Exscientia AI Ltd.

OXFORD, England--(BUSINESS WIRE)-- Exscientia Ltd. (Nasdaq: EXAI) today announced clinical trial application (CTA) approval of IGNITE-AI, enabling site activation in its first European country. IGNITE-AI is a Phase 1/2 trial studying EXS-21546 ('546), Exscientia’s A2A receptor antagonist in combination with anti-PD-1 therapy in patients with immunotherapy relapsed or refractory renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). The study will evaluate safety, efficacy, pharmacokinetics and pharmacodynamics in up to 110 patients. Exscientia intends to expand to additional tumour types, including breast cancer, in future trials after assessment of ‘546 activity and validation of its selection biomarkers. "High adenosine levels in the tumour microenvironment have the potential to suppress immune function, which can inhibit the efficacy of checkpoint inhibitors," said Dr. Michael Krams, Chief Quantitative Medicine Officer of Exscientia. "We have designed this trial not only to learn about ‘546, but also to enhance our confidence in our patient enrichment strategy. We place a strong emphasis on biomarker qualification, because our goal is to identify the right patients for the right treatment." Exscientia used simulation guided clinical trial design to determine the operating characteristics of the two stages of the trial. The first stage will apply a continuous reassessment model to use accruing data from the dose escalation phase to establish the maximum tolerated dose (MTD) of Exscientia’s A2A receptor antagonist. Once the MTD is identified with sufficient confidence, the study will advance to the second stage, where the MTD is applied to an expansion cohort. The goal of the expansion phase is to create evidence of efficacy of '546 in combination with a PD-1 inhibitor as well as further enhance confidence in Exscientia's biomarker signature. At a medical meeting in December, Exscientia will present data on its novel multi-gene signature for identifying high adenosine patient populations, referred to as the adenosine burden score (ABS). IGNITE-AI is designed to prospectively evaluate the ABS in comparison to patient responses in order to validate its use in patient selection. Once statistical confidence in the ABS has been reached, the Company plans to apply the biomarker signature to directly enrich the patient population in clinical development. “We are proud to move forward with this industry-leading trial and the first patient study for Exscientia. Exscientia is a precision medicine company, and this trial exemplifies how we are extending our AI-driven, adaptive learning approach that we use in discovery now into development,” said Professor Andrew Hopkins, D.Phil., founder and Chief Executive Officer of Exscientia. "We believe that our precision medicine platform can help us select the right patients, which could allow us to translate the scientific potential for A2A receptor antagonists into clinical results." About the Phase 1/2 IGNITE-AI trial The IGNITE-AI Phase 1/2 trial is a multicentre, open-label, two-stage clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of EXS-21546 in combination with PD-1 inhibition. The Company intends to enrol patients with relapsed or refractory RCC or NSCLC who previously received treatment with an immune checkpoint inhibitor. By evaluating patients that have progressed after checkpoint inhibition therapy, the trial is designed to test whether A2A receptor antagonism will restore the ability of the immune system to respond to checkpoint inhibitors. The dose escalation portion of the trial will enrol a maximum of 30 patients across up to seven dose levels, depending on how many dose levels are needed to define the maximum tolerated dose (MTD). The dose expansion phase of the trial will commence upon identification of the MTD and will enrol up to 80 patients. The primary efficacy endpoint of the expansion phase is objective response rate (ORR). EXS-21546 is a highly selective A2A receptor antagonist ​​co-invented and developed through a collaboration between Exscientia and Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; Nasdaq: EVO). The molecule was identified in 9 months after testing 163 compounds and is one of the first AI designed drugs in the industry to enter the clinic. In June 2022, Exscientia reported topline data from a healthy volunteer study which confirmed Exscientia’s target product pro including potency, high receptor selectivity and expected low brain exposure with no CNS adverse events reported. About Exscientia Exscientia is an AI-driven pharmatech 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 is headquartered in Oxford (England, U.K.), with offices in Vienna (Austria), Dundee (Scotland, U.K.), Boston (Mass., U.S.), Miami (Fla., U.S.), Cambridge (England, U.K.), and Osaka (Japan). Visit us at or follow us on Twitter @exscientiaAI.

