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Avotres Announces Completion of Enrollment of its Phase I/II Trial of AVT001 in Patients with Type 1 Diabetes (T1D)

Avotres Inc. is a clinical stage biotechnology company developing novel immune therapies for autoimmune diseases, cancers, and transplantation

CEDAR KNOLLS, NJ, UNITED STATES, December 7, 2021 / — Avotres Inc., a clinical stage biotechnology company developing novel immune therapies for autoimmune diseases, cancers, and transplantation, announced today that they have completed the enrollment of the combined Phase I/II study (NCT03895996) for the treatment of new onset T1D patients with AVT001.

“The completion of enrollment in our T1D trial is an important step forward in advancing AVT001 as a potential new treatment option for patients suffering from T1D.” said John Houghton, President and Chief Executive Officer of Avotres. “We look forward to building on this momentum and sharing topline results from this Phase I/II trial in the second quarter of 2022.”

Avotres is currently conducting a combined phase I/II trial among new onset T1D patients with its lead asset, AVT001, a novel autologous dendritic cell-based therapy aiming to restore self-tolerance by correcting the dysfunctional HLA-E restricted CD8+ regulatory T cell mediated pathway. Last patient first dose for this study was administered on December 6, 2021.

T1D is one of the most common chronic diseases of childhood. It accounts for approximately two-thirds of all cases of diabetes in subjects ≤19 years of age. According to the Juvenile Diabetes Research Foundation, it is estimated that as many as 3 million subjects have T1D in the U.S., with more than 15,000 children and 15,000 adults diagnosed each year. These facts underscore the devastating impact of T1D on patients and marked adverse financial consequences for society. It has therefore become imperative to develop more effective treatments for T1D.

About AVT001

AVT001 is an investigational autologous dendritic cell-based therapy for a broad spectrum of autoimmune diseases. It specifically targets restoring the normal function of the HLA-E restricted CD8+ T cell mediated regulatory pathway. The dysfunction of this pathway is considered potentially responsible for the onset of autoimmune diseases as the common root cause.

AVT001 is currently in an ongoing combined phase I/II, randomized, double-blind, placebo-controlled study for the treatment of new onset Type 1 Diabetes with AVT001 for patients aged 16 and older. For more information, please click this link NCT03895996.

Avotres is also conducting human ex-vivo preclinical studies of AVT001 in several other autoimmune diseases including Multiple Sclerosis, Rheumatoid Arthritis and Systemic Lupus Erythematosus. “Our human ex vivo studies in approximately 200 clinically diagnosed patients across 26 distinct autoimmune diseases have demonstrated that AVT001 therapy is targeting a potential common root cause of autoimmune diseases”, said Dr. Hong Jiang, the scientific founder, and Chief Scientific Officer of Avotres.

About Avotres

Avotres Inc. is a private biotechnology company with a focus on the development of novel immune therapies for autoimmune diseases, cancers, and transplantation. Targeting these therapeutic areas with high unmet medical needs, we apply cutting edge science to unveil potentially paradigm shifting immunological pathways in the hope to transform the treatment for millions of patients. We consider it our mission to tackle these diseases from their root cause(s) and aim to reach the goal of relieving patients from the disease burden. Find out more at

Emmie Fan
Avotres Inc.

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