Vyriad Begins Phase 1 Clinical Trial for Lead In Vivo CAR T Cell Therapy VV169 Following FDA Acceptance of IND Application

Vyriad Begins Phase 1 Clinical Trial for Lead In Vivo CAR T Cell Therapy VV169 Following FDA Acceptance of IND Application

The trial will evaluate VV169 for relapsed/refractory multiple myeloma and is actively enrolling patients at Mayo Clinic

Vyriad, Inc., a clinical-stage biotechnology company developing targeted genetic therapies for cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a clinical trial of VV169, an off-the-shelf, in vivo CAR T cell therapy targeting BCMA in patients with relapsed/refractory multiple myeloma. The Phase 1 trial is now open for enrollment at Mayo Clinic.

“VV169 is designed to create CAR-T cells directly inside the body, offering a new way of delivering this powerful therapeutic approach to patients with multiple myeloma. The Phase 1 clinical trial for VV169 being open for enrollment is a significant milestone for Vyriad and we are proud to reach it alongside Dr. Yi Lin and her team at Mayo Clinic,” said Luke Russell, Ph.D., MBA, President of Vyriad. “This reflects years of sustained effort from investigators, study staff, and the R&D and manufacturing teams here in Rochester. We are grateful to everyone who made it happen, and to the patients who choose to take part.”

VV169 was developed using Vyriad’s proprietary in vivo lentiviral platform centered on blinded and retargeted VSV-G pseudotyping. To enable direct in vivo delivery, VV169 utilizes the targeted lentiviral vector to deliver a potent anti-BCMA CAR payload. Upon intravenous administration, the vehicle specifically targets and transduces T cells, enabling rapid generation of functional CAR T cells. This targeted approach results in highly specific payload expression and minimizes the risk of infusional toxicities.

“For patients with aggressive multiple myeloma, waiting weeks for a therapy to be manufactured can be a significant barrier,” said Chief Scientific Officer Stephen Russell, M.D., Ph.D. “VV169 is designed to change that by creating CAR T cells directly inside the body, thereby making this off-the-shelf approach to CAR T more accessible for patients. We look forward to evaluating the potential of this program in the clinic.”

The Phase 1 trial will evaluate the safety and initial efficacy signals of VV169 in up to 40 patients with relapsed/refractory multiple myeloma. The trial, conducted at Mayo Clinic by principal investigator Yi Lin, M.D., Ph.D., head of the center’s in vivo CAR T program, will have key primary objectives to assess overall safety, identify dose-limiting toxicities, and determine the recommended Phase 2 dose. The secondary objective will focus on assessing preliminary efficacy signals of VV169 and evaluating in vivo CAR T cell expansion and persistence.

For more information, including trial details and eligibility criteria, please visit the study page on clinicaltrials.gov (NCT07802717).

About Vyriad

Vyriad is a clinical-stage biotechnology company developing targeted genetic medicines for cancer and other serious diseases. The company uses engineered viruses, viral vectors, and viral envelope glycoproteins to deliver therapeutic genes directly to selected cells. Vyriad’s programs include oncolytic virotherapy, in vivo gene therapy, and gene editing applications, with ongoing Phase 1–2 trials in multiple cancer indications. Vyriad is a privately held company based in Rochester, Minnesota.

For more information, visit www.vyriad.com

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