Public Funding for Vesynta Limited

**Who is Vesynta?** A diagnostic enabled precision medicine company. We combine patient monitoring with clinical decision support to maximise therapeutic potential and de-risk drug treatment. **Who are we helping?** The 40% of cancer patients eligible for immunotherapy treatment **What's the challenge?** Immunotherapies are fast becoming standard of care in cancer management. Despite their promising performance, they have been shown to cause side effects in up to 70% of patients, including fever and mental disturbance, which can be fatal if left unmanaged. Detecting these side effects in a timely manner is a challenge, placing the patient at significant risk. **Why is side effect monitoring a challenge?** These side effects appear when the patient is at home. In the UK_,_ monitoring services look to measure specific blood markers that can confirm the occurrence of immunotherapy related side-effects. Unfortunately, these services require the patient to come into hospital, after the event has already happened. **What do clinicians and patients want to improve?** Clinicians are asking for real-time information on multiple marker levels following immunotherapy treatment, to detect side effects earlier. Patients want to take control of their monitoring, with tools that empower them from their own home. **Is this difficult?** Changing the way healthcare monitors immunotherapy patients requires innovations that support remote measurements and side effect predictions. However, a solution that combines diagnostic, device engineering and pharmacology expertise could make this level of side-effect testing and management standard of care for all. **What does Project Checkpoint achieve?** An immunotherapy toxicity monitoring test, suitable for patient-use, paired with a prediction algorithm that helps detect side effects earlier and encourage personalised treatment interventions. **Can we deliver?** Our team includes world-leading engineers, pharmacologists, entrepreneurs, data scientists and diagnostic developers. NIHR-funding and private investment already supports development of our hospital-based drug monitoring platform. Checkpoint builds on these principles to revolutionise toxicity marker monitoring for patients at home. **Who else benefits?** Any setting that requires patient-led side effect monitoring. Checkpoint makes side effect monitoring more accessible and inclusive, creating opportunities to support development of immunotherapies during clinical trials to improve approved dose labels. Ultimately, care providers, society and the wider economy will benefit from safer and more efficacious immunotherapy that improves long-term quality of life for the patient.

**Who is Vesynta?** A personalised medicine company that delivers data-guided precision dosing via rapid patient monitoring. **Who are we helping?** The 400,000 children diagnosed with cancer globally each year. **What's the challenge?** Choosing the optimal chemotherapy dose. Many factors (fat distribution/organ function/enzyme availability, etc.) affect how drugs are metabolised and cleared from our bodies. These differences are exaggerated in children due to their rapidly developing anatomy. **What does this mean in practice?** Two people given the same dose may have very different "drug-exposures" i.e. concentration of a drug in the blood and the length of time it stays there. **Which drugs is this a problem for?** Drugs used to treat critical illnesses, including chemotherapeutics. If drug exposure is too low, cancer will continue to grow. Whereas, if drug exposure is too high the patient may suffer from toxic side effects. **How have clinicians dealt with this?** Until now, the patient's weight or surface area is used to determine the chemotherapy dose. This does not dynamically capture the entire clinical complexity of an individual patient. **How could we improve?** Provide access to evidence that supports chemotherapy dose adjustments towards a "target drug exposure". By measuring drug concentrations from blood samples taken over time, we can predict the right dose to achieve the optimum drug exposure. **Is this difficult?** Each dose adjustment requires pharmacology expertise and processing of clinical data. However, with intelligent software that complements a point-of-care monitoring device, this level of personalisation could become standard of care for all. **What will the software do?** It will use concentration data to build a unique "pharmacokinetic" model for each patient. A user-friendly bedside interface will support clinicians to deliver the optimal dose every time, making personalised childhood cancer treatment more safe, effective and precise. **Can we deliver?** Our team includes world-leading engineers, pharmacologists, entrepreneurs, and paediatric oncologists. NIHR-funding already supports development of our drug monitoring hardware. Dosologic now develops a precision dosing software to create a "Dose-Measure-Learn" precision dosing loop. **When will I see this in action?** Our innovation pipeline will require rigorous testing and regulatory approval, entering the clinical setting in 2024\. **Who else benefits from personalised dosing?** Any patient group that requires tailored treatment due to clinical trial under-representation (elderly, women, ethnic minorities, patients with rare disease). Healthcare providers, families and the wider economy all benefit from fewer toxic events and enhanced quality of life for children with cancer.

