Impact case study database

Economic benefits are four-fold:

(i) The formation of a company, Bramble Energy Ltd (BE) [A], which employs fourteen FTEs (Kucernak – founder and CSO, Dr Tom Mason – CEO, Dr. Erik Engebretsen – Head of Engineering, Dr. Vidal Bharath Head of Operations, Prof. Dan Brett - Director of Innovation) and manages the development of the underlying technology. This has led to wealth creation and employment within the UK. BE has received Series A investment of £5M [A], an event noted in the Daily Telegraph [B]. In 2020 BE first had initial sales XXXXXX. BE additionally supports down-stream job creation in a number of suppliers including ZOT Engineering, GGM Engineering, Air Engineering Group, and PDR.

(ii) BE supports a number of other “downstream” companies as its model is to outsource manufacture to a number of sub-companies, such as ZOT printed circuit boards [C]. ZOT employs 220 people at their site in Inveresk Mills Industrial Park, Musselburgh. BE also uses components manufactured from important UK industrial producers such as Johnson Matthey Fuel Cells, who manufacture catalysts and electrodes for fuel cells. BE partners with users in a wide range of areas. Examples include BOC (Linde) who are using BE fuel cells in their products [D], and companies such as Taylor Construction Plant Ltd (TCP) who are using the BOC systems (containing BE fuel cells) to power a wide range of devices such as industrial lighting towers [D, E].

(iii) From an investor perspective, BE is one of a range of companies allowing the rapid growth of the Clean Technology sector in the UK [B]. The Office of National Statistics has estimated that turnover in the UK low carbon and renewable energy economy (LCREE) has increased to £46.7 billion in 2018, compared to £40.4 billion in 2015 [F]. In the recent business section of the Sunday Times [27 December 2020, “HOPE BLOOMS FOR 2021”], Entrepreneurs were asked to list the start-ups they see thriving in the new Britain of 2021. In the article Stephen Welton wrote that “ *To achieve the UK's target of net zero greenhouse-gas emissions by 2050 will require revolutionary changes in energy use, and that can't be done without innovative start-ups. BE makes hydrogen fuel cells, which generate power from an electrochemical reaction rather than combustion. The technology can use existing manufacturing facilities, cutting the time and investment needed to bring the products to market.*” [B].

(iv) Contribution to the emerging “Green Industrial Revolution” energy sector. BE is a start-up working in the area supported by the UK government push towards the use of hydrogen in the governments “ The Ten Point Plan for a Green Industrial Revolution” in which point 2 is “Driving the growth of low carbon hydrogen”, an area which could deliver support for up to 8,000 jobs by 2030, potentially unlocking up to 100,000 jobs by 2050 in a high hydrogen net zero scenario with over £4 billion of private investment in the period up to 2030 leading to savings of 41 MtCO2e between 2023 and 2032, or 9% of 2018 UK emissions. This area is associated with £350 million worth of funding to help decarbonise industry, including dedicated funding for green hydrogen.

George Mills Technology, Investor at the major investment fund BGF wrote “ Bramble has created a world-first in the production of hydrogen fuel cells, with the potential to transform a global and growing market. Critically, Bramble has inherent scale-up potential with fuel cells that can be made in PCB factories around the world. BGF is backing a pioneering team with significant commercial acumen. As the UK advances towards its greener future, the cleantech industry is one of increasing interest to BGF, with our capital and financial firepower designed to help accelerate growth and provide long-term partnerships.” [E]

Neil Cameron, Investment Director at the major investment fund Parkwalk wrote “ The fuel cell market appears to have finally reached a tipping point within which Bramble’s highly scalable technology can enable widescale adoption.” [E, G]

Societal benefits. BE is involved in bringing the concepts of lower carbon footprint and energy usage to the general society. DEFRAs recent CLEAN AIR STRATEGY 2019 states that the long-term exposure to man-made air pollution in the UK has an annual impact on shortening lifespans, equivalent to 28,000 to 36,000 deaths with the majority of those deaths associated with transport emissions. This has resulted in the Department of transport to mandate the shift to electric vehicles (including Hydrogen Fuel Cell vehicles) by 2030 ( Government takes historic step towards net-zero with end of sale of new petrol and diesel cars by 2030). BE has already demonstrated the use of its fuel cells in transport [D, G, H] and is working with a number of automotive providers XXXX XXXXXXX to implement their fuel cells in passenger vehicles.

