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Guest User 29/10/2024 Guest User 29/10/2024

Dr. Falk Pharma acquires Kynos Therapeutics, adding acute pancreatitis as a therapeutic focus and further strengthening its development portfolio

Kynos Therapeutics Ltd, a clinical stage biotechnology company developing first-in-class small molecule kynurenine 3-monooxygenase (KMO) inhibitors for acute and chronic inflammatory disorders, today announces the key findings from the first in human Phase I trial of its lead drug candidate, KNS366.

Freiburg, Germany, 29. October 2024 | Download the PDF

Today, Dr. Falk Pharma GmbH announces the successful acquisition of Kynos Therapeutics Ltd., a clinical stage biopharmaceutical company focusing on the development of novel treatments for patients suffering from acute and chronic inflammatory diseases. The company was founded as a spin-out of the University of Edinburgh, Scotland, together with lead investor Epidarex Capital, a leading early-stage transatlantic venture fund, along with IP Group, and Scottish Enterprise. Effective immediately, Kynos Therapeutics will be integrated into the Falk Group.

Kynos Therapeutics’ lead investigational asset is KNS366, a highly potent and selective first-in-class inhibitor of the enzyme kynurenine 3-monooxygenase (KMO). In a Phase I clinical trial, KNS366 was shown to be safe and well-tolerated at multiple doses. The compound also led to a dose-dependent inhibition of the enzyme KMO and modulation of its downstream metabolites.

Dr. Falk Pharma is excited about the addition of KNS366 to its R&D pipeline and will further explore the potential of KNS366 in future clinical trials, initially focusing on acute pancreatitis. This new asset will enhance Dr. Falk Pharma´s expansion into rare digestive and metabolic diseases and conditions.

About KNS366

Kynos Therapeutics’ lead investigational asset KNS366 selectively inhibits the enzyme kynurenine 3-monooxygenase (KMO). KMO is a key enzyme in the tryptophan metabolic pathway and has also been shown to play an important role in modulating immune processes. By inhibiting KMO activity, KNS366 interferes with inflammation and other immune system pathologies by lowering levels of its downstream metabolite – 3- hydroxykynurenine (3HK) – high levels of which have been linked to tissue damage and dysregulation of the immune system during inflammation. Inflammatory diseases including acute pancreatitis trigger an exacerbated, systemic pro-inflammatory response, making KMO inhibitors a promising next-generation treatment option for disorders characterized by severe inflammation.

About acute pancreatitis

Acute pancreatitis is a sudden inflammation of the pancreas that can be triggered by a number of factors. In its severe form, this acute inflammation can cascade to a reaction in the entire body over several days to weeks that can result in systemic inflammation, organ failure, and death. Accordingly, acute pancreatitis requires immediate medical intervention to manage patients’ symptoms and prevent worsening of their condition, often necessitating prolonged hospitalization. Currently, acute pancreatitis occurs in about 240,000 people in Europe and 300,000 people in the United States each year, with 1 in 5 acute pancreatitis patients requiring intensive care. To date, there are no proven or approved treatment options to prevent organ failure and death resulting from severe acute pancreatitis, meaning there is an urgent need for effective treatments.

About partnering with Dr. Falk Pharma

Dr. Falk Pharma engages in a variety of collaboration and partnership models to develop and deliver innovative treatment concepts with great potential. These treatments can be based on any type of pharmacological approach, from small molecules to biologics to novel drug delivery technologies. The company is involved in partnership projects across the range of phases and partners, from all stages of pre-clinical/clinical development and marketing as well as with academic researchers, start-ups, and established companies.

Dr. Falk Pharma is an industry leader in innovative pharmaceutical formulations that deliver active substances to specific functional segments of the gastrointestinal tract. Many of their products have attained standard-of-care status. The company enjoys strong, long-standing collaborations with renowned clinical centres and with academic and clinical key opinion leaders in the fields of gastroenterology, hepatology and metabolic diseases.

About Dr. Falk Pharma GmbH

Dr. Falk Pharma GmbH has been developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis for over 60 years. As the international experts in digestive and metabolic medicine, the company brings together physicians, scientists, and patients to devise new and powerful approaches to patient care. Dr. Falk Pharma engages in pre-clinical and clinical stage research that aims to meaningfully improve therapeutic practice as well as patient health and well-being. A family-owned business with a global presence, Dr. Falk Pharma has ten affiliates in Europe and Australia and is continuously growing. The company has its headquarters and R&D facilities in Freiburg, Germany, its pharmaceutical products are manufactured in Europe, mainly at sites in Germany, France, Italy and Switzerland. Dr. Falk Pharma GmbH employs approximately 1250 individuals globally and 323 in Freiburg.

