C. difficile! Microbiome-based biotherapeutics are taking off and showing promising results in clinical trials. Sebela Pharmaceuticals has laid eyes and up to £472 million on NTCD-M3, Destiny Pharma's lead candidate. NTCD-M3 is a naturally occurring non-toxigenic strain of C. difficile that lacks the genes expressing the bacterial toxins. The company reports Phase 3 studies will commence in 2024. More on clinical trials, or rather the lack of them, the Association of the British Pharmaceutical Industry has reported a 44% drop in participants recruited to commercial clinical trials in the last 5 years. The UK Government has appointed Lord James O’Shaughnessy to address the issue. Meanwhile, the UK Department for Business, Energy and Industrial Strategy has returned £1.6 billion of funds to the Treasury, which were previously allocated to cover the Horizon Europe debacle. Thankfully, things might improve regarding Horizon, but we will discuss that next week. Quick Four Nations round-up. Friends in Northern Ireland have been busy the last few weeks with a different matter. Wales is thriving: life sciences businesses have generated £2.62 billion in turnover, a 12% rise on the previous year. Dr Liz Fletcher, Director of Business Engagement & Operations at the Scottish Industrial Biotechnology Innovation Centre, has written a piece on the Catch-22 situation for biotech companies in Scotland. And in England, SugaROx has raised £850,000 in seed funding, now totalling £1.4 million, NRG Therapeutics has been awarded a second $500,000 grant from the Michael J. Fox Foundation for Parkinson’s Research, and the University of Newcastle has been awarded a $3 million grant to lead an NSW Government's clinical pharmacy trial. The Medicines and Healthcare products Regulatory Agency plans to establish a new system for regulating medical technology on seven regulatory pillars. It will be interesting to see how the final roadmap compares to the Swiss model (i.e. a third party to the European regulation). Amadeus Capital Partners and APEX Ventures have launched the €80 million Amadeus APEX Technology Fund. Dame Angela McLean, Professor of Mathematical Biology at the University of Oxford, has been appointed as the new Government Chief Scientific Adviser, and Professor Molly Stevens has been awarded the 2023 Novo Nordisk Prize for her pioneering work in innovative regenerative bioengineering. The Interesting Readings section features a roadmap to unitary patents, SPAC graveyard, and a somewhat controversial piece by Prof Kieron Flanagan on R&D public policy. Santana to combat cold and plans for Friday evening if you are based in Cambridge. Let's dive in!

Glasgow-based Causeway Therapeutics has raised £8.75 million investment. The funding was led by Prof Declan Doogan and participated by existing investors Mediqventures, Scottish Enterprise and Glasgow University Holdings Ltd. The company’s pipeline focuses on tendinopathy, interverbal disc disease, osteoarthritis and skin ageing. The proceedings of the round will be used to conduct an international multi-centre Phase 2 clinical trial in the US, Netherlands, and UK of its lead compound (TenoMIRä) in lateral epicondylitis. Lateral epicondylitis a diseases characterised by inflammation and microtearing of the tendons that join the forearm muscles on the outside. TenoMIRä is a therapy that mimics a natural small RNA molecule called microRNA-29a (miR29a). Injury-induced loss of miR-29a in damaged tendons is a critical factor in the development of tendinopathy. It has shown positive effects in the first human Phase 1b trial. Causeway is developing novel microRNA therapies for the treatment of common musculoskeletal and age-related diseases.

Oxford-based SugaROx has raised £850k in seed funding, thus totalling £1.4 million. The investment was participated by Regenerate Ventures and the UK Innovation & Science Seed Fund. The proceedings of the round will be used to develop the company’s biostimulant platform, accelerate field testing, prepare for registration in major markets, and obtain proof-of-concept on additional crops. The platform, which was originally developed by Rothamsted Research and Oxford University, uses a single molecule trehalose-6-phosphate (T6P) biostimulant to boost crop yields. The biostimulant platform has shown a 12-22% improvement in wheat yields and has produced positive results under controlled conditions for barley, millet, and sorghum.

