Topas Therapeutics GmbH

HAMBURG, Germany I October 15, 2024 I 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. About Topas Therapeutics Topas Therapeutics, a clinical stage biotech company, is advancing a highly differentiated and versatile approach to establish immune tolerance in autoimmune and immune-mediated diseases. Our proprietary Topas Platform, comprising antigen-coupled nanoparticles, targets liver sinusoidal endothelial cells to drive T cells toward tolerance. The topline readout from our Phase 2a clinical trial in celiac disease validates the power of this new drug modality and its potential to address a broad range of immune-mediated indications, positioning us to deliver significant therapeutic benefits to patients. For further information: https://topas-therapeutics.com/ SOURCE: Topas Therapeutics

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Serial exec Amit Munshi returns to biotech arena with Moderna alumni ReNAgade Therapeutics Amit Munshi, to no one’s surprise, has landed back on his feet and walked into a new C-suite, just over a year after Arena Pharmaceuticals was bought by Pfizer. The serial biopharma executive is taking the helm of ReNAgade Therapeutics, an all-in-one RNA shop that launched this week with $300 million from a series A. It was the largest single fundraising round of the year for a few hours, before ElevateBio took the crown the following day. The former Arena CEO was sold on the company’s RNA delivery focus, working to expand which tissues the polymeric molecules can enter. The company plans to incorporate gene editing tech directly into the platform to widen the diseases RNA can treat.  But arguably more valuable to the company’s early hype are the other C-suite members, including CSO Pete Smith, Ph.D., who was previously the SVP of nonclinical early development work at Moderna before moving to Alnylam. He’ll be joined by Chief Operating Officer Ciaran Lawlor, Ph.D., a principal scientist at Moderna who then worked for Boston Consulting Group.  The company has already launched a joint venture with fellow circular RNA-focused biotech Orna Therapeutics and inked a deal with Merck for up to five targets. ReNAgade’s leadership did not disclose financial details but said they already unlocked a milestone payment for identifying a target in the vaccine space. Fierce Biotech Larkspur launches with all-female leadership team Larkspur Biosciences One of the more persistent diversity trends in biotech is the lack of female executives. Data from a 2022 BIO report found that women make up 34% of biotech executives but 49% of all employees, and 37% of responding companies reported “little change” in the number of female executives in 2021 compared to 2020.  Larkspur Biosciences is helping tip the scales toward equity. The company unveiled this week with an all-female leadership team led by CEO Catherine Sabatos-Peyton, Ph.D., a former executive director at the Novartis Institute for BioMedical Research. She’s joined by Chief Scientific Officer Krista Goodman, Ph.D., and Emily Corse, Ph.D., EVP of biology and translation. Goodman jumps from British Big Pharma GSK where she was global head and senior director of flexible medicinal chemistry and medicine design. Corse was the executive director of cancer immunology at Boehringer Ingelheim.  It’s a deeply experienced trio that comes equipped with experience that mirrors the biotech’s ambitions. The company is working on a slate of precision immunotherapies to target “bottlenecks” wielded by tumors against the immune system. The company is first aiming its technology at a subtype of patients with colorectal cancer. Release  CytoDyn president takes medical leave  CytoDyn CytoDyn president Cyrus Arman, Ph.D., is taking a medical leave of absence from the company, with Chief Financial Officer Antonio Migliarese replacing him in the meantime. It’s unclear how long Arman may be away from the company, and CytoDyn did not specify what’s keeping him out. Migliarese will have at his side new interim Chief Medical Officer Melissa Palmer and clinical and strategic adviser Salah Kivlighn, Ph.D., both of whom recently joined the company. It’s a difficult time for CytoDyn as it struggles to find any kind of clinical momentum, and Arman’s absence comes just eight months after he took the helm. His first order of business was redirecting the company’s lead asset, leronlimab, away from COVID-19. Then, a month later, the company pulled an FDA approval application for leronlimab as an HIV treatment, citing “systemic issues” with the data from a CRO.  The biotech filed a claim for damages against the CRO and said at the time that resolving the issues with the data would require “significant additional investment.” CytoDyn is now aiming leronlimab at a new, notoriously difficult-to-treat disease—nonalcoholic steatohepatits. Oh, and it’s still exploring potential partnerships. Source  > Jeremy Chadwick, Ph.D., is leaving Takeda to become chief operating officer at Kymera. He held a variety of roles at the Japanese pharma, including SVP and head of the global development office. Release > Talaris Therapeutics has appointed its only C-suite member left, Chief Financial Officer Mary Kay Fenton, as interim CEO and president. Fenton will also continue to serve as CFO and succeeds former CEO Scott Requadt, who left as part of a 95% workforce reduction. Release > BioAge labs has promoted BJ Sullivan to the inaugural chief strategy officer position. He previously served as the company’s chief of staff and VP of strategy and business operations. Release > Obsidian Therapeutics is crystalizing its top brass, naming Madan Jagasia, M.D., as the new CEO and Parameswaran Hari, M.D., as chief development officer. Both new hires come from Iovance Biotherapeutics, with Jagasia serving as the VP of medical affairs while Hari was the VP of clinical science. Release > Ming Yang, Ph.D., has been tapped to lead life biosciences development efforts as SVP of R&D. He previously held the same role at Graybug Vision after working at Genentech. Release > Former medtech executive and consultant Ken Mariash is joining Sinaptica Therapeutics as CEO. He was recently founder and managing partner of medtech consulting firm Rubicon Strategy Partners, a company he launched after running marketing efforts at EBT Medical. Release > Arcutis’ chief commercial officer Ken Lock is stepping down to “attend to personal matters,” the company announced this week. He’ll be temporarily replaced by Ayisha Jeter, VP of market access. Release > TScan Therapeutics acting CEO Gavin MacBeath, Ph.D., will be handed the keys to the car after being permanently named chief executive. He took over temporarily in May and will no longer serve as chief scientific officer. Release > In addition to announcing the start of a new phase 2 trial testing a treatment for celiac disease, Topas Therapeutics has hired two new executives to the C-suite. The German biotech has brought on Mireia Gómez-Angelats, Ph.D., has chief business officer and Christian Schröter, Ph.D., as chief operating officer. Release > Cancer detection company Harbinger Health has hired May Orfali, M.D., to be chief medical officer. She joins a leadership team led by former FDA Commissioner Stephen Hahn, M.D., who’s CEO of the company. Release > Rani Therapeutics has appointed Kate McKinley as chief business officer. She was previously founder and CEO of Spark Outcomes. Release