Further information on Dr. Falk Pharma can be found online: https://drfalkpharma.com/en/

For further information please contact:

Dr. Falk Pharma GmbH
Babette Kopp
Head of Corporate Communications
Leinenweberstr. 5
79108 Freiburg, Germany
Phone: +49 761 1514-0
E: babette.kopp@drfalkpharma.de

Guest User 22/04/2024 Guest User 22/04/2024

Kynos Therapeutics announces positive top line results from the first-in-human Phase I study of its KMO inhibitor, KNS366, demonstrating safety, tolerability and target engagement

Edinburgh UK, 22 April 2024 | Download the PDF

KMO is an enzyme that acts at a key point in the kynurenine pathway of tryptophan metabolism, converting kynurenine into 3-hydroxykynurenine (3-HK). By inhibiting KMO activity, KNS366 is designed to reduce elevated 3-HK in order to prevent excess tissue damage and dysregulation of the immune system occurring during inflammation.

The Phase I study of KNS366 was a randomized, double-blind, placebo-controlled dose escalation study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of KNS366 in healthy adult participants. During the multiple dose part, KNS366 was administered over seven days.

All doses of KNS366 were safe and the molecule showed excellent tolerability. Pharmacodynamic measures clearly demonstrated KNS366 is a potent inhibitor of the KMO enzyme, with a high level of inhibition achieved as demonstrated by a substantial reduction in the enzyme product 3-HK.

Kynos Therapeutics founder and CSO Damian Mole said, “The headline data from this Phase I study have demonstrated KNS366 is safe and well tolerated at exposures that resulted in a high level of KMO enzyme inhibition. Information from the study, including pharmacodynamic measures, enables the selection of doses for future clinical studies in patients. To our knowledge, this is the first time a KMO inhibitor has been administered across multiple days resulting in sustained KMO inhibition in humans. We are therefore also able to generate information on the biological pathways impacted by this mechanism in humans, through an ongoing exploratory biomarker analysis as a valuable tool to inform further clinical development.”

Kynos Therapeutics CEO Jonathan Savidge said, “The successful completion of this Phase I study is a significant milestone for Kynos and the results provide an excellent basis for further development of KNS366. The full analysis of the wealth of data from the study will generate invaluable information on this first-in-class mechanism to enable optimization of the further clinical development pathway. We appreciate the funding contribution from Innovate UK to conduct this important clinical trial.”

-ENDS-

About Kynos Therapeutics – www.kynostx.com

Kynos Therapeutics is a clinical-stage private company developing an innovative pipeline of first-in-class kynurenine 3-monooxygenase (KMO) inhibitors. KMO plays a major role in the regulation of inflammation, acting at the interface between inflammation, immunity and metabolism, and inhibition of KMO has therapeutic potential in both acute inflammatory conditions such as acute kidney injury and acute pancreatitis and in chronic immuno-inflammatory disorders. Spun out from the University of Edinburgh, Kynos leverages a decade of drug discovery research on KMO inhibitors originally co-developed through a collaboration between GSK and the University of Edinburgh and now exclusively licensed to Kynos. Based in Edinburgh, UK, the company is backed by founding investor Epidarex Capital as well as IP Group plc and Scottish Enterprise with additional non-dilutive funding from Innovate UK.

For further information please contact:

At the Company
Jonathan Savidge, CEO, Kynos Therapeutics
E: admin@kynostx.com

Media enquiries
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

Guest User 18/05/2023 Guest User 18/05/2023

Kynos Therapeutics announces a first-in-human phase I study of its novel small molecule KMO inhibitor, KNS366, is underway

Kynos Therapeutics Ltd, a biotechnology company developing a portfolio of first in class kynurenine 3-monooxygenase (KMO) inhibitors, today announces that dosing is underway in a first in human phase I trial of its lead drug candidate, KNS366.

Edinburgh UK, 18 May 2023 | Download the PDF

The first-in-human study of KNS366 is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses in healthy adult participants. The study is being conducted at a single site in the UK. Full results from the study are expected in early 2024.

KMO plays a major role in the regulation of inflammation, acting at the interface between inflammation, immunity and metabolism, and inhibition of KMO has therapeutic potential in a range of indications.

Kynos Therapeutics founder and CSO Damian Mole said, “KMO is a target of increasing interest for the development of new medicines and it is fantastic to see our highly selective KMO inhibitor, KNS366, moving into clinical development. The data generated from the advanced analysis of biomarkers will allow measurement of KMO inhibition and the impact that has on inflammatory mechanisms important in human disease. This information will be invaluable for designing the next stage of clinical trials in patients.”