Stevenage-based NRG Therapeutics has been awarded a second $500,000 grant from The Michael J. Fox Foundation for Parkinson’s Research. The company is targeting mitochondrial dysfunction and is developing first-in-class treatments for Parkinson’s by inhibiting the mitochondrial permeability transition pore (mPTP) in brain cells. The grant will support experiments to validate a novel mitochondrial drug target for Parkinson’s, with the overall goal of developing drugs that block the opening of the mPTP, leading to the death of dopamine-producing brain cells. Classical inhibitors of the mPTP, such as cyclosporin A, have been unsuccessful in crossing the blood-brain barrier.

The University of Newcastle has been awarded a $3 million grant to lead the NSW Government's clinical pharmacy trial. The trial will allow pharmacists to prescribe treatments for urinary tract infections (UTIs) and continue a prescription for the oral contraceptive pill. The project aims to make it easier and quicker for people, particularly women, to access important prescription medications and treatments, and will evaluate and implement innovative services delivered by 2,100 community pharmacies across NSW under a clinical trial framework.

The UK Department for Business, Energy and Industrial Strategy is returning £1.6 billion of funds to the Treasury. The funding was previously allocated to Horizon Europe. The Campaign for Science and Engineering discovered this in page 300 of a technical accounting document and announced it to the wider public on February, 21. This piece in Nature gathers some of the reactions.

Meanwhile, [recent figures](https://businessnewswales.com/latest-figures-show-how-wales-is-fuelling-the-uks-life-sciences-vision/?) from the Office for Life Sciences Wales show that the income growth of Welsh life sciences businesses has generated £2.62 billion in turnover in Wales - a 12.1% rise on the previous year. The latest export figures for Wales reveal the growing global influence of Welsh life sciences, with medicinal and pharmaceutical products among the top 5 products being exported from Wales.

Cambridge-based Amadeus Capital Partners and Vienna-based APEX Ventures have launched a €80 million Amadeus APEX Technology Fund. It will support deep tech early-stage startups, predominantly in the DACH region. The fund’s investment committee includes Amadeus’ Co-Founders Anne Glover and Hermann Hauser and APEX Partners Andreas Riegler and Wolfgang Neubert. The Amadeus APEX Technology Fund will initially invest between €1-1.5M in seed and series A stage deep tech ventures with unique and defendable technology.

Deep Science Ventures has launched the Venture Science Doctorate, a 3-year, fully-funded PhD program aimed at training 1,000 science entrepreneurs per year within ten years. The program is sector-agnostic and inclusive, and candidates work with leading research groups and venture partners to develop scalable technologies and investment cases. Upon graduation, candidates continue to lead their ventures as co-founders. The program has partnered with leading institutions such as Imperial College and Cornell University.

Stevenage Bioscience Catalyst program has launched the next edition of its accelerator programme. It focuses on startups developing therapeutic innovations that have obtained either a proof-of-concept or £1-3 million funding. Companies with integrated digital technologies (ML/AI) in the R&D workflow are encouraged to apply. It is a 8-week program that includes developing a commercialisation strategy to go from prototype to commercially-viable product, as well as leadership coaching, HR and partnerships support. The program is backed by Triple Chasm and Mindstream-AI.

The British Business Bank has released an interim evaluation report on British Patient Capital (BPC). The report indicates that BPC has helped create up to 5,000 additional jobs across the country through its investments. Additionally, beneficiary companies grew their employment by an average of 55%, and demonstrated an increase in turnover between £4.7 million and £5.4 million per year.

The Medicines and Healthcare products Regulatory Agency plans to establish a new system for regulating medical technology on seven regulatory pillars. The first statutory instrument (SI) is expected in spring 2023, formalising the one-year delay in the entry into force of the main UK regulation. The second SI will focus on post-market surveillance, whereas the third will implement the bulk of the new regulatory system. In contrast to this approach, the Swiss parliament (a third country to the EU in terms of medical device market) has taken a leading position by approving the principle of allowing US Food and Drug Administration-approved products onto the local market.

