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). Therefore, the overall sample size will be a maximum of 40 patients.

Start Date09 Apr 2019

Sponsor / Collaborator

Vyriad, Inc.Startup

[+1]

NCT03120624 / Active, not recruitingPhase 1

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.

bioRxiv : the preprint server for biology

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

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 ; Bergsrud, Kelly ; Groschen, Donna ; Preusser, Caitlin ; Winter, Amber ; Farrar, Michael A ; Sarver, Aaron L ; Cutter, Gary R ; Russell, Stephen J ; Mills, Lauren J ; Schwabenlander, Marc D ; Wolfe, Melissa ; Naik, Shruthi

Abstract:

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 described 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 RNAseq 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 Aug 2020·Molecular cancer research : MCRQ2 · MEDICINE

Radiation Attenuates Prostate Tumor Antiviral Responses to Vesicular Stomatitis Virus Containing IFNβ, Resulting in Pronounced Antitumor Systemic Immune Responses

Q2 · MEDICINE

Article

Author: Barber, Glen ; Marples, Brian ; Udayakumar, Thirupandiyur S. ; Patel, Mausam ; Tao, Wensi ; Pollack, Alan ; Totiger, Tulasigeri M. ; Betancourt, Dillon M. ; Ahmad, Anis

Abstract:

Vesicular stomatitis virus (VSV) expressing IFNβ induces apoptosis in multiple tumor models while maintaining an excellent safety profile. VSV-IFNβ is oncoselective due to permissive replication in cells with an altered IFN pathway. The human VSV-IFNβ (hIFNβ) vector is currently used in clinical trials as a standalone therapy; however, we hypothesized that oncolytic virotherapy might be more effective when used in combination with radiotherapy (RT). We investigated the synergistic effects of RT and VSV-hIFNβ in the subcutaneous PC3 and orthotopic LNCaP prostate xenograft models and a syngeneic RM9 prostate tumor model. VSV-IFNβ combined with RT amplified tumor killing for PC3 and LNCaP xenografts, and RM9 tumors. This was attributed to the induction of proapoptotic genes leading to increased VSV-IFNβ infection and replication, VSV expression, and oncolysis. In the RM9 tumors, combination therapy resulted in a robust antitumor immune response. Treated RM9 tumor-bearing mice demonstrated an increase in CD8+ and CD4+ T-cell numbers, 100% resistance to tumor rechallenge, and reduced resistance to reimplantation challenge with CD8+ knockdown. RT enhanced the activity of VSV-mediated oncolysis via attenuation of the innate antiviral response, resulting in increased VSV replication and the generation of an adaptive immune response earmarked by an increase in CD8+ lymphocyte numbers and antitumor activity. Local tumor irradiation combined with VSV-IFNβ affects tumor cell death through direct and systemic activity in conjunction with pronounced antitumor immunity.

Implications::

Radiotherapy enhances VSV-mediated oncolysis and anti-tumor immunity, indicating that the ombination has promise for very high risk prostate cancer.

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
Colorectal Cancer	Phase 2	US	Vyriad, Inc.Startup	24 Apr 2020
Colorectal Cancer	Phase 2	BR	Vyriad, Inc.Startup	24 Apr 2020
Melanoma	Phase 2	US	Vyriad, Inc.Startup	24 Apr 2020
Melanoma	Phase 2	BR	Vyriad, Inc.Startup	24 Apr 2020
Squamous Cell Carcinoma of Head and Neck	Phase 2	US	Vyriad, Inc.Startup	24 Apr 2020
Squamous Cell Carcinoma of Head and Neck	Phase 2	BR	Vyriad, Inc.Startup	24 Apr 2020
Neuroendocrine Carcinoma	Phase 2	US	Vyriad, Inc.Startup	09 Apr 2019
Non-Small Cell Lung Cancer	Phase 2	US	Vyriad, Inc.Startup	09 Apr 2019
Malignant Solid Neoplasm	Phase 1	US	Vyriad, Inc.Startup	17 Apr 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03017820 (ASCO2023) Manual	Phase 1	T-cell lymphoma recurrent	43	VSV-IFNbeta-NIS	rmicopptyw(fdofivglok) = Grades 3 and higher AEs were hematologic with transient lymphopenia (63.6%), neutropenia (36.4%) being the most common. nzalpampvn (mykiylgleb ) View more	Positive	31 May 2023
NCT03017820 (ASCO2023)	Phase 1	Hematologic Neoplasms	30	Voyager-V1	jwxakyhaco(xlvhbaxsna) = yzzzpbcwwk zkjsualoeu (eykcpqpkdj )	Positive	31 May 2023
NCT03017820 (ASCO2021) Manual	Phase 1	T-cell lymphoma recurrent	15	VSV-IFNβ-NIS	ozgygiiyqu(eqndqkqmme) = CRS grades 1 (6.7%) and 2 (46.6%) were the non-hematologic AEs of note. pksxuxizlx (isghlilrpq ) View more	Positive	20 May 2021

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