LONDON, May 21, 2024 (GLOBE NEWSWIRE) — Engitix Ltd (‘Engitix’), a biotechnology company with a portfolio of drug discovery programmes in fibrosis and solid tumours using its proprietary human extracellular matrix (ECM) platform, today announces the appointment of Matthew Edwards, Ph.D., as Senior Vice President of Discovery Sciences, and Emma Huang, Ph.D., as Vice President of Data Sciences.
Dr. Edwards is a seasoned drug discovery leader with extensive industry experience. He has developed six clinically-enabled novel therapeutics and has deep immunology and oncology domain expertise. He joins Engitix from Johnson & Johnson, where he was the Global Head of Discovery and Translational Sciences for Interventional Oncology. In this role, he developed a portfolio of immuno-oncology assets primarily designed to be delivered intra-tumourally, which included low molecular weight drugs, therapeutic antibodies and RNA therapeutics. Prior to this, further industrial drug discovery experience included leadership positions at Novartis, and GSK in the respiratory and immunology therapeutics areas.
At Engitix, he will be responsible for leading the company’s internal drug discovery scientific strategy.
Dr. Huang brings to Engitix a strong track record of identifying and executing on transformative opportunities harnessing data science to accelerate the development of novel therapies and solutions for patients. She joins Engitix from Johnson & Johnson, where she served as Head of Data Sciences for Interventional Oncology. In this role, she shaped and built key data science capabilities including the data, analytics, platforms, and partnerships necessary to support discovery and translational biomarker efforts.
With over 40 peer reviewed papers, and a career spanning academia, government, and industry, Emma has consistently demonstrated her commitment to scientific advancement and collaboration through roles such as Deputy Chair of the MRC Population & Systems Medicine Board. She holds a Ph.D. in Biostatistics from the University of North Carolina-Chapel Hill, and a B.S. in Mathematics from Caltech.
At Engitix, she will be responsible for leading the company’s data and analytics strategy supporting platform development, internal drug discovery pipeline, and external partnerships.
Dr. Christopher Stevenson, CSO at Engitix, said, “I am delighted to welcome Matt and Emma to Engitix. We have created the roles of SVP Discovery and VP Data Sciences to expand our leadership team and capabilities. The expertise Matt and Emma bring will galvanise the team’s focus on translating the insights gained from Engitix’ proprietary platform technologies into transformational therapies for patients.”
Dr. Matthew Edwards, SVP Discovery Sciences of Engitix, said, “Engitix is undoubtedly a company with world leading disease ECM analysis capability providing a unique opportunity for novel target identification. I’m excited to take on this critical role and help build and prosecute our internal drug discovery pipeline and expedite bringing novel therapeutics to patients with high unmet medical need.”
Dr. Emma Huang, VP Data Sciences of Engitix, said, “What attracted me to Engitix, was its innovative ECM platform generating high-quality, disease-relevant datasets to drive drug discovery. It’s an incredibly exciting opportunity to combine these novel data with cutting-edge analytics to help develop therapeutics addressing a broad range of medical needs.”
Notes to Editors:
About Engitix Ltd
Engitix is progressing a portfolio of internal and partnered drug discovery programmes in fibrosis and solid tumours using its pioneering human extracellular matrix (ECM) platform. Engitix patient-centric ECM platform is underpinned by an extensive bioarchive, one of the world’s largest ECM databases, and best-in-class, human in vitro 3-D cell culture bioassays. Together, these unique capabilities transform its ability to identify new targets and biomarkers, investigate novel mechanisms of action, and more accurately predict the efficacy of therapeutic candidates. It has a strategic drug discovery partnership with Dompé farmaceutici where Engitix’s internal drug development programmes are being accelerated by leveraging Dompé’s AI-enabled high performance computing platform, Exscalate, and drug discovery and development collaborations with Takeda in advanced fibrotic liver diseases, including non-alcoholic steatohepatitis (NASH), and in fibrostenotic Inflammatory Bowel Disease (IBD), including Crohn’s disease and ulcerative colitis.