Cambridge-based Eagle Genomics and the International Crops Research Institute for the Semi-Arid Tropics(ICRISAT) have signed a Memorandum of Understanding. Their partnership aims to deliver innovative solutions to drive global climate resilience, sustainable food systems, and improved nutrition by networking microbiome science. The collaboration will advance the understanding of microbiome interactions and their relationship with the food system, and offer new approaches to sequester carbon efficiently, enhance nitrogen and phosphate availability for plants, reduce soil erosion and flooding, and improve crop and community resilience to climate change and climatic events.

Edinburgh-based Macomics and the University of Edinburgh have published a review in Nature Reviews Cancerdetailing the discoveries of a new class of tumour-associated immune cells, revealing opportunities to develop novel cancer treatments. The review highlights the potential for developing precision medicines to modulate macrophages for the treatment of cancer by targeting tumour-associated macrophages (TAMs) in the tumour microenvironment (TME). Macomics is an immuno-oncology company set up to take forward these learnings and opportunities.

London-based Automata has partnered with The Francis Crick Institute to provide integrated automation for genomics sample preparation. The partnership aims to unlock the potential of genomics labs by automating three workflows, decreasing manual touchpoints, increasing throughput, and optimising R&D flexibility. As part of the collaboration, the Crick will have early access to Automata demos, and will become a key stakeholder in new product development. Automata will able to use the system to test new software and learn from user feedback and platform metrics.

Inventia Life Science has announced a collaboration with MSD to develop 3D in vitro models for preclinical screening of therapeutic candidates for neurodegenerative diseases. The collaboration will leverage Inventia's RASTRUM 3D cell culture platform to create highly reproducible cell models that closely mimic the human brain, with the aim of accelerating the drug discovery process by evaluating therapeutic candidates on 3D in vitro models of various neurological disorders, including Alzheimer's disease and Parkinson's disease.

Oxford-based Brainomix is participating in a new study on post-stroke atrial fibrillation (AF) sponsored by the University of Liverpool. The study aims to determine the clinical effectiveness, cost-effectiveness, and acceptability of Huawei Smartwear in detecting AF in patients following an acute ischemic stroke. Atrial fibrillation is a common heart rhythm disorder that increases the risk of stroke five-fold and affects about a quarter of post-stroke patients. Brainomix's e-Stroke platform will collect real-time imaging data and transfer it securely to the central investigators. The goal is to improve the detection of AF so that early treatment can be initiated and the risk of recurrent stroke can be reduced in post-stroke populations.

Researchers at the Babraham Institute have published research on developing preventative therapy for diabetes in mice, which is being commercialised through spin-out Aila Biotech Ltd and shows promise for preventing both type 1 and type 2 diabetes.

The Association of the British Pharmaceutical Industry has reported a 44% drop in participants recruited to commercial clinical trials in the last 5 years. The UK government has appointed Lord James O’Shaughnessy to conduct an independent review into the UK commercial clinical trials landscape. The review will offer recommendations on how commercial clinical trials can help the life sciences sector unlock UK growth and investment opportunities and how to resolve key challenges in conducting commercial clinical trials in the UK. The review will build on the government’s 10-year vision for clinical trials, Saving and Improving Lives: The Future of UK Clinical Research Delivery.

Dame Angela McLean, Professor of Mathematical Biology at the University of Oxford, has been appointed as the new Government Chief Scientific Adviser (GCSA). She will be the first woman to hold the role and will take up the post on April 1st. The role of the GCSA is to provide independent scientific advice to the Prime Minister and members of cabinet, advise the government on aspects of policy on science and technology and ensure and improve the quality and use of scientific evidence and advice in government.

Prof Molly Stevens has been awarded the 2023 Novo Nordisk Prize for her pioneering work in innovative bioengineering approaches to solve key problems in regenerative medicine and biosensing. Her research focuses on the interface between materials and biology, and how it can be applied in various ways, such as regenerative medicine, biosensing, and drug delivery. She leads an academic group at the Imperial College London as well as a satellite group at Karolinska Institutet. The Novo Nordisk Prize is awarded annually to active scientists who have made outstanding contributions to advance medical science to benefit people's lives and is accompanied by DKK 5 million.