As an Innovation Scholar, **Anand Pallipurath Radhakrishnan (APR)**, would swiftly transition from University College London (UCL) Electrochemical Innovations Lab (EIL) to work with the host company, **Vesynta Ltd.**, marking a new knowledge exchange partnership. **The miniDOC project**, led by UCL, will be partnered by Vesynta with additional input from multi-institutional academic partners and NHS clinicians, all **with a common goal of developing a point-of-care drug monitoring device with a pressing need in breast cancer therapy**. In pursuit of developing a dose optimising blood test device, APR will broaden his technical skills to advance smart engineering solutions **from a laboratory to the patient bedside in a healthcare setting**, satisfying a long-term career aspiration in the process. Rigorous device prototyping, scalable manufacturing techniques, _in vitro_ diagnostic regulatory requirements, robotic automation, and clinical trial design, are but a few skills APR would be equipped with through the miniDOC project. Additionally, Vesynta's core strengths, such as personalised medicine and monitoring, device manufacturing and prototyping, access to patient samples and a strong network of clinical and academic partners, will be exploited to significantly enhance APR's professional profile. **Career mobility is envisioned as APR will be considered for a Research and Development Technical Lead role within Vesynta** by the end of the secondment period. This further strengthens the implementation of a successful product development pipeline and truly supports the deployment of the device at the point-of-care. **Guidance and mentorship will be sought from UCL Institute of Healthcare Engineering** to ensure monitoring of the program objectives and to manage the associated risks. Simultaneously, this partnership shall leverage APR's skills in microfluidic engineering, advanced computational image analysis and biotechnology innovation, to solve challenges faced by Vesynta. During the secondment, **APR will facilitate cross-pollination of innovative ideas between UCL and Vesynta, seeking new avenues of research into bioanalytical sensing** furthering EIL's expertise in electrochemical analysis. Specific, measurable and achievable objectives have been drawn out to elicit APR's technical potential and to exploit Vesynta's core strengths, whilst accelerating the development of a platform that supports the practice of personalised medicine. **The successful delivery of the miniDOC project has the potential for a high impact on the treatment outcomes of cancer patients.** Through the adoption of safe and effective personalised drug monitoring practices with precision dosing aimed at adults with breast cancer, **the miniDOC project will make a direct impact on not only the healthcare sector but also on the economy**.

This bi-directional collaboration, offers a secondee from Newcastle University an opportunity to work with an innovative biomedical start-up, Vesynta Ltd, for the development of a novel companion monitoring tool, enabling doctors to accurately monitor anti-cancer drug-exposure in children. It will provide an immediate, simple to use, bedside measurement of medicine concentration in the blood: an essential improvement in care. Cancer is the leading cause of death in children aged 0-14 years. Giving the safest and most effective dose of anti-cancer drugs to children is a clinical challenge for doctors. They currently calculate the amount of anti-cancer drugs the patient will have using their height and weight as a guide. However, as children's bodies all process medicines very differently, this method is not accurate and leads to marked differences in drug exposure between patients. As a result, ~40% of children suffer from medicine related side-effects which reduces their quality of life and costs healthcare providers. To give the correct amount of treatment, doctors need technologies which provide real-time and accurate patient drug exposure data; yet, this information is rarely available and challenging tto obtain. Vesynta has developed a technology with promises to meet these criteria, however, it requires quality assurance over its technology, further design considerations to ensure it is suited for the end-user, and an expansion of the technology to co-medicines which are also given to children, to ensure maximum patient benefit. This project will leverage the secondee's skills in drug testing development, clinical pharmacology and problem-solving using analytical instruments, to validate the platform technology. In return, the secondee shall become a 'Translation and Innovation Lead' at Newcastle University, with skills exposure to human factors design, medical device regulation and health economics. The project shall build on the voiced needs of patients, parents and doctors, as captured from stakeholder engagement workshops designed by the secondee, who shall also support follow-up research plans through clinical trial design. This carefully planned research, will provide benefit to both secondee and host organisation, in terms of skills, knowledge and career porosity. The successful delivery of this project will propel the secondee in his professional ambitions and support Vesynta in accelerating their research and development activity. Crucially, facilitation of biomedical innovation will fast-track the implementation of personalised medicine in paediatric oncology, for the benefit to children and the wider healthcare sector. Update (Oct. 2022) - following discussion with our project manager (Liz Littlewood) we have a new secondee in place to take this project forward following staffing changes here at the university. The new secondee has a >90% match of the original learning outcomes and their role exactly aligns with the original proposals, due to similarity of the role the new individual holds within the host organization.