Written by Trophic Communications on . Posted in News, Presentations and Keynotes.
Topas Therapeutics will present at the Nanotech in Life Science conference hosted by Fraunhofer IMTE in Lübeck on 14 April 2026. The keynote will highlight Topas’ nanoparticle platform designed to target liver sinusoidal endothelial cells (LSECs) for the induction of antigen-specific immune tolerance.
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Topas Therapeutics will present at the 9th Antigen-Specific Immune Tolerance Summit in Boston on 4 March 2026. The presentation will highlight Topas’ approach to assessing antigen-specific immune tolerance induction and advancing precision immunotherapies, including TPM502 for celiac disease.
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Topas Therapeutics presents new data from its Phase 2a clinical study of TPM502 at UEG Week in Berlin. The results provide further evidence that TPM502 induces antigen-specific immune tolerance through targeted modulation of gluten-specific T cells in patients with celiac disease. The abstract was recognized with a Top 5 Abstract Award, highlighting the significance of the findings and supporting the continued development of TPM502 as a potential treatment for celiac disease.
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Topas Therapeutics will present its antigen-specific immune tolerance platform at BioCentury’s Grand Rounds Europe in Cambridge on 18 September 2026. The presentation will highlight Topas’ antigen-specific immune tolerance platform for autoimmune and antigen-driven diseases, including progress in celiac disease and type 1 diabetes.
Written by Trophic Communications on . Posted in News, Scientific Poster.
Authors: R.Hardet, M.Blandin, S.-H.Wang, R.Digigow, C.Gottwick, M.Heine, L.M.Marques Mesquita, M.Fanzutti, A.-L.Vocaturo, D.Mungalpara, O.Boyer, S.Fleischer, S.Adriouch
Introduction: Adeno-associated viral (AAV) gene transfer is still impeded by deleterious immune responses against capsid- and transgene-derived antigens. We developed an innovative approach for inducing antigen-specific tolerance to tackle these limitations. For that, nanoparticle-carriers were designed to preferentially deliver antigenic peptides to liver sinusoidal endothelial cells (LSECs) exploiting their natural potential of cross-presenting antigens and tolerizing T cell responses.
Objectives: Different mouse models of AAV-mediated gene transfer to muscle and liver were used to assess whether nanoparticles coupled to capsid- and transgene-derived peptides can effectively inhibit vector- and transgene-specific immune responses and improve transgene persistence.
Methods: Nanoparticle-peptide-carriers were intravenously administered at predefined timepoints in the context of muscle- and liver-directed AAV-gene transfer. T- and B-cell responses were analysed by ELISpot, flow cytometry, and ELISA; transgene expression by qPCR. Non-parametric Mann-Whitney test and one-way ANOVA were used to compare differences between two or multiple groups, respectively.
Results: LSEC-targeting nanoparticle-peptide-carriers abrogated CD4+ and CD8+ T cell immune responses towards the targeted peptide-epitopes and significantly improved transgene persistence in liver and muscle. Furthermore, nanoparticles carrying a single peptide-epitope recognized by anti-transgene CD8+ T cells also induced tolerance in CD8+ and CD4+ T cells specific for other transgene- and capsid-derived peptide-epitopes. This remarkable extension of tolerance, which combines linked suppression and infectious tolerance, is reported here for the first time and termed tolerance-spreading (Tspread). Importantly, Tspread remained restricted to the antigens carried by the AAV vectors and did not impair concurrent vaccination against an unrelated third-party tumour antigen.
Conclusion: Reported for the first time in immunotherapy, nanoparticle-peptide-carriers targeting LSECs induce Tspread to other relevant capsid- and transgene-derived epitopes, which is beneficial for achieving robust and durable tolerance in vivo. This finding is of great clinical importance, offering a novel antigen-specific strategy to improve viral vector-mediated gene transfer.
Written by Trophic Communications on . Posted in News, Scientific Poster.
