Exscientia Gains Full Rights to Promising CDK7 Inhibitor Before Phase 1 Data

Exscientia plc, a company listed on Nasdaq, has entered into an agreement to acquire GT Apeiron’s share in a programme concerning an oral CDK7 inhibitor. This acquisition grants Exscientia full control over the compound known as GTAEXS617 ('617) and the related intellectual property.

The ELUCIDATE trial is currently underway to evaluate the safety, pharmacokinetics, and pharmacodynamics of '617 in patients with advanced solid tumors. Initial phases involve monotherapy dose escalation, with data expected by late 2024. Following this, the trial will move into a combination dose escalation phase, beginning with HR+/HER2- breast cancer patients who have not responded to CDK4/6 inhibitors, in combination with a selective estrogen receptor degrader (SERD).

Dr. David Hallett, the interim Chief Executive Officer and Chief Scientific Officer of Exscientia, expressed enthusiasm about gaining full control over this promising asset. He highlighted the significance of using artificial intelligence (AI) in designing a potent and selective compound with balanced properties, including a reversible mechanism of action and appropriate human half-life, to maximize its therapeutic potential. Hallett emphasized that CDK inhibitors are crucial in oncology, and the distinct characteristics of '617 could significantly benefit patients, demonstrating Exscientia’s leadership in technology-driven drug design.

As per the agreement, Exscientia will possess full rights and control over the CDK7 inhibitor programme. The financial terms include a $10 million upfront cash payment, a $10 million equity payment to GT Apeiron, and the assumption of all existing development costs. Additionally, Exscientia will pay single-digit royalties if '617 is commercialized by either Exscientia or a third party. Despite the expenditure, Exscientia’s financial forecast remains strong, with sufficient funds expected to last well into 2027.

The ELUCIDATE trial is structured as a multicenter, open-label, two-stage clinical trial, assessing the oral administration of '617 both as a monotherapy and in combination with standard therapies. The trial focuses on patients with various types of advanced, recurrent, or metastatic solid tumors who have not responded to standard treatments. These include cancers of the head and neck, colorectal, pancreatic, non-small cell lung cancer (NSCLC), breast, and ovarian cancers.

The trial will determine the optimal biological dose (OBD) during dose escalation phases for both monotherapy and combination therapy. Following the identification of the OBD, the trial will proceed to the dose expansion phase, with the primary goal of achieving an objective response rate (ORR).

CDK7 inhibition offers multiple potential benefits, such as inhibiting transcription, reducing aberrant kinome activation, controlling the cell cycle, and modulating estrogen receptor activity. These advantages make it a compelling target to overcome resistance pathways commonly associated with CDK4/6 inhibition, which focuses solely on the cell cycle. Exscientia believes that '617 can address significant safety and efficacy shortcomings of current treatments, thanks to the underlying biology of CDK7 and their focus on maximizing therapeutic index through an AI-designed molecule, ensuring tight control over the extent and duration of target inhibition.

Exscientia is a company dedicated to the technology-driven design and development of drugs. Their aim is to create more effective medications for patients, faster. By integrating precision design with thorough experimentation, and utilizing AI in drug discovery, Exscientia has led the way in bringing AI-designed small molecules into clinical settings. Their internal pipeline primarily targets oncology, while their collaborative pipeline spans several therapeutic areas. Exscientia is committed to revolutionizing drug discovery economics and rapidly advancing scientific ideas into viable medicines.