On July 18, 2024 Exscientia plc (Nasdaq: EXAI) reported 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 (Press release, Exscientia, JUL 18, 2024, View Source [SID1234644953]).
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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.