The biotech IPO market awoke from its summer hibernation on Friday morning with a small ADHD drug developer seeking a modest raise, but late Friday night saw another company file its SEC paperwork, one that will likely shoot for the stars. Exscientia, the UK-based AI outfit with bold claims about its platform, submitted its F-1 on Friday, penciling in an initial $100 million raise estimate. That figure will almost certainly end up much higher, as Exscientia has spent most of 2021 racking up huge fundraising sums thanks to a Series C extension headed by BlackRock, and an up to $525 million Series D that included a $300 million equity investment from SoftBank. AI biotechs have proven largely successful at drumming up hype around their technology, and Exscientia is no different. Promising to cut down on the lengthy process that is drug development by months, if not years, Exscientia will seek to join one of its main competitors in Recursion on Nasdaq. Both companies claimed to be the first to put an AI-developed drug into the clinic. Recursion did so in July 2019, even though CEO Chris Gibson readily conceded the program originally came out of Dean Li’s lab at Merck. Exscientia followed up with its announcement in January 2020, though its candidate — developed in partnership with Sumitomo Dainippon — emerged after the pair synthesized 350 compounds and tested them in a lab before deciding on one to move forward. Whether either program truly came from AI is largely beside the point, however, as both biotechs continue to enlist major partners and significant investment. In particular, Exscientia expanded a Celgene-era deal with Bristol Myers Squibb in May, one that could see more than $1.2 billion paid out when all is said and done. The biotech followed that up with a small acquisition for the molecule-screening biotech Allcyte in June, and less than two weeks later joined forces with EQRx. Following its own massive fundraising rounds, Recursion went public in April to the tune of a $436.4 million raise, a figure that could prove a useful barometer for Exscientia’s Nasdaq ambitions. There’s also the machine learning biotech insitro, which hasn’t announced plans to go public just yet but raked in $400 million in a Series C this past March. Though it helped Sumitomo advance two additional programs into Phase I, one of which brought about Exscientia’s “first AI” claims, the biotech has just one in-house candidate in human studies: an A2a receptor antagonist co-developed with Evotec. This candidate entered the clinic in April, and Exscientia plans to funnel a good chunk of its IPO raise toward the program. The biotech hasn’t specified how it plans to divvy up its new cash, only listing the “development” of its platform and the in-house compound as the main beneficiaries. There will also be $70 million set aside for Exscientia’s Gates Foundation- partnered pandemic preparedness program. As the calendar approaches the fourth quarter, the biotech IPO market remains on pace to eclipse last year’s record raise of $16.5 billion. Through nearly nine months, the sector has combined to raise nearly $13 billion per the Endpoints News tally , and two more biotechs in DiCE Therapeutics and Tyra Biosciences are expected to land nine-figure raises later this week. Passing 2020’s figure may ultimately require an end-of-year boost, given the slowdown of pricings over the summer. If Exscientia comes anywhere close to Recursion’s total, the industry may be well on its way to another phenomenal IPO year.

Pharmatech Exscientia is to acquire precision medicine company Allcyte to help increase its understanding of patient biology and expand out of artificial cell lines and animal models. × Expand Acquisition Allcyte has developed a platform that anticipates the effectiveness of cancer treatments by using AI to analyse the activity of drugs in live patient samples at single-cell resolution. Through the acquisition, Exscientia will work to expand Allcyte’s platform and extend it into early discovery, so that AI approaches are applied from target discovery and drug optimisation to patient selection. It’s hoped that this end-to-end approach will allow discovery projects to be assessed in a biological setting that more accurately reflects the actual patient environment, improving translation from laboratory to clinic. “Allcyte is able to demonstrate what therapy actually works in the individual patient with the most disease relevant screening platform we have seen,” said Andrew Hopkins, Exscientia’s CEO. “Combining Allcyte’s platform with Exscientia’s technologies can redefine how drugs are developed, enabling integrated discovery and patient selection. Allcyte has assembled an outstanding team in Vienna and integration of the two platforms truly allows us to build our vision of patient-first AI.” Commenting on the acquisition, Nikolaus Krall, Allcyte CEO added, “We are incredibly excited about the opportunity to immediately apply this technology to a wide range of drug discovery projects at Exscientia. This will also provide our team with the scale to expand our operations much more quickly to help provide important personalised, precision medicines to as many patients as possible.” Exscientia will pay €50 million in cash and shares for the acquisition. The company has also announced it plans to expand its Vienna site as the hub of its European Union.