First multi-centre trial, EXCYTE-1, evaluating the potential of Exscientia’s functional precision medicine platform in solid tumour indication
Builds off of pioneering AI-guided functional precision medicine research in haematological cancers
Exscientia plc (Nasdaq: EXAI) today announced the initiation of EXCYTE-1, a prospective observational study in ovarian cancer to investigate the relationship between ex vivo drug response (EVDR) in primary tumour-derived samples using the company’s precision medicine platform and actual patient clinical response. This first of its kind observational study in solid tumours will run at multiple medical research centres in Europe with a focus on ovarian cancers. It aims to inform and enable future studies in other solid tumours.
Ovarian cancer represents a high unmet need for predicting patient response to diverse therapy options. The study will be conducted in collaboration with the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Study Group, one of the leading non-profit clinical research networks in gynaeco-oncology worldwide.
“We are thrilled to work with Exscientia to advance the state of science and potential treatment of ovarian cancer patients," said Professor Philipp Harter M.D., Ph.D., Head of Gynaecology and Gynaeco-Oncology at Evangelische Kliniken Essen-Mitte, Germany, and Chair of the AGO Study Group. "This study will enable us to explore new ways to identify the right treatment for individual patients, especially in cases with no available molecular biomarkers. We look forward to being a part of this important scientific evaluation.”
By combining high-content imaging of samples and deep learning image analysis, the company’s AI-based precision medicine platform leverages a patient’s biopsies to assess drug activity at a single cell level ex vivo. The EXCYTE-1 trial follows the prospective EXALT-1 trial in haematologic malignancies, the first study to leverage AI-driven ex vivo drug testing to guide treatment selection and improve outcomes in patients with advanced haematological cancers. Patients who received drugs prioritised by the platform experienced significantly better outcomes, with 54% of patients demonstrating clinical benefit of >1.3-fold enhanced progression free survival (PFS) compared to prior therapy. The EXCYTE-1 trial is designed to expand the scope of Exscientia’s precision medicine platform in solid tumours.
“The outcomes from this study could have broad implications for how we evaluate drug candidates and support clinical practice in the future,” said Dr. Nikolaus Krall, EVP of Precision Medicine at Exscientia. “If established, a robust correlation between our platform’s results and clinical outcomes will support the greater use of human tumour samples in the preclinical development of new drug candidates and translational cancer research. This has the potential to overcome the limited clinical relevance of mouse and other animal models that are presently used. In addition, this study may further pave the way for the use of functional drug testing to guide treatment selection to achieve better patient outcomes.”
About EXCYTE-1 Prospective Observational Study
The EXCYTE-1 trial is a multi-centre two-phase study evaluating the correlation between clinical and ex vivo drug response as measured using Exscientia’s AI-based precision medicine platform in ovarian cancer. The study is designed to compare results from the precision medicine platform to clinical outcomes via tissue collection and drug response analysis.
The objective of the pilot phase of the study is to collect patient tissue samples and analyse the drug response of the tissue in a lab setting before scaling up to a larger expansion phase. Two patient populations will be included: patients newly diagnosed with advanced ovarian cancer and those with relapsed ovarian cancer. Before undergoing therapy, malignant ascites will be collected, accompanied by solid tissues where available. The EVDR of commonly used standard of care therapies will then be evaluated in these patient samples by Exscientia’s AI-based precision medicine platform. These results will be compared against patients’ clinical response to treatment, which will be chosen and evaluated by physicians blinded to the EVDR data. Progression free survival (PFS) of patients will be monitored as the key clinical endpoint and assessed to monitor association with EVDR. Secondary endpoints will include EVDR predicted early relapse and PFS >12 months.
Exscientia is an AI-driven precision medicine company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline broadens our approach to other therapeutic areas. By pioneering a new approach to medicine creation, we believe the best ideas of science can rapidly become the best medicines for patients.
Exscientia Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the collaboration with the AGO Study Group; and the timing and progress of, and data collected during and reported from, the EXCYTE-1 clinical trial, as well as expectations with respect to the outcome or benefit of such trial. Any statement describing Exscientia’s goals, plans, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to: the initiation, scope and progress of Exscientia’s and its partners’ planned and ongoing pre-clinical studies and clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; the process of discovering, developing and commercialising product candidates that are safe and effective for use as human therapeutics; and the endeavour of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Exscientia’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 23, 2022 (File No. 001-40850), and other filings that Exscientia makes with the SEC from time to time (which are available at https://www.sec.gov/), the events and circumstances discussed in such forward-looking statements may not occur, and Exscientia’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Exscientia’s forward-looking statements reflect the good faith judgement of its management, these statements are based only on facts and factors currently known by the Company. As a result, you are cautioned not to rely on these forward-looking statements.