepatotoxicity that resolved spontaneously. There was no shedding of infectious virus. Correlative pharmacokinetic studies revealed elevated levels of VSV RNA in blood in dogs with measurable disease remission. This is the first evaluation of intravenous oncolytic virus therapy for spontaneous canine cancer, demonstrating that VSV-IFNβ-NIS is well-tolerated and safe in dogs with advanced or metastatic disease. This approach has informed clinical translation, including dose and target indication selection, leading to a clinical investigation of intravenous VSV-IFNβ-NIS therapy, and provided preliminary evidence of clinical efficacy and potential biomarkers that correlate with therapeutic response. Mol Cancer Ther; 17(1); 316–26. ©2017 AACR.

News (Medical) associated with VSV-IFNbeta-NIS

14 Jun 2023

·www.prnewswire.com

Vyriad Announces Expansion of T-Cell Lymphoma Trial at Mayo Clinic

More Patients Added to Phase 1 Trial Following Encouraging Early Results ROCHESTER, Minn., June 14, 2023 /PRNewswire/ -- Vyriad, Inc., announces an expansion of a Phase 1 investigator-initiated trial at Mayo Clinic evaluating the safety and efficacy of Voyager-V1 (VSV-hIFNbeta-NIS) in patients with peripheral T-cell lymphoma (PTCL) following encouraging initial results1. Voyager-V1 is an investigational therapy being co-developed with Regeneron Pharmaceuticals, Inc., to treat patients with recurrent or treatment resistant cancers. It is an oncolytic virotherapy designed to target and dissolve cancer cells and stimulate the patient's immune system in hopes of preventing recurrence. "The expansion of this Phase 1 program is an important step toward delivering targeted genetic medicines to patients with resistant PTCL," said Stephen J. Russell, MD, Ph.D., Vyriad's chief executive officer and chief scientific officer. "Early Phase 1 results offered an indication that a single infusion of Voyager-V1 has the potential to provide significant benefit to patients with PTCL, a cancer with a generally poor prognosis." PTCLs comprise a diverse group of uncommon and aggressive diseases in which the patient's T cells become cancerous. PTCLs are a varied group of diseases that are not well understood. Techniques to distinguish and study the various subtypes of PTCL have only recently been developed.2 Current first-line therapies for patients with PTCL can be curative, but most patients will experience a recurrence of the disease. Funding for the trial is provided by Regeneron, the National Institutes of Health, and Vyriad. The trial is being conducted at Mayo Clinic Rochester and Mayo Clinic Arizona. For more information on the Phase 1 study please visit Clinical Trials.Gov/study/NCT03017820. About Vyriad, Inc. Vyriad is a clinical-stage biotechnology company developing virus-based therapeutics, focusing initially on proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Our lead platforms, derived from either vesicular stomatitis virus (VSV) or measles virus, are being evaluated in ongoing Phase 1-2 clinical trials addressing multiple cancer types. Vyriad is a privately held company based in Rochester, Minnesota. For more information, visit . 1 5 of 9 patients experienced positive results in a trial published by Cook et al. Blood Advances. 2022. Clinical activity of single-dose systemic oncolytic VSV virotherapy in patients with relapsed refractory T-cell lymphoma. PMID: 35175355 2 Peripheral T-Cell Lymphoma Facts. Leukemia & Lymphoma Society. This communication contains information about an investigational product. This product is limited by Federal (U.S.) law to investigational use only. Vyriad makes no claims regarding the safety or effectiveness of the unapproved investigational product. The intent of providing this information is to convey research and development initiatives underway at Vyriad. Contact: Scott Beck Chief Operating Officer [email protected] SOURCE Vyriad, Inc.

Phase 1Clinical Result

100 Deals associated with VSV-IFNbeta-NIS

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Head and Neck Carcinoma	Phase 2	United States	Vyriad, Inc.Startup	24 Apr 2020
Advanced Head and Neck Carcinoma	Phase 2	Brazil	Vyriad, Inc.Startup	24 Apr 2020
Colorectal Cancer	Phase 2	United States	Vyriad, Inc.Startup	24 Apr 2020
Colorectal Cancer	Phase 2	Brazil	Vyriad, Inc.Startup	24 Apr 2020
Melanoma	Phase 2	United States	Vyriad, Inc.Startup	24 Apr 2020
Melanoma	Phase 2	Brazil	Vyriad, Inc.Startup	24 Apr 2020
Squamous Cell Carcinoma of Head and Neck	Phase 2	United States	Vyriad, Inc.Startup	24 Apr 2020
Squamous Cell Carcinoma of Head and Neck	Phase 2	Brazil	Vyriad, Inc.Startup	24 Apr 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 2	United States	Vyriad, Inc.Startup	09 Apr 2019
Large cell neuroendocrine carcinoma	Phase 2	United States	Vyriad, Inc.Startup	09 Apr 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03120624 (Voyager-V1, ASGCT2019)	Phase 1	Metastatic endometrial cancer \| Recurrent Endometrial Cancer IFNβ levels \| RNAseq	7	VSV-IFNβ-NIS dose level 1	bazhrsdaay(oudrjllhpi) = N=2 mlmcoaapzq (gekeaujgvg ) View more	Positive	22 Apr 2019

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