Authors: Isabelle Serr, Daria Krzikalla, Barbara Metzler, Sabine Fleischer, Carolin Daniel
Type 1 Diabetes (T1D) is characterized by the loss of immune tolerance to beta-cells in the pancreas, resulting in their immune-mediated destruction. Restoring antigen-specific immune tolerance, thereby circumventing critical side effects of non-specific immunosuppression is a long-awaited goal for the prevention of T1D. We tested peptideconjugated nanoparticles developed by Topas Therapeutics that leverage the tolerogenic capacity of liver sinusoidal endothelial cells (LSECs) to restore antigen-specific immune tolerance in T1D
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Authors: Cornelia Gottwick, Pia Averhoff, Christian Casar, Laura Anne Liebig, Sabrina Melanie Pilz, Victor Haas, Daria Krzikalla, Sabine Fleischer, Norbert Hübner, Lorenz Adlung, Dorothee Schwinge, Christoph Schramm, Antonella Carambia, Johannes Herkel
Liver sinusoidal endothelial cells (LSECs) have a key role in maintaining organismal homeostasis by scavenging blood-borne molecules and inducing specific immune tolerance to ingested antigens. The scavenger and tolerance function of LSECs can be harnessed for specific treatment of autoimmune diseases by nanoparticle-mediated autoantigen delivery to LSECs. In liver fibrosis, which is a frequent condition in human populations, LSECs undergo changes promoting pro-fibrotic and pro-inflammatory activation of other hepatic cells, but it is unclear whether the scavenger and immune tolerance functions of LSECs are affected. Utilizing two mouse models of liver fibrosis, we explored the ability of LSECs to take up nanoparticles conjugated with antigen peptides, to present the ingested antigen peptides to T cells and to induce peptide-specific immune tolerance in vitro and in vivo in the context of autoimmune diseases. LSECs from fibrotic livers showed few distinct adaptations regarding immune functions; however, overall LSEC identity was largely maintained. Accordingly, endocytosis of nanoparticles by LSECs in vivo, as well as processing and presentation of nanoparticle-bound antigen peptides was not compromised by liver fibrosis. LSECs from fibrotic livers maintained the ability to effectively induce the generation of regulatory T cells from conventional CD4 T cells. Hence, targeted delivery of autoantigen peptides to LSECs in vivo effectively induced specific tolerance despite liver fibrosis, providing protection in two models of experimental autoimmune disease. Analysis of datasets from human subjects with or without liver cirrhosis confirmed that scavenger and tolerance pathways in LSECs were preserved in human liver fibrosis. Scavenger activity and antigen-specific tolerance induction by LSECs are preserved in liver fibrosis. Thus, LSECs remain reliable mediators of homeostasis and tolerance under fibrotic conditions, and particularly suitable targets for nanomedicine products.
Written by Trophic Communications on . Posted in News, Publications.
Authors: Romain Hardet, Shu-Hung Wang, Sandrine Delignat, Marine Blandin, Reinaldo Digigow, Cornelia Gottwick, Markus Heine, Lígia Margarida Marques Mesquita, Marco Fanzutti, Anna-Lisa Vocaturo, Disha Mungalpara, Olivier Boyer, Sébastien Lacroix-Desmazes, Sabine Fleischer, Sahil Adriouch
Liver sinusoidal endothelial cells (LSECs) naturally cross-present antigens and induce T cell tolerance. Targeting LSECs with peptide-coupled nanoparticles offers an efficient strategy to induce antigen-specific immune tolerance. Previous preclinical and clinical studies have shown that peptide-coupled nanoparticles can effectively inhibit T cell responses to the selected cognate peptide epitopes. However, clinical situations such as viral-vector-mediated gene therapy would benefit from simultaneous tolerance induction to multiple epitopes/antigens, posing a significant challenge. In this study, we used mouse models of adeno-associated virus (AAV)-mediated gene transfer to assess the in vivo effects of peptide-loaded nanoparticles designed to tolerize immune responses to transgene- or/and capsid-derived epitopes. We report here for the first time that LSEC-targeting nanoparticles coupled to a single peptide epitope promoted extension of tolerance to multiple relevant epitopes/antigens and simultaneously tolerized both CD4+ and CD8+ T cell responses. This tolerance spreading, which we termed “Tspread,” remained specific to the transgene- and capsid-derived antigens conveyed by the administered AAV vector and did not impair immune responses to an unrelated vaccine antigen. These findings delineate a novel LSEC-mediated tolerance spreading with important clinical implications for viral-vector gene therapy, where tolerance to multiple epitopes/antigens is essential for long-term expression of therapeutic genes.
