Exscientia Acquires Full Rights to Potential Best-in-Class CDK7 Inhibitor Ahead of Phase 1 Dose Escalation Data Readout
18 Julio 2024 - 6:00AM
Business Wire
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
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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version on businesswire.com: https://www.businesswire.com/news/home/20240718738353/en/
Investor Relations: Sara Sherman / Chinedu Okeke
investors@exscientia.ai
Media: David Keown media@exscientia.ai
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