“The granted patent is a significant milestone for Diamyd Medical and our focus on precision medicine for autoimmune diabetes”, says Ulf Hannelius, CEO of Diamyd Medical. “The time is ripe for safe and targeted therapeutic diabetes vaccines, therapies that may revolutionize our possibilities to eliminate this devastating disease.”

HLA DR3-DQ2 has been shown to be associated with autoimmunity against GAD and represents one of the most common genetic risk factors for type 1 diabetes since about 40% of individuals with type 1 diabetes carry  the gene. A large-scale meta-analysis published in Diabetologia in 2020 showed that positivity for HLA DR3-DQ2 is associated with clinical response to the diabetes vaccine Diamyd^®. This was prospectively confirmed in the Phase IIb trial DIAGNODE-2 that was published in Diabetes Care in May 2021.

In addition to the precision medicine patent that will be granted in Europe, Diamyd Medical already holds, as part of an exclusive license from the University of California, Los Angeles (UCLA), patent protection in the United States, which is valid until 2032 for the treatment of diabetes with GAD, a major autoantigen in autoimmune diabetes. Diamyd Medical also holds patent protection valid until 2035 in Europe, Japan, Russia, Israel and Australia for intralymphatic administration of Diamyd^®, the administration route used in the DIAGNODE-1 and -2 clinical trials and to be used in the upcoming Phase-3 trial with Diamyd^®.

As a biological drug, Diamyd^® will, independently of patent protection, enjoy twelve and ten years market exclusivity from the date of market approval in the US and Europe respectively.

About Diamyd Medical
Diamyd Medical develops precision medicine therapies for type 1 diabetes. The diabetes vaccine Diamyd^® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine was administered directly into a lymph node in children and young adults with recently diagnosed type 1 diabetes. Preparations for a confirmatory Phase III trial in the US and Europe are on-going, to start recruting patients later in 2021. A vaccine manufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd^®. Diamyd Medical also develops the GABA-based investigational drug Remygen^® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen^® trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma 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; phone: +46 8-528 00 399, e-mail: info@fnca.se.

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)
Kungsgatan 29, SE-111 56 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

This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on August 9, 2021.