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Authors: Dario Didona, Christoph Hudemann, Holger Garn, Daria Krzikalla, Shu-Hung Wang, Julia Hinterseher, Karolin Volkmann, Alexandra Polakova, Anna Zakrzewicz, Simon Feldhoff, Ritva Tikkanen, Reinaldo Digigow, Wolfgang Pfützner, Antonio Santos, Christine L Zimmer, Maik Hahmann, Susanne Harnisch, Siegfried Rösch, Sandra Huguenin, Rüdiger Eming, Matthias Hahn, Franziska Schauer, Emiliano Antiga, Stefano Senatore, Roberto Maglie, Jörg Täubel, Kamran Ghoreschi, Katharina Meier, Farzan Solimani, Michael Sticherling, Lukas Sollfrank, Claudia Günther, Kerstin Steinbrink, Nina Magnolo, Erno van Schaick, Veronica Asnaghi, Frank S Zollmann, Johannes Pohlner, Julia Hummel, Rupert Sandbrink, Cristina de Min, Sabine Fleischer, Christian Möbs, Michael Hertl
Pemphigus is a rare but potentially life-threatening disease. It causes blisters to form on the skin, mouth and genitals. It can lead to the loss of body fluids and proteins. It is also associated with severe infections. Blisters are caused by ‘autoantibodies’ (misguided defence proteins in the immune system) that bind to a component of the skin called Dsg3. The autoantibodies are produced by specialized immune cells known as ‘B cells’ with the help of another group of immune cells called ‘T cells’. These cells play an important role in starting autoimmune responses.
In this study, we tried to block the effects of T cells in pemphigus. We did this using ‘nanoparticles’ to deliver pieces of Dsg3 to the liver. These nanoparticles have the potential to inhibit (or stop) the misdirected immune response. We carried out a study in Germany, Italy and the UK and gave increasing doses of Dsg3-loaded nanoparticles to a group of 17 patients with the disease. We found that the treatment was well-tolerated by the patients. They did not experience any severe side effects. We also found changes in the patients’ blood. This provided the first hints that T cells and activated B cells that promote inflammation could be blocked, leading to a decrease in pemphigus autoantibodies.
Our study findings suggest that Dsg3-loaded nanoparticles should be further developed. The aim would be to treat pemphigus, and maybe even other autoimmune diseases, in a safe and specific way.
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Hamburg, Germany, May 6, 2025 – Topas Therapeutics presented positive clinical proof-of-concept data demonstrating gluten-specific tolerance induction in celiac disease (CeD) patients. Data from a Phase 2a clinical trial evaluating TPM502, the company’s lead candidate, demonstrated a positive safety and tolerability profile, a significant reduction of the inflammatory responses to gluten and long-lasting phenotypic changes to gliadin-specific T cells. In addition, TPM502-treated patients reported a beneficial impact on symptoms post a gluten challenge. Developed using Topas’ proprietary platform, TPM502 consists of nanoparticles coupled with CeD disease-relevant antigens. The study findings were presented at Digestive Disease Week® (DDW) 2025 on Monday, May 5, 2025, in an oral presentation and were selected for the American Gastroenterological Association Presidential Plenary
“The data presented at DDW represent a significant validation of TPM502 as a potential treatment for celiac disease. The observed safety profile, combined with the clear, dose-dependent reduction of IL-2 and IFN-γ release by gluten-specific T cells as well as phenotypic changes in antigen-specific CD4+ T cells, reinforces TPM502’s ability to precisely and durably modulate the underlying autoimmune response to gluten,” stated Knut E. A. Lundin, MD, PhD, Principal Investigator of the Phase 2a study and Professor and Head of Clinical Education at the Institute of Clinical Medicine, University of Oslo.
“By directly addressing the pathogenic T-cell activation central to celiac disease, TPM502 could redefine the treatment paradigm and provide a much-needed therapeutic option for patients who currently have no approved alternatives to a lifelong gluten-free diet. Indeed, the gluten-free diet does not meet the medical needs of many celiac disease patients,” added Cristina de Min, MD, CMO of Topas Therapeutics. “Our Phase 2a trial data also support the application of our nanoparticle platform for a range of autoimmune disease indications for which tolerance induction could be a transformative therapeutic approach.”