Public policy or services benefits. BE and specifically Kucernak have been involved in a number of Governmental and industrial workshops and contributed to the major Royal Society policy briefing document “ Options for producing low-carbon hydrogen at scale” associated with scoping out the future pathways towards rapidly accelerating decarbonisation of society.

Positive health impacts and environmental benefits. The systems that BE are working on will contribute to a cleaner environment with reduced emissions of harmful gaseous pollutants which are estimated to cause an extra 4.2 million yearly deaths worldwide (source: WHO) or an extra to 28,000 to 36,000 deaths per year in the UK (source: European Heart Journal) . Reduction in emissions associated with particulates and NOx from diesel emissions will contribute to a less polluted urban environment through the use of BE hydrogen fuel cells in electric vehicles (see below). Furthermore, BE is working with a portable industrial electricity generator company xxxxxxx on portable fuel cell generators to reduce air pollution on industrial sites [D]: a 5kW diesel generator produces as much carbon monoxide as 450 cars (Source US consumer product safety commission)! By working with BOC, TCO and others xxxxxx, BE is developing replacements for these generators with clean, quiet fuel cell systems which only produce water as their exhaust [D, E]. (2) The longer-term goal is to put BE fuel cells in vehicles, as these will be able to drastically decrease the emissions and improve the energy efficiency of transport. To that goal, BE is already negotiating with vehicle manufacturers about the use of fuel cells in their vehicles and have demonstrated a project in which BE fuel cells operate efficiently in transportation [D, G, H]. The company is in discussion with various other manufacturers and centres: Advanced propulsion centre, and major automobile manufacturers xxxxxxxxxxxxxxxxxxxxxxxxxx. As fuel cells demonstrate a much higher energy efficiency than internal combustion engines, the shift to hydrogen powered fuel cells will allow a reduction in UK emissions of carbon dioxide, and also provide a path towards a sustainable economy in which the storage of renewable energy is facilitated through water electrolysis to hydrogen and when required the energy stored within the hydrogen is converted back to electricity in a fuel cell.

Formation of Econic and Job Creation

Research at Imperial led by Professor Charlotte Williams identified and validated a system to use carbon dioxide at low pressure as a feedstock to produce polycarbonate diols, which are 30-50 mol% derived from CO₂. This work led to the formation of Econic Technologies in 2011 [A], which has since attracted £24 million in external investment in 4 funding rounds [A]. Much of this investment has occurred since August 2013, with Econic attracting £17 million in equity investment primarily from venture capital sources, with an additional £2.5 M in public funding including a H2020 SME award [B]. Private backers include OGCI Climate Investments, IP Group and Jetstream Capital, while public funders include EU Horizon 2020, European Institute of Innovation and Technology (EIT), UK Climate-KIC and EPSRC (early research). The company employs 30 people at several UK sites with CEO Dr Rowena Sellens and co-founder Professor Williams as CSO [B].

Building Industrial Partnerships

Econic’s initial focus is on manufacturers of polyols, which typically have numerous internal sources of CO₂ on site, many of which are already captured and others that will soon have to be depending on country jurisdiction. Econic’s technology unlocks the potential of CO₂ as a carbon feedstock with no additional energy requirement. This creates an economic benefit, where producers can achieve 30% cost savings on raw material feedstock as well as a substantial CO₂ reduction. Indeed, for every 1 tonne CO₂ used, a further 2 tonnes are abated through reduced fossil-based feedstock demand. As well as the economic benefit there is the environmental benefit of using captured waste CO₂ in the production of plastics.

Econic is closely working with many of the major global petrochemical producers of polyols, in 2021 these consortia will carry out large-scale trials in the existing commercial plants of those producers in Europe and China [B].

In October 2017 the UK government launched its Clean Growth Strategy, reaffirming that carbon capture, usage and storage (CCUS) has the potential to decarbonise the economy and maximise economic opportunities for the UK. Following this in 2018, Econic opened the UK's first carbon capture utilisation (CCU) polymerisation demonstration facility in Runcorn [B, C]. It incorporates a fully integrated polycarbonate polyols production process producing multi-kg samples at industrially relevant temperatures and pressure s for customer testing. Bespoke amounts of CO₂ can be used from low levels up to the maximum 50%, depending on the application of the polycarbonate polyol [D]. The opening of the CCU demonstration facility combined with Econic’s move from London in 2017 created 12 jobs across the two Econic sites in Cheshire [B, C].

