Vyriad Announces Initiation of Phase 2 Trial in Multiple Cancer Indications

Vyriad, Inc. announced today the dosing of the first patient in a Phase 2 clinical trial to evaluate its investigational oncolytic virus Voyager-V1 in combination with the PD-1 inhibitor Libtayo® (cemiplimab) in four difficult-to-treat or refractory advanced stage cancers. Libtayo is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement.

The open-label study will enroll up to an estimated 152 patients with non-small cell lung cancer or melanoma who have progressed on checkpoint inhibitor treatment and patients with hepatocellular carcinoma or endometrial cancer. The study will evaluate overall patient responses to the treatment, as well as safety, tolerability, pharmacodynamic and pharmacokinetic data. For additional information about the study, please visit www.clinicaltrials.gov (search identifier NCT04291105).

Voyager-V1 is an engineered vesicular stomatitis virus programmed to target, infect and kill cancer cells, while activating immune system responses that may enhance the restoration of antitumor T cell response by Libtayo.

“We are optimistic that this therapeutic combination will meaningfully increase the treatment responses of cancer patients with high unmet clinical needs,” said Stephen Russell, M.D., Ph.D., Vyriad President and Chief Executive Officer.  “We are pleased the study has commenced and we look forward to the results.”

“The promise of cancer immunotherapies has yet to be fulfilled as evidenced by their limited effectiveness in many patient groups,“ said Steven Powell, M.D., a medical oncologist who is the study’s principal investigator at Sanford Health, which treated the first patient in the study. “We’re excited to evaluate this therapy, which combines a systemically active oncolytic with an effective immunotherapy. We hope that this combination approach may turn cold tumors hot and facilitate clinically meaningful anti-cancer immune responses in multiple cancer types.”

Libtayo was invented by Regeneron using the company's proprietary VelocImmune® technology which uses a unique genetically-humanized mouse to produce optimized fully-human antibodies.

About Vyriad, Inc.Vyriad is a clinical-stage company developing virus-based therapeutics, focusing initially on proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Founded by scientists at Mayo Clinic and the University of Miami, Vyriad programs viruses to selectively attack cancer cells, thereby igniting antitumor immune responses that can complete the process of tumor destruction and prevent disease recurrence. Our lead platforms, derived from either vesicular stomatitis virus or measles virus (VSV), are being evaluated in ongoing Phase 2 clinical trials addressing multiple cancer types. Vyriad and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have entered into a broad strategic agreement for the discovery and development of new oncolytic virus treatments for cancer leveraging Vyriad’s VSV platform and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) as well as its unmatched antibody discovery capabilities. Vyriad is a privately held company based in Rochester, Minnesota. For more information, visit www.vyriad.com.

Contacts:

Media RelationsDavid Walsh(651) [e-mail]

Investor RelationsBarb Duckett(507) [e-mail]