PRV! Shorter and quieter week for the ecosystem as some went on holidays for a few days to be able to face Q2 in full shape. Somebody who has not been much on holidays recently must be Bent Jackobsen. In the last few months we have talked a lot about Adaptimmune, Immunocore and Etcembly and more recently Accession Therapeutics. Now SynaptixBio, which he co-founded in 2021, has raised £13.2 million. In quite a short time, the company has achieved two FDA designations, an Orphan Drug Designation and a Rare Paediatric Disease Designation, the first step to gaining a Priority Review Voucher (PRV). For context, in July 2022 Novartis acquired a PRV from Mallinckrodt paying $100 million.

Things seem to not go that well for the UK Government's Future Fund, more on this under Public Policy and Regulation. Fridge-free vaccines developer Stablepharma is considering an IPO and Oxford Medical Products has been awarded a £1.25 million grant from Innovate UK’s Biomedical Catalyst 2022 Competition to fund clinical trials of its proprietary weight-loss hydrogel Sirona. More from UK Research and Innovation: the Good Food Institute Europe (yes, your read that well), an international food sustainability nonprofit, has raised £12 million from the Engineering and Physical Sciences Research Council and the collaborative partnership has brought along Hoxton Farms, Quest Meat, Qkine, and multiple universities. The Association of Investment Companies reports that venture capital trusts raised £1.08 billion in the 2022/23 tax year. Shout out to LifeArc as it joins the Campaign for Science and Engineering. Abingworth/Carlyle company Launch Therapeutics has partnered with Medidata to optimise trial planning through the use of the Medidata AI Intelligent Trials' Study Feasibility solution. We shall see how that goes. The Crick has grown by another mind as Francesca Ester Morreale, PhD joins as Group Leader and Microbiotica has announced a clinical trial collaboration with MSD to evaluate its MB097 candidate in combination with —you guessed it— Keytruda. Music by Nicola Conte, bossa nova, Italian and Indian traditional music all together, and arts by Hilma af Klint and Piet Mondrian. Let’s dive in!

Oxford-based SynaptixBio has raised £13.2 million (details not disclosed) to develop the world’s first treatment for TUBB4A-related leukodystrophy. TUBB4A-related leukodystrophy is a rare and deadly disease caused by a mutation in the TUBB4A gene. The disease can lead to significant impairment of motor skills, severe swallowing, and hearing and speech difficulties. Currently, there is no cure. The company’s therapeutic development is based onto novel science conceived in the laboratory of Dr Adeline Vanderver (MD Program Director of the Leukodystrophy Center of Excellence Children's Hospital of Philadelphia). The company has entered into a sponsored research agreement with the Children’s Hospital of Philadelphia to develop an antisense oligonucleotides (ASOs) therapy, which can prevent or alter the production of proteins. SynaptixBio’s therapy was granted FDA rare paediatric disease designation. With the new funding, SynaptixBio aims to take its therapy to human clinical trials in 2024. The company has adopted a virtual business model, with only three staff and a part-time office, thus operating at a fraction of the cost of traditional biotech. The company is led by Bent Jackobsen PhD (co-founder and Executive Director; founder of Adaptimmune and Immunocore, and CEO at Accession Therapeutic Ltd), Dan Williams PhD (co-founder, CEO and Executive Director), Michelle Teng PhD (co-founder, CSO and Executive Director) and Nick Cross MBA (Chairman and Non-Executive Director).

The Good Food Institute Europe, an international food sustainability nonprofit, has raised £12 million from the Engineering and Physical Sciences Research Council (EPSRC), part of UK Research and Innovation (UKRI). The proceedings of the investment will be used to fund the Cellular Agriculture Manufacturing Hub (CARMA), led by the University of Bath. The hub will operate for 7 years and will aim to improve the manufacturing operations for cultivated meat . CARMA is the largest single investment the UK Government has made to date in sustainable proteins. The partnership includes University of Birmingham, the University of Aberystwyth, University College London, the Royal Agricultural University as well as Hoxton Farms (London) and Quest Meat (Birmingham). Qkine (Cambridge) has also been selected as a project partner aiming to leverage its growth factor expertise to create improved cell culture media and help building a reproducible, regulatory compliant, animal-free supply chain for bioactive proteins.

