SELLAS Life Sciences Announces IND Acceptance for First Clinical Trial of GPS in China

On January 26, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS” or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported that an IND application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been accepted by China’s National Medical Products Administration ("NMPA") (Press release, Sellas Life Sciences, JAN 26, 2022, View Source [SID1234607422]). The IND, for a small Phase I clinical trial investigating safety, was submitted by SELLAS’ partner in China, 3D Medicines Inc. ("3D Medicines"). 3D Medicines expects to initiate the trial by mid-2022 and will be responsible for all expenses related to executing the trial in China. The approval of the IND by the NMPA will trigger a milestone payment to SELLAS. The current clinical development plan provides for initiation of a Phase II clinical trial following receipt of satisfactory safety data from the Phase I study; the initiation of the Phase II study will also trigger a milestone payment to SELLAS. Total remaining potential milestone payments to SELLAS under the license agreement between the two companies could total $192.5 million, not including future royalties.

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"Acceptance from China’s NMPA of 3D Medicines’ IND application to initiate a Phase I clinical trial of GPS in patients with hematological malignancies in China marks an important regulatory milestone for SELLAS," said Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "The results of our own Phase I and II clinical trials in acute myeloid leukemia (AML), malignant pleural mesothelioma (MPM), multiple myeloma (MM), and relapsed ovarian cancer have been extremely encouraging. We look forward to expanding the reach of GPS outside the U.S. and Europe and we view 3D Medicines’ initiation of the clinical development program of GPS in China to be a key step in our plans to improve clinical outcomes for cancer patients, not only in China, but worldwide."

"In addition, we are exploring the possibility of 3D Medicines participating in SELLAS’ ongoing randomized, multi-center Phase III REGAL clinical trial currently underway in the U.S. and Europe in patients with AML who have achieved their second complete remission. Such participation would trigger a milestone payment to SELLAS. Furthermore, GPS has the potential to create synergies in combination with envafolimab, 3D Medicines’ PD-L1 product formulated for subcutaneous injection, which received marketing approval from the NMPA in China at the end of 2021. We, together with 3D Medicines, plan to explore the combination for advanced treatment for different types of cancers," concluded Dr. Stergiou.

About 3D189
3D189, also known as SELLAS’ lead product candidate, GPS, is an immunotherapeutic that targets the Wilms Tumor 1 (WT1) protein which is present and over-expressed in an array of hematological malignancies and solid tumors. When administered to a patient as a monotherapy or in combination with standard treatments, GPS’ induced immune response has the potential to recognize and destroy cancer cells and provide ongoing support to the immune system so that it can continue to target and destroy recurring tumors and residual cancer cells. The immunotherapy has the potential to be a highly effective approach to prolonging survival by delaying or preventing recurrence in patients in complete remission or with minimal residual disease.

3D Medicines holds the exclusive license from SELLAS to develop, manufacture and commercialize 3D189 in China, Hong Kong, Macau and Taiwan region for all therapeutic and other diagnostic uses.

Prokarium Expands R&D Capabilities with London Biofoundry to Deepen Microbial Immunotherapy Pipeline

On January 26, 2022 Prokarium, a biopharmaceutical company pioneering the oncology field of microbial immunotherapy, reported that has entered into an agreement, through Imperial Projects, to work with independent researchers from Imperial College London to develop Prokarium’s next-generation therapeutic candidates, engineered to deliver payloads within the tumor microenvironment (Press release, Prokarium, JAN 26, 2022, View Source [SID1234606801]).

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"Prokarium is designing the perfect bacteria to be the next cancer immunotherapy, and we believe leveraging Salmonella’s unique biology will allow us to combine a powerful innate approach with a tailored adaptive response," said Kristen Albright, PharmD, Chief Executive Officer of Prokarium. "This agreement will significantly expand our R&D capabilities and will further deepen our immunotherapy pipeline."

This new multi-year agreement builds on work between Prokarium and London Biofoundry that was initiated in 2020 and will further expand Prokarium’s operations. The team from Imperial’s and SynbiCITE’s London Biofoundry specializes in the design, engineering and functional characterisation of synthetic DNA and organisms.

