Clinical Programs

Striving to Improve Lives With Medicines That Inspire Hope

Delivering potentially curative medicines to as many patients as possible takes expertise and dependability. Our clinical trials are conducted in partnership with leading pharmaceutical companies and top medical research centers. Vyriad’s clinical team is highly experienced, and has overseen the administration of oncolytic virotherapies to over 300 patients at over 40 clinical sites in the USA and Brazil.

Vyriad’s programs cover all phases of clinical development, and many of our oncolytic virotherapies are being assessed in phase 1 and 2 trials as monotherapies, and in combination with other immunotherapies for multiple cancer indications. These oncolytic virotherapies can be uniquely tracked with imaging to guide the intelligent development and clinical validation of virus-drug combination regimens. In parallel, we are developing theranostics and algorithms to predict the best possible treatment regimens for patients.

Clinical programs for oncolytic virotherapies are focused on Voyager-V1, an armed and trackable vesicular stomatitis virus (VSV), and measles virus encoding the human thyroidal sodium iodide symporter (MV-NIS). For more information about these ongoing clinical programs, including patient enrollment and eligibility, refer to the clinical studies listed below.

Vyriad Clinical Studies

Voyager-V1 + cemiplimab

Multiple Cancer Indications

Phase 2

Voyager-V1 in combination with cemiplimab

Vyriad and Regeneron Pharmaceuticals are collaborating on a Phase 2 study to evaluate the therapeutic combination of one dose of oncolytic virus, Voyager-V1 and cemiplimab, a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1, given every 3 weeks in select solid tumors.

Enrollment Status: Recruiting
Research Partner: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04291105

Voyager-V1 + pembrolizumab or ipilimumab / nivolumab

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 relapsed or refractory neuro-endocrine tumors and Voyager-V1 in combination with ipilimumab / nivolumab in patients with first-line MSCLC or R/R NEC.

Enrollment Status: Recruiting
ClinicalTrials.gov Identifier: NCT03647163

Voyager-V1

Solid Tumors

Complete

Voyager-V1 monotherapy

This is a 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: Trial completed
Research Partner: NA
ClinicalTrials.gov Identifier: NCT02923466

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

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

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

MV-NIS

Medulloblastomaand 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