F2G Ltd Receives European Orphan Drug Designation for its Lead Candidate F901318

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MANCHESTER, UK – 09 January 2017 – F2G Ltd, a UK Biotech developing novel therapies for life threatening fungal infections, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted orphan drug status to its lead clinical candidate, F901318, for the treatment of invasive Aspergillosis and rare mould infections caused by Scedosporium species.

Orphan drug designation will allow F901318 up to ten years market exclusivity following market authorisation in the EU.

F901318 is the first member of a novel class of systemic antifungal agents targeting life threatening mould infections and acting through a completely novel cellular target. F901318 is being developed for both intravenous and oral formulations and will enter Phase II clinical development in mid-2017.

Dr John H. Rex, Chief Medical Officer, F2G Ltd, said: “Given the global acknowledgement of increasing resistance of moulds to the azole antifungal class, we are delighted that the EMA has granted orphan drug status to F901318. We believe this agent will offer important therapeutic options to clinicians treating these deadly infections.”

Ian Nicholson, Chief Executive Officer, F2G Ltd, added: “Receiving the European orphan drug designation for F901318 offers certain benefits and incentives, including marketing exclusivity, that are strategically important from a regulatory and commercial perspective. The positive decision of the EMA orphan drug committee is further validation of F901318 and our development program as we look forward to accelerating our Phase II clinical programme this year. ”

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About European Union (EU) Orphan Drug Designation: The European Commission grants orphan drug designation status to provide incentives to develop medicinal products to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the European Union.

About F2G Ltd: F2G is a world-leading UK biotech company focused on the discovery and development of novel therapies to treat life threatening invasive fungal infections, with experienced management & board. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Due to their new mechanism of action, orotomides are active against fungal infections resistant to current therapies, a growing problem globally. A limited Phase II study for F901318 is planned imminently with pivotal registration trials in Invasive Aspergillosis planned for 2017 based on an accelerated regulatory pathway agreed with the relevant agencies. F901318 is being developed both as IV and oral formulations and promises to have a safe and well-tolerated profile. The company recently announced a $60 million financing to develop its pipeline of novel therapies to treat life threatening invasive fungal infections.

AMBS Ignition Funding Opportunity- Deadline Fast Approaching

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We are seeking to inspire the next generation of individuals or teams with entrepreneurial ideas:Layout 1

  • Are you currently working or studying at AMBS or a recent graduate?
  • Is your idea likely to be an entrepreneurial or innovative solution to a business, societal or environmental problem?

Awards:

Funding from £500 – £2000 is available, for individuals to try out or grow their entrepreneurial ideas. This might mean finding out if your idea is viable, learning more about what is needed to develop the idea by testing the project on a small scale, right through to more robust road-testing of the idea. We also provide one to one support to assist you with your applications and informative workshops for successful applicants.

Eligibility:

The funding opportunity provided by UMIP and MEC is open to all AMBS members of staff, research students (inc. DBA, MBA) and recent graduates (graduated within the last 2 years).

Key Dates:

  • Closing date for applications is Friday 20thJanuary 2017
  • Successful applicants will be informed by Friday 3rdFebruary 2017

Click AMBS Ignition Fund Application Form-final to download an application form and contact ignitionawards@umip.com for further information.

UMI3 Ltd appoints Dr. Luke Hakes as its new Chairman

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Dr. Luke Hakes

Dr. Luke Hakes

The University of Manchester’s Innovation Company (UMI3 Ltd) is pleased to announce the appointment of Dr. Luke Hakes as its new independent Chairman, following a search exercise by the University (advised by Odgers Berndtson – nationally recognised headhunters).

Luke will commence his role on 1st January 2017. A triple graduate of the University in biochemistry with biotechnology; bioinformatics; and computational genetics, Luke completed a PhD in 2006. He is currently Investment Director at venture capital firm, Octopus Ventures, based in the City of London. Over the last eight years Luke has advised and been a board member of a number of University spin-out companies. In addition he has held numerous non-executive directorships at start up and growth companies and has considerable experience of building and exiting businesses in the disruptive technology arena.

Outside of Octopus, Luke is an angel investor and advisor to a number of early stage companies with a particular interest in the Artificial Intelligence and Genomics spaces.

Dr. Hakes comments: “I am delighted to be joining UMI3 as Chairman. Universities play a hugely important role in fostering innovation and talent and nowhere is this more true than at The University of Manchester. I am incredibly excited to work with the fantastic team at UMI3 to support its continued growth and success.”

Clive Rowland, UMI3 CEO, comments: “Luke’s appointment is an important step for us as we embark on a new business plan in an exciting time of development for the University and the Northern Powerhouse. Luke’s enthusiasm for technology venturing, his commitment to help the University further enhance its standing in this area and his expertise and wide investor networks all bring a new and refreshing dimension to our approach which is crucial for our next phase.”