The multi-center, double-blind, randomized, placebo-controlled Phase 2a study evaluated TPM502 in HLA-DQ2.5 positive adults with confirmed CeD on a gluten-free diet (NCT05660109). HLA-DQ2.5 is a very common genetic variant among CeD patients, representing approximately 90% of the total disease population.[1] A total of 38 patients that achieved a predefined IL-2 response to bolus gluten challenge (6 g gluten) were randomized and assigned to placebo or 1 of 4 dose cohorts, receiving 2 intravenous infusions of TPM502 (from 0.72 μmol to 7.2 μmol total peptide dose) on day 1 and day 15. A total of 26 patients received TPM502 and 12 received placebo. The gluten challenge was repeated 7 days after the second administration of TPM502 or placebo. As reported in the DDW presentation, TPM502 demonstrated a favorable safety profile. Treatment-related adverse events (TAEs) were reported in 27 patients, including 8 on placebo, with the majority being Grade 1 or 2 events such as nausea, headache, and vomiting; only a single patient experienced four Grade 3 TAEs.
Importantly, a significant and dose-related reduction of IL-2 and IFN-γ release by gluten-specific T cells was observed after TPM502 treatment at the highest dose, which was maintained throughout the study period of 1 month following the last TPM502 administration. In addition, immunomodulation was demonstrated by post-treatment phenotypic changes in gluten-specific CD4+ T cells consistent with T cell anergy or exhaustion and a significant increase in gluten-specific regulatory CD4+ T cells at the highest TPM502 dose, suggesting the induction of regulatory status in these T cells. Patient-reported outcomes using a Celiac Disease Patient‐Reported Outcome (CeD PRO®) tool, indicated a dose-dependent reduction in gastrointestinal symptoms in TPM502-treated patients compared to placebo, following the post treatment gluten challenge.
“Topas Therapeutics is committed to advancing TPM502 as a much-needed treatment option for celiac disease patients, building on data that represent a breakthrough for this and potentially other immune-mediated diseases,” said Hugo Fry, CEO of Topas Therapeutics. “With this validation of our technology and its ability to modulate immune responses in a precise and durable manner, we look forward to the next clinical steps for TPM502 and our pipeline.”
Written by Trophic Communications on . Posted in News, Press releases.
Hamburg, Germany, April 24, 2025 – Topas Therapeutics today announced that it will present clinical Phase 2a data on its lead candidate, TPM502, in celiac disease patients at the upcoming Digestive Disease Week® (DDW) 2025, held from May 3–6, 2025, in San Diego, CA. TPM502 comprises a tolerizing nanoparticle mixture that carries the crucial gluten epitopes for HLA-DQ2.5, present in most celiac disease patients. In October of last year, the company announced positive topline results from its Phase 2a trial evaluating TPM502, showing persistent, antigen-specific tolerogenic effects in patients with celiac disease.
The abstract was selected for presentation in two sessions at DDW. Further details are listed below and available for registered attendees on the DDW conference website.
Session Title: American Gastroenterological Association (AGA) Clinical Science Plenary
Session Date & Time: Monday, May 5th, 08:00 – 9:30 am PDT
Abstract Title: 621: Safety, Tolerability and Pharmacodynamic Effects of TPM502, a Mixture of Tolerizing Nanoparticles for Treatment of Celiac Disease (CeD)
Presenter: Knut Lundin, MD, PhD, Principal Investigator of the Phase 2a study and Professor and Head of Clinical Education at the Institute of Clinical Medicine, University of Oslo
Session Title: AGA Presidential Plenary: AGA at its Best and the Best of AGA
Session Date & Time: Monday, May 5th, 10:00 – 11:30 am PDT
Abstract Title: Sp832: Safety, Tolerability and Pharmacodynamic Effects of TPM502, a Mixture of Tolerizing Nanoparticles for Treatment of Celiac Disease (CeD)
Presenter: Knut Lundin, MD, PhD, Principal Investigator of the Phase 2a study and Professor and Head of Clinical Education at the Institute of Clinical Medicine, University of Oslo
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Hamburg, Germany, March 17, 2025 – Topas Therapeutics today announced the publication of data highlighting the ability of its proprietary antigen-coupled nanoparticles’ to achieve tolerance induction in relevant autoimmune disease models, under the title “Nanoparticle Platform Preferentially Targeting Liver Sinusoidal Endothelial Cells Induces Tolerance in CD4+ T Cell-Mediated Disease Models” in the journal Frontiers in Immunology. The Topas platform consists of Topas Particles (TPs), that serve as a highly flexible scaffold for coupling with disease-relevant antigens to generate Topas Particle Conjugates (TPCs) that preferentially harness liver sinusoidal endothelial cells (LSECs) to generate antigen-specific tolerance. The publication describes the ability of TPCs to specifically reach LSECs and to generate tolerance in well-established animal disease models of Type 1 Diabetes (T1D) and Multiple Sclerosis (MS). In addition to the proof-of-concept data from the Phase 2a trial evaluating Topas’ lead candidate TPM502 in adults with celiac disease, the preclinical data reported in the publication underscores the broad potential of this innovative platform approach.