London-based Automata has announced its expansion into the US. The expansion in Boston will include lab space, team expansion to advance automation hardware and software applied to workflows in pharmaceutical and biotech companies, academic institutes, core testing labs, and contract development and manufacturing. The expansion builds on $50m in Series B fundraising in 2022. Its partnerships in the UK include supporting bit.bio to scale the manufacturing of human cells; powering genome sample preparation at The Francis Crick Institute; and automating diagnostic testing with the UK’s National Health Service.

London-based Relation Therapeutics has announced the opening of its 5,500 sq ft flagship integrated wet-dry laboratory in London's Knowledge Quarter, which will combine sophisticated functional genomic techniques with computational power and machine learning to improve drug discovery and development. In addition, the company has appointed Dr Edith Hessel (ex-GSK executive) as Chief Scientific Officer to lead the drug discovery direction of the company and the progression of its pipeline to the clinic.

Californian property company BioMed Realty has appointed ex-Savills employee William Clarke as director of leasing in the UK to help with its expansion plans in Cambridge, including the delivery of 600,000 sq ft of laboratory space on the Cambridge International Technology Park site.

Bruntwood SciTech has launched the Biospheric Network as a nationwide initiative that connects high-growth businesses in the UK life sciences sector with experienced mentors, advisors, and corporate partners. The network provides growth-oriented support, including business consultancy, sector-specialised networking, and access to finance. It operates across innovation districts in cities including Manchester, Birmingham, Cambridge and Cheshire’s Alderley Park, and its first cohort for 2023 is made up of 15 corporate partners, including Acceleris KPMG, Coulter Partners, Deloitte, Praetura Ventures, and 21 mentors.

London-based Eden Bio has appointed Evgenia Markova, PhD as Chief Scientific Officer. Dr Markova has been promoted from VP of Science. Prior to Eden Bio, she co-founded and served as Chief Executive Officer at TerraBite App and was part of Entrepreneur First.

Oxford-based Ochre Bio has appointed David Coughlan, PhD as Vice President of Translational Development. Prior to Ochre Bio, he was Chief Technical Officer at Afimmune Ltd, focused on cardiometabolic, hepatic, haematological and related indications. In the past, he held senior leadership positions at DS Biopharma and Merrion Pharmaceuticals PLC.

Edinburgh-based Green Bioactives has appointed John Stevenson, MBA as Head of Biomanufacturing. He will collaborate to scale-up the company’s plant-cell based manufacturing platform. Stevenson has over 35 years of engineering experience and has previously led the scale-up of biotechnologies from the lab through to commercialisation. In the past, he held senior roles at Suez Water Technologies & Solutions, William Grant & Sons and Celtic Renewables.

Oxford-based OMass Therapeutics has appointed Winfried Barchet, PhD as Vice President of Immunology. Prior to joining OMass, Winfried worked on innate immunity drug discovery and translational studies with IFM Therapeuticsand at Roche pRED.

London-based OKYO Pharma has appointed Dr Jay S Pepose to its Scientific Advisory Board. Dr Pepose is a world-renowned ophthalmologist and will bring his expertise in the medical and surgical treatment of ocular surface diseases to the board, as well as guide the clinical programs for OKYO's OK-101, a treatment for dry eye disease. He is the founder and Medical Director of the Pepose Vision Institute and a professor of Clinical Ophthalmology & Visual Sciences at Washington University School of Medicine.

Cambridge-based CMR Surgical has appointed Supratim Bose as Senior Advisor to the CEO. He will lead the company's commercial operations in Asia, the Middle East, and Africa. Bose has over 40 years of experience in the medical technology industry and has held leadership positions at Johnson & Johnson, Boston Scientific, and ConvaTec. CMR Surgical aims to make surgical robotics more accessible and Bose's appointment will support the company's growth in some of the fastest-growing markets in the world.

