Clinical Program

A new modality for the treatment of cancer

Vyriad has a broad portfolio of oncolytic viruses in discovery, translational and clinical phases of development.  The clinical program is focused on two engineered viruses: Voyager-V1, a vesicular stomatitis virus, and MV-NIS, an attenuated measles virus.  The clinical development program is designed to establish clinical proof of concept for oncolytic virotherapies as a monotherapy or in combination with immune checkpoint inhibitors.

Our oncolytic virotherapies are uniquely trackable using novel biomarkers to guide the intelligent development and clinical validation of virus-drug combination regimens. I n parallel, we are developing theranostics and algorithms to predict the best possible treatment regimens for patients.

A series of Phase 1 and 2 clinical studies are ongoing in multiple cancer indications with both Voyager-V1 and MV-NIS.  These trials are being conducted in partnership with leading pharmaceutical companies and top medical research centers, including Vyriad’s founding academic partners, Mayo Clinic and University of Miami.

Vyriad Clinical Studies

Voyager-V1 + cemiplimab

Multiple Cancer Indications

Phase 2

Voyager-V1 in combination with cemiplimab

Vyriad and Regeneron have agreed to conduct a Phase 2 study to evaluate the therapeutic combination of Voyager-V1 and cemiplimab, a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1), in multiple types of cancer.

  • Enrollment Status:
    Starting in 2020
  • Research Partner:
    Regeneron

Voyager-V1 + pembrolizumab

Non-Small Cell Lung Cancer, Head and Neck Cancer

Phase 2

Voyager-V1 in combination with pembrolizumab

This is an open label Phase 2 study evaluating the safety and efficacy of intravenous administration of Voyager-V1 in combination with pembrolizumab, an anti-PD1 antibody marketed by Merck & Co., Inc., in patients with refractory non-small cell lung cancer and squamous cell carcinoma of the head and neck.

  • Enrollment Status:
    Recruiting
  • ClinicalTrials.gov Identifier:
    NCT03647163
Learn More

including patient eligibility and enrollment process

Voyager-V1 + avelumab

Metastatic Colorectal Cancer

Phase 2

Voyager-V1 in combination with avelumab

This is the phase 2 stage of a Phase 1-2 trial evaluating the safety and efficacy of intravenous administration of Voyager-V1 in combination with avelumab in patients with metastatic colorectal cancer.

  • Enrollment Status:
    Recruiting
  • Research Partner:
    EMD Serono, the biopharmaceutical business of Merck KGaA.
  • ClinicalTrials.gov Identifier:
    NCT02923466
Learn More

including patient eligibility and enrollment process

Voyager-V1

Solid Tumors

Phase 1

Voyager-V1 monotherapy

This is an open label Phase 1 dose escalation study to evaluate safety, maximum tolerated dose and efficacy of Voyager-V1, in patients with advanced relapsed refractory solid tumors, given by intratumoral or intravenous administration.

  • Enrollment Status:
    Recruiting (intravenous cohort)
  • Research Partner:
    NA
  • ClinicalTrials.gov Identifier:
    NCT02923466
Learn More

including patient eligibility and enrollment process

MV-NIS

Bladder Cancer

Phase 1

MV-NIS Monotherapy

This is an open-label Phase 1 study designed to test the tolerability and feasibility of intravesical therapy with an attenuated measles virus (MV) in patients with urothelial carcinoma who are undergoing radical cystectomy but are ineligible or do not desire neoadjuvant chemotherapy.

  • Enrollment Status:
    Recruiting
  • Research Partner:
    Mayo Clinic
  • ClinicalTrials.gov Identifier:
    NCT03171493
Learn More

including patient eligibility and enrollment process

Investigator-Sponsored Clinical Studies

Voyager-V1 +/- ruxolitinib

Multiple Myeloma, T Cell Lymphoma

Phase 1

Voyager-V1 monotherapy or in combination with ruxolitinib

This is a Phase 1 dose escalation trial evaluating the safety, maximum tolerated dose and efficacy of intravenous administration of Voyager-V1 in patients with relapsed refractory multiple myeloma or T-cell lymphoma, as a monotherapy or in combination with ruxolitinib, a Jak/Stat inhibitor.

  • Enrollment Status:
    Recruiting
  • Research Partner:
    Mayo Clinic
  • ClinicalTrials.gov Identifier:
    NCT03017820
Learn More

including patient eligibility and enrollment process

Voyager-V1 +/- ruxolitinib

Endometrial Cancer

Phase 1

Voyager-V1 monotherapy or in combination with ruxolitinib

This is a Phase 1 dose escalation trial evaluating the safety, maximum tolerated dose and efficacy of intravenous administration of Voyager-V1 in patients with stage IV endometrial cancer or relapsed endometrial cancer, as a monotherapy or in combination with ruxolitinib, a Jak/Stat inhibitor.

  • Enrollment Status:
    Recruiting
  • Research Partner:
    Mayo Clinic
  • ClinicalTrials.gov Identifier:
    NCT03120624
Learn More

including patient eligibility and enrollment process

MV-NIS

Medulloblastoma and Recurrent ATRT

Phase 1

MV-NIS Monotherapy

This is an open label Phase 1 study will assess the safety and efficacy of the modified measles virus (MV) in children and young adults with recurrent medulloblastoma or atypical teratoid rhabdoid tumor (ATRT). MV, which is designed to kill tumor cells without damaging normal cells, will be administered directly into the tumor bed in patients locally recurrent tumors or into the subarachnoid space in patients with disseminated recurrent tumors.

  • Enrollment Status:
    Recruiting
  • Research Partner:
    University of California, San Francisco, Pacific Pediatric Neuro-Oncology Consortium
  • ClinicalTrials.gov Identifier:
    NCT02962167