WALTHAM, Mass., and SHANGHAI, China, July 31, 2022 — Zenas BioPharma, a global biopharmaceutical firm dedicated to advancing immune-based therapies, has announced the approval of its Investigational New Drug (IND) application by China’s National Medical Products Administration (NMPA) to commence a Phase 1/2 clinical study of ZB001 for the treatment of Thyroid Eye Disease (TED). This study will primarily focus on assessing the safety, tolerability, pharmacokinetics, and initial efficacy of ZB001.

TED is a serious autoimmune condition that can threaten vision, characterized by inflammation and fibrosis in the eye’s orbit. Patients in China currently have limited treatment options, as there are no approved therapies specifically for TED. Existing treatments often rely on high doses of steroids, which can lead to severe side effects, or require surgical intervention. ZB001 is a humanized monoclonal antibody specifically targeting the insulin-like growth factor 1 receptor (IGF-1R), developed to offer a differentiated therapeutic approach for TED.

Dr. Hua Mu, CEO of Zenas, expressed pride in the swift approval of the IND application, which came just two months post-submission, underscoring the team’s efficiency in advancing development programs. He stated, “We are excited to collaborate with leading clinical experts in China to expedite the development of ZB001, aiming to fulfill the significant unmet clinical need in thyroid eye disease.”

In October 2020, Zenas BioPharma secured exclusive rights to develop, manufacture, and commercialize ZB001 (known as Viridian VRDN-001) and other IGF-1R-targeting compounds for non-oncology indications in the Greater China region from Viridian Therapeutics, Inc. Following the submission of an IND for VRDN-001 to the U.S. Food and Drug Administration in October 2021, Viridian initiated a Phase 1/2 clinical trial in December 2021 in North America to establish proof of concept in TED patients, which reported promising interim data indicating strong activity and favorable safety and tolerability profiles.

About Zenas BioPharma:
Zenas BioPharma operates as a global biopharmaceutical company headquartered in the USA and China, focusing on the development and commercialization of immune-based therapies for patients globally. The company is committed to advancing a robust pipeline of innovative therapeutics, driven by an effective business development strategy and a proficient leadership team dedicated to operational excellence. For more information about Zenas BioPharma, visit www.zenasbio.com and follow us on Twitter @ZenasBioPharma and LinkedIn.