Glasgow-based Solasta Bio has raised £4 million in a pre-Series A funding round to scale up development of its eco-friendly insecticides. The funding was led by Yield Lab Europe and participated by Rubio Impact Ventures, Scottish Enterprise, Cavallo Ventures, SIS Ventures, UKI2S and other private agritech investors. SOLASTA Bio has developed a technology platform for creating sustainable nature-inspired Insect Control Agents (ICAs) that target pests while preserving beneficial pollinators such as bees. The funding will be used to scale up operations in the UK and the US, expand technical and commercial teams, accelerate technology development and target new markets. The company has already run several early-stage R&D trials with commercial partners and aims to bring its first ICAs to market in 2027. The company is led by Shireen Davies, PhD (CEO and co-founder), Professor Julian Dow (CSO and co-founder), Dr Rob Wylie (Chairman), David Armour (Chief Financial Officer), and Dr Daphne Preuss (Chief Commercial Officer).

Oxford-based Oxford Medical Products has been awarded a £1.25 million grant from Innovate UK’s Biomedical Catalyst 2022 Competition to fund clinical trials of its proprietary weight-loss hydrogel Sirona. Oxford Medical Products has partnered with University Hospital Southampton (UHS) NHS Foundation Trust to carry out first-in-human clinical trials. Sirona is designed to achieve significant weight loss by reducing appetite. The hydrogel is taken orally as a pill and expands once in the stomach to occupy physical space and reduce hunger. The aim is to provide an affordable and effective treatment for the 1.9 billion people globally affected by excessive weight. The Innovate UK grant will support the later phase of OMP's pilot clinical trial.

London-baased Little Journey has raised £2.5 million seed funding to further develop an app that helps children prepare for medical interventions, reducing anxiety and stress before, during and after healthcare procedures. The round was led by Octopus Ventures. Little Journey’s app includes management portals for hospitals and for clinical trials and animated characters, relaxation animations and games to distract children during their time in the hospital. It also includes modules to help families understand and track adherence to medication. Little Journey claims that the end product can reduce anxiety by 32%, recovery time by 30% and on-the-day cancellations by 42%. The new funding will be used to further develop the product and boost international expansion.

Newcastle Upon Tyne-based **Cognassist has secured a £4 million investment from Gresham House Ventures. The startup was founded in 2019 and is developing a digital health and education platform. The funding will be used to expand Cognassist's neuro-inclusive services from the education sector to the enterprise market and expand the team.

Bath-based Stablepharma, which develops fridge-free vaccines, is considering an IPO or a Series B financing round to bring two vaccines to market, SPVX02 for tetanus and diphtheria (Td) and SPVX06 for tetanus. Ahead of an IPO, Stablepharma could raise up to GBP 5m in bridge financing, while an IPO to raise GBP 15m to GBP 20m would take place in late 2024. Alternatively, the company would raise capital via an around EUR 20m Series B round by early 2024.

Albion Capital has raised £80 million across six venture capital trusts (VCTs). Albion Capital invests mainly in the software and healthcare/health tech markets, with £630m in assets. The firm has backed notable tech companies such as Grapeshot, valued at $325m, Speechmatics, valued at $372m, and Elliptic, valued at $360m. The funds will be used to support their existing portfolio of around 60 businesses that employ some 5,000 people across software, healthcare, and tech-enabled services. Over the past decade, Albion Capital VCTs have returned an average annual return of 8.4% per annum, 9.0% per annum over 5 years, and 6.3% per annum over 3 years excluding tax relief. All six VCTs have an annual dividend target of around 5% of net asset value.

The Association of Investment Companies (AIC) has published that venture capital trusts (VCTs) raised £1.08 billionn in the 2022/23 tax year. This is the second highest fundraising ever by VCTs, representing a 5% decrease compared with the 2021/22 tax year. During 2022, VCTs invested £700 million in new and follow-on investments in small private companies and Alternative Investment Market (AIM) companies in the UK. The lion's share, £652m (93%), was invested in private companies with £48 million invested in AIM-quoted companies. Last year VCTs invested £672 million in new and follow-on investments. VCTs have a strong long-term performance, with the average VCT returning 108% over ten years.

LifeArc has joined the Campaign for Science and Engineering (CaSE). CaSE is a non-partisan organisation that works to put science and engineering at the heart of the UK’s future, with a membership of more than 115 scientific organisations, including businesses, universities, learned societies and charities, as well as individual scientists and engineers. LifeArc is a self-funded, non-profit medical research organisation that focuses on translation – advancing lab-based scientific discoveries so they can be developed into the next generation of diagnostics, treatments and cures. LifeArc is committed to spending £1.3 billion by 2030 in areas of high unmet medical need.