In vivo data included in the publication show that intravenous administration of TPCs resulted in predominant uptake by LSECs with negligible uptake by other non-parenchymal liver cells, confirming its cellular targeting specificity. LSECs are lining the liver sinusoids, a position that puts them in direct contact with antigens in the blood. This location, combined with their extraordinary clearance and tolerogenic function, facilitate LSECs’ rapid uptake of nanosized peptide carriers for antigen-specific tolerance induction in various CD4+ T cell-dependent disease models. In a translational mouse model of T1D, a Topas particle mixture comprising five different peptide-coupled TPCs, significantly reduced the frequency of hyperglycemia onsets compared to control, suggesting that even for complex diseases such as T1D, induction of immune tolerance is possible. In a mouse model of multiple sclerosis (MS), administration of TPCs both prior to disease induction and during disease onset, significantly attenuated disease severity and mitigated demyelination within spinal cords as compared to the control, highlighting the TPCs’ ability to induce tolerance prophylactically and therapeutically.
“These published results, coupled with the efficacy data we have established in celiac disease, further support our broad development strategy of advancing TPM502 into a Phase 2b study in celiac disease patients while expanding our pipeline with TPC candidates in highly prevalent autoimmune diseases,” said Cristina de Min, MD, CMO of Topas Therapeutics. “We look forward to presenting the full data analysis of our Phase 2a study during the Digestive Disease Week in San Diego in May, as a further clinical demonstration of what we believe can be transformative approach in promoting immune tolerance.”
“The publication in Frontiers in Immunology underscores the potential of the innovative Topas platform for reinstating antigen-specific tolerance in many autoimmune diseases, while avoiding the complications of broad immunosuppression,” said Hugo Fry, CEO of Topas Therapeutics. “The data pave the way for exploring our TPCs in indications like type 1 diabetes and serves as a foundation to realize the significant potential across autoimmune and immune-mediated diseases.”
The open access article is available via this link.
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Hamburg, Germany, October 15th, 2024 – Topas Therapeutics today announced positive topline results from its Phase 2a trial evaluating lead candidate, TPM502, in patients with celiac disease. The study data serves as the first clinical proof of concept for Topas’ proprietary nanoparticle platform and its potential to induce targeted, antigen-specific tolerogenic effects.
The international, multi-center, double-blind, randomized, placebo-controlled Phase 2a trial (NCT05660109) was initiated in 2023 to investigate the safety, tolerability and pharmacodynamics of two infusions of TPM502 in adult patients with celiac disease. Pharmacodynamic parameters were assessed through a gluten challenge after patients received treatment with TPM502 or placebo. Initial analysis showed that antigen-specific markers of tolerance induction exhibited a clear dose-response that reached statistical significance. Further, these antigen-specific effects persisted throughout the study’s follow-up period. TPM502 was safe at all doses investigated. Topas intends to submit the full data and analysis for presentation at an upcoming scientific conference and for publication in a peer-reviewed journal.
“This first look at the TPM502 Phase 2a data is an important milestone for the Topas team and our mission to demonstrate that our platform induces antigen-specific tolerogenic effects. The data generated in this study underscore the potential of this versatile, novel modality in a broad spectrum of autoimmune and immune-mediated diseases,” said Hugo Fry, CEO of Topas Therapeutics. “We believe these results provide a valuable springboard to the next stage of development for Topas and position the company extremely well in the immune-tolerance space.”
Topas’ lead candidate, TPM502, leverages the company’s proprietary platform, a nanotechnology-based modality designed to induce targeted, antigen-specific immune tolerance. TPM502 is comprised of a mixture of nanoparticles that carry the major gluten epitopes for HLA-DQ2.5, present in the majority of celiac disease patients. TPM502 has been developed to establish long-term immune tolerance that will offer significant therapeutic benefit to celiac patients, who currently have no treatment options.