Established to commercialise cutting-edge research from the Institute for Liver and Digestive Health, Division of Medicine, University College London (UCL), Engitix is headquartered in Westworks, White City Place, London, UK. It has raised more than $60m in equity from investors including Netherton Investments (a fund investing on behalf of Mike Platt) and Dompé farmaceutici S.P.A.
For more information, please visit www.engitix.com
Merck Global Head of R&D and Chief Medical Officer Danny Bar Zohar joins Former Israeli Prime Minister Naftali Bennett on Board of Directors
NEW YORK–(BUSINESS WIRE)–Remepy, a pioneer in “hybrid drugs,” today announced that it has successfully closed a $10M seed investment round, which together with earlier funding totals $15M. The round was led by NFX, joined by Vine Ventures, PsyMed Ventures, Supernode Ventures and Firstime Ventures, joining previous pre-seed lead investor TechAviv as well as Fresh.fund, Samsung Next, StageNext Fund and 97212 Ventures.
Remepy’s new hybrid drugs combine traditional drugs with its “digital molecules.” Digital molecules are therapeutic interventions that trigger physiological effects (aka MOAs, Mechanisms of Action) through the brain. These physiological changes have been known to enhance the effectiveness of traditional drugs.
The digital molecules are designed for hybrid drug experiences. They are based on non-invasive cognitive, psychological, and behavioral interventions that follow principles of sensory integration, sensory substitution and sensory deprivation. The interventions trigger multiple unique mechanisms of actions, including: changes to brain connectivity in important brain areas; changes to immune system blood biomarkers, and important behavioral changes.
Remepy has already demonstrated the effects of its digital molecule interventions in clinical trials using extensive fMRI imaging, blood and saliva samples analysis and standardized questionnaires. It is among the first in the world to show that its patent–pending digital therapies can modulate blood biomarkers.
Many diseases are better treated by combining drugs with non-pharmacological interventions. Remepy is making such combinations standardized, accessible and personalized at scale with the use of its digital molecules.
Remepy is targeting neurodegenerative diseases, cancer, autoimmune diseases, and degenerative eye diseases. Remepy’s innovative approach creates a new market for hybrid medications, and a whole new world of data and IP assets for pharmaceutical companies.
Dr. Danny Bar Zohar, Merck’s Global head of R&D and Chief Medical Officer, who shares the company’s vision for hybrid drugs states: “As a physician and drug developer, it is fascinating for me to see Remepy’s clinical data, which shows how these unique non-invasive digital interventions can modulate the immune system, make significant changes to brain plasticity, and drive behavioral changes. Remepy’s product has the potential to enhance immunotherapy for cancer, or improve existing drug therapy for neurodegenerative diseases such as Parkinson’s Disease and MCI (Mild Cognitive Impairment). These proprietary digital-drug combinations could significantly improve patient outcomes and create tangible value for patients and healthcare systems.”
Dr. Michal Tsur, Remepy Co-CEO: “I am thrilled that Dr. Danny Bar Zohar has joined us as a board member. Many industries have transformed by adopting a hybrid product approach, integrating new technology with traditional products.” Co-CEO Or Shoval added: “I am particularly excited about the prospects of improving Parkinson’s Disease patients’ lives with a hybrid PD drug that will better address cognitive, movement, speech, sleeping and psychological symptoms and has the potential of disease modification with changes to brain connectivity.”
“Remepy’s vision of enhancing drugs with digital companions is groundbreaking and their clinical proof that such enhancement is possible is incredibly exciting,” adds Gigi Levy-Weiss, Managing Partner at NFX “Remepy has an experienced team of entrepreneurs and world-class scientists that are defining a new category in pharma.”
