The Australian Patent Office has granted a patent protecting a novel immunotherapeutic composition developed by Diamyd Medical for use in the treatment and prevention of autoimmune diabetes. The patent, valid until 2035, covers a composition comprising the antigens glutamic acid decarboxylase (GAD) and proinsulin immobilized on separate carrier particles.
"This patent expands our precision medicine platform for autoimmune diabetes and reinforces the intellectual property protection around our immunotherapeutic technologies," says Anton Lindqvist, Chief Scientific Officer of Diamyd Medical. "Targeting specific responders with a combination of GAD and insulin epitopes provides an important step forward for tailoring treatment to the individual and reflects the evolving scientific understanding of how to best modulate the autoimmune response in diabetes."
The patent complements two existing Australian patents granted to Diamyd Medical, which cover direct lymph node administration of GAD and other beta cell antigens including proinsulin, insulin, ZnT8, IGRP, and others for the prevention or treatment of autoimmune diabetes. Similar claims that are now approved in Australia have also been approved in Israel, additional countries pending.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying a HLA DR3-DQ2 gene. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase 3 trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. An early read-out of the Phase 3 trial is expected in March 2026. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial. The DIAGNODE-3 trial is recruiting only this patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with Type 1 Diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com
The information was provided by the contact person above, for publication on April 15, 2025, 17.45 CET.