Luke succeeds Dr Rajagopal in the role.

F2G Ltd announces the appointment of John H. Rex as Chief Medical Officer

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MANCHESTER, UK – 05 December 2016 – F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of John H. Rex, MD, FACP to the position of Chief Medical Officer, effective from 2nd November 2016.

Dr Rex is a distinguished research scientist and a key opinion leader in the field of infectious disease therapy, in particular antifungal agents. He held the position of Senior Vice President and Head of Infection, Global Medicines Development at AstraZeneca until October 2016. Prior to joining AstraZeneca in 2003, Dr Rex was Professor of Medicine at the University of Texas Medical School at Houston. Dr Rex has been the Industry Representative on the US FDA Anti-Infective Drug Advisory Committee (2007-2011), has served as Chair of the Consensus Committee on Microbiology for the Clinical Laboratory Standards Institute (CLSI, formerly NCCLS), is a member of the Wellcome Trust Seeding Drug Discovery Committee, was formerly an Editor for Antimicrobial Agents and Chemotherapy and currently serves on several editorial boards. He holds a BA in Biochemistry from Rice University as well as an MD from Baylor College of Medicine in Texas. Dr Rex has served as a non-executive director of F2G since September 2012 and is an Operating Partner at Advent Life Sciences.

Ian Nicholson, Chief Executive Officer, F2G Ltd commented: “John’s guidance and insight have been instrumental in shaping F2G’s development and regulatory strategy. We are delighted that he is now able to increase his commitment to the company as we progress our new class of antifungal agents into our next clinical trials.”

John Rex added: “I am delighted to have the opportunity to work more closely with F2G as we take the first orotomide antifungal forward through Phase 2 and Phase 3. Just as with antibacterial resistance, antifungal resistance is a growing threat and F2G’s discovery of an entirely novel class of IV/PO antifungal agent is a key part of the global response to this challenge.”

About F2G Ltd: F2G is a world-leading UK biotech company focused on the discovery and development of novel therapies to treat life threatening invasive fungal infections, with experienced management & board. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Due to their new mechanism of action, orotomides are active against fungal infections resistant to current therapies, a growing problem globally. A limited Phase II study for F901318 is planned imminently with pivotal registration trials in Invasive Aspergillosis planned for 2017 based on an accelerated regulatory pathway agreed with the relevant agencies. F901318 is being developed both as IV and oral formulations and promises to have a safe and well-tolerated profile. The company recently announced a $60 million financing to develop its pipeline of novel therapies to treat life threatening invasive fungal infections.

www.f2g.com

New Project Engineer Joins Graphene Enabled

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Ushpal Thind

Ushpal Thind

Ushpal Thind, an experienced mechanical engineer, has joined Graphene Enabled Systems Ltd, The University of Manchester’s graphene and 2D materials commercialisation business.

Previously a test engineer for the micro-CHP and utilities business, Flow Products, based in Capenhurst Cheshire, Ushpal brings a wealth of experience in industrial product design and manufacturing know-how.

Ushpal will work closely with the academic teams at the University, industrial partners, suppliers and customers.  As well as being an experienced design engineer, Ushpal has an MSc in Materials Science and Engineering from Delft University of Technology in the Netherlands and a BEng in Mechanical Engineering from Imperial College London.

 

 

 

Graphene Enabled Systems Ltd, which is headquartered on Grafton Street in Manchester, is owned by the University. The new company’s mission is to create a number of highly profitable ‘spin-off’ businesses based on the University’s graphene patents. The University expects that many of these future ‘spin-off’ businesses will be based in and around Manchester, creating new jobs in the region and benefiting the local economy.

Using the University’s patents and working closely with scientists, Graphene Enabled will seek out new markets for graphene-based products. Once these markets have been identified, Graphene Enabled will create high-quality product prototypes which will showcase the technology to potential industrial partners and customers.

As an important part of the University’s graphene strategy, Graphene Enabled works in close collaboration with the University’s research teams, innovation and IP groups (UMI3 and UMIP), the National Graphene Institute (NGI) and, in 2018 and beyond, the new Graphene Engineering Innovation Centre (GEIC).

Andrew Wilkinson, Graphene Enabled’s CEO, commented: “We are very excited that Ushpal has joined us. His experience in product design and industrialisation will help to create high quality product demonstrators and prototypes capable of exciting customers in a wide range of markets and applications. In the coming months we will continue to build our engineering team, enabling us to accelerate the pace at which we bring new product concepts to market.”

For further information about Graphene Enabled, please visit our website www.graphene-enabled.com and follow us on Twitter @GrapheneEnabled.

 

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