Building on positive clinical data from Topas’ Phase 1 study of TPM203 in pemphigus vulgaris patients, the Phase 2a study in celiac disease patients initiates clinical development for TPM502 and aims to achieve clinical proof of concept Recent leadership team expansion reflected by the additions of Christian Schröter as COO and Mireia Gómez-Angelats as CBO HAMBURG, Germany--(BUSINESS WIRE)-- 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 pro 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 announced the addition of Cristina de Min, MD, who joined the company as Chief Medical Officer. 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 pro 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. About Topas Therapeutics Topas Therapeutics is committed to developing novel disease-modifying treatment options for patients suffering from autoimmune and inflammatory diseases. With a versatile and personalized platform, Topas designs and produces antigen-specific nanoparticle conjugates aimed to elicit immune tolerization in T-cell mediated diseases. Based in Hamburg, Germany, Topas Therapeutics is led by a seasoned team of biotech/pharma experts and is backed by an international consortium of investors, including BioMedPartners, Boehringer Ingelheim Venture Fund, EMBL Ventures, Epidarex Capital, Evotec, Gimv, Vesalius Biocapital III. *** For further information: View source version on businesswire.com: Contacts Topas Therapeutics Mireia Gómez-Angelats, PhD Chief Business Officer info@topas-therapeutics.com Trophic Communications Gretchen Schweitzer or Dr. Priscillia Perrin +49 (0) 172 861 8540 topas@trophic.eu Source: Topas Therapeutics View this news release online at: