DiaPrecise, a Phase II Open Label Study to Evaluate the Safety and Feasibility of Intralymphatic Administration of Diamyd® in Individuals At Risk for Type 1 Diabetes Carrying the HLA DR3-DQ2 Haplotype

A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.

Start Date09 Jul 2024

Sponsor / Collaborator

Diamyd Medical AB

EUCTR2022-002356-39-SE

/ Unknown statusPhase 2

DiaPrecise, A Phase II Open Label Study to evaluate the safety andfeasibility of intralymphatic administration of Diamyd® inindividuals at risk for Type 1 diabetes carrying the HLA DR3-DQ2haplotype - DiaPrecise

Start Date14 Dec 2022

Sponsor / Collaborator

Diamyd Medical AB

NCT05018585

/ RecruitingPhase 3

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.

Start Date19 May 2022

Sponsor / Collaborator

Diamyd Medical AB

100 Clinical Results associated with Autoimmune diabetes vaccine (Diamyd)

100 Translational Medicine associated with Autoimmune diabetes vaccine (Diamyd)

100 Patents (Medical) associated with Autoimmune diabetes vaccine (Diamyd)

136

Literatures (Medical) associated with Autoimmune diabetes vaccine (Diamyd)

01 Oct 2024·Cytokine

The potential therapeutic role of IL-35 in pathophysiological processes in type 1 diabetes mellitus

Review

Author: Hussein, Heba A A ; Abuelsaad, Abdelaziz S A ; Ahmed, Osama M ; Bakery, Heba H ; Khalil, Rehab G

A chronic autoimmune condition known as type 1 diabetes mellitus (T1DM) has characteristics marked by a gradual immune-mediated deterioration of the β-cells that produce insulin and causes overt hyperglycemia. it affects more than 1.2 million kids and teenagers (0-19 years old). In both, the initiation and elimination phases of T1DM, cytokine-mediated immunity is crucial in controlling inflammation. T regulatory (Treg) cells, a crucial anti-inflammatory CD4⁺ T cell subset, secretes interleukin-35 (IL-35). The IL-35 has immunomodulatory properties by inhibiting pro-inflammatory cells and cytokines, increasing the secretion of interleukin-10 (IL-10) as well as transforming Growth Factor- β (TGF-β), along with stimulating the Treg and B regulatory (Breg) cells. IL-35, it is a possible target for cutting-edge therapies for cancers, inflammatory, infectious, and autoimmune diseases, including TIDM. Unanswered questions surround IL-35's function in T1DM. Increasing data suggests Treg cells play a crucial role in avoiding autoimmune T1DM. Throughout this review, we will explain the biological impacts of IL-35 and highlight the most recently progresses in the roles of IL-35 in treatment of T1DM; the knowledge gathered from these findings might lead to the development of new T1DM treatments. This review demonstrates the potential of IL-35 as an effective autoimmune diabetes inhibitor and points to its potential therapeutic value in T1DM clinical trials.

01 May 2024·Current Diabetes Reviews

Current Vaccination Practice in Diabetic (Diabetes I) Patients

Review

Author: Kumar, Yati ; Sundaram, Sonali ; Yadav, Deepika

Abstract:The worldwide prevalence of diabetes, an endocrine condition, is rising quickly. The alarming rise of diabetes in recent years has emerged as a major contributor to premature death and illness among persons of working age. The potential use of immunomodulatory drugs to prevent diabetes has been a source of worry in light of recent advances in our understanding of the role of autoimmune responses in the development of diabetes. Vaccines can work in a variety of ways, including by eliminating autoreactive T-cells or by blocking the connections between immune cells. Most diabetes vaccines that have been created so far have only been evaluated in animal models, with just a small number having undergone successful human trials. In this article, the authors also look at the clinical trial research that are currently being conducted to create a prototype diabetes vaccine.

01 Nov 2023·Diabetes, Obesity and Metabolism

A 1‐year pilot study of intralymphatic injections of GAD‐alum in individuals with latent autoimmune diabetes in adults (LADA) with signs of high immunity: No safety concerns and resemblance to juvenile type 1 diabetes

Article

Author: Grill, Valdemar ; Hals, Ingrid K ; Ludvigsson, Johnny ; Casas, Rosaura ; Balasuriya, Chandima ; Björklund, Anneli

