On October 3, 2023 Exscientia plc (Nasdaq: EXAI) reported 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 (Press release, Exscientia, OCT 3, 2023, View Source [SID1234635620]).
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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:
GTAEXS617 (CDK7):
‘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
EXS74539 (LSD1):
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 (Free ESMO Whitepaper) in October, including data in primary AML tissues
Potential programmes for partnering or out-licensing
EXS21546 (A2A):
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
EXS73565 (MALT1):
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 (Free ESMO Whitepaper) in late October highlighting ‘565’s precision design and its potential for low drug-drug interaction
Discovery programmes:
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
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.