Kynos Therapeutics CEO Jonathan Savidge said, “Progressing our lead KMO inhibitor rapidly into Phase I is a major milestone for Kynos. We are not aware of any other KMO inhibitors in clinical development and look forward to generating data in humans with this first-in-class mechanism. We appreciate the support of Innovate UK for its contribution to the financing of this trial.”

About Kynos Therapeutics – www.kynostx.com

Kynos Therapeutics is developing an innovative portfolio of first-in-class medicines where there is an unmet medical need for new therapies. It is a spin-out from the University of Edinburgh commercialising a decade of drug discovery research on kynurenine 3-monooxygenase (KMO), a pivotal enzyme in the kynurenine pathway of tryptophan metabolism. Its innovative pipeline of first-in-class KMO inhibitors across key indications in inflammation, immunity and metabolism, was originally co-developed through a collaboration between GSK and the University of Edinburgh and is now exclusively licensed to Kynos.

Based in Edinburgh, UK, the company is financed by equity investment from Epidarex Capital, IP Group plc and Scottish Enterprise as well as a grant from Innovate UK.

For further information please contact:

At the Company
Jonathan Savidge, CEO, Kynos Therapeutics
E: admin@kynostx.com

Media enquiries
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

Guest User 19/01/2023 Guest User 19/01/2023

Kynos Therapeutics announces the strengthening of its board with the appointment of experienced biotech entrepreneur Jean Combalbert as Independent Chair

Edinburgh UK, 19 January 2023 | Download the PDF

Jean Combalbert PharmD, PhD has an impressive track record with over 20 years’ experience building research and development-stage biotech companies and achieving high-value exits. Jean is currently a non-executive director at Epics Therapeutics SA, having previously served as its founding CEO from 2017. Jean was Chair of the Board at Syndesi Therapeutics SA from 2018 until its sale to AbbVie in 2022. Previously, he was CEO of Ogeda SA from 2006 until its sale to Astellas Pharma Inc. in 2017. Earlier in his career, Dr Combalbert held senior positions with Sanofi and Galderma in France and the United States.

Commenting on his appointment, Jean Combalbert said “Kynos is uniquely positioned as a leader in the development of small molecule KMO inhibitors which have broad therapeutic potential. I’m excited to join the company and I look forward to working with the management team and the Board as Kynos moves into clinical development.”

Kynos Therapeutics CEO Jonathan Savidge said “I am delighted Jean has been appointed as Chair of the Board. Together with the rest of the Kynos management team and Board I would like to welcome him to the company. Kynos will benefit hugely from Jean’s expertise and leadership in drug development, financing and corporate development.”

About Kynos Therapeutics – www.kynostx.com

Based in Edinburgh, UK, the company is financed by equity investment from Epidarex Capital, IP Group plc and Scottish Enterprise as well as a grant from Innovate UK.

For further information please contact:

At the Company
Jonathan Savidge, CEO, Kynos Therapeutics
E: admin@kynostx.com

Guest User 11/11/2022 Guest User 11/11/2022

Kynos Therapeutics announces the expansion of its leadership team with the appointment of Jonathan Savidge as CEO

Edinburgh UK, 11 November 2022 | Download the PDF

Kynos Therapeutics Ltd, an immune-metabolic company with world-leading expertise in the kynurenine pathway and kynurenine 3-monooxygenase (KMO) biology, today announced the appointment Dr Jonathan Savidge as CEO. The appointment is part of the next stage in the development of the company as it moves novel KMO inhibitors into clinical development. Jonathan brings a wealth of experience in fundraising and business and corporate development, having previously been founding CEO of Syndesi Therapeutics and concluding an acquisition deal earlier this year with a headline value of $1BN.

Jonathan joins the Kynos Therapeutics leadership team comprising the founders, Professors Damian Mole and Scott Webster and CFO Alison Strutt. Professor Mole, founding CEO, will continue to play a key role in the company as scientific expert and champion, assuming the title of Chief Scientific Officer. Professor Webster will continue to oversee the development of molecules into the clinic as Chief Technology Officer.

Commenting on his appointment as CEO, Jonathan Savidge said “I am thrilled to join the team at Kynos at this exciting time as the company prepares to move into clinical development. The Kynos founders have built a world-leading expertise in the KMO target with a lead molecule poised to enter the clinic. I look forward to working with them, the rest of the Kynos team and the Board to progress development of these innovative KMO inhibitors and evolve the company to its next stage.”

