Exscientia Acquires Full Rights to Potential Best-in-Class CDK7 Inhibitor Ahead of Phase 1 Dose Escalation Data Readout

Rhea-AI Summary

Exscientia plc (Nasdaq: EXAI) has acquired full rights to the oral CDK7 inhibitor programme, including GTAEXS617, from GT Apeiron. This acquisition maximizes the potential of the precision-designed compound ahead of its Phase 1 dose escalation data readout. The ELUCIDATE Phase 1/2 trial is progressing well, with monotherapy dose escalation data expected in the second half of 2024. A combination dose escalation study for HR+/HER2- breast cancer is planned for late 2024/early 2025. Exscientia will pay GT Apeiron $10 million in cash, $10 million in equity, and single-digit royalties on potential commercialization. Despite this transaction, Exscientia's cash runway is expected to extend well into 2027.

Positive

• Acquisition of full rights to CDK7 inhibitor programme, including GTAEXS617
• Phase 1 dose escalation data readout on track for second half of 2024
• Planned combination dose escalation study for HR+/HER2- breast cancer
• Cash runway expected to extend well into 2027 despite the acquisition costs

Negative

• Upfront payment of $20 million ($10 million cash, $10 million equity) to GT Apeiron
• Assumption of all existing development costs
• Potential future single-digit royalty payments on commercialization

Financial Analyst

Exscientia's acquisition of full rights to GTAEXS617 is a strategic move that could potentially have impactful financial implications. Firstly, the immediate $20 million investment—split into cash and equity—shows the company's commitment to its long-term growth. However, investors should take note of the ongoing development costs, which Exscientia has agreed to bear. These could be substantial, although not explicitly mentioned.

The company's claim that their cash runway will extend well into 2027 is an optimistic signal, suggesting that they have managed their finances prudently. Given the burn rates associated with drug development, this is a positive indicator of financial health but should be monitored closely as clinical trials progress.

Another point of interest is the potential for single-digit royalties. While these royalties might not significantly impact revenue in the short term, they present a future revenue stream if '617 is commercialized successfully. For an investor, this translates into a blend of near-term costs with potential long-term benefits.

In the context of the broader biotech market, securing full intellectual property rights and control over a promising drug is a high-stakes but potentially high-reward scenario. This acquisition positions Exscientia to leverage its AI-driven capabilities fully, potentially accelerating its market position if '617 proves successful in trials.

Oncology Doctor

The CDK7 inhibitor, GTAEXS617, presents a promising therapeutic approach in oncology, particularly for patients with HR+/HER2- breast cancer who have exhausted other treatments. CDK inhibitors are an established class in treating cancer, but CDK7 inhibition offers a unique mechanism of action that could target different pathways involved in tumor progression and resistance to existing therapies.

The ELUCIDATE Phase 1/2 trial aims to assess not only the safety but also the pharmacokinetics and pharmacodynamics of '617. This data will be important in understanding the drug's efficacy, potential side effects and optimal dosing strategies. The planned combination dose escalation phase, starting in late 2024/early 2025, will explore further therapeutic synergies, potentially enhancing the drug's effectiveness when used alongside other treatments.

The reversible mechanism of action and suitable human half-life, as mentioned, are particularly noteworthy. These features suggest that '617 could offer a balanced therapeutic index, maximizing efficacy while minimizing adverse effects—an important consideration for patient quality of life. Overall, the drug's potential to expand treatment options in a heavily pre-treated patient population is significant, making this development noteworthy for both clinicians and patients.

Medical Research Analyst

The acquisition underscores Exscientia's confidence in its AI-driven drug design capabilities. By gaining full control over GTAEXS617, Exscientia can streamline the development process, potentially reducing time to market. This autonomy allows for more agile decision-making and personalized trial designs, which could translate to faster, more efficient clinical outcomes.

The planned data readouts in the second half of 2024 will be pivotal. Positive results could dramatically boost the company's valuation and attract further investment. However, investors should temper expectations with the understanding that clinical trials are inherently risky and subject to setbacks. The combination treatment phase targeting HR+/HER2- breast cancer patients is particularly intriguing. If successful, this could carve out a niche in a competitive oncology market and set a precedent for future AI-designed drugs.

From an investor's perspective, the strategic move to fully acquire the drug and its related IP rights aligns with Exscientia's long-term vision of being a leader in precision-designed therapies. It also exemplifies the increasing role of AI in drug development, potentially setting a new standard in the biotech industry.

Maximises upside potential of precision-designed GTAEXS617 with purchase of rights from GT Apeiron

Monotherapy dose escalation data readout for ELUCIDATE Phase 1/2 trial on track for second half of 2024

Combination dose escalation study starting with HR+/HER2- breast cancer to commence in late 2024/early 2025

OXFORD, England--(BUSINESS WIRE)-- Exscientia plc (Nasdaq: EXAI) today announced it has reached an agreement to acquire GT Apeiron’s share of its oral CDK7 inhibitor programme, gaining full control of GTAEXS617 (‘617) and all related intellectual property.