AbstractAimsTo test, for the first time in latent autoimmune diabetes in adults (LADA), the effects of autoantigen‐specific immunotherapy by intralymphatic administration of aluminium‐formulated recombinant human glutamic acid decarboxylase 65 (GAD‐alum); specifically, to test if this treatment is safe, to test whether it induces a strong immunological response akin to a similar protocol in type 1 diabetes and to look for associations with preserved beta‐cell function.Materials and MethodsThree GAD‐alum injections, 4 μg each, were administered 1 month apart into an inguinal lymph node in 14 people with newly diagnosed LADA (age 30‐62 years) presenting with high levels of antibodies against glutamic acid decarboxylase (GADA). Adverse effects, immunological variables and beta‐cell function were monitored, with detailed measurements at 5 and 12 months from baseline.ResultsClinical adverse effects were minor and transient and measured laboratory variables were unaffected. All participants completed the study. Treatment raised levels of GADA, elicited strong effects on reactivity of peripheral blood mononuclear cells to GAD and raised cytokine/chemokine levels. Beta‐cell function appeared stable preferentially in the seven participants carrying human leukocyte antigen (HLA) haplotypes DR3DQ2, as assessed by C‐peptide glucagon tests (P < 0.05 vs. seven non‐carriers).ConclusionIntralymphatic treatment with GAD‐alum in LADA is without clinical or other safety concerns over a 12‐month period. As in a similar protocol used in type 1 diabetes, treatment exerts a strong immunological impact and is compatible with protection of beta‐cell function preferentially in HLA‐DR3DQ2 LADA patients. These findings pave the way for a randomized controlled trial in this important subgroup of LADA patients.

News (Medical) associated with Autoimmune diabetes vaccine (Diamyd)

13 Jan 2025

·www.prnewswire.com

Diamyd Medical updates U.S. market potential for Diamyd®

STOCKHOLM, Jan. 13, 2025 /PRNewswire/ -- Diamyd Medical has released an updated analysis of the commercial potential for its lead product candidate, the precision immunotherapy Diamyd® (rhGAD65/alum) in the U.S. market. The addressable patient population for its launch indication is estimated at over 60,000 individual patients, with annual peak sales projections well exceeding block buster potential*. Diamyd® has Orphan Drug Designation status in the U.S. for its launch indication, and follow-on indications represent a market potential that is expected to equal or even exceed its primary indication. *Defined as annual sales of at least $1 billion. Addressable market at launch The addressable market for Diamyd® at launch consists of two distinct populations, both comprising patients aged 12 years and older. Newly diagnosed Stage 3 Type 1 Diabetes patients In 2024, approximately 47,000 patients in the U.S. are expected to be newly diagnosed with Stage 3 T1D. Of these, an estimated 19,000 individuals (40 %) are HLA DR3-DQ2 positive and eligible for Diamyd® treatment. Recently diagnosed Type 1 Diabetes patients with retained beta cell function An additional opportunity exists among recently diagnosed Type 1 Diabetes patients who retain beta cell function for up to two years following diagnosis. This population is estimated at 62,000 individuals in 2024, of whom approximately 25,000 are HLA positive. While this group is expected to shrink as Diamyd® is adopted in newly diagnosed patients, it will remain a significant contributor to the addressable market. These combined populations will annually total over 60,000 patients in the U.S. the coming years when accounting for incidence and population growth. Market assumptions Pricing: Diamyd®'s base case gross price is projected at $157,000 per course, supported by market research with payers and providers. Limited standard Gross-to-Net discounts, which account for rebates, discounts, and other payer incentives, are expected. The final gross price will be dependent on the Phase 3 data, with potential for a gross price up to $200,000 per course. Price increases of 2% per year are expected. Access and coverage: Diamyd® is expected to achieve over 80 % market access. This is based on broad insurance coverage of Type 1 Diabetes and expected high prior authorization approvals, reflecting its strong clinical differentiation as a disease-modifying therapy and its status having an FDA granted orphan drug designation. Market penetration: Qualitative market research supports an estimate of at least 30 % of Type 1 Diabetes patients being a reasonable penetration assumption for base case projections. Clear growth drivers and upsides Latent Autoimmune Diabetes in Adults (LADA): LADA, a condition affecting approximately 7 % of the 1.2 million adults diagnosed annually with Type 2 Diabetes in the U.S., represents an addressable market that is equal or larger than the Stage 3 Type 1 Diabetes market. Earlier Type 1 Diabetes Stages: Expanding Diamyd®'s indication to include Stage 1 and Stage 2 Type 1 Diabetes patients offers opportunities for early intervention. The size of the addressable market is heavily dependent on the availability and coverage of screening programs. Booster courses: Booster treatments for patients previously treated with Diamyd® present an additional market segment. Ex-U.S. market: Global opportunities could account for an additional 40 % of Diamyd®'s total sales potential, based on analogs from the Type 2 Diabetes market. The market research underscores the importance of enhancing Health Care Practitioner (HCP) education and engagement, as many physicians lack familiarity with the genetic and clinical profiling necessary to identify eligible patients, such as HLA testing and C-peptide measurements. Given that Diamyd® could be the first or among the first therapies approved to preserve insulin-producing capacity in Type 1 Diabetes, measured by C-peptide, it is essential to educate HCPs, patient advocacy groups, and payers about the critical value of maintaining endogenous insulin production and its long-term benefits for patient outcomes. The market research was conducted in collaboration with the Kondrad Consulting Group, LLC, Sarasota, FL USA, . 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 antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Breakthrough Designation and Fast Track Designation by the U.S. FDA for the treatment of Stage 3 Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymph node can be performed in minutes and are intended to optimize the treatment response. 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: [email protected] This information was brought to you by Cision . The following files are available for download: SOURCE Diamyd Medical AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugPhase 2Fast TrackPhase 3Immunotherapy

10 Jan 2025

·www.prnewswire.com

Diamyd Medical confirms key advances toward Accelerated Approval for Diamyd® following FDA Type C Meeting

STOCKHOLM, Jan. 10, 2025 /PRNewswire/ -- Diamyd Medical provides an update following the receipt of final meeting minutes from a positive Type C meeting with the U.S. Food and Drug Administration (FDA) held in December 2024. The meeting focused on refining study protocol and analysis strategies for Diamyd® (rhGAD65/alum) in preparation for Accelerated Approval of the antigen-specific immunotherapy targeting Stage 3 Type 1 Diabetes. The final minutes from the Type C meeting confirm alignment on critical development milestones and the statistical plan, setting the stage for an expedited review pathway. As previously announced on December 13, Diamyd Medical had held a positive in-person meeting with the FDA. Following the meeting, Diamyd Medical has now received the final minutes. The FDA provided affirmative feedback on several pivotal aspects of Diamyd Medical's development program, including: Accelerated Approval Pathway: Confirmation that the ongoing DIAGNODE-3 Phase 3 trial aligns with requirements for an Accelerated Approval, leveraging interim efficacy data based on stimulated C-peptide as the primary endpoint from approximately 170 evaluable participants who will complete their 15-month assessments by early 2026. Safety Dataset and Confirmatory Evidence: Concurrence on the suitability of both the safety dataset and the confirmatory evidence for a potential accelerated approval. The safety dataset includes data from DIAGNODE-3 at filing, along with data from other intralymphatic trials with Diamyd® and the three placebo-controlled trials evaluating subcutaneous injections of Diamyd® from the original meta-analysis published by Hannelius et al. in Diabetologia (2020). Furthermore, concurrence on that DIAGNODE-3 serves as the pivotal trial to demonstrate substantial evidence of effectiveness, supported by DIAGNODE-2 and the aforementioned placebo-controlled trials as confirmatory evidence. Co-Primary Endpoints: Agreement on simultaneous evaluation of stimulated C-peptide levels and HbA1c as co-primary endpoints at the 24-month final analysis. Statistical Analysis Plan: Acceptance of the testing strategy for endpoint evaluation, ensuring robust data integrity for both accelerated and full approvals. The FDA emphasized that the analysis presented in the Trial Outcome Markers Initiative (TOMI) meta-analysis, published by Taylor et al. in Lancet (2023), provides critical insights into the association between C-peptide preservation and clinical outcomes in type 1 diabetes. The FDA agreed that the justification for the required level of C-peptide preservation to support an accelerated approval, including its relationship to a clinically meaningful reduction in HbA1c, could be further discussed at a pre-BLA meeting and included in the Biologics License Application (BLA). Additionally, the FDA reaffirmed the Orphan Drug Designation for Diamyd® for treating a subset of Type 1 Diabetes patients with residual beta cell function. This designation highlights the therapy's potential to address significant unmet needs in this well-defined patient population. 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 antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Breakthrough Designation and Fast Track Designation by the U.S. FDA for the treatment of Stage 3 Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymph node can be performed in minutes and are intended to optimize the treatment response. 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: [email protected] This information was brought to you by Cision . The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugPhase 2Fast TrackImmunotherapyPhase 3

13 Dec 2024

·www.prnewswire.com

Diamyd Medical Aligns with FDA on Key Elements for an Accelerated Approval Process

