Exscientia plc today announced the enrollment of the first patient in its Phase 1/2 "ELUCIDATE" study evaluating the CDK7 inhibitor GTAEXS617 precision-engineered by Exscientia, for the treatment of advanced solid tumors. The clinical trial will evaluate the safety, efficacy and pharmacokinetics of GTAEXS617 at multiple ascending doses in patients with advanced solid tumors including head and neck cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast carcinoma and ovarian cancer. '617 is a new CDK7 inhibitor that was designed by Exscientia in collaboration with GT Apeiron to seek potency, selectivity,

We are very pleased to begin clinical evaluation of another AI-created molecule at Exscientia,” said Dr. Michael Krams, Chief Quantitative Medicine Officer at Exscientia. “The '617 molecule was created to address critical design issues unsolved by traditional drug discovery methods, focusing on potency, selectivity and target safety. Combined with our unique ability to gather data from primary patient samples to predict response, we believe our '617 program demonstrates the power of our different ways of creating value through our medicine platform. precision.

Similar to Exscientia's IGNITE trial which evaluated its A 2A R antagonist, EXS21546, the company used a simulation-guided clinical trial design to determine the operating characteristics of both trial stages. The dose escalation (Phase 1) portion of the study will characterize the safety profile of '617 and establish the recommended dose for Phase 2 (RP2D), both as monotherapy and combination with selected standard treatment regimens. The dose expansion phase (Phase 2) of the study will evaluate the preliminary antitumor activity of '617 as monotherapy and in combination with standard treatments.

Exscientia has already highlighted new ex vivo patient sample response data at the EORTC-NCI-AACR (ENA) Symposium in October 2022, which identify and confirm CDK7-specific pharmacodynamic biomarkers in cancer and immune cells , and which identify patient groups with strong and weak response to patient samples in all indications tested ex vivo. Exploitation of these translational data could help predict the response to '617 treatment in individual patients, thereby increasing the likelihood of treatment success. Along with evaluating '617 in the ELUCIDATE trial program, Exscientia and GT Apeiron will also provide data including clinical endpoints, peripheral and tumor multi-omics data, and correlate data and ex vivo response and results previously collected to enhance the value of Exscientia's precision medicine platform.

About the Phase 1/2 ELUCIDATE trial

The ELUCIDATE trial is a multicenter, open-label, two-stage clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of '617 administered orally as monotherapy and in combination with standard therapies of care. The company recruits patients with advanced, recurrent or metastatic solid tumors who have not responded to standard treatments.

The monotherapy and combination therapy dose escalation portion of the trial will enroll patients receiving up to seven dose levels, depending on the number of dose levels needed to define IP2D. The dose escalation phase of the trial will begin upon identification of IP2D. The primary efficacy endpoint of the expansion phase is the objective response rate (ORR).

CDK7 inhibition combines cell cycle disruption and transcriptional inhibition, thus becoming an attractive target for overcoming resistance pathways common to CDK4/6 inhibition, which only targets the cell cycle. With its differentiated reversibility and potentially reduced gastrointestinal toxicity, '617 may overcome significant safety and efficacy limits of existing treatments.

About Exscientia

Exscientia is an AI-powered precision medicine company committed to discovering, designing and developing the best possible medicines in the fastest and most efficient way. Exscientia has developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to advance small molecules designed with to AI. Our portfolio of internal projects builds on our precision medicine platform in oncology, while our portfolio of partnered projects expands our approach to other therapeutic areas.

Check out our site at https://www.exscientia.ai or follow us on Twitter at @exscientiaAI .

About GT Apeiron

GT Apeiron is reimagining medical discovery with artificial intelligence that streamlines the drug development process, from target selection to clinical trials. With strategic locations in Shanghai and the San Francisco Bay Area, and significant partnerships in Europe, Apeiron integrates talent and cutting-edge technology across multiple regions. We believe that by pushing the boundaries of biomedical innovation and mobilizing talent globally, we can create breakthrough medicines to address the greatest unmet medical needs.

Forward-looking statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including but not limited to: the timing and progress of clinical trials of '617 and other Exscientia product candidates, and reported data by these tests; and, if approved, any possible benefit of '617 to patients. Any statement describing Exscientia's objectives, plans, expectations, projections, intentions or beliefs represents a forward-looking statement and should be considered an at-risk statement. These statements are subject to a number of risks, uncertainties and assumptions, including those relating to: initiation, the scope and progress of Exscientia and its partners' scheduled and ongoing preclinical studies and clinical trials and their financial consequences; clinical, scientific, regulatory and technical developments; the process of discovering, developing and commercializing product candidates that are safe and effective for use in the treatment of human diseases; and the effort to build a society around these product candidates. Given these risks and uncertainties, and other risks and uncertainties described in the Risk Factors section and other sections of Exscientia's Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC ) on March 23, 2022 (File No. 001-40850),https://www.sec.gov/ ), the events and circumstances discussed in these forward-looking statements may not occur, and Exscientia's actual results may differ materially and adversely from those anticipated or implied by such statements. Although Exscientia's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known to the company. Accordingly, you are cautioned not to rely on these forward-looking statements.

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Contacts
Investor Relations:
Sara Sherman
investors@exscientia.ai

Media:
Oliver Stohlmann
media@exscientia.ai

 

Source:businesswire.com

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