"Prokarium has uniquely positioned their Salmonella platform as an innovative immunotherapy approach for the treatment of solid tumors, and we are excited to support their efforts in pioneering the cancer treatment paradigm shift from synthetic chemistry to synthetic biology," said Marko Storch, PhD, Head of Synthetic Biology and Automation. "At the London Biofoundry, we developed a cutting-edge SynBio stack and the expertise to collaborate with researchers and biotechs to advance their R&D. We are thrilled to leverage our leading research capabilities to support the development of Prokarium’s new class of medicines in oncology."

Aeterna Zentaris Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Rule

On January 26, 2022 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported that the Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") has notified the Company that it has been granted an additional 180 calendar day period, through July 23, 2022, to evidence compliance with the US$1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market (Press release, AEterna Zentaris, JAN 26, 2022, View Source [SID1234607404]).

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If at any time before July 23, 2022, the bid price for the Company’s common shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days (and generally not more than 20 consecutive business days, in Nasdaq’s discretion), it is expected that Nasdaq would provide formal notice that the Company has regained compliance with the bid price requirement.

In the event the Company does not evidence compliance with the minimum bid price requirement during the 180-day grace period, it is expected that Nasdaq would notify the Company that its shares are subject to delisting. At such time, the Company may appeal such determination to a Nasdaq Hearings Panel (the "Panel’) and it is expected that the Company’s securities would continue to be listed and available to trade on Nasdaq at least pending the completion of the appeal process. There can be no assurance that any such appeal would be successful or that the Company would be able to evidence compliance with the terms of any extension that may be granted by the Panel.

The Nasdaq notification letter does not impact the Company’s compliance or listing status on the Toronto Stock Exchange.

Adlai Nortye Announces Global License-out Agreement with Biotime for Several Products Including PD-L1 Inhibitor (AN4005) and Anti-hTNFR2 Antibody (AN3025)

On January 26, 2022 Adlai Nortye Ltd. ("Adlai Nortye"), a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, reported that it has entered into a Global License Agreement with Xiamen Biotime Biotechnology Co., Ltd. ("Biotime") for several compounds (Press release, Adlai Nortye Biopharma, JAN 26, 2022, View Source [SID1234607423]). This includes the rights and interests of Adlai Nortye in the development, manufacturing and commercialization of AN4005 and AN3025 in Greater China, and AN1005, AN6015 and AN9015 worldwide. According to the terms of the agreement, the total amount of this cooperation will reach hundreds of millions of yuan, including the upfront payments, progress-dependent milestone payments and tiered royalties on sales.

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According to Jianping Yu, the chairman secretary of Biotime, "Based on independent innovation, Biotime has started involving in innovative drug business, increased R&D investment, actively integrated into the global innovation network and focused on creating an innovation engine for high-quality development. The cooperation with Adlai Nortye, a leading brand of innovative drugs, will be a win-win attempt."

Dr. Nanhai He, the head of drug discovery of Adlai Nortye, said, "We are very happy to reach this agreement with Biotime, who has strong technical capabilities and scientific and technological strength, and puts a high value on product R&D and technological innovation. This cooperation will pave the way for the development and commercialization of several products, including AN4005 and AN3025, on a global scale, and benefit patients all over the world. We firmly believe that the partnership with Biotime will greatly accelerate the R&D and commercialization of these drugs."

About AN4005

AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates anti-tumor activity by the blockade of PD-1/PD-L1 interaction. In preclinical studies, AN4005 has demonstrated significant pharmacological activity, target affinity and acceptable safety profiles, which support the clinical development as a potential therapy for advanced malignancies. In pharmacology studies, AN4005 was shown to overcome the inhibition derived from PD-1/L1 interaction in hPBMC-based functional assays. Small molecule PD-L1 inhibitors are expected to provide several benefits over mAbs, such as, allowing for oral administration, lower production costs, improved tumor penetration, and lack of immunogenicity.