STOCKHOLM, Dec. 13, 2024 /PRNewswire/ -- Diamyd Medical today announced a positive in-person Type C meeting with the U.S. Food and Drug Administration (FDA), where alignment was achieved on key components of the planned early readout and an accelerated approval pathway for the antigen-specific immunotherapy, Diamyd® (rhGAD65/alum). Additional details of the FDA interaction will be disclosed upon receipt of the final meeting minutes, expected in January 2025. "We are very pleased with the positive and constructive dialogue and the alignment achieved with the FDA on key elements of the accelerated readout procedure," says Ulf Hannelius, CEO of Diamyd Medical. "This represents a significant milestone as we advance toward making Diamyd® available to patients with Type 1 Diabetes needing disease-modifying treatments. Importantly, the accelerated approval pathway could allow Diamyd® to reach the market more than a year earlier, addressing the urgent need for innovative therapies." The early readout, planned for March 2026 for the ongoing Phase 3 DIAGNODE-3 trial, will include approximately 170 evaluable participants who have completed their 15-month assessment. As of today, 191 patients have been randomized in the trial. This analysis will provide efficacy data based on preservation of C-peptide levels, which the FDA, following a Type C meeting held in July 2024 with Diamyd Medical, recognizes as a surrogate endpoint reasonably likely to predict clinical benefit in Type 1 Diabetes, and can therefore be used to obtain Accelerated approval. 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 antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Breakthrough Designation and Fast Track Designation by the U.S. FDA for the treatment of Stage 3 Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymphnode can be performed in minutes and are intended to optimize the treatment response. 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 also develops the GABA-based investigational drug Remygen® as a component in the treatments of metabolic diseases. 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: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Diamyd Medical AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Fast TrackImmunotherapyOrphan DrugPhase 3

100 Deals associated with Autoimmune diabetes vaccine (Diamyd)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	SE	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	ES	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	DE	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	Phase 3	NL	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	IND Application	SI	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	IND Application	FI	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	IND Application	FR	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	IND Application	GB	Diamyd Medical AB	01 Jul 2008
Diabetes Mellitus, Type 1	IND Application	IT	Diamyd Medical AB	01 Jul 2008
Latent Autoimmune Diabetes in Adults	Preclinical	SE	Diamyd Medical AB	01 Dec 2004

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


1499-P (ADA2024)	Not Applicable	Pancreatic adenocarcinoma Neoadjuvant \| Second line GAD65 antibody \| CA 19-9 \| CEA	-	GAD65 Antibody (Pancreatic Adenocarcinoma)	qxfbwuuedm(ohegmkroja) = barvjcchld orufdstepj (swaohwjotf ) View more	Positive	14 Jun 2024
NCT03345004 (DIAGNODE-2, CTgov)	Phase 2	Diabetes Mellitus, Type 1	109	Vitamin D+Diamyd (Active Arm)	jmeoehcjxy(dbkdnhblex) = fgoozlczjt ncutyiumqv (oqzszcxflq, obhxhfmzqm - lykxvhctiw) View more	-	09 Jan 2023
NCT03345004 (DIAGNODE-2, CTgov)	Phase 2	Diabetes Mellitus, Type 1	109	Placebo for Diamyd (Placebo Arm)	jmeoehcjxy(dbkdnhblex) = iionnoseyz ncutyiumqv (oqzszcxflq, nxsbndoebb - soovtktnnt) View more	-	09 Jan 2023
NCT02352974 (DIAGNODE \| DIAGNODE-1, CTgov)	Phase 1	Diabetes Mellitus, Type 1	12	GAD-Alum+Vitamin D	shzwltksmh(wdsdozwruk) = leqcyjmvcl vdzzyzypxj (glmfejjvhe, rjekxkopej - uhfrqjefqj) View more	-	27 Apr 2020
NCT02352974 (DIAGNODE-1, Biospace) Manual	Phase 1/2	Diabetes Mellitus, Type 1	12	Diamyd	gugwigjkss(enhzdqzvrz) = gcjmzfreai tqaellmxpl (cxbhkakcxf ) View more	Positive	20 Dec 2019
NCT01122446 (DIAPREV-IT, CTgov)	Phase 2	Diabetes Mellitus, Type 1 \| Prediabetic State	50	Placebo comparator (Placebo Comparator)	(yyshiqwwzp) = atbkqezbqx oqqbiltqbd (rbgsicgxuj, tohmpzbmcv - eitxaumucz) View more	-	06 May 2019
NCT01122446 (DIAPREV-IT, CTgov)	Phase 2	Diabetes Mellitus, Type 1 \| Prediabetic State	50	Diamyd (Alum-GAD (Diamyd))	(yyshiqwwzp) = mlkeiskhnj oqqbiltqbd (rbgsicgxuj, iufqkhmcxe - okyxvvejgx) View more	-	06 May 2019

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Autoimmune diabetes vaccine (Diamyd)

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