Author: Topas Therapeutics

• 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

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.

• Dr. de Min brings over 25 years’ experience in drug development in both big pharma and biotech
• She will drive the advancement of Topas’ development programs, including lead clinical program TPM203 for treatment of pemphigus vulgaris and TPM502 for treatment of celiac disease

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.”

• Funds to be used to obtain clinical proof of concept in two programs and to accelerate innovative pipeline focused on restoring immune tolerance to treat and potentially cure autoimmune diseases
• Initial clinical data for lead program, TPM203, in pemphigus vulgaris expected this year; second program, TPM502, planned to enter clinic by year end for celiac disease
• In strong support of Topas’ technology and programs, all existing investors – BioMedPartners, Boehringer Ingelheim Venture Fund, EMBL Ventures, Epidarex Capital, Evotec, Gimv and Vesalius Biocapital III – participated in the extension

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 that the Company has successfully extended its Series B round with an additional €18 million (~$22 million) raised, bringing the total for this financing to €40 million. All of Topas’ existing investors participated in the extension.

The funding will be used to obtain clinical proof of concept in two programs and to accelerate the Company’s proprietary pipeline based on the Topas Particle Conjugates technology platform. In addition to lead program, TPM203, which is continuing in clinical development for the treatment of pemphigus vulgaris, a second product candidate, TPM502, is now slated to enter the clinic for the treatment of celiac disease by the end of this year.

Topas will also be advancing several of its pre-clinical-stage programs, including one for the treatment of rheumatoid arthritis and one for Type I diabetes. Topas’ novel technology induces antigen-specific immune tolerance by harnessing the liver’s natural tolerization capabilities. The Company is utilizing this platform to develop products for autoimmune diseases where better treatment options and cures are urgently needed.

Klaus Martin, Ph.D., Chief Executive Officer of Topas, said: “We are excited by the trust our investors are showing by participating in this extended financing round, recognizing our progress and underpinning their great belief in the potential of Topas’ innovative technology and programs. This strong support is enabling us to accelerate our product development work and to advance several programs in parallel. We look forward to seeing the first clinical results from our platform, expected later this year.”

Topas has raised a total of €58 million since its inception. The recent Series B extension is enabling the Company to accelerate the development of various autoimmune disease programs.

Erich F. Greiner, M.D., Chairman of the Supervisory Board, said: “I am very pleased and grateful that all of Topas’ investors decided to further strengthen the Company and its programs. We are delighted by the progress we have made to date with the Topas nanoparticle conjugate technology platform and eagerly await the first clinical results. Once clinical proof of concept is established, we see multiple opportunities for this unique and versatile platform to rapidly generate additional exciting programs in a variety of disease areas. The Topas technology has the potential to bring truly breakthrough products to patients with diseases of high unmet medical need for which there are currently no effective or curative treatment options.”

• Topas Therapeutics GmbH (Topas), a Hamburg, Germany-based private platform company leveraging the natural immune tolerance induction capabilities of the liver, today announced the appointment of Klaus Martin, Ph.D., as Chief Executive Officer. Effective August 1, 2020, Dr. Martin replaced Timm Jessen, Ph.D., who resigned for personal reasons. Dr. Jessen will remain with Topas in a consulting capacity to ensure a smooth transition.Dr. Martin joins Topas from Toronto-based Apobiologix, Apotex’ biotechnology division, where he had served as President since 2018. During his tenure, he led the development, sales & marketing and operational organization and played a key role in Apobiologix’ registrations, partnerships and in achieving a market leadership position. Prior to that, he was Chief Scientific Officer of Polpharma Biologics, the biologics arm of Polpharma S.A., where he set up the organization and managed all portfolio, licensing and late-stage development activities for biosimilar and innovative biologics. Previously, he worked at Sandoz Biopharmaceuticals, both in Germany and Austria, most recently serving as Global Head Business Development & Licensing (BD&L) and Portfolio Management where he drove the portfolio strategy and managed all licensing negotiations. While at Sandoz Biopharmaceuticals, he also served in global development management functions and during that time supported the registration of Sandoz’s first three biosimilars in the U.S., Europe, Canada and Japan. Dr. Martin holds a Ph.D. in molecular genetics from Cambridge University and Darwin College, United Kingdom.