In January 2020, Econic Technologies started a major partnership with the electrical power generation company, Drax Group, to utilise the waste CO₂ captured from Drax’s biomass power generation as a feedstock in polycarbonate polyols production thereby reducing the amount of oil required [B, E]. The partnership represented a major step which allows other sectors, including automotive, consumer, and construction sectors, to produce more sustainable polyurethane products, by making use of the waste CO₂ in the process [B, E]. Will Gardiner, Drax Group CEO said: “ By working with innovative tech companies like Econic […], *we are exploring new opportunities for clean growth, which could be critical not only for beating the climate crisis, but also in enabling a just transition, protecting jobs across the North – delivering for the economy and the environment.*” [E]

While the polyurethane market was the initial focus for Econic and where it has gained significant traction, the underpinning catalysts systems are also now being applied and adapted to other plastic sectors, to produce glycerol carbonates, polyalkylene carbonates or aromatic polycarbonates. Indeed, in 2017 Econic Technologies partnered with Asian petrochemical group SCG Chemicals to develop the production of high molecular weight polymers using Econic’s catalyst technologies [F].

Long term projections indicate that using Econic’s catalyst systems to make plastics for the widest viable applications could eliminate over 500 million tonnes of CO₂ per year by 2070.

Outreach and Engagement

The Williams group has undertaken outreach, specifically around using waste CO₂ to make plastics, which has resonated with the public. In 2014 with the assistance of Lord Robert Winston, a CPD module titled “'Changing Materials”. This was distributed to UK primary schools and teachers as part of Reach Out CPD materials designed to help Primary school teachers create engaging science lessons. Since its launch in October 2014 the course page and video has been viewed by 4,403 users with 1,086 viewings of the video [G].

In 2015, Econic Technologies won the Shell UK Chairman Special Award at the Shell Springboard awards, along with a €64,000 prize. In 2019 the company was named in the prestigious Global Cleantech 100 of leading companies in sustainable innovation [H].

Both the work of the Williams group and Econic Technologies itself have received significant and highly complementary coverage in high profile national UK media outlets, including the BBC News Online, BBC Radio 4, The Times, Daily Express and The Telegraph as well as in specialist journals and trade publications including Chemistry World, The New Scientist, Carbon Capture Journal, Polyestertime, Industry Europe, Energy Live News and the British Plastics and Rubber Magazine. Representative media coverage is given in Econic Media Coverage [I] and is underscored in the quote below by Harry de Quetteville and Hannah Boland (Telegraph Special Correspondents for Technology):

“Perhaps the most eye-catching British start-up hoping to make a fortune from CO₂, however, is Econic Technologies, a British company spun out from Imperial College London. It has developed catalysts and processes it claims can incorporate CO₂ into polymers, which it mixes with oil-based raw materials to create anything from mattresses and car seats to bendy phones.” – Telegraph, 2019 [I].

Transitioning to a net zero emissions economy was one of the focuses of the AtlantIC Alliance between IC, Georgia Tech and Oak Ridge National Labs [A]. In 2006, members of the group, co-led by Professor Richard Templer, published the conceptual design of a near net zero industrial economy, underpinned by sustainable biopower and biomaterials (see section 2). To help bring this net zero vision to reality the team sought to create a climate-change innovation organisation. In 2009, scientists at IC and ETH Zurich wrote a successful bid to fund an EU innovation partnership, the Climate Knowledge and Innovation Community KIC (Climate-KIC). Professor Templer led and wrote the components on the creation of an Accelerator Programme and an allied education programme in the art of the efficient commercialising of innovation.

The IC-based Climate-KIC Accelerator, has been one of the most prolific programmes of its kind in this area. It ran from 2011 until 2020, with a total of €9.4 million of funding from the EU (renewed yearly) and has recently been awarded £5.9 million from HSBC and the European Regional Development Fund to run from 2021-2025.

Propelling clean tech solutions

Successful applicants received up to €40k each in seed funding from the Accelerator. Out of the 95 entrants to the programme, 64 have gone on to ‘graduate’ by raising over €200k investment each and/or achieving significant sales within 18 months. Collectively these startups have raised a total of $300 Million, creating upwards of 1000 jobs [B]. This represents a 67% success rate in raising significant funds and a 25-fold return on initial public funding. Successful graduate companies include Lixea (lixea.co), Puraffinity (puraffinity.com) RFC Power (rfcpower.com) and SweetGen (sweetgen.co.uk) (see section 2).

Lixea was awarded €2.3 million (£2m) from the European Innovation Council in December 2019 in order to build a pilot plant to scale its innovative biomass fractionation process for the production of biochemicals, bioplastics, and biofuels from wood waste [C].

