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Exscientia plc (Nasdaq: EXAI) has announced the initiation of the EXCYTE-2 study, an observational clinical study in acute myeloid leukaemia (AML) to investigate the relationship between ex vivo drug response (EVDR) measured in primary blood or bone marrow samples using the company’s deep learning, single-cell precision medicine platform and actual patient clinical response. The study aims to collect blood and bone marrow samples from first-line patients with AML, with an option to expand to second-line patients, representing areas of high unmet medical need with low survival rates. The study will also evaluate the activity of EXS74539 (‘539), Exscientia’s LSD1 inhibitor, in a large clinically annotated sample set, with the potential to support the ongoing development of ‘539, particularly in the selection of patients for future clinical trials. This study builds on other previously initiated precision medicine focused studies, including EXALT-1 and EXCYTE-1, and continues the company's focus on establishing AI-led ex vivo drug testing in human tissue samples as the most comprehensive strategy for preclinical testing of novel therapies, additive to mouse and other animal models.
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The initiation of the EXCYTE-2 study by Exscientia plc is a significant step towards integrating artificial intelligence into precision medicine, particularly in the treatment of acute myeloid leukemia (AML). As a Medical Research Analyst, it is important to highlight the potential of Exscientia's AI-driven platform to revolutionize the preclinical testing landscape. By analyzing primary blood or bone marrow samples, the platform seeks to establish a correlation between ex vivo drug response and actual clinical outcomes. The implications of such a study are vast, as it could lead to a more personalized approach to AML treatment, which is known for its low survival rates and high unmet medical need.

Furthermore, the study's design to potentially expand to second-line patients indicates a commitment to broadening the therapeutic impact across various stages of AML. The evaluation of the LSD1 inhibitor, EXS74539, within this framework could expedite its development by identifying responsive patient subsets. This stratification could improve the efficiency of future clinical trials, reducing the time and cost associated with bringing new treatments to market.

As an Oncology Doctor, understanding the clinical relevance of the EXCYTE-2 study is paramount. AML is a devastating disease with a dire prognosis and current treatments often have limited effectiveness. The application of Exscientia’s single-cell precision medicine platform could lead to a paradigm shift in the management of AML by providing insights into individual patient responses to specific drugs. This is crucial because AML is a heterogeneous disease and patients often react differently to the same treatment.

The use of the company's cloud-based AI for remote analysis of samples is a noteworthy advancement, potentially increasing the speed and scalability of drug testing. Moreover, the study's approach to correlate ex vivo drug response with clinical outcomes could substantially enhance the predictive power of preclinical models, thus refining the selection process for clinical trial participants. This could translate into more targeted and effective therapies, improving survival rates and quality of life for AML patients.

From a Market Research Analyst perspective, the announcement of the EXCYTE-2 study by Exscientia plc represents a strategic investment in the company's pipeline and could have significant market implications. The focus on AML, a condition with limited treatment options, positions Exscientia in a niche but critical segment of the oncology market. The success of the EXCYTE-2 study and the potential of the LSD1 inhibitor, EXS74539, could attract partnership opportunities, enhance investor confidence and potentially lead to an increase in the company's market valuation.

Moreover, the integration of AI and deep learning in drug development is a growing trend that is being closely watched by investors and industry stakeholders. Exscientia’s progress in this area, particularly if the EXCYTE-2 study yields positive correlations between EVDR and clinical outcomes, could establish the company as a leader in AI-driven precision medicine. This, in turn, could have a ripple effect on the stock market, as similar companies might also receive increased attention from investors seeking to capitalize on this innovative approach to drug development.

Multicentre EXCYTE-2 study to evaluate precision medicine platform in patients with acute myeloid leukaemia

Supports ongoing development of LSD1 inhibitor (EXS74539) currently in preclinical development

OXFORD, England--(BUSINESS WIRE)-- Exscientia plc (Nasdaq: EXAI) today announced the initiation of EXCYTE-2, an observational clinical study in acute myeloid leukaemia (AML) to investigate the relationship between ex vivo drug response (EVDR) measured in primary blood or bone marrow samples using the company’s deep learning, single-cell precision medicine platform and actual patient clinical response.

