GT Apeiron Announces Enrollment of First Patient in Phase 1/2 “ELUCIDATE” Clinical Trial of CDK7 Inhibitor, GTAEXS617, in Advanced Solid Tumors
10 Julho 2023 - 8:00AM
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 trialThe
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 ApeironGT 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.us
About ExscientiaExscientia 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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