Brighton-headquartered Destiny Pharma (LON: DEST) has entered into a £472 million exclusive collaboration and co-development agreement with US Sebela Pharmaceuticals. This agreement covers the North American rights of NTCD-M3, which is the company's lead asset for the prevention of Clostridioides difficile infection recurrence. Sebela will finance the future clinical development and commercialisation activities of NTCD-M3 in North America, while Destiny Pharma retains the majority of rights for Europe and the rest of the world. Sebela Pharmaceuticals is known for its market-leading position in gastroenterology and its focus on innovation in women's health. C. difficile is one of the leading causes of hospital-acquired infections in the US, and poor treatments from antibiotics lead to cycles of repeated recurrence in many patients. NTCD-M3 is a naturally occurring non-toxigenic strain of C. difficile that lacks the genes that can express C. difficile toxins. NTCD-M3 acts as a safe "ground cover" that prevents toxic strains of C. difficile from proliferating in the colon after antibiotic treatment.

The National Institute for Health and Care Excellence (NICE) has approved the use of CAR-T therapy Yescarta (Kite Pharma) for adults with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma who have had two or more lines of systemic therapy. The therapy modifies a patient's own immune cells to attach to and kill cancer cells, and is administered as a one-off intravenous infusion. The treatment was previously available through the Cancer Drugs Fund and will now be commissioned routinely to patients in England after a confidential commercial deal was struck with the company. Around 450 people in England will be eligible to receive this new treatment.

Manchester-headquartered C4X Discovery Holdings (AIM: C4XD) has launched PatientSeek, a precision medicine platform that uses genetic data to identify patients most likely to benefit from a medication. The platform was validated for patient stratification using results from a failed Phase 3 clinical trial into Parkinson’s disease, and identified a subgroup of patients that responded to treatment despite the trial’s failure to reach its clinical endpoint overall. The platform has the potential to identify biomarkers which could inform clinical trial design and enable the development of companion diagnostics. The collaboration builds on successful research collaboration with Garvan Institute of Medical Research.

London-headquartered ViiV Healthcare has received EU Marketing Authorisation for Triumeq PD, a dispersible tablet formulation containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine. NRTIs and integrase inhibitors interfere with the action of the two enzymes to prevent the virus from replicating and further infecting cells. for the treatment of paediatric patients with human immunodeficiency virus type 1 (HIV-1). The authorisation provides access to age-appropriate formulations of dolutegravir for a younger population and helps to close the gap between HIV treatment options available for adults and children living with HIV. ViiV Healthcare is a global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders.

Cambridge-headquartered Arecor Therapeutics plc (AIM: AREC) has been granted a patent (IN412485) by the Indian Patent Office protecting novel formulations of the Group’s proprietary insulin products AT247 and AT278 until 2038. These have been designed to significantly accelerate insulin absorption post injection across a range of insulin concentrations.

Special Purpose Acquisition Companies (SPACs) became very popular in 2020 and 2021 as investors bulked up large reserves of cash resulting from the blooming IPO and M&A panorama. Success, let aside revenues, turned out to be different than expected and, blimey, companies struggled to go public with only one asset. Now it seems reverse merges are taking over. This piece explores the issue more in detail.

Food for thought. Prof Kieron Flanagan (Professor of Science & Technology at the Manchester Institute of Innovation Research, University of Manchester) has written an interesting article eloquently titled Science ministry must avoid being all R and no D. Worth reading.

Dr Liz Fletcher, Director of Business Engagement & Operations at the Scottish Industrial Biotechnology Innovation Centre (IBioIC), has published a piece on the challenges facing Scotland's biotech sector, including the difficulty of scaling laboratory work into businesses with scale and the lack of infrastructure for UK companies to de-risk the process of scaling. She argues that publicly funded infrastructure is key to creating a clearer path for bio-focused companies to set up and scale in the country and compete on the world stage.

Law firm Hindles has prepared a great article on whether to register a Unitary Patent. If you are just about to navigate such oceans, this is a good start.