  Erich F. Greiner, M.D., Chairman of the Supervisory Board, said: “We are delighted to have Klaus join Topas. He is an accomplished biotech leader with a proven track record in development and operations, as well as partnering and commercialization. His transatlantic experience managing all stages of the biotechnology value chain and in growing businesses are a great fit for Topas as the Company advances its pipeline.”

  Dr. Greiner continued: “On behalf of the entire Board, I would like to warmly thank Timm Jessen, who founded Topas and has served as CEO since the Company’s inception. He has successfully led Topas from discovery into the clinic, secured several pharmaceutical collaborations and successfully completed all financing rounds. We are extremely pleased that he will remain as a consultant to ensure a smooth transition and very much look forward to working with him in his new role.”

  Klaus Martin, Ph.D., Chief Executive Officer, said: “Topas has a novel and compelling technology platform with the potential to develop promising treatments where new options for patients are urgently needed. I am excited to lead the Company and work with the Topas team to continue to grow and build our pipeline.”

• Co-led by new investors, Vesalius BioCapital III and BioMedPartners, with participation from all existing investors
• Funds to be used to advance innovative pipeline based on Topas Particle Conjugates technology platform
  • Lead program TPM203 in clinical development for pemphigus vulgaris
  • Second program, TPM501, progressing towards clinic for treatment of celiac disease
• New investors join Supervisory Board; Erich F. Greiner, M.D., becomes Chairman

Topas Therapeutics GmbH (Topas), a Hamburg, Germany-based private platform company leveraging the natural immune tolerance induction capabilities of the liver, today announced the successful closing of a €22 million (~$26 million) Series B financing round. New investors Vesalius BioCapital III and BioMedPartners co-led this transaction, which included participation from all of Topas’ existing investors. The funding will be used to advance the Company’s proprietary pipeline based on the Topas Particle Conjugates technology platform. This includes progressing lead program TPM203, currently in clinical development for the treatment of pemphigus vulgaris, and bringing TPM501, Topas’ candidate for the treatment of celiac disease, into the clinic.

Klaus Martin, Ph.D., Chief Executive Officer of Topas, said: “I am particularly gratified to begin my tenure at Topas with the completion of a successful financing round. We are grateful for the ongoing support of our existing investors and are proud to have had such high calibre new investors participate. They share our belief about the strong potential of Topas’ innovative technology platform, and I am very happy to welcome them as new members of the Supervisory Board.”

Marc Lohrmann, Managing Partner of Vesalius Biocapital III, said: “We are delighted to join Topas Therapeutics in its Series B round and look forward to contributing to the future success of the Company. We are excited about the opportunities of the unique and versatile Topas tolerization platform and are highly committed to supporting the new CEO, Klaus, and the whole management team, to accelerate the development of the Company’s promising clinical programs.”

Michael Wacker, Ph.D., Partner of BioMedPartners, said: “The immune tolerance space is an area of untapped potential. We are impressed by the Topas Particle Conjugates technology and its potential to ameliorate and in some cases even cure a variety of immune-mediated diseases. Together with our fellow investors, we look forward to seeing the Company advance its lead program, TPM203, in the debilitating autoimmune disease, pemphigus vulgaris, as well as bring other programs forward into the clinic.”

Topas also today reported changes to the Company’s Supervisory Board, effective immediately:

In connection with the financing, Marc Lohrmann, Vesalius Biocapital III, and Michael Wacker, Ph.D., BioMedPartners both have joined the Supervisory Board.

Existing Board member, Erich F. Greiner, M.D., has become Chairman. Dr. Greiner is CEO and President of Cedrus Therapeutics Inc. and has served on the Topas Supervisory Board since June 2016.

Sebastian Kreuz, Ph.D. has replaced Detlev Mennerich, Ph.D. on the Board as representative of the Boehringer Ingelheim Venture Fund.

