Concentrating rapidly emerging pipeline on most differentiated, highest value oncology targets, including CDK7 and LSD1 programmes
Partnering or discontinuing internal development of programmes outside of core focus, including A2A and select discovery targets
Strategy will support continued investment into market-leading technology while maintaining cash runway well into 2026
Partnered pipeline continues to progress with achievement of first milestone for Sanofi collaboration and new collaboration with Merck KGaA
Exscientia plc (Nasdaq: EXAI) today provided an update on its pipeline prioritisation strategy designed to further strengthen the Company’s focus, investment and infrastructure on programmes of greatest potential for differentiation and value creation.
Exscientia has built a highly efficient and versatile AI-led drug discovery platform. To date, its platform has yielded eight differentiated clinical development candidates across a variety of therapeutic areas, and at a pace that is substantially faster than current industry standards. The Company anticipates its capabilities will continue to grow, driven by recent investments in automation as well as other leading technological and scientific advancements which may further accelerate pipeline growth. In this context, the Company intends to prioritise its internal development efforts and focus its resources on the most differentiated, highest value oncology targets within its portfolio, such as LSD1 and CDK7. This strategic focus is designed to allow Exscientia to maximise its pipeline value and output while continuing to develop novel technologies to transform drug discovery and development. In addition, it will enhance operational and financial efficiency with a cash runway well into 2026.
“Exscientia creates value by using technology to solve previously unsolved discovery challenges and achieving great data-driven operating efficiency,” said Professor Andrew Hopkins FRS FMedSci, founder and Chief Executive Officer of Exscientia. “Our oncology programmes like LSD1 and CDK7 focus on well-understood development challenges where our platform can have a clear impact that, if successful, would lead to significant therapeutic benefit. Beyond a focused number of high-value internal programmes in areas where we have deep expertise and strong differentiation, we believe the best way Exscientia can create an abundance of novel medicines for patients is by pairing our platform with strong partners in existing and future collaborations.”
Prioritising CDK7 and LSD1 advancement:
- ‘617 is a potential best-in-class, reversible, candidate designed for improved potency, selectivity and pharmacokinetics compared to other molecules in development
- Patient enrolment continues in the ELUCIDATE Phase 1/2 adaptive trial in patients with advanced solid tumours including head & neck cancer, HR+/HER2- breast cancer, non-small cell lung cancer, pancreatic cancer, ovarian cancer and colorectal cancer
- The model-driven adaptive trial is studying ‘617 as monotherapy and in combination with standard of care, where Exscientia's precision medicine platform is expected to play a critical role in determining the best combinations
- The Company will further prioritise the advancement of its LSD1 inhibitor into the clinic
- IND submission expected in the first quarter of 2024
- ‘539 is highly differentiated in predicted human pharmacokinetics, pre-clinical safety and flexibility of dosing. Based on the unique combination of reversible mechanism of action and CNS penetration it has the potential to be first and best-in-class for small cell lung cancer (SCLC) and acute myeloid leukaemia (AML)
- The Company intends to initiate a Phase 1 healthy volunteer trial in the first half of 2024 that could support more efficient development of ‘539 in multiple indications and in combination with other therapies
- LSD1-related data from Exscientia's precision medicine technology will be presented at ESMO in October, including data in primary AML tissues
Potential programmes for partnering or out-licensing
- In addition to a validated patient selection strategy, the Company believes a prolonged, high level of target coverage is necessary for therapeutic effect, which has been supported by recently announced peer data. Based on modelling of the clinical and preclinical data, it will be challenging for ‘546 to reach a suitable therapeutic index
- The Phase 1/2 trial will be wound down and internal research around the target will be discontinued
- Exscientia believes in the A2A mechanism and its value for a potential partner with an existing immunotherapy pipeline. Exscientia will evaluate potential partnerships for its next-generation compounds and precision medicine capabilities
Additional ongoing clinical, IND-enabling and discovery programmes
- Exscientia’s MALT1 inhibitor is progressing through IND/CTA enabling studies and the Company expects to be able to provide further updates in the first half of 2024. Exscientia believes that '565 is highly differentiated due to reduced UGT1A1 inhibition combined with potency and selectivity
- Data will be presented at ESMO in late October highlighting '565's precision design and its potential for low drug-drug interaction
The Company will continue to identify targets and design novel compounds internally and for partners, where there is strong differentiation. Exscientia intends to advance a small number of new candidates for internal clinical development that demonstrate clear differentiation and market need while also utilising Exscientia’s existing infrastructure. A majority of the future pipeline will be advanced through high-value partnerships or outlicensing
- New collaboration with Merck KGaA initiated, with 3 programmes
- First milestone achieved in the Sanofi collaboration
- The Company will continue to identify targets and design novel compounds internally and for partners, where there is strong differentiation. Exscientia intends to advance a small number of new candidates for internal clinical development that demonstrate clear differentiation and market need while also utilising Exscientia’s existing infrastructure. A majority of the future pipeline will be advanced through high-value partnerships or outlicensing
Other clinical programmes:
- EXS4318 (PKC-theta), DSP-0038 (5-HT1A agonist/5-HT2A antagonist) and DSP-2342 (dual 5-HT2A/5-HT7 antagonist) all are continuing in Phase 1 studies by partners Bristol Myers Squibb and Sumitomo Pharma
The Company ended the second quarter of 2023 with $508.6 million of cash, equivalents and short-term deposits. With today’s announcement, the Company expects to remain well capitalised through the potential achievement of multiple clinical and partnership milestones.
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 https://www.exscientia.ai or follow us on Twitter @exscientiaAI.
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 initiation, timing and progress of, and data collected during and reported from, the Company's clinical trials, as well as expectations with respect to the outcome or benefit of such trial, expectations regarding the growth of the Company’s capabilities and the performance of its technology platform and the Company’s belief that its existing cash and cash equivalents will be sufficient to fund its operations into 2026. 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.