The initiation of the Phase 2a study for TPM502 builds on promising preclinical data and the excellent safety profile demonstrated in the Phase 1 study assessing Topas’ TPM203 in pemphigus vulgaris patients. The company’s next development steps for TPM502 will be based on the full data analysis.
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Hamburg, Germany, May 7th, 2024 – Topas Therapeutics, a clinical-stage biotech company developing novel antigen-specific immune tolerance therapies to treat autoimmune disorders, announced today the appointment of Hugo Fry as its new Chief Executive Officer. Bringing three decades of experience including senior management and executive roles at both large pharmaceutical and innovative biotechnology companies, Hugo has a significant track record in leading companies from early research and development through product commercialization.
“Hugo joins Topas at the right time to provide his broad expertise and strategic direction as we advance our mission of developing novel, disease-modifying treatment options for a range of autoimmune and inflammatory diseases,” commented Erich F. Greiner, Executive Chairman of Topas Therapeutics. “With data from a Phase 2a trial of lead candidate TPM502 in celiac disease expected later this year, we believe Hugo’s leadership will drive value for the company and fully leverage the potential of its innovative approach.”
“Topas is at the forefront of tolerance induction therapy with a cutting-edge nanoparticle technology platform designed to elicit immune tolerization in T-cell-mediated diseases,” said Hugo Fry, CEO of Topas Therapeutics. “As I take the helm, I am excited to advance the work of this talented team and look forward to leading Topas’ strategic efforts to progress our corporate and clinical development.”
Hugo Fry has an extensive and diverse career spanning three decades within the pharmaceutical and biotechnology sectors, characterized by strategic and leadership roles, including Chief Commercial Officer at Imbria Pharmaceuticals and Chief Business Officer and Managing Director at 20Med Therapeutics as well as CEO of RQ Biotechnology. With a focus on guiding companies toward success, Hugo has previously led R&D, Industrial Affairs as well as Commercial teams and is experienced in licensing, fundraising and forging strategic partnerships. He has also held several executive positions spanning multiple countries, including Managing Director of Sanofi UK and Ireland, and Vice President and Chief Marketing Officer for the Sanofi Pasteur MSD joint venture, along with being the Vice-President of the Association of the British Pharmaceutical Industry. Hugo holds a B.Sc. in Chemistry from the University of Salford and has completed further studies in Finance at London Business School and Leadership at Duke University.
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Topas Therapeutics Initiates Phase 2a Clinical Trial for TPM502 in Celiac Disease; Appoints Chief Business Officer and Chief Operating Officer
Topas Therapeutics, a clinical stage biotech company developing novel antigen-specific immune tolerance therapies to treat autoimmune disorders, announced today the launch of a Phase 2a clinical study (NCT05660109) evaluating the safety, tolerability and pharmacodynamics of TPM502 in patients with celiac disease. Engineered leveraging the company’s Topas Particle Conjugates (TPCs) nanotechnology, TPM502 is a mixture of nanoparticles carrying gluten specific antigenic peptides comprising the major gluten epitopes for HLA-DQ2.5 present in the majority of celiac disease patients. The company has received approval to initiate TPM502’s clinical development in a Phase 2a study based on TPM502 preclinical data and clinical results from the Phase 1 study assessing Topas’ TPC TPM203 in patients with pemphigus vulgaris. Celiac disease is an autoimmune disorder affecting multiple millions of patients worldwide who suffer from symptoms ranging from mild digestive discomfort to severe long-lasting complications.
“The Phase 2a study will determine the capacity of TPM502 to promote immune tolerization in celiac disease patients and will confirm the safety profile of TPCs. It will also further establish the potential of the Topas platform to generate novel therapeutics for the treatment of T-cell-mediated diseases,” commented Cristina de Min, MD, Chief Medical Officer of Topas Therapeutics. “The development of TPM502 is a significant step forward in the advancement of our immune tolerance-based clinical pipeline and illustrates our mission to bring novel disease-modifying treatments to patients with limited pharmacological options.”
The multi-center, double-blind, randomized, placebo-controlled Phase 2a trial will include 42 adult patients diagnosed with celiac disease and will evaluate the safety, tolerability and pharmacodynamic effects of 2 administrations of TPM502 in dose escalating cohorts. Immune tolerance and symptom severity will be assessed following exposure to gluten. For more information on the Ph2a, please visit clinicaltrials.gov.