Kynos Therapeutics founder and CSO Damian Mole said “I am delighted to welcome Jonathan to the company. His track record and complementary skill set significantly strengthens the existing Kynos leadership team and will accelerate the development of the company and its KMO platform.”

About Kynos Therapeutics – www.kynostx.com

Based in Edinburgh, UK, the company is financed by equity investment from Epidarex Capital, IP Group plc and Scottish Enterprise as well as a grant from Innovate UK.

For further information please contact:

At the Company
Jonathan Savidge, CEO, Kynos Therapeutics
E: admin@kynostx.com

Guest User 23/06/2022 Guest User 23/06/2022

Kynos builds out senior management team with appointment of Dr Alison Strutt, a seasoned biotech and ex-GSK executive, as CFO

Edinburgh UK, 23 June 2022 | Download the PDF

Kynos Therapeutics Ltd (Kynos or the Company), an immune-metabolic company with world-leading expertise in the kynurenine pathway and kynurenine 3-monooxygenase (KMO) biology today announced the appointment of Dr Alison Strutt as Chief Finance Officer (CFO). Alison Strutt is a seasoned healthcare finance executive with extensive strategic, transactional, and operational experience. She will combine her current role as Chief Operating Officer at NodThera Inc. whilst supporting Kynos Therapeutics as CFO. She formerly held a number of senior finance roles at GSK, including as Chief of Staff to the Chief Finance Officer, where she was responsible for transforming GSK’s financial reporting processes and organisation as well as leading local completions of the global Novartis transaction. Alison also served as CFO of GSK’s drug discovery group, where she established the Tres Cantos Open Lab and Catalyst Science Park at GSK’s UK flagship R&D site. Prior to time at GSK, Alison led the UK M&A life sciences team at Deloitte in London. She holds a Ph.D. in chemistry and physical chemistry from the University of Wales, Cardiff and is a Fellow of the Institute of Chartered Accountants for England and Wales.

Welcoming Alison to the company, CEO of Kynos Therapeutics, Damian Mole said, “Alison is an exceptional addition to the Kynos leadership team, and we are delighted to have been able to attract her to the Company. Kynos is rapidly building momentum towards the clinic, and Alison’s experience across large pharma and biotech covers finance at the operational level as well as a strategic outlook. This breadth of skill and experience will support Kynos to achieve the strong position that we are aiming for in the near future.”

Alison Strutt, CFO of Kynos Therapeutics, said, “I am very excited to be getting involved in Kynos at this critical point in its journey, and I am really looking forward to working with the leadership team and the Board to help create a leading company in immunometabolic medicine.”

About Kynos Therapeutics – www.kynostx.com

Based in Edinburgh, UK, the company is financed by equity investment from Epidarex Capital, IP Group plc and Scottish Enterprise as well as a grant from Innovate UK.

For further information please contact:

At the Company
Jonathan Savidge, CEO, Kynos Therapeutics
E: admin@kynostx.com

Guest User 07/04/2022 Guest User 07/04/2022

Kynos therapeutics emerges from stealth with £9 million financing and phase 1-ready KMO inhibitor

Kynos Therapeutics Ltd (Kynos or the Company), an immunemetabolic company with world-leading expertise in the kynurenine pathway and kynurenine 3monooxygenase (KMO) biology, today emerges from stealth mode with £9 million to finance its lead KMO inhibitor (KMOi) programme through Phase 1 clinical trials and to progress its innovative pipeline of first-in-class KMOi across key indications in inflammation, immunity and metabolism.

Edinburgh UK, 7 April 2022 | Download the PDF

Kynos is a spin-out from the University of Edinburgh (UoE), based on over a decade of research into KMO biology and its inhibitors. Its technology and KMOis were co-developed during a multi-year collaborative programme between the UoE founders and GSK. The collaboration concluded in 2019 and data packages and all rights and intellectual property were transferred to the UoE. GSK is eligible for a royalty should a medicine be registered.

The £6.5m initial venture financing round was led by Epidarex Capital, joined by IP Group and Scottish Enterprise. Kynos has also been awarded £2.5m through an Innovate UK grant to fund a first-time in human Phase 1 clinical trial of its lead KMOi, KNS366. Kynos has a completed INDenabling package and is preparing to start a single ascending dose study with biomarker analysis.

KMO plays a major role in the control of inflammation and metabolism, contributing to the regulation of the immune system. It is a mitochondrial enzyme that converts kynurenine into biologically active 3HK that damages cells. Blocking KMO reduces 3HK, protecting against tissue damage.