The monotherapy dose escalation phase of ELUCIDATE is designed to assess the safety, pharmacokinetics and pharmacodynamics of '617 in advanced solid tumours. Recruitment for the trial is progressing well with monotherapy dose escalation data on track to readout in the second half of 2024. In late 2024/early 2025, the study will transition to a combination dose escalation phase. The first tumour type to be explored in this portion of the study is expected to be HR+/HER2- breast cancer patients that have progressed on CDK4/6 inhibitors, assessing ‘617 in combination with a selective estrogen receptor degrader (SERD).

“We are excited to have full ownership of this potentially transformative asset,” said David Hallett, Ph.D., interim Chief Executive Officer and Chief Scientific Officer of Exscientia. “This underlines our confidence that we have not only used AI to design a potent and selective compound, but one that has balanced overall properties; these include a reversible mechanism of action and an appropriate human half-life to maximise the therapeutic index of this important cellular mechanism. CDK inhibitors are a major class of oncology drugs, and we believe our highly differentiated compound has the potential to greatly expand impact for patients and exemplifies our leadership in technology-driven drug design.”

Under the terms of the agreement, Exscientia will own full rights to the intellectual property as well as full control of this CDK7 inhibitor programme. Exscientia will pay GT Apeiron $10 million in upfront cash, $10 million in upfront equity, and take on all existing development costs, in addition to paying single digit royalties if Exscientia or a third party commercializes '617. Following the transaction, Exscientia’s cash runway is still expected to extend well into 2027.

About ELUCIDATE

The ELUCIDATE trial is a multicentre, open-label, two-stage clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of ‘617 administered orally as monotherapy and in combination with standard of care therapies. The company is enrolling patients with solid tumours including head and neck cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), breast cancer and ovarian cancer, who have advanced, recurrent or metastatic disease and have failed standard of care.

Both the monotherapy and combination therapy dose escalation portion of the trial will enrol patients across multiple dose levels to determine the optimal biological dose (OBD). The dose expansion phase of the trial will commence upon identification of the OBD. The primary efficacy endpoint of the expansion phase is objective response rate (ORR).

CDK7 inhibition combines many potential benefits such as transcription inhibition, reduction of aberrant kinome activation, cell cycle inhibition and modulation of estrogen receptor activity. This makes it an attractive target to overcome common resistance pathways associated with CDK4/6 inhibition, which only targets the cell cycle. Exscientia believes ‘617 has the potential to overcome significant safety and efficacy limitations of existing approved treatments due to the underlying biology of CDK7 and our laser focus on maximising therapeutic index through an AI-designed molecule that enables tight control of both extent and duration of target inhibition.

About Exscientia

Exscientia is a technology-driven drug design and development company, committed to creating more effective medicines for patients, faster. Exscientia combines precision design with integrated experimentation, aiming to invent and develop the best possible drugs in the most efficient manner. Operating at the interfaces of human ingenuity, artificial intelligence (AI), automation and physical engineering, we pioneered the use of AI in drug discovery as the first company to progress AI-designed small molecules into a clinical setting. We have developed an internal pipeline focused on oncology, while our partnered pipeline extends to many other therapeutic areas. By leading this new approach to drug creation, we believe we can change the underlying economics of drug discovery and rapidly advance the best scientific ideas into medicines for patients.

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

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the advantages of the Company’s technology platform and its drug discovery programmes; the Company’s belief that using generative AI will accelerate drug development; the anticipated benefits and upside potential of the Company’s control and full ownership of the intellectual property related to the CDK7 inhibitor program; the initiation, timing and progress of, and data collected during and reported from, the Company’s and its partners’ clinical trials, as well as the Company’s expectation that its existing cash runway will be sufficient to fund its operations well into 2027. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the company’s control. These risks and uncertainties include, but are not limited to, the risk that the company’s platform technology may fail to discover and design molecules with therapeutic potential or may not result in the discovery and development of commercially viable products for the company or its collaborators; the company may be unable to advance its drug candidates through clinical development, regulatory approval or commercialisation; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on the Company’s business, clinical trials and financial position; the company’s ability to realise the benefits of its collaborations; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. These and other risks and uncertainties are described in the “Risk Factors” section of Exscientia’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on March 21, 2024, and well as discussions of potential risks, uncertainties and other factors in Exscientia’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law.

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Investor Relations:

Sara Sherman / Chinedu Okeke

investors@exscientia.ai

Media:

David Keown

media@exscientia.ai

Source: Exscientia plc

FAQ

What did Exscientia acquire from GT Apeiron regarding GTAEXS617?

Exscientia acquired full rights to the oral CDK7 inhibitor programme, including GTAEXS617, and all related intellectual property from GT Apeiron.

When is the Phase 1 dose escalation data for GTAEXS617 expected to be released?

The monotherapy dose escalation data from the ELUCIDATE Phase 1/2 trial is expected to be released in the second half of 2024.

What is the next planned study for GTAEXS617 after the monotherapy dose escalation?

A combination dose escalation study for HR+/HER2- breast cancer patients who have progressed on CDK4/6 inhibitors is planned to start in late 2024 or early 2025.

How much did Exscientia (EXAI) pay to acquire the full rights to GTAEXS617?

Exscientia paid $10 million in upfront cash and $10 million in upfront equity to GT Apeiron, along with assuming all existing development costs and agreeing to pay single-digit royalties on potential commercialization.