About Remepy:
Remepy is pioneering Hybrid Drugs: traditional drugs combined with digital therapeutics that are personalized and enhance the effect of pharmaceutical treatments. Remepy has already proven in human studies the effect of its products, using extensive brain imaging, as well as blood and saliva samples, with promising results for Oncology, MCI, and Parkinson’s Disease. Their approach offers an efficient method to create new proprietary pharma assets, unlocking an entire new market and world of data. The Remepy team includes top scientists, physicians, and technologists.
A public-private consortium formed by the biotech company Hemostatics, located in the Barcelona science Park, the Clínica Universidad de Navarra (CUN) and the Institute of Chemical Research of Catalonia (ICIQ) will accelerate the development of a next generation drug to tackle severe haemorrhagic processes, such as those associated with major surgery, trauma or intracranial haemorrhage, without effective treatment.
The aim of the consortium, which has obtained €2.5 M from the Spanish Research Agency, is to reach the clinical phase of the antifibrinolytic agent CM-352, a drug with a revolutionary therapeutic approach in this field. Until now, the total capital raised to develop the compound amounts to €3M, including €0,3 M from the CDTI’s Neotec programme received in 2022, plus other private funds.
According to SEMICYUC, haemorrhage accounts for 50% of deaths within 24 hours of traumatic injury, and of up to 80% of intra-operative trauma mortality. It is a very common complication in clinical situations, such as surgeries, and in cardiovascular patients and patients with certain rare genetic diseases. WHO also warns that postpartum haemorrhage (PPH) affects 14 million women each year and is the world’s leading cause of maternal death.
Barcelona, 20 March 2024. A public-private consortium formed by the biotech Hemostatics, based at the Barcelona Science Park, the Clínica Universidad de Navarra (CUN) and the Institute of Chemical Research of Catalonia (ICIQ), has received 2.5 million euros from the Spanish Research Agency (AEI), under the call for grants for Public-Private Collaboration Projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhage.
The aim of the project, led by Hemostatics – a spin-off from Cima Universidad de Navarra, attached to the CUN – is the preclinical and clinical development of the antifibrinolytic agent CM-352, a first-in-class drug that represents a pioneering therapeutic approach to control severe bleeding in unmet medical needs, such as those associated with major surgery, trauma or intracranial haemorrhage (ICH).
The CM-352 compound is the result of a long research process led by Dr. Josune Orbe (CSO of Hemostatics), head of the CIMA’s Atherothrombosis research group, and Dr. José Antonio Páramo (CMO) of the Hematology Service of the Clínica Universidad de Navarra and member of the Spanish Society of Thrombosis and Haemostasis (SETH).
Based on a technology transfer and exclusive patent licensing agreement, Hemostatics was born in 2020, promoted by CIMA and a team of experts from the health and business sector, led by Dr. Orbe, Dr. Páramo and Nicolas Saglio, CEO of Hemostatics and managing partner at biomedical innovation consultancy HealthTech180, with more than 20 years’ experience in strategic consulting and innovation for technology and healthcare companies.
Until now, the total capital raised to develop the compound amounts to €3M, including €0,3 M from the CDTI’s Neotec programme received in 2022, plus other private funds.
A global health and economic issue
Haemorrhage accounts for up to 50% of trauma deaths occurring worldwide within 24 hours of traumatic injury, according to SEMICYUC-Spanish Society of Intensive and Critical Care Medicine and Coronary Units, and up to 80% of intraoperative trauma mortality. It is a very common complication in cardiovascular patients, or patients with certain rare genetic diseases, as well as in different clinical situations, such as surgeries, or postpartum haemorrhage, which is estimated to affect 14 million women each year and represents the world’s leading cause of maternal death, according to WHO, with some 70,000 deaths annually.