Puraffinity received $3.55 million (£2.8m) from leading sustainability investors in 2019. This has allowed them to focus their PFAS water contamination solution on industries facing the most severe problems, such as airports, military bases and chemical manufacturing. Lead investor Kindred Capital commented: “We see their new product as a pioneering development which leverages chemistry principles in an advanced way to provide a solution to a key environmental issue.” [ D]

RFC Power has secured xxxxxxx from investors including IP Group, who noted that “the market opportunity for long duration battery storage is already large and it is likely to grow rapidly over the next 10 years,” adding that “RFC can achieve a sustainable competitive advantage thanks to its two highly distinctive patent-protected systems with lower levelised cost than current offerings.” [ E]

After winning the Royal Society of Chemistry’s Emerging Technologies Competition 2016, SweetGen has now completed a trials and demonstration period and focusing its abiotic wastewater fuel technology on the water treatment industry before expanding to different sectors including brewing, chemical and food and agriculture industries. [ F]

Building a legacy in policy

Following seminal green chemistry research at IC and the success of the Climate-KIC Accelerator, Templer was asked by the London Sustainable Development Commission (LSDC) to lead a team advising the Mayor of London on how to strengthen the growth of new clean technology (cleantech) businesses in London. This led to the ‘Better Future’ (2016) roadmap for the development of a cleantech innovation cluster [G].

Better Future’s central conclusion was that both greater visibility and accelerated growth rate of the cleantech sector would be supported by the establishment of an innovation cluster.

To test some of the ideas within Better Future, IC chemists collaborated with partners including the Greater London Authority (GLA) and West London Business, through a European Regional Development Fund funded project – Better Futures [H]. This examined the effect of geographical clustering of a community of 56 cleantech businesses and the impact of technical assistance from IC’s researchers and postgraduate internships.

The influence of Better Future can now be seen in four major aspects of Mayoral strategy and policy – notably in the London Plan (2017); the Mayor’s Environment Strategy (2018); the Mayor’s Economic Development Strategy (2018); and Cleantech London (2020).

The London Plan is the key document defining binding policy and regulation for development in London [I]. In Policy E8, part F, it is written that “Clusters such as Tech City and MedCity should be promoted and the development of new clusters should be supported where opportunities exist, such as CleanTech innovation clusters”. This policy and recommendation follow directly from Better Future’s recommendations. Notably, the London Plan was approved by the UK Secretary of State for Housing, Communities and Local Government in January 2021 [I].

The impact of Better Future in both the Environment Strategy and Economic Development Strategy is corroborated by a letter from Aram Wood (Assistant Director, Energy and Environment Team, Greater London Authority) [J].

Aram Wood, Assistant Director, Energy and Environment Team, writes:

‘The Mayor recognises that for London to remain an influential global city it must be at the forefront of developing the solutions to address the challenges of climate change. Prof. Templer’s contributions have been timely and important in helping us to determine how we turn these challenges into important opportunities.’

‘We have taken the ideas presented in Better Future and embedded them in Mayoral policy; they will continue to be influential policy until at least 2040; they form the basis for a significant part of London’s approach to addressing the climate emergency, and will be important in developing green and sustainable jobs for Londoners hit by the Covid-19 pandemic.’

Mayoral support for Better Future’s vision led to Templer working with the GLA to undertake a further study of how a cleantech cluster might be formed. This led to the development of the collaborative Cleantech London initiative [K] launched in March 2020. Its stated mission is to help London become a world-leading cleantech innovation hotspot and Professor Templer now sits on the Board.

Since its formation in 2005, the Institute of Chemical Biology in the Department of Chemistry has had considerable influence on the chemistry-facing multidisciplinary landscape at IC and beyond. Its success in forging links between physical and life scientists, as well as with engineers and clinicians, underpinned the approach and design of the £167 million Chemistry-led Molecular Sciences Research Hub (MSRH) at IC’s White City Campus, which opened in October 2019 [A]. Representing the largest investment in a university building in 21st century London, the MSRH is designed to break down traditional barriers between chemistry, other physical sciences, biological sciences and medical disciplines: it brings together the collective expertise of more than 800 scientists, clinicians, engineers and corporate business partners.

