Exscientia Acquires Full Rights to Potential Best-in-Class CDK7 Inhibitor Ahead of Phase 1 Dose Escalation Data Readout
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
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
Under the terms of the agreement,
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.
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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
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