Exscientia plc (Nasdaq: EXAI) announced today that it has enrolled the first patient in its Phase I/II “ELUCIDATE” (GTAEXS617-001) study evaluating GTAEXS617 (‘617), a precision engineered CDK7 inhibitor for the treatment advanced solid tumors. The clinical study will evaluate the safety, efficacy and pharmacokinetics of ‘617 in multiple escalating doses and patients with advanced solid tumors including head and neck cancer, colon cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), HR+/HER2 Breast Cancer and Ovarian Cancer ‘617 is a novel CDK7 inhibitor developed by Exscientia in collaboration with GT Apeiron for high potency, selectivity, oral bioavailability and safety.
“We are extremely excited to begin clinical evaluation of another AI-engineered molecule at Exscientia,” said Dr. Michael Krams, Chief Quantitative Medicine Officer at Exscientia could not be overcome by traditional drug discovery methods with an emphasis on targeted potency, selectivity and safety. Coupled with our unique ability to collect data from primary patient samples to predict response, we now believe our ‘617 programs demonstrate the possibilities of the different ways we add value using our precision medicine platform . We now look forward to enrolling additional patients in the ELUCIDATE trial and predict that once approved, ‘617 can significantly improve patient outcomes.”
In Exscientia’s IGNITE study to evaluate its A2AR antagonist EXS21546, the company used a simulation-guided clinical study design to determine the efficacy characteristics of the two phases of the study. The dose escalation portion (Phase I) of the study will characterize the safety profile of ‘617 and determine the Phase II Recommended Dosing (RP2D) as monotherapy and in combinations with the chosen standard of care regimens. The dose expansion portion (Phase II) of the study will evaluate the preliminary antitumor activity of ‘617 as monotherapy and in combination with standard of care.
Exscientia emphasized novel at the EORTC-NCI-AACR (ENA) Symposium in October 2022 ex vivopatient sample response data, identifying and confirming the CDK7-specific pharmacodynamic biomarkers for cancer and immune cells and identifying high and low response groups in patient samples with respect to the ex vivo tested indications. Utilizing this translational data has the potential to ultimately predict ‘617 treatment success in individual patients, thereby improving the chances of treatment success. In addition to evaluating ‘617 as part of the ELUCIDATE study program, Exscientia and GT Apeiron will also generate data including clinical endpoints, peripheral and tumor multi-omics, and correlated and response data to previously collected data ex vivoFindings to further support the value of Exscientia’s precision medicine platform.
About the Phase I/II ELUCIDATE study
The ELUCIDATE study is a multicenter, open-label, two-phase clinical study evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of ‘617 administered orally as monotherapy and in combination with standard of care therapies. The Company is currently recruiting patients with solid tumors who have advanced, recurrent, or metastatic disease and have failed standard therapy.
For the dose escalation portion of the study of both monotherapy and combination therapy, patients will be recruited for up to seven doses, depending on how many doses are needed to define RP2D. The dose expansion phase of the study will begin with the identification of RP2D. The primary endpoint of the expansion phase is objective response rate (ORR).
CDK7 inhibition combines cell cycle disruption with transcription inhibition, making it an attractive target for overcoming the common resistance pathways in cell cycle-only CDK4/6 inhibition. ‘617 has the potential to overcome important limitations in the safety and efficacy of existing treatments due to its differential reversibility and potentially reduced gastrointestinal (GI) toxicity.
About Exscientia
Exscientia is a pharmaceutical technology company dedicated to discovering, designing and developing the best possible medicines in the fastest and most effective way using AI. Exscientia has developed the first functional precision oncology platform that successfully guides treatment choices and improves patient outcomes in a prospective clinical intervention study. She is also advancing small molecule compounds developed with the help of AI to clinical development. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline is expanding our approach to other therapeutic areas. We believe that with our new approach to creating medicines, the best ideas in science can be quickly translated into the best medicines for patients.
For more information, visit https://www.exscientia.ai or follow us on Twitter @exscientiaAI.
About GT Apeiron
GT Apeiron redefines the medical findings with the help of artificial intelligence and thus optimizes the drug development process — from target selection to clinical studies. With strategic locations in Shanghai and the San Francisco Bay Area and significant partnerships in Europe, Apeiron integrates talent and leading technologies across multiple regions. We believe that by pushing the boundaries of biomedical innovation and recruiting global talent, we have the ability to create breakthrough medicines to address the greatest unmet medical needs.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements related to: the timing and progress made and the data reported from the ‘617 clinical trials and the other Exscientia product candidates; and any potential post-approval benefits of ‘617 to patients. Any statements that describe Exscientia’s goals, plans, expectations, projections, intentions or beliefs are forward-looking statements and should be considered statements that involve risk. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to: the initiation, scope and progress of Exscientia’s and its partners’ planned and ongoing preclinical studies and the impact on their costs; clinical, scientific, regulatory and technical developments; and those inherent in the process of researching, developing and commercializing product candidates that can be used safely and effectively as human medicines and seeking to build a business around such products. Considering these risks and uncertainties as well as other risks and uncertainties discussed in Exscientia’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2022 (File Number 001-40850) and other filings that Exscientia makes periodic filings with the SEC (available at https://www.sec.gov/), the events and circumstances discussed in such forward-looking statements may not occur and Exscientia’s actual results could be materially and adversely affected differ from the expected or implied results. Although Exscientia’s forward-looking statements reflect judgments made by the Company’s management in good faith, these statements are based only on facts and factors currently known to the Company. Therefore, forward-looking statements should not be relied upon.
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