“The socio-economic cost of acute bleeding in trauma cases alone is enormous and causes more than 6 million deaths per year (more than all communicable diseases combined, including COVID-19, malaria, tuberculosis, HIV/AIDS, etc.), and is responsible for a total cost of over $670 billion in the United States alone. However, an antihaemorrhagic agent, that can address the unmet medical needs of severe haemorrhagic processes and minimise the risk of possible side effects in the face of less severe haemorrhagic episodes, has not yet been found,” reveals Nicolas Saglio. “Our compound, CM-352, in addition to reducing this major burden of morbidity and mortality, will significantly reduce the healthcare cost of annual expenditure on blood and transfusion-related activities”.
Public-private partnership to create a next generation antifibrinolytic
CM-352 is a drug with a completely innovative mechanism of action, as it targets cessation of bleeding by inhibiting matrix metalloproteinases (MMPs), a revolutionary pharmacological strategy that promises to be more effective and safer than the current standard antifibrinolytics (TXA and EACA) used in clinical practice to control acute bleeding.
The regulatory preclinical phase will be coordinated by Hemostatics Pharmaceuticals and will involve the integration of the efforts of the Atherothrombosis Research Group (CIMA), led by Dr. Josune Orbe.
“We already have experimental results indicating that CM-352 is highly effective in all major bleeding scenarios, with no signs of toxicity, thrombosis, or off-target adverse effects. We will now complete efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in several preclinical models required by regulatory agencies. Obtaining these results will allow us to reach a key milestone of the project: approval from the health authorities to test CM-352 in a phase I clinical trial. Our initial focus will be on the US FDA. Subsequently, we will also go to the EMA in Europe, and everything will be done in close collaboration with the Spanish agency, the AEMPS,” Saglio explains.
Through the Innovation and Valorisation Laboratory and the High Throughput Experimentation (HTE Laboratory), the ICIQ will address the identification and optimisation of a CM-352 synthesis route that improves the efficiency and reduces the cost of the production process of the molecule. The team involved in the project will be led by Dr. Fernando Bravo, manager of the Knowledge and Technology Transfer Department (KTT) and Industrial Projects, and Dr. Xisco Caldentey, manager of HTE.
“The current synthesis route of CM-352 has enabled us to obtain sufficient compound quantities to progress through the preclinical phases, and ICIQ’s involvement will focus on developing a synthetic process with a new optimised synthesis route, which also allows for robust, reproducible scaling with safety guarantees. This objective will be addressed through a combination of intelligent catalyst design and high-performance parallelisation techniques for reaction optimisation. In this regard, techniques involving the screening of hundreds of reactions using automated analysis systems will be applied, such as the one available at ICIQ’s HTE Laboratory, a unique facility in Spain, with few similar models worldwide. The selection of the final synthetic route for obtaining CM-352 will be based on techno-economic criteria (cost/kg), including the relative cost of purification processes, efficiency, safety, and minimization of environmental impact, thereby facilitating its future industrialization and commercialization”, says Dr. Bravo.
Finally, the CM-352 phase I trial will involve the active participation of CUN, with technical support from CIMA and will focus on severe haemorrhage in traumatology, where there is no treatment with proven clinical efficacy. The study will be carried out by the Haemostasis and Thrombosis Unit of the Haematology Department and the Department of Orthopaedic Surgery, under the coordination of Dr. José Antonio Páramo.
“Our objective will be to evaluate the tolerance and safety of CM-352 in patients undergoing scheduled total knee replacement surgery (total knee arthroplasty) to prevent possible hemorrhagic complications, which constitute a serious associated adverse event. This represents a very important milestone in the compound’s development since, in existing literature, no clinical study has reported the use of MMP inhibitors to treat hemorrhages. The absence of toxicity and secondary effects after treatment with CM-352 will also represent the first time such results are obtained for an MMP inhibitor in humans, allowing us to move to a Phase II focused on severe hemorrhages in traumatology, where there is currently no treatment with proven clinical efficacy”, noted Dr. Páramo.