About BioMedPartners

Based in Basel, Switzerland, BioMedPartners is an independent European venture capital firm that acts as lead-or co-lead investor providing private equity to early-to mid-stage life sciences companies. Since 2002, BioMedPartners has invested in several highly innovative companies of which twenty-two have already either successfully been acquired by leading biopharma companies or have completed an IPO. With more than CHF 350 million in capital under management and a strong team of experienced industry experts as well as an extensive scientific and pharma network, BioMedPartners has established itself as one of the leading early-stage human healthcare investors in Europe. In February 2018, the company announced the closing of BioMedInvest III, their third equity venture capital fund of CHF 100 million. In this third fund BioMedPartners is focusing on the build-up of companies with highly innovative early stage assets and technology platforms. The first investment of BioMedInvest III was in the Swiss immuno-oncology company Amal SA (Geneva) which has been acquired by Boehringer Ingelheim in June 2019.

For more information, please visit www.biomedvc.com.

About Vesalius Biocapital III

Vesalius Biocapital (Vesalius), the specialist life sciences venture capital investor, has supported companies active in human health through venture capital funds since 2007. Since inception, Vesalius has raised over €260 million in three funds and contributed to the development of over 30 companies. The team consists of seasoned life science professionals with healthcare industry, corporate finance and strategy consulting experience, supporting companies through their growth cycle. The team is based in Europe and explores investment opportunities and valuation potential for the portfolio.

Vesalius Biocapital III, launched in April 2017, announced a final close with EUR 120 million in commitments in 2019. The fund targets later-stage European life science companies in drug development, medtech, diagnostics and digital health.

For more information, please visit www.vesaliusbiocapital-3.com.

Topas Therapeutics GmbH (Topas), a Hamburg, Germany-based private platform company leveraging the natural tolerance induction capabilities of the liver, today announced that the first patient has been enrolled in a first-in-human Phase 1 trial evaluating TPM203 in patients with pemphigus vulgaris (PV), an orphan autoimmune disease. TPM203 is Topas’ most advanced program and the first one from the Company’s proprietary Topas Particle Conjugates (TPC) platform technology to enter the clinic.

“The initiation of the first clinical study with our lead product candidate is an exciting and at the same time value-generating step forward for Topas,” said Timm Jessen, PhD, Chief Executive Officer. “Pemphigus vulgaris is a well characterized disease with extensive knowledge on the most related autoimmune antigen and biomarkers available. It provides a very good setting to demonstrate the successful translation of our Topas Particle Conjugates platform into the clinic. While treatments do exist for this painful condition, there currently is no cure, and we look forward to advancing TPM203 with the goal of helping patients with this debilitating disease.”

The Phase 1 trial is an open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of TPM203, as well as to explore early signs of effectiveness for TPM203 to induce antigen-specific immune tolerance in this patient population. The study has a single-ascending dose phase, followed by a multiple dose phase. The trial is planned to treat 24 patients and will be conducted at approximately seven sites in Germany; the coordinating investigator is Prof. Michael Hertl from the Dept. of Dermatology and Allergology at University Medical Center Marburg.

Topas Particle Conjugates technology platform harnesses the liver’s natural immunology capabilities
Topas’ technology platform harnesses the natural mechanisms of the liver to promote immune tolerance to blood borne antigens. Small peptide-loaded nanoparticles, Topas Particle Conjugates (TPCs), mimic such blood borne antigens and are taken up by liver sinusoidal endothelial cells (LSECs). LSECs present these antigens to T cells under anti-inflammatory conditions conducive to the induction of tolerogenic regulatory T cells (Tregs) and/or by other mechanisms. Tregs are pivotal for immune tolerance, and their in vivo generation serves to re-instate healthy immune balance (homeostasis) and provide a cure for diseases characterized by undesirable or dysregulated inflammatory immune reactions. The fast and active uptake of circulating TPCs by LSECs leads to rapid clearance of the particles from the bloodstream, allows an exact dosing of the antigen residing in the liver and avoids undesired immune reactions. TPCs provide major competitive advantages, including in vivo traceability, dose-ability, biodegradability and scalability along GMP requirements.