Monograph Capital is now a member of the British Private Equity & Venture Capital Association.

Bad idea, bad timing or bad implementation? Let’s open the debate from the floor. The UK Government's Future Fundwas designed to help promising startups survive during the pandemic by lending them up to £5 million, matched by private investment. The Guardianhas published a piece gathering some of the criticism the idea has gathered. A venture capital investor, “who asked not to be named” referred to the Future Fund as "naive and stupid idea". The failures have raised concerns about the lack of due diligence performed by the British Business Bank, which administered the fund. Many of the loan recipients were not early-stage or fast-growing startups, and some had connections to the Conservative party.

London-based Leucid Bio has signed a non-exclusive License and Supply Agreement with ImaginAb . Under the agreement, ImaginAb will license and supply clinical doses of ImaginAb’s investigational CD8 ImmunoPET tracer to Leucid for use in its basket study in solid tumors. Leucid is developing cell therapies for refractory cancers, especially solid tumors, and was founded to translate 20 years of King's College London research in the CAR-T field. This partnership will allow Leucid to generate data that demonstrates the tracking of LEU011 to tumour sites in the first phase of the trial. CD8 ImmunoPET is currently in Phase II clinical trials and has been licensed by pharmaceutical and biotech companies for use in immunotherapy clinical trials. ImaginAb is a global biotechnology company developing next-generation imaging agents and radiopharmaceutical therapy products.

Cambridge-based Charco Neurotech’s device CUE1 is being trialed at the Addenbrooke's Hospital for the first time in patients. CUE is worn on the chest and is hoped to improve the mobility of people with Parkinson's disease by delivering vibration and pulses to alleviate stiffness and improve motor skills. The hospital has purchased 10 devices with the help of its charitable trust, and the pilot will allow clinicians to collect data and understand how best to use the CUE1 device in people with Parkinson's, who have been admitted to hospital. The CUE1 is also intended to reduce the number of falls experienced by Parkinson's patients.

Cambridge-based Microbiotica has announced clinical trial collaboration with MSD to evaluate MB097 in combination with Keytruda in a Phase 1b clinical trial in melanoma. Under the agreement, Microbiotica will conduct a phase 1b clinical trial to evaluate the safety and tolerability, and initial signs of clinical activity of its live biotherapeutic product, MB097, in combination with Keytruda in melanoma patients with primary resistance to an anti-PD-1-containing immunotherapy. MB097 is a live biotherapeutic product consisting of a defined consortium of nine bacterial strains designed to enhance the efficacy of immune checkpoint inhibitors such as Keytruda. Microbiotica’s discovery platform identifies bacterial signatures associated with clinical response. MB097 displayed anti-tumor efficacy in combination with ICIs in vivo and demonstrated multiple immuno-stimulatory mechanisms in primary human immune cell assays in vitro.

Abingworth/Carlyle company Launch Therapeutics has partnered with Medidata to optimise trial planning through the use of the Medidata AI Intelligent Trials' Study Feasibility solution. This solution leverages data from over 30,000 clinical trials to improve enrollment and quality. The partnership aims to find solutions that address key industry challenges and advance study timelines. Medidata is a subsidiary of Dassault Systèmes, which provides a platform for the digital transformation of life sciences.

London-based MiNA Therapeutics has shown positive Phase 1b data for MTL-CEBPA in combination with an anti-PD1 checkpoint inhibitor. MTL*‑*CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cells. Dysregulated myeloid cells are implicated in several diseases including solid tumor cancers. MTL-CEBPA is designed to improve the effectiveness of checkpoint inhibitors and other immunotherapies by enhancing the body’s immune response and ability to attack the cancerous cells. Findings validate clinical proof of mechanism of MTL-CEBPA as a combination therapy in solid tumour cancers. Company plans to out-license its immuno-oncology portfolio, including MTL-CEBPA. MiNa Therapeutics is developing small activating RNA therapeutics or RNAa for oncology applications.

The Deciphering Developmental Disorders study conducted over 10 years in the UK and Ireland analysed the DNA of 13,500 families with unexplained disorders. The study has been published in the New England Journal of Medicine. and has identified a diagnosis to 5,500 families, revealing 60 new conditions. This discovery can lead to better care and help parents decide whether to have more children. The study was funded by the Health Innovation Challenge Fund and Wellcome Sanger Institute.