Kynos’s pipeline is focused on three key areas: in critical illness post-surgery; in conditions driven by inflammation; and in cancers where inflammation is preventing the immune system from fighting back. This financing will be used to build out its core team and to fund preclinical indication expansion studies as well as to initiate development of oral formulations of KMO inhibitors. These activities will run in parallel to the Innovate UK-funded Phase 1 clinical trial in humans.

Kynos’s core founding team are leading experts in KMO biology and medicinal chemistry with clinical, translational and drug discovery experience: CEO Damian J Mole (Professor of Surgery and MRC Senior Clinical Fellow, the University of Edinburgh Centre for Inflammation Research; and CSO Scott Webster (Professor of Medicines Discovery, Centre for Cardiovascular Science, University of Edinburgh). The industry engagement and launch of the spin-out company have been supported by Edinburgh Innovations, the University of Edinburgh’s commercialisation service.

Professor Damian Mole, CEO of Kynos Therapeutics, said: “Our goal is to improve health and make a positive impact for patients, by developing our programme in the therapeutic area of inflammation and immunometabolism. We are very excited by the potential of our first-in-class KMO inhibitors and we are ready to enter the clinic with our lead asset.

“Our programmes are based on extensive industry collaborative research with a robust science base supported by multiple high impact publications. There are no approved or marketed medicines for our gateway indication, for which there is a significant unmet need.”

Following the Financing Dr Elizabeth Roper, Partner at Epidarex Capital, and Dr Tassos Konstantinou, Investment Manager, Life Sciences at IP Group plc, have joined Kynos’s board of directors.

Dr Elizabeth Roper, Partner at Epidarex Capital and Kynos Investor Director, said: “Kynos has a first-in-class set of KMO inhibitors that we believe have potential in multiple therapeutic areas. We look forward to working closely with the team and the syndicate to progress these assets into the clinic and to realise the potential of Kynos’s world-class science.”

Dr Sam Williams, Managing Partner of Life Sciences at IP Group plc, said: “KMO is rapidly becoming a target of great interest in drug discovery. IP Group is excited to support Kynos as it seeks to become a leading player in the KMO field and develop inhibitors with the potential to transform patients’ lives across multiple indications.”

Kerry Sharp, Director of Growth Investments at Scottish Enterprise said: “Scotland is globally renowned for its strengths in life sciences because of our innovative companies, incredible talent and world-class universities. Supporting companies in this sector, such as Kynos Therapeutics, to progress its ground-breaking medical research is a priority for Scottish Enterprise. Kynos is developing an innovative portfolio of first-in-class medicines and this funding will help deliver therapies for patients impacted by inflammatory conditions.”

About Kynos Therapeutics – www.kynostx.com

Kynos Therapeutics is developing an innovative portfolio of first-in-class medicines where there is an unmet medical need for new therapies. It is a spin-out from the University of Edinburgh commercialising a decade of drug discovery research on kynurenine 3-monooxygenase (KMO), a pivotal enzyme in the kynurenine pathway of tryptophan metabolism. Its innovative pipeline of firstin-class KMO inhibitors across key indications in inflammation, immunity and metabolism, was originally co-developed through a collaboration between GSK and the University of Edinburgh and is now exclusively licensed to Kynos.

Based in Edinburgh, UK, the company is financed by equity investment led by Epidarex Capital joined by IP Group plc and Scottish Enterprise, as well as a grant from Innovate UK.

About IP Group plc - www.ipgroupplc.com

IP Group develops world-changing science and technology businesses across life sciences, technology and cleantech. The Group has a strong track record of success, having been the founder investor in a number of high-profile companies including Oxford Nanopore Technologies plc, and has one of the most exciting portfolios of high-growth businesses in Europe. The Group also owns Parkwalk, the UK's largest growth EIS fund manager which backs world-changing technologies emerging from the UK’s leading universities and research institutions. IP Group is listed on the Main Market of the London Stock Exchange under the code IPO.

About Epidarex Capital - www.epidarex.com

Epidarex Capital is a transatlantic venture capital firm with a track record of building exceptional life science companies in emerging hubs in the US and UK. Epidarex’ experienced team of early-stage investors partner with entrepreneurs and leading research institutions to transform world-class science into highly innovative products addressing major unmet needs in the global healthcare market.

About Scottish Enterprise - www.scottish-enterprise.com

Scottish Enterprise is Scotland's national economic development agency. We’re committed to growing the Scottish economy for the benefit of all, helping create more quality jobs and a brighter future for every region.

For further information please contact:

At the Company
Jonathan Savidge, CEO, Kynos Therapeutics
E: admin@kynostx.com