About AN3025

AN3025 is a novel humanized IgG1 (variant) anti-hTNFR2 antibody that is currently under preclinical study. This antibody binds to the extracellular domain of human TNFR2 with sub-nanomolar affinity and occludes its ligand TNFa from accessing TNFR2. Since TNFR2 is highly expressed on a subset of immunosuppressive cells, including regulatory T cells (Tregs) and MDSCs, within the tumor microenvironment, AN3025 is expected to amplify the antitumor immune response to aid in immunotherapy.

Wed, 26 Jan, 2022, 08:15 – English – Quarterly Report I 21/22

On January 26, 2022 Diamyd Medical reported it’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B (Press release, Diamyd Medical, JAN 26, 2022, View Source;ClipID=4167222 [SID1234607387]).

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September 1, 2021 – November 30, 2021

Net result: MSEK -37.8 (104.9). The previous year contains a one-off effect of corresponding MSEK 117.5 from divestment of shares in Companion Medical, Inc.
Result per share: SEK -0.5 (1.5)
Cash flow from operating activities: MSEK 0 (-14.0)
Cash and cash equivalents at November 30, 2021: MSEK 240.7 (173.0)
Significant events during the first quarter, September 1, 2021–November 30, 2021

Diamyd Medical paused start of Phase III trial pending additional evaluations of manufacturing process
Diamyd Medical announced to initiate its type 1 diabetes Phase III trial in Europe as discussions continue with FDA regarding partial clinical hold in the US
Diamyd Medical and partners were awarded SEK 40 million in VINNOVA funding
First regulatory approval to start the Phase III trial was received
Start of the Phase III trial in the US was paused pending clarification of FDA questions
Property with manufacturing facility in Umeå was acquired
SEK 150 million was raised via a directed share issue
Other events during the first quarter

Clinical results with Diamyd Medical’s study drug Remygen were published in a scientific journal
A new analysis supporting the effect of Diamyd was elected to be presented at the ISPAD scientific conference
Significant events after the first quarter

Interim report indicated similar immunological response in LADA-patients treated with intralymphatic Diamyd as in type 1 diabetes patients
Other events after the first quarter

Diamyd Medical patent for intralymphatic Diamyd to be granted in China
Australia granted Diamyd Medical a broadening of patent for intralymphatic injection of antigens in autoimmune diabetes
Comments by CEO Ulf Hannelius
We are very much looking forward to the upcoming Phase III precision medicine trial DIAGNODE-3, approved so far by Competent Authorities and Ethical Review Boards in the Czech Republic, the Netherlands, Spain and Poland. To get started with the trial soon – and since we do not compromise on safety anywhere – we have been working hard to rule out that a potential contamination early in the process could in any way affect the drug product. Indeed, we have a safe and robust process that encompasses several purification steps designed to remove contaminants of this nature and additional analyses are ongoing with the goal of being able to initiate DIAGNODE-3 and other trials in the development pipeline soonest possible.

Our investment in the Umeå manufacturing facility is central to securing long-term access and control over our Diamyd flagship asset. The experimental small-scale manufacturing process is in place and the large-scale process equipment have been installed. Next, the plan is to have the process in Umeå tested, validated and GMP certified later this year and to get the facility approved and production ready in the second calendar quarter of 2023.

It was rewarding to see the interim results in December from GADinLADA, the pilot trial in LADA evaluating intralymphatic injections of Diamyd. No safety issues were observed, and the immune response appears similar to what has been observed in type 1 diabetes patients treated with Diamyd. This is the first time this administration mode of Diamyd is evaluated in individuals diagnosed with LADA, providing important additional support for the safety and convenience of the therapy in a new indication as well as data that support the use of intralymphatic administration in individuals that are up to 70 years of age. A more thorough analysis of the clinical course, immune response and next steps including a potential pivotal trial in LADA will be possible once we have the 12 months results from GADinLADA trial later during 2022.