The TRACERx study, a flagship lung cancer study in the UK, has revealed new insights into how lung cancer can evolve, spread, and resist treatment. The most recent findings have been published in Nature. Researchers have been able to analyse the DNA of different subclones within the same tumour, which was previously restricted, and have identified specific mutations in subclones that make them more likely to metastasise. TRACERx is an ongoing program to transform the field of lung cancer research through data sharing, development of new technologies, and training future leaders in lung cancer research.

London-based Ambrose Healthcare has announced the expansion of its collaborative network with two rare disease specialists in the UK, CamRARE (Cambridge Rare Disease Network), and UK Digital Health. Ambrose Healthcare's collaborations with CamRARE and UK Digital Health will support clarification of the unmet patient needs, clinical development of Ambrose Healthcare's drug products, and delivery of new treatments for rare diseases and unmet clinical needs of patients managed in hospital and specialist care environments. CamRARE is a platform that unites patients, advocates, experts, and leaders to address the challenges faced by people affected by rare diseases.

Oxford-based Perspectum and Singapore-based BluMaiden Biosciences are collaborating to develop solutions for liver diseases and microbiome analysis. BluMaiden's AI technologies will be used alongside Perspectum's medical imaging solutions to identify biomarkers and small molecule therapeutics from within the human microbiome. The collaboration aims to improve clinical trial outcomes and enhance the potential of microbiome-derived biomarkers. Perspectum and BluMaiden Biosciences will combine their expertise to develop cutting-edge end-to-end solutions for the assessment and management of liver-related diseases like NASH.

Cardiff-based CatSci Ltd and Barcelona-based AGC Pharma Chemicals have formed a partnership to allows CatSci's customers to use AGC's manufacturing expertise to support clinical phase projects. AGC's customers can take advantage of CatSci's development capabilities for the development of their new therapeutics. The companies will work together to provide scalable small molecule API manufacturing, from pre-clinical development to large scale commercial production. Customers will get access to a wide range of manufacturing technologies. The new alliance aims to add strategic value to their customers' drug development journey.

Cambridge-based Cambridge Epigenetix has renamed and is now biomodal. In addition, the company has launched its duet multiomics solution +modC to enable the simultaneous phased reading of genetic and epigenetic information in a single sample, with one workflow, using any sequencer.

London-based Proximie has released the PxLens - a lightweight smart glasses device with a 4K camera and embedded software. The device is integrated with Proximie's cloud-based platform for telepresence, content, and insights from the OR, and allows surgeons to share a first-person perspective of surgeries. Voice-activated commands enable hands-free control, and battery packs can be swapped mid-procedure. The device claims to be usable by anyone, anywhere, within 15 minutes of unboxing when paired with the Proximie mobile app. To date, Proximie has conducted thousands of surgical procedures and has been deployed in over 500 hospitals across 100 countries on five continents. The PxLens was tested in pilot procedures in November 2022 in the UK and the US, and was used in colorectal, otolaryngology, orthopedic, plastics, and urology surgeries. The device is designed to improve patient care, training, skills development, and overall surgical efficiency.

London-based Multus has launched Proliferum LSR, a serum-free medium for the life sciences sector. This sustainable product allows researchers to move away from using Foetal Bovine Serum (FBS) for cell growth to a more eco-friendly option that gives reproducible results. In addition, Multus has signed an exclusive distribution agreement with Appleton Woods Ltd to supply its Serum Free media range to the UK Life-Science Market, making their advanced growth media formulations and ingredients available for life science researchers in the UK.

The Francis Crick Institute has appointed Francesca Ester Morreale, PhD as Group Leader. Dr Morreale joins from the Research Institute of Molecular Pathology in Vienna. Her team in the Targeted Protein Degradation and Antibiotic Research Laboratory will investigate protein degradation in disease-causing bacteria, with the aim of finding new targets for antibiotics.

London-based Enedra Therapeutics has appointed industry executives as co-founders to develop the next generation of cancer-selective therapies that defy tumour heterogeneity. New co-founders include Keith Blundy, former CEO of Storm Therapeutics and Cancer Research Technology Limited; Ian Collins, scientific co-founder of Monte Rosa Therapeutics; and Tim Hammonds, former VP Drug Discovery at Entact Bio. Enedra's unique platform, CASPAROV, harnesses the genetic heterogeneity of tumours to turn cancer from a heterogeneous disease to one that can be treated with personalized medicines. Enedra was founded through investment from Deep Science Ventures and Cancer Research Horizons.