Allied to this major multidisciplinary initiative, the ICB has long placed considerable emphasis on translation, drawing in commercial and clinical partners – an approach which also underpinned the wider innovation initiatives at the IC White City campus. This ecosystem now includes space and specialist facilities for ideation and business development at every stage – from prototyping facilities at the Chemistry-led IC Advanced Hackspace, to laboratories and offices for early-stage start-ups at the IC White City Incubator, as well as greater scope for fast growing companies at the Scale Space facility [A]. This ecosystem has also proved attractive for multinationals, for example with the pharmaceutical giant Norvartis locating its European HQ to White City in 2020 [A] along with L’Oréal, the world’s largest cosmetics company [A].

Highlighted below are three recent ventures, that have respectively resulted from research in drug discovery, healthcare diagnostics and on personal care products at the ICB (detailed in Section 2).

New therapeutic approaches to cancer: Myricx

The MYC family oncogene is deregulated in over half of all human cancers and is frequently associated with poor prognosis and patient survival. Indeed, MYC has a central role in almost every aspect of the oncogenic process, orchestrating proliferation, apoptosis, differentiation, and metabolism. However, direct targeting of MYC has been a challenge for decades owing to its supposed ‘undruggable’ protein structure. Yet, recent work from the laboratory of Professor Ed Tate in Chemistry has shown N-myristoyltransferase (NMT) inhibition, with a potent and selective small molecule, is lethal to MYC-deregulated cancer cells. This mechanistic framework supports NMT inhibition as a novel targeted therapeutic approach and led to the formation of small molecule drug discovery company Myricx Pharma, with Professor Tate as Chief Scientific Officer (CSO) and Dr Roberto Solari, from the National Heart & Lung Institute at IC as Chief Executive Officer (CEO). The Company raised an initial £4.5million in seed investment from Sofinnova Partners and Brandon Capital Partners in 2020 [B] ****************************************************************** ******************************* ******************************** ****** The initial focus is the development of novel NMT inhibitors for oncology xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx x. The Myricx collaborative team has also been actively studying the role that NMT plays in viral pathogens, with a view to developing anti-viral therapies.

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Next generation diagnostics: Vidya Health

The consumer health monitoring market has gained traction recently, with companies offering at-home postal blood testing services. A closed-loop saliva test would be far more attractive prospect, allowing longitudinal testing at different times of day. Professor David Klug is the Chief Scientific Officer of Vidya Health – a company developing technology for saliva testing at home, at the point of care and in retail outlets, underpinned by Chemistry research in the ICB at IC. Vidya has raised a cumulative total of around ********** in investment to date from a syndicate of investors [C]. Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx. Vidya recently took part in a trial of its technology supported by Innovate UK and in collaboration with UCL, St. Bartholomew's Hospital, Royal Free Hospital and UCLH aimed at detecting coronavirus antibodies in around 300 healthcare workers [D]. This is helping to address specific questions around immune function. Future trials in other clinical areas are planned, with the ultimate aim being early detection of a range of conditions including but not limited to cancers, liver and kidney conditions, diabetes, pregnancy related conditions, cardiovascular and inflammatory and infectious conditions [E].

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Consumer dental health: BioMin Technology

Virtually all toothpastes currently on the market rely on very old technology from the 1930s. Essentially the presence of fluoride, F^-, inhibits the reaction between food and drink-derived acid (e.g. citric, maleic, tartaric, lactic, phosphoric acid) and the alkaline (OH^-) tooth surface. Over a number of years, ICB Professor Robert Law developed a novel toothpaste additive that rapidly dissolves during teeth brushing and directly crystallises to cover the tooth surface to resist acid erosion and enable remineralisation of enamel. In addition, this precipitation allows suppression of hypersensitivity at the gum-tooth join through the occlusion of dentinal tubules. This technology platform led to the creation and funding of BioMin Technologies Ltd. in 2013 (biomin.co.uk). Several independent dental clinical studies have confirmed the efficacy of the additive against dental tooth decay and hypersensitivity (e.g. **[F]**). The company began production and online sales of its proprietary toothpaste in 2018, through Amazon [G]. Currently the company is valued at xxxxxxxxxx and has a turnover of xxxxxxxx, which includes direct sales and licensing [H]. Indeed, the active ingredient of the toothpaste has been sold under license to other toothpaste manufacturers around the world including those in China (Guangdong Kanwan Cosmetics Corp.), India (Group Pharmaceuticals Ltd. (Elsenz)), USA (Dr.Collins, Inc.), Australia (BioMin Technologies Ltd.) and Europe (BioMin Technologies Ltd.). Uniquely in the USA, BioMin Technologies Ltd possesses a considerable market advantage in producing only remineralising toothpaste product available that contains a single active component and therefore compliant with FDA regulations for medical devices [I]. Through this global expansion, the company aims to reduce the economic and healthcare burden associated with dental diseases.