About Hemostatics Pharmaceuticals
Hemostatics Pharmaceuticals S.L.(https://hemostatics.com/) is a biotechnology company created in 2020 by a highly experienced team that set up a strategic partnership and exclusive licence for the technology with the Foundation for Applied Medical Research (FIMA), which manages CIMA, the Centre for Applied Medical Research of the Clínica Universidad de Navarra (CUN). Hemostatics is developing a new proprietary antifibrinolytic agent, CM-352, to reduce bleeding in disabling and life-threatening haemorrhagic conditions and address a number of important unmet medical needs in trauma, surgery, intracranial haemorrhage (ICH), postpartum haemorrhage (PPH) and gastrointestinal bleeding.
About Clínica Universidad de Navarra (CUN)
With more than 2,800 full-time professionals at its Pamplona and Madrid sites, Clínica Universidad de Navarra (https://www.cun.es/) is an academic hospital and a benchmark in personalised medicine in Spain. Recognised for its research and teaching work, the prestige of its professionals and its experience in the diagnosis and treatment of highly complex pathologies, Clínica Universidad de Navarra is a hospital that produces results through speedy diagnoses, thanks to its multidisciplinary work and acquisition of the latest technology, that allow it to offer care in 46 medical and surgical specialities. Clínica Universidad de Navarra is among the world’s 50 best hospitals, according to the World’s Best Hospitals ranking, and among the 35 best oncology hospitals worldwide according to the World’s Best Specialized Hospitals ranking. For the sixth consecutive year, it has been the private hospital with the best reputation in Spain (according to the MRS ranking).
About the Institute of Chemical Research of Catalonia (ICIQ)
The Institute of Chemical Research of Catalonia (https://www.iciq.org/) is a research centre dedicated to advancing scientific knowledge to address social and economic challenges such as climate change and the sustainable supply of raw materials and energy. It has two Severo Ochoa accreditations as a centre of excellence, which underline its recognition as an international benchmark in frontier chemical research. The ICIQ’s research is based on three pillars: sustainable catalysis, renewable energies and health. Also noteworthy are the lines of collaboration with industry, transferring knowledge and promoting the development of innovative applications, with a special focus on patents and spin-offs.
Project CPP2022-009643 funded by:
For further information:
Azucena Berea • Press Officer • Barcelona Science Park • +34 93 403 46 62 • aberea@pcb.ub.es
Miguel García San Emeterio • Media Director • Clínica Universidad de Navarra • +34 948 255 400 • mgsanemeterio@unav.es
Orbis’ platform is first to systematically explore macrocycle chemical space using unique combination of high-throughput chemical synthesis and large-scale assaying, supported by machine learning
Pipeline to initially focus on high-value oral alternatives to blockbuster biologic drugs and opening new targets to therapeutic intervention
COPENHAGEN, Denmark–(BUSINESS WIRE)–Orbis Medicines, a leader in oral macrocycle drug discovery, today announces its launch with a €26 million financing led by global life sciences investor Novo Holdings and European life sciences venture firm Forbion. The funding will support Orbis’ expansion and advancement of its portfolio of next-generation macrocycle drugs it calls ‘nCycles’. Macrocycles are a large and diverse family of compounds with highly desirable therapeutic properties, defined by the presence of a cyclic structure. nCycles are systematically designed by Orbis’ nGen1 platform to be orally bioavailable and membrane permeable, solving decades-long challenges in macrocycle drug design.
The Orbis pipeline includes programs against targets validated by blockbuster biologic drugs, with the goal of providing oral alternatives that will enable the treatment of many more patients. In addition, Orbis is developing a pipeline of nCycles for other attractive target classes, both intra- and extra-cellular. Oral macrocycle drugs can potentially address a very wide range of diseases based on their ability to target a majority of the potential molecular targets in the body.
