RTTNews | Oct 1, 2021 08:31AM EDT

08:31 Friday, October 1, 2021 (RTTNews.com) - Precigen ActoBio, a wholly-owned subsidiary of Precigen Inc. (PGEN), announced additional positive interim data from the ongoing Phase 1b/2a clinical study investigating AG019 ActoBiotics for the treatment of recent-onset type 1 diabetes or T1D.

The company noted that AG019 showed stabilization of the long-term glycemic control markers, HbA1c and IDAA1c, for the majority of patients treated with the AG019 monotherapy and AG019 combination therapy.

Antigen-specific immune modulation, which is the keystone for the mechanism of action of AG019 as demonstrated in preclinical studies, is now translated into the immunological clinical data in the Phase1b/2a clinical study.

The company state that the new data presented at EASD strengthens previously reported findings on C-peptide and antigen-specific immune modulation, and the exciting data for the AG019 monotherapy reinforces its belief that AG019 is promising as a standalone therapy.

The company looks forward to further investigating the potential of AG019 in type 1 diabetes.

The Phase 1b open-label portion of the study evaluates the safety and tolerability of AG019 as a monotherapy in adult (age 18-42) and adolescent (age 12-17) patients. The Phase 2a double-blind portion of the study investigates the safety and tolerability of AG019 in combination with an investigational anti-CD3 monoclonal antibody, teplizumab (PRV-031).

Previously reported Phase 1b/2a data showed the potential of oral AG019 treatment to preserve insulin production in recent-onset T1D through its capacity to induce antigen-specific immune modulation.

New AG019 monotherapy data show that glycated hemoglobin (HbA1c) was below the 7% target for 100% of adult patients (9 of 9) and 92% of the patients aged 17 years and above (11 of 12) up to 12 months after dosing initiation.

Read the original article on RTTNews ( https://www.rttnews.com/3229883/precigen-reports-addl-positive-data-from-study-of-ag019-actobiotics-for-type-1-diabetes-treatment.aspx)

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