GT Apeiron Announces Enrollment of First Patient in Phase 1/2 “ELUCIDATE” Clinical Trial of CDK7 Inhibitor, GTAEXS617, in Advanced Solid Tumors
- Preclinical data from AI-optimized GTAEXS617 support potential for improved therapeutic index compared to other CDK7 inhibitors under development
- Parallel translational initiative to evaluate preclinically identified non-invasive PD biomarkers with potential to predict GTAEXS617 treatment responders
SAN FRANCISCO & SHANGHAI, July 10, 2023 -- GT Apeiron, a biopharmaceutical company harnessing the power of artificial intelligence (AI) to develop targeted precision therapies for unmet medical needs, today announced the enrollment of the first patient in the Phase 1/2 “ELUCIDATE” study which is designed to evaluate GTAEXS617 for the treatment of advanced solid tumors. Developed in collaboration with its strategic partner, Exscientia plc (Nasdaq: EXAI), GTAEXS617 is a highly selective, small molecule, non-covalent inhibitor of cyclin-dependent kinase 7 (CDK7). The ELUCIDATE trial is designed to evaluate the safety, efficacy, and pharmacokinetics of GTAEXS617 across multiple ascending doses, as a monotherapy and in combination with standard of care therapy, in adults with advanced solid tumors.
"The initiation of the ELUCIDATE study represents a significant milestone in our company’s development and is the first drug candidate from our partnership with Exscientia to enter clinical studies," said Mingxi Li, Ph.D., chief executive officer of GT Apeiron. "GTAEXS617 is a product of our collaboration that uses AI-driven precision design to create a potentially best-in-class therapy and provide a new therapeutic option for patients with these difficult to treat cancers."
GTAEXS617 provides a differentiated approach to treating a range of 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. As a highly selective, noncovalent inhibitor of CDK7, GTAEXS617 combines the ability to disrupt the cell cycle and inhibit transcription in tumor cells, offering a promising alternative to CDK4/6 inhibitors, which only target the cell cycle and lead to the emergence of resistance pathways. In addition, orally available GTAEXS617 has the potential to overcome significant safety and efficacy limitations of treatments currently in development due to its differentiated reversibility and potentially reduced gastrointestinal toxicity.
In parallel to ELUCIDATE, GT Apeiron and Exscientia are undertaking a comprehensive translational initiative to study the potential enrichment for patients most likely to respond to GTAEXS617. This precision medicine-based approach involves the integration of data from clinical endpoints, peripheral and tumor multi-omics data, and correlation of those data with previously collected ex vivo results to potentially predict GTAEXS617 treatment response, thus increasing the probability of treatment success.
Fred Aswad, J.D., Ph.D., senior vice president, shared, "In collaboration with Exscientia we have used the power of AI to enable the efficient discovery and development of GTAEXS617. Our preclinical data in models of multiple solid tumor types demonstrate potent anti-tumor activity of this novel CDK7 inhibitor and support its clinical development. We are excited to advance GTAEXS617 into clinical testing and take this next step towards making a potentially transformative impact on the treatment of solid tumors."
About the Phase 1/2 ELUCIDATE trial
The ELUCIDATE trial is a multicenter, open-label, two-stage clinical trial designed to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of GTAEXS617 administered orally as monotherapy and in combination with standard of care therapies. The trial is enrolling patients with solid tumors 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 enroll patients in up to seven dose levels to define the recommended Phase 2 dose (RP2D). The dose expansion phase of the trial will commence upon identification of the RP2D. The primary efficacy endpoint of the expansion phase is objective response rate (ORR).
About GT Apeiron
GT Apeiron is redefining medical discovery, using artificial intelligence to streamline 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 technologies spanning multiple regions. We believe that by pushing the frontiers of biomedical innovation and engaging talent globally we can create breakthrough medicines for the highest unmet medical needs. For additional information visit www.apeiron-bio.com
About Exscientia
Exscientia is an AI-driven precision medicine company committed to discovering, designing, and developing the best possible drugs in the fastest and most effective manner. Exscientia 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 progress AI-designed small molecules into the clinical setting. The company’s internal pipeline is focused on leveraging its precision medicine platform in oncology, while its partnered pipeline broadens its approach to other therapeutic areas. By pioneering a new approach to medicine creation, Exscientia believes the best ideas of science can rapidly become the best medicines for patients.
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