The company also announced two appointments to its executive management team. Mireia Gómez-Angelats, PhD, has joined as Chief Business Officer and Christian Schröter, PhD, as Chief Operating Officer, adding significant international pharmaceutical experience to Topas’ leadership as the company moves to mid-stage clinical development. Topas most recently welcomed Cristina de Min, MD, who joined the company as Chief Medical Officer at the end of 2021.
Erich F. Greiner, Executive Chairman at Topas Therapeutics commented: “Topas is moving at a fast pace with the initiation of its second clinical study. We look forward to adding Christian and Mireia´s expertise to the executive team. They each bring two decades of experience in the pharmaceutical industry, which will be invaluable as Topas advances its platform into clinical development.”
Prior to joining Topas Therapeutics, Dr. Christian Schröter worked at Merck Group for more than 20 years, in multiple countries and at increasing levels of responsibility. He was notably Head of Strategy, Global Healthcare Operations, and Senior Director, Pharma Business Integration. He obtained his PhD in immunology at the University of Tübingen.
Dr. Gómez-Angelats brings a track record of pharmaceutical experience from the US and Europe, in roles with increasing responsibilities in business development and R&D at Novartis, Bristol Myers Squibb, Johnson & Johnson and Almirall. Mireia holds a PhD in biochemistry and molecular biology from the University of Barcelona.
Biographies of Mireia Gómez-Angelats and Christian Schröter are available here.
About Celiac Disease
Celiac disease is an autoimmune disorder characterized by an aberrant immune reaction to ingested gluten that results in damage to the small intestine. It affects 1% of the population and manifests through a wide range of digestive as well as non-digestive symptoms. Diagnosed patients are limited to a gluten-free diet, nevertheless, in a third of cases, severe symptoms persist despite gluten avoidance. There is currently no available medical treatment for celiac disease.
About Topas Particle Conjugates
Topas Particle Conjugates are polymer-coated iron oxide nanoparticles comprising a proprietary biocompatible polymer and conjugated disease-relevant antigens. They are designed to deliver antigens to liver sinusoidal endothelial cells, which have potent immune-tolerogenic capabilities including triggering antigen presentation to T cells and tolerance induction. In clinical and preclinical studies, TPCs have elicited an outstanding safety profile and rapid clearance. The TPC platform has generated two clinical-staged drug candidates, TPM502 and TPM203, and has the potential to address multiple indications across the spectrum of autoimmune and inflammatory diseases.
Written by Topas Therapeutics on . Posted in News, Press releases.
Topas Therapeutics GmbH (Topas), a private biotechnology company developing immune tolerance-inducing drugs to treat and potentially cure a variety of autoimmune diseases, today announced the appointment of Cristina de Min, M.D., as Chief Medical Officer. In this position, she will be responsible for Topas’ clinical development programs based on its proprietary Topas Particle Conjugates technology platform, with a focus on lead product candidate, TPM203, currently in clinical development for the treatment of pemphigus vulgaris, and TPM502 for the treatment of celiac disease, which is expected to enter the clinic in the coming months.
Klaus Martin, Ph.D., Chief Executive Officer, said: “I am thrilled to welcome Cristina to Topas. She is a great addition to our team as she brings a wealth of experience from the translational stage of drug development through regulatory approval. Her strategic acumen combined with her hands-on approach will be invaluable as we move our programs through development and the regulatory process.”
Dr. de Min spent eleven years at Roche in various executive positions, including Life Cycle Leader for the development of the IL-6 receptor antagonist tocilizumab (Actemra) for rheumatic diseases. She also served as Medical Director of Roche’s affiliate in Italy, where she set up the medical department. This included creating a new structure based on therapeutic areas and defining and implementing new processes. Following her years at Roche, she joined Novimmune, serving for nine years as Chief Medical Officer before the company was acquired by Swedish Orphan Biovitrum (SOBI). At Novimmune, she set up the clinical development department and was responsible for the global development strategy for drug candidates from translational activities across all phases of clinical development and registration, as well as prioritizing the portfolio.
Cristina de Min, M.D., Chief Medical Officer, said: “I am excited to join the Topas team. I have been very impressed with the data generated to date with the Topas Particle Conjugates technology platform, which show the potential of the platform and the opportunity to bring more effective, potentially curative therapies to patients who today have limited treatment options. I look forward to working with the team to advance the product candidates in pemphigus vulgaris and celiac disease, as well as other programs in earlier stages of development, such as in rheumatoid arthritis and Type I diabetes.”