The EXCYTE-2 study will collect blood and bone marrow samples from first-line patients with AML, with an option to expand to second-line patients. Both patient groups represent areas of high unmet medical need with low survival rates. Biobanked tissue samples, alongside clinical patient data including diagnostic and outcome data, will be collected from treatment centres with samples to be processed by Exscientia or partner laboratories. These partner laboratories will be using Exscientia’s cloud-based AI to analyse samples remotely.

In addition, the study allows for the evaluation of activity of EXS74539 (‘539), Exscientia’s LSD1 inhibitor, in a large clinically annotated sample set. This work has the potential to support the ongoing development of ‘539, particularly in the selection of patients for future clinical trials.

The EXCYTE-2 study builds on other previously initiated precision medicine focused studies, including EXALT-1 and EXCYTE-1. The EXALT-1 trial was an interventional trial and the first trial to leverage analysis of drug action in primary human cancer tissues using high content imaging and deep learning to guide treatment selection and improve outcomes in patients with late-stage haematological cancers. EXCYTE-2 will leverage the progress the company has made on its AI-driven precision medicine platform since the EXALT-1 trial was completed and will specifically evaluate earlier stage patient populations. EXCYTE-1 is an ongoing prospective observational study focused on ovarian cancer.

“This study continues our focus on establishing AI-led ex vivo drug testing in human tissue samples as the most comprehensive strategy for preclinical testing of novel therapies, additive to mouse and other animal models,” said Dr. Nikolaus Krall, EVP of Precision Medicine at Exscientia. “A robust correlation between our platform’s results and clinical outcomes has the potential to change clinical practice for the benefit of AML patients.”

About EXCYTE-2

The EXCYTE-2 trial is a multicentre two-phase study evaluating the correlation between clinical and ex vivo drug response as measured using Exscientia’s AI-based precision medicine platform in AML.

Initially the trial will focus on newly diagnosed AML patients, with the option to include relapsing/refractory AML patients after an interim analysis. Blood or bone marrow collected from patients prior to initiation of therapy will be obtained from biobanks. 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. Complete remission will be used as the primary clinical endpoint and assessed to monitor association with EVDR. Measurable residual disease is included as a secondary clinical endpoint.

About Exscientia

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. For more information visit us on www.exscientia.ai or follow us on LinkedIn @ex-scientia and X @exscientiaAI.

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 progress of discovery and development of candidate molecules. Any statement describing Exscientia’s goals, plans, expectations, projections, 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 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, 2023 (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.

Investor Relations Contact:

Sara Sherman / Chinedu Okeke

investors@exscientia.ai



Media Contact:

Oliver Stohlmann

media@exscientia.ai

Source: Exscientia plc

The purpose of the EXCYTE-2 study is to investigate the relationship between ex vivo drug response (EVDR) measured in primary blood or bone marrow samples using Exscientia's precision medicine platform and actual patient clinical response in acute myeloid leukaemia (AML) patients.

The study will evaluate the activity of EXS74539 (‘539), Exscientia’s LSD1 inhibitor, in a large clinically annotated sample set, with the potential to support the ongoing development of ‘539, particularly in the selection of patients for future clinical trials.

The EXCYTE-2 study builds on other previously initiated precision medicine focused studies, including EXALT-1 and EXCYTE-1.

Dr. Nikolaus Krall, EVP of Precision Medicine at Exscientia, is leading the EXCYTE-2 study.
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at the forefront of small molecule drug discovery we are the first company to automate drug design, surpassing conventional human endeavour. our ai driven systems actively learn best practice from vast repositories of discovery data and are further enhanced with knowledge acquired from seasoned drug hunters. with better information to hand than any researcher could acquire individually, our knowledge-driven systems design millions of novel, project-specific compounds and pre-assess each for predicted potency, selectivity, adme and other key criteria. from this, a selection of the best, information-rich compounds are selected for synthesis and assay. with new experimental data generated, the results are integrated and the next design cycle initiated. rapid design-make-test cycles ensure unparalleled progress towards desired project goals. exscientia has already delivered exceptional productivity, generating candidates in roughly one-quarter of the time of traditional approaches.