The quarter has seen advances in our patent portfolio where the Chinese patent office recently informed that they will approve patent claims that protect the intralymphatic administration mode of Diamyd. These key patent claims have already been approved among other countries, in Europe and Japan and provide protection until 2035. The Australian patent office also informed that they approve, as the first region, intralymphatic administration of other beta cell antigens beyond GAD, most importantly insulin. These broadened patent claims provide incentives to develop antigen specific therapies that complement GAD, which given the importance of precision medicine in type 1 diabetes, is of high interest. Insulin-based immunotherapies should likely be targeted to individuals that carry the HLA DR4-DQ8 haplotype while GAD-based therapies like Diamyd will be targeted to individuals that carry the HLA DR3-DQ2 haplotype.

With all activities ongoing that further strengthen the foundation of Diamyd Medical, we are fortunate to have a strong financial position; more than SEK 200 million in cash as of today will carry us well into 2023. I would like to thank the team and collaborators for your hard work and enthusiasm and our shareholders for helping us breaking new ground.

Stockholm, January 26, 2022
Ulf Hannelius, President and CEO

Significant events during the first quarter
September 1 – November 30, 2021

Diamyd Medical paused start of Phase III trial pending additional evaluations of current manufacturing process
Diamyd Medical decided to pause the start of the precision medicine Phase III trial DIAGNODE-3 with the diabetes vaccine Diamyd (GAD/alum) in recent onset type 1 diabetes, as well as the initiation of other clinical trials with Diamyd pending additional evaluations of the current manufacturing process. A new analysis has shown the potential presence of a contamination early in the manufacturing process of the drug substance (GAD65) used in the existing study drug. Diamyd Medical will evaluate its specific removal before additional clinical work is conducted. The potential contamination is not connected to the new manufacturing facility being established in Umeå.

Diamyd Medical announced to initiate its type 1 diabetes Phase III trial in Europe as discussions continue with FDA regarding partial clinical hold in the US
The FDA requested additional data to support Diamyd Medical’s IND application for DIAGNODE-3. Outstanding questions largely pertained to manufacturing of the study drug and needed to be addressed before FDA’s partial clinical hold for the Phase III trial in the US can be lifted. Given the delay this may entail, Diamyd Medical announced commence its initiation of the Phase III trial in Europe, while interactions with the FDA continue.

Diamyd Medical and partners were awarded SEK 40 million from VINNOVA for the prevention of autoimmune diseases
The Swedish governmental innovation agency VINNOVA awarded SEK 40 million in financing for an innovation milieu in sustainable precision health that will be led by Diamyd Medical. The project aims to develop and evaluate new algorithms based on artificial intelligence (AI) for preventive precision medical treatments for type 1 diabetes and other autoimmune diseases. The innovation milieu also includes Mainly AI AB, Lund University, Sahlgrenska University Hospital, the National Diabetes Register and the Leading Healthcare Foundation. Diamyd Medical’s part of the five- year grant amounts to approximately SEK 18 million.

First regulatory approval received to start the DIAGNODE-3
The Swedish Medical Products Agency gave approval for the start of DIAGNODE-3. The trial is designed to confirm the efficacy and safety of Diamyd in individuals recently diagnosed with type 1 diabetes, who carry the genetically defined haplotype HLA DR3-DQ2.

FDA paused the start of DIAGNODE-3 in the US
The start of DIAGNODE-3 in the United States was paused by the US Food and Drug Administration (FDA) to clarify certain outstanding questions regarding the study drug.

Acquisition of property with manufacturing facility in Umeå
Diamyd Medical announced the acquisition of the property in Umeå, Sweden, where production of the recombinant protein GAD65, the active component in the therapeutic diabetes vaccine Diamyd is being established. The property is acquired for a purchase price of SEK 24.5 million and comprises approximately 20 000 square feet including the 10 000 square feet Diamyd Medical AB rents, as well as 90 000 square feet of land area.

Proceeds of SEK 150 million were raised via a directed share issue
A directed share issue of 5 357 143 B-shares at a price of SEK 28 per share was completed. Through the directed share issue, the Company received gross proceeds of SEK 150 million. The directed share issue was subscribed by qualified investors.

Other events during the first quarter

Clinical results with Diamyd Medical’s study drug Remygen were published in a scientific journal
The clinical results from the dose-escalation part of the investigator-initiated clinical Phase I/II trial ReGenerate-1 evaluating Remygen (GABA) in individuals with long-standing type 1 diabetes, have been published in the scientific journal BMJ Open Diabetes & Care. The patent-pending findings showed, as previously announced, that Remygen established a counter-regulatory response to severely reduced blood sugar levels (hypoglycemia), indicating its potential use as a hypoglycemia-preventing treatment.

Analysis that supports the effect of the diabetes vaccine Diamyd was presented at the ISPAD conference
An analysis showing the effect of the diabetes vaccine Diamyd (GAD-alum) in reducing the time a patient has high blood glucose, was presented at the ISPAD conference (The International Society of Pediatric and Adolescent Diabetes), by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.

Significant events after the first quarter

Interim report indicated similar immunological response in LADA-patients treated with intralymphatic Diamyd as in type 1 diabetes patients
An initial interim report from the open-label investigator-initiated clinical trial GADinLADA, in which the diabetes vaccine Diamyd is administered directly into the lymph node in 14 patients aged 30 to 70 years with the autoimmune form of diabetes called LADA (Latent Autoimmune Diabetes in Adults), showed that treatment after five months is safe and tolerable. Preliminary analyses indicated that the immunological response to the treatment is similar to what has been observed in individuals with type 1 diabetes treated with Diamyd.

Other events after the first quarter

Patent for intralymphatic injection of GAD in autoimmune diabetes to be granted in China
The patent that will be granted by the Chinese Patent Office is valid until 2035. The patent primarily protects the administration method of Diamyd (GAD/alum) which has shown positive results in the Phase I/II and Phase IIb trials DIAGNODE-1 and DIAGNODE-2 and will be evaluated in the Phase III trial DIAGNODE-3.

Australia granted as first region Diamyd Medical a broadening of a patent for intralymphatic injection of antigens in autoimmune diabetes
The patent covers intralymphatic injection of beta cell antigens including insulin for the treatment and prevention of autoimmune diabetes. The approval is a division of the patent application previously approved in Australia on intralymphatic injection of GAD, the active component in the diabetes vaccine Diamyd that Diamyd Medical is developing for type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA).

Two drugs in clinical development

Diamyd and Remygen are drugs in clinical development that focus on the underlying disease mechanisms of diabetes; the dysfunction and loss of insulin-producing beta cells in the pancreas.

Diamyd is an antigen-specific immunomodulating precision medicine diabetes vaccine for the treatment and prevention of autoimmune diabetes (type 1 diabetes and LADA, Latent Autoimmune Diabetes in Adults).

Clinical data indicate the potential of the diabetes vaccine Diamyd to halt or stop the autoimmune destruction of insulin-producing beta cells in individuals that carry the HLA DR3-DQ2 haplotype. The effect is achieved by antigen-specific reprogramming of immune cells by administration of low doses of Diamyd in superficial lymph nodes. By maintaining the endogenous insulin production, Diamyd has the potential to make a significant difference in the daily life of patients as well significantly reduce the complications of type 1 diabetes. Topline results from the Phase IIb trial DIAGNODE-2 demonstrated a significant treatment effect of Diamyd in the predefined genetic patient group.

Remygen is an oral regenerative and immunomodulatory drug candidate for the treatment of autoimmune- and type 2 diabetes. By stimulating the growth of insulin-producing cells, Remygen has the potential to reverse the disease progression in autoimmune- and type 2 diabetes. Based on clinical data, Remygen has also the potential to protect against hypoglycemia by improving the hormonal response. Remygen is now being investigated in a clinical Phase I/II trial (ReGenerate-1), where clinical efficacy is evaluated with the aim of optimizing the treatment regimen ahead of registration-based trials.

Clinical trials
Type 1 diabetes is a devastating disease which requires daily treatment with insulin to sustain life. The importance of finding a drug that improves the prospects for patients with diabetes is of utmost importance. The effect of intralymphatic administration of Diamyd, an antigen-specific precision medicine immunotherapy aimed at stopping the immune system’s attack on insulin-producing beta cells in autoimmune diabetes, will be evaluated in the Phase III trial DIAGNODE-3 and is evaluated in the Phase II trial GADinLADA.

Remygen, which aims to stimulate the growth of beta cells in patients with diabetes, is evaluated in patients in a Phase I/II trial.

Upcoming clinical trial

Trial with Diamyd in lymph node

DIAGNODE-3 – DIAMYD IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
The placebo-controlled Phase III trial DIAGNODE-3 will include approximately 330 individuals aged 12 to 28 who have been recently diagnosed with type 1 diabetes and who carry the genetically defined haplotype HLA DR3-DQ2. The trial will be conducted at approximately 50 clinics, where almost half of all individuals with type 1 diabetes are estimated to carry the current haplotype. After an initial month in which all trial participants receive vitamin D, the individuals will be randomized 2:1, ie two out of three trial participants will receive three intralymphatic injections of Diamyd and one in three will receive the corresponding placebo at one month intervals, with one primary reading 24 months after trial start. The design provides, based on efficacy data from previous studies on the HLA-restricted patient population, a high probability of reaching the primary endpoints; preservation of stimulated C-peptide and lower HbA1c. The Coordinating Investigator for the trial is Professor Johnny Ludvigsson at Linköping University. The Sponsor of the trial is Diamyd Medical.

Ongoing clinical trials

Trial with Diamyd in lymph node

GADinLADA – DIAMYD IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
The main aim of the trial is to evaluate the safety of intralymphatic treatment with Diamyd in patients with LADA (Latent Autoimmune Diabetes in Adults). The patients have been recruited in Norway at the Norwegian University of Science and Technology (NTNU) in Trondheim, in collaboration with St. Olavs Hospital, University Hospital in Trondheim, and in Sweden at the Center for Diabetes, Akademiskt specialistcentrum, an academic specialist unit run in collaboration between Stockholm County’s healthcare area, Karolinska Institutet and Karolinska University Hospital. The patients included in the trial are between 30 and 70 years old, have been diagnosed with LADA within the last 18 months and are not yet on insulin therapy. The Sponsor of the trial is the Norwegian University of Science and Technology with Ingrid K Hals as Sponsor’s representative. Diamyd Medical contributes with study drugs, expertise and some financial support for immunological analyzes and determination of HLA haplotypes. 12 month results are expected later in 2022.

Trial with Remygen (GABA)

REGENERATE-1 – REMYGEN /ALPRAZOLAM
An open-label, investigator initiated clinical trial with Remygen. The trial includes approximately 36 patients aged 18-50 who have had type 1 diabetes for more than five years with low to non-existing insulin production. Safety and initial efficacy results from the dose escalation section of the trial have paved the way to initiate the main trial and have also demonstrated a potential effect of Remygen to improve the hormonal response to hypoglycemia. The main trial evaluates whether the insulin-producing cells can be regenerated and if the hormonal response to hypoglycaemia can be improved using Remygen and the combination of Remygen and Alprazolam. The trial is led by Professor Per-Ola Carlsson at Uppsala University, Sponsor of the trial.

Manufacturing of GAD65 in Umeå
A new facility for vaccine manufacturing is being set up in Umeå, the Capital of Västerbotten County in Sweden, for the manufacture of recombinant GAD65, the active pharmaceutical ingredient in the therapeutic diabetes vaccine Diamyd currently in late-stage clinical development. The 10 000 square feet site, comprising of clean rooms, laboratory facilities and office space, will facilitate full control, predictability and scalability of the manufacturing technology of the active ingredient. Diamyd Medical has chosen Cytiva’s configurable single-use bioprocess manufacturing platform FlexFactory for the process. Small-scale experimental production of GAD65 is now established at the manufacturing facility. Large-scale production is being set up primarily using Cytiva equipment.