About Pemphigus Vulgaris
PV, an orphan disease, is an autoimmune condition involving a painful blistering on the skin and mucous membranes. If extensive, blistering can lead to life-threatening fluid loss, infection, and disfigurement. In this disease, patients have autoantibodies against desmogleins (proteins that play a role in connecting cells), which disrupt the connections between the squamous cells of the epidermis and cause blisters that can easily burst. Treatment consists of immunosuppressive agents; prognosis is variable, but many patients have a higher than normal mortality rate, and there is no cure.

Topas Therapeutics GmbH (Topas), a Hamburg, Germany-based private platform company leveraging the natural tolerance induction capabilities of the liver, today announced that the Company will participate at several conferences this spring.

Learn more about the Topas Particle Conjugates (TPC) technology platform at these upcoming conferences:

2^nd Antigen-Specific Immune Tolerance Drug Development Summit 2019
March 26-28, 2019
Boston, MA, USA

Timm Jessen, PhD, Chief Executive Officer of Topas, will give a talk entitled, “Preparation of Liver-Targeting Nanoparticles for Clinical Trials,” on March 28^th at 10:30 AM EDT.

As the race to generate compelling clinical data to prove the concept of antigen-specific immunotherapies gains momentum, the conference seeks to help large pharma, biotech, and academic researchers overcome the complexity of auto-immune mediated disorders, expand opportunities through combination strategies and undertake a more precise and antigen-specific approach to novel drug development. Please click here for more details about the event.

TReg Directed Therapies Summit
May 20-22, 2019
Boston, MA USA

Sabine Fleischer, MD, Head of Translational Medicine of Topas, will give a presentation entitled, “Leveraging Tolerogenic Nanoparticles to Induce Antigen-Specific Immune Tolerance in vivo,” on May 22^nd at 2:15 PM EDT.

The conference is dedicated to the clinical translation of engineered and stimulated cell therapy and small molecule approaches to deliver cures for autoimmune and inflammatory indications. For more information, click here.

Meet with Topas management at these industry events:

2019 German Biotech Days (Deutsche Biotechnologietage 2019)
April 9-10, 2019
Würzburg, Germany

Topas will attend this event. To request a meeting, please contact Dr. Timm Jessen at jessen@topas-therapeutics.com.

The 2019 German Biotech Days event is co-organised by BIO Deutschland and the Council of German BioRegions and provides a forum for all stakeholders in Germany’s biotech scene to exchange views and experiences. The conference is a meeting place for more than 850 representatives from business, science and government, including partners from funding institutions and public administration. The conditions for innovation in biotechnology and the wide range of biotech applications will be discussed through a series of talks, panel discussions and breakfast sessions. For more information, please click here.

20^th Annual Bio€quity Europe
May 20-21, 2019
Barcelona, Spain

Topas will give a corporate presentation and host 1X1 meetings at this event. To request a meeting with Topas, please sign up through the event’s partneringONE meeting system or contact Dr. Timm Jessen at jessen@topas-therapeutics.com. Bio€quity Europe is the seminal industry event for financial dealmakers looking for investor-validated life science companies positioning themselves to attract capital and for pharmaceutical licensing professionals to assess top prospects. Bio€quity Europe has showcased more than 800 leading European companies to thousands of investment and pharma business development professionals. Delegates from 24 nations attended the 2018 event. More information on the event can be found here.

Meet with Topas at the following industry events this fall:

• Sachs 18 th Annual Biotech in Europe Forum
• BIO-Europe® 2018
• Meetings around JP Morgan 36 th Annual Global Healthcare Conference
• Immunology of Diabetes Society Congress 2018
• Antigen-Specific Immune Tolerance Europe Conference

Hamburg, 27^th September 2018 – Topas Therapeutics GmbH (Topas), a Hamburg, Germany-based private platform company leveraging the natural tolerance induction capabilities of the liver, today announced that the Company will participate at the following conferences this fall:

Meet with Topas at the following industry events:

• Companies join forces in immune tolerance to tackle ADA (anti-drug antibodies)
• Initial focus on next generation vector-based therapeutics
• Boehringer Ingelheim is granted option to in-license several pre-clinical development candidates produced under the collaboration