The London Institute for Healthcare Engineering (LIHE) has appointed Dr Nicolas Huber joins the as Director, Commercial Operations and Partnerships. The institute will launch its inaugural acceleration programme in 2024. LIHE brings together research and development expertise across academia, the NHS and MedTech companies, providing physical space for start-ups and multinational companies. LIHE’s mission is to transform patient care through MedTech innovation, from conception to commercialisation, enabling early NHS adoption of cutting-edge technology.

London-based CHARM Therapeutics is moving to the Babraham Research Campus in Cambridge. The  Kadans Science Partner's B900 facility will serve as the new research and development site for CHARM Therapeutics, which uses 3D deep learning to develop transformational medicines. This move allows CHARM to expand and advance its drug discovery programs. The Babraham Research Campus is known for supporting early-stage bioscience enterprises, with over 60 companies and 2,000 employees co-located with the Babraham Institute. Kadans Science Partner works with the Babraham Research Campus team to provide facilities and amenities for tenants.

Belfast-based Cumulus Neuroscience has announced the establishment of new offices in the Boston area, which will strengthen its partnerships with biopharma innovators. The new office will be located in the Cambridge Innovation Center (CIC) and will foster collaborations across diverse aspects of Central Nervous System (CNS) innovation. Cumulus is aiming to improve precision in clinical trials through its neuro-assessment platform. The platform provides more frequent, objective assessments – accelerating go/no-go decisions for development teams. Cumulus anticipates establishing additional clinical-stage collaborations in the coming year.

NucleateUK has appointed Rich Turner as National Director of Research.

London-headquartered GSK (LSE/NYSE: GSK) has reported positive results for the EAGLE-2 and EAGLE-3 trials for gepotidacin, an oral antibiotic for uncomplicated urinary tract infections (UTI). The trials showed that gepotidacin was non-inferior to existing treatment nitrofurantoin and demonstrated statistically significant superiority. The development of gepotidacin has been funded with US federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority. Gepotidacin is part of the GSK’s growing late-stage pipeline of antimicrobials for potential treatment of UTI. FDA submission is expected for Q2 2023.

Cambridge-headquartered AstraZeneca (LSE/STO/Nasdaq: AZN) has reported results on the AEGEAN Phase III trial. Data showed that treatment with Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before and after surgery led to a meaningful improvement in event-free survival (EFS) versus neoadjuvant chemotherapy alone for patients with resectable early-stage non-small cell lung cancer (NSCLC). The combined therapy also led to a significant improvement in pathologic complete response compared to neoadjuvant chemotherapy alone. Patients treated with the Imfinzi-based regimen before and after surgery showed a 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone. The trial will continue to assess key secondary endpoints including disease-free survival and overall survival.

Researchers at the Francis Crick Institute have found that retroviral remnants in our DNA can be targeted by antibodies to treat lung cancer. These antibodies bind to tumour-specific proteins produced by endogenous retroviruses, which make up 5% of human genomes. The viral genes are silenced in most healthy tissue but can be activated in cancers. The presence of antibodies targeting ERVs is associated with longer survival in mice treated with checkpoint inhibitors, and ERV expression predicts response to checkpoint inhibitors in patients. The findings could help improve the effectiveness of immunotherapy treatments for lung cancer.

Cambridge-based Qkine has written a piece on cardiac organoids and the challenges to bring homogeneity and reproducibility into the development process.

An international coalition of scientists led by The Michael J. Fox Foundation has developed a new tool called αSyn-SAA which can detect abnormal alpha-synuclein in cells. The tool can detect pathology in spinal fluid not only of people diagnosed with Parkinson's, but also in individuals who have not yet been diagnosed or shown clinical symptoms of the disease, but are at a high risk of developing it. The assay has proved to be 93% accurate, and could lead to earlier diagnosis and targeted treatments for Parkinson's disease.

The Higher Education Policy Institute (HEPI) has published a report on the role of universities in attracting foreign direct investment (FDI) to the UK. The report outlines the benefits of a coordinated approach, including overcoming growth and productivity challenges, attracting high-quality investment to local economies, supporting innovation clusters, increasing private sector investment in R&D, and leveraging global connections for economic benefit. The report also highlights the complex policy landscape that involves universities in FDI and the need for a national policy framework or agency to support local economic growth.