“After decades of challenging de novo synthesis, the universe of potential macrocycle targets is now available for exploration. Not only can Orbis reach a wealth of new targets, both inside and outside cells, but we can do this while preserving an oral format to pioneer a new therapeutic class of oral macrocycles. It’s a milestone for drug development,” said Morten Døssing, Chair of the Orbis Board and Partner at Novo Holdings. “We believe Orbis has the premier chemistry-led approach in the field, which gives us a distinct data advantage. We can generate hundreds of thousands of diverse compounds in record time and immediately apply a range of functional assays in a high-throughput fashion to each individual compound to home in on winners. Establishing this robust, reliable engine for candidate design was crucial for us as we look to bring macrocycle drugs to major patient populations.”
Orbis was founded in 2021 by the Seeds Investment team of Novo Holdings, with Mr. Døssing as Executive Chair and João Ribas as interim CBO establishing the company’s team and building its corporate strategy. The scientific foundation of Orbis was developed by Prof. Christian Heinis and Sevan Habeshian at the Swiss Federal Institute of Technology in Lausanne (EPFL).
“The broad potential of oral macrocycle drugs to address challenging targets untouchable by small molecules, coupled with recent momentum in the field, makes this an incredibly exciting development,” said Marco Boorsma, Ph.D., General Partner at Forbion. “With a compelling AI-enabled platform technology, scientific expertise and a clear strategy for growth, Orbis is attracting strong interest for its approach to finally delivering on the promise of this class for medicine. We believe Orbis’ combinatorial approach and ability to continuously generate big data from real compounds gives them an undeniable opportunity to unlock the potential of orally available macrocycle drugs for significantly larger patient populations.”
The chemical methods by which Orbis rapidly generates vast libraries of diverse macrocycle compounds ready for immediate assay were previously published in Nature Communications. Authors of the paper, which included Orbis’ founders Professor Heinis and Dr. Habeshian, detail how the methods draw on a large range of components to build compounds, including both natural and synthetic amino acids, creating an extremely large chemical space for exploration. Additionally, research recently published in Nature Chemical Biology demonstrates nGen’s ability to deliver nCycles that are orally bioavailable, marking a new era for macrocycle drug discovery.
About Orbis Medicines
Orbis Medicines is a biotechnology company focused on pioneering a new era for oral macrocycle drug discovery. Macrocycles are a large and diverse family of compounds with highly desirable therapeutic properties, defined by the presence of a cyclic structure. Orbis’ nGen platform is designed to systematically explore the macrocycle chemical space using a highly automated chemistry platform and deliver oral macrocycle drug candidates – nCycles – suitable for both intra- and extracellular targets. Orbis’ programs are focused on high-value oral alternatives to blockbuster biologic drugs and targets challenging for established modalities. Orbis was founded by Novo Holdings. For more information, please visit: www.orbismedicines.com
1About nGen
nGen is Orbis’ technology platform for generating oral macrocycle drug candidates, which it calls nCycles. It consists of multiple proprietary integrated elements starting with hit finding libraries of 100 billion compounds. Hits identified are progressed using Orbis’ highly automated chemistry-based platform that rapidly creates and tests hundreds of thousands of individual analogues with a full suite of assays to identify the most desirable ones. The scale and quality of the data produced from these real compounds, paired with machine learning, creates an industry-leading platform that de-risks and accelerates development. Recently published research in Nature Chemical Biology demonstrates nGen’s ability to deliver nCycles that are orally bioavailable, marking a new era for macrocycle drug discovery.
About Novo Holdings A/S
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.
Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novozymes A/S and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2022, Novo Holdings had total assets of EUR 108 billion. www.novoholdings.dk
About Forbion
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies that are active in the biopharmaceutical space, managing €3 billion across multiple fund strategies that cover all stages of biopharmaceutical drug development. The firm’s current team consists of more than 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in over 100 companies across 8 funds. Forbion’s record of sourcing, building and guiding life sciences companies has resulted in many breakthrough therapies and valuable exits. In addition to its financial return objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. More information can be found at www.forbion.com
