Exscientia Announces First-in-Human Study for Bristol Myers Squibb In-Licensed PKC Theta Inhibitor, EXS4318

Rhea-AI Summary

Exscientia (NASDAQ: EXAI) announced that its candidate EXS4318 has begun Phase 1 clinical trials in the U.S., marking its entry into the immunology & inflammation therapeutic area. This compound, developed with Bristol Myers Squibb, is a selective PKC theta inhibitor aimed at treating autoimmune diseases. Exscientia is eligible for milestone payments and tiered royalties on sales upon approval. This milestone highlights the efficacy of Exscientia's AI-driven drug design platform, which identified EXS4318 within 11 months, showcasing its commitment to rapid drug development.

Positive

• EXS4318 enters Phase 1 clinical trials, indicating progress in drug development.
• Partnership with Bristol Myers Squibb allows Exscientia to receive milestone payments and royalties.
• The compound represents a first-in-class approach with potential to treat prevalent autoimmune diseases.

Negative

• None.

- EXS4318 is the first immunology & inflammation candidate designed by Exscientia and its fourth molecule to enter the clinic -

- Exscientia invented a potentially first-in-class potent and selective PKC theta inhibitor -

- Eligible for pre-commercial milestone payments and, if approved, tiered royalties on net product sales -

OXFORD, England--(BUSINESS WIRE)-- Exscientia plc (Nasdaq: EXAI) today announced that EXS4318 ('4318) a compound precision designed by Exscientia and in-licensed by Bristol Myers Squibb in August 2021, has entered Phase 1 clinical trials in the United States. The compound is in development for immunology & inflammation (I&I) indications. Bristol Myers Squibb will oversee the clinical and commercial development and Exscientia is eligible for milestone payments and, if approved, tiered royalties on net product sales.

"We are excited for Bristol Myers Squibb to begin clinical evaluation of '4318, the first Exscientia I&I candidate to enter the clinic. PKC theta is an attractive immune modulating drug target; however, it has been challenging for the field to design a small molecule with the required potency as well as selectivity against other closely related kinases," said David Hallett, Ph.D., Chief Scientific Officer at Exscientia. "Our expert-led AI design platform was able to deliver a balanced candidate which has demonstrated high on-target activity while maintaining high selectivity and favourable therapeutic index in IND-enabling studies. This is a significant milestone for Exscientia that illustrates the strength and flexibility of our precision design platform in efficiently developing high quality therapeutics.”

Expert drug hunters using the Company’s AI generative design platform identified EXS4318 within 11 months after initiating design and was the 150^th novel compound synthesised in this programme. The target product profile was particularly challenging due to the need for sustained, high levels of target inhibition to drive efficacy as well as the requirement for low daily dose in humans. PKC theta is structurally similar to several related kinases making it difficult to achieve the high levels of selectivity required to avoid off-target effects.

PKC theta, previously referred to as Kinase X by Exscientia, was one of the first small molecule programmes that formed part of the original Bristol Myers Squibb collaboration signed with Celgene in 2019. In May 2021, Bristol Myers Squibb and Exscientia expanded the collaboration in I&I and oncology, with increased economics for Exscientia. EXS4318 is the fourth drug candidate invented by Exscientia to enter the clinic.

About PKC theta

PKC theta plays a critical role in controlling T cell function and is a key driver of several highly prevalent autoimmune diseases. PKC theta inhibitors have potential in inflammatory and immunologic diseases.

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.

Visit us at https://www.exscientia.ai or follow us on Twitter @exscientiaAI.

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 progress of discovery and development of candidate molecules, and the timing and progress of, and data reported from, clinical trials of Exscientia’s product candidates. 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 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.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the collaboration. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to, the collaboration may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that Bristol Myers Squibb may fail to discover and develop any commercially successful product candidates through the collaboration, and that the product candidate may not achieve its primary study endpoints or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indications described in this release will be commercially successful.

No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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Investor Relations:

Sara Sherman

investors@exscientia.ai

Media:

media@exscientia.ai

Source: Exscientia plc

FAQ

What is the significance of EXS4318 entering Phase 1 trials for Exscientia (EXAI)?

The entry of EXS4318 into Phase 1 trials represents a major milestone for Exscientia, as it is the first compound in their immunology & inflammation pipeline to reach this stage.

How does Exscientia (EXAI) benefit financially from the collaboration with Bristol Myers Squibb?

Exscientia is eligible for pre-commercial milestone payments and tiered royalties on net product sales if EXS4318 is approved.

What is the role of PKC theta in the development of EXS4318 by Exscientia (EXAI)?

PKC theta is a target involved in controlling T cell function and is associated with several autoimmune diseases, making it a significant focus for therapeutic intervention.

When did Bristol Myers Squibb in-license EXS4318 from Exscientia (EXAI)?

Bristol Myers Squibb in-licensed EXS4318 from Exscientia in August 2021.