Cancer is the second leading cause of death, with 9.6M deaths in 2018 globally and 178K in the UK. Novel therapeutics to better treat resistant cancers have a major impact on the quality of lives and significantly mitigate the high economic costs of these terrible diseases.

Following drug discovery and the identification of ICEC0942 as the most preferred pre-clinical candidate, Drs Theo Balasas and Tommy Rennison from Cancer Research Technologies (CRT) in collaboration with Imperial Innovations and the Office of Technology Transfer in Emory University marketed the IC CDK inhibitor portfolio which led to a successful mutually beneficial licensing deal with Carrick Therapeutics [ http://www.carricktherapeutics.com/], a newly formed Biotechnology company. Access to the IC IP, was instrumental to the company, which raised $95M to develop ICEC0942 (renamed by Carrick as CT7001 and subsequently Samuraciclib) further and to take it into clinical trials and full commercialisation. The funders for Carrick Therapeutics were a consortium of ARCH Venture Partners, Woodford Investment Management, Cambridge Enterprise Seed Funds, Cambridge Innovation Capital, Evotec AG, Google Ventures and Lightstone Ventures. The licensing deal with Carrick Therapeutics was significant for IC, Emory and Cancer Research UK, XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX The $95M funding raised was to take CT7001 into the clinic as well as to develop other new cancer medicines [A, B].

Initially, Carrick and their UK CRO, Sygnature Discovery Ltd (Nottingham) were advised by Barrett and Dr Alex Bondke (a former Barrett PhD student) and carried out the design, synthesis and bioassay of further analogues of CT7001 to encompass additional chemical space and further patents were filed with Barrett and Bondke as co-inventors. Following further late-stage preclinical studies by Carrick, the efficacy of CT7001 in further cancers including triple negative breast cancer and adult myeloid leukemia was demonstrated. Finally, with WuXi AppTec and STA (Shanghai), Carrick completed the manufacture of sufficient CT7001 on a multikilogram scale for both Phase I and Phase II trials using the method invented by the Barrett team [A, C].

The first-in-human phase-1 trial was started in November 2017, with dose-escalation, investigating the safety and tolerability of CT7001 in monotherapy in XX patients with advanced solid malignancies, to identify the minimum biologically active dose (MBAD) and maximum tolerated dose (MTD), towards establishing the optimal monotherapy dose of CT7001. This multi-centre study, in which patients were recruited into the study at the Christie NHS Foundation Trust/University of Manchester, Department of Oncology, University of Oxford and at Imperial College London, is now complete. The maximal dose level of 360 mg per day was established, CT7001 plasma exposure increased dose proportionally and pharmacologically active concentrations were achieved throughout the entire dosing period XXXX XXXXXX XXXXXXXXXXX XXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX and target engagement in normal cells was assessed by two PD markers of CDK7 inhibition. Across dose levels, a significant and sustained reduction was observed in phosphorylated RNA polymerase II in peripheral blood mononuclear cells (p<0.01) and in the number of circulating reticulocytes. Although anti-cancer efficacy of the drug is the not the endpoint of a Phase I cancer trial, data also demonstrated anti-tumour effects XXXX XXXX XXXXXXX XXXXXX late-stage prostate cancer who showed a sustained reduction in Prostate Specific Antigen and symptomatic remission XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXX MBAD was identified as 120 mg once daily and MTD as 360 mg once daily. The recommended dose for Phase II has been established as 360 mg [A, B, D, E, F, G, H, I].

Phase-2 clinical trials of Samuraciclib are now underway in over 30 hospitals in the UK and USA including Manchester, Oxford, IC, Glasgow, Cambridge, Southampton and the Dana Farber Cancer Institute, Boston, USA. Recruitment for these trials include XX patients with late-stage triple-negative breast cancer; XX patients with castration-resistant prostate cancer as well as patients with hormone receptor positive (HR+ve) and human epidermal growth factor-2 negative (HER2-ve) breast cancers.

Patients are being treated with monotherapy using Samuraciclib or combination therapies with Fulvestrant. Based on these studies, beneficiaries are patients with advanced breast, prostate and lung cancers, responsible for >30% of all recorded cancers, comprising, respectively, 165K and 5.5M new cases each year in the UK and globally as well as other resistant cancers. XXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX