KT-253 demonstrates initial clinical proof of concept in patients with tumor types shown to be sensitive in preclinical models, including responses in MCC and AML
Evidence of target engagement and potent upregulation of p53 pathway biomarkers even at the lowest dose levels in solid tumor and AML patients
KT-253 was generally well tolerated without hematologic adverse events seen with traditional MDM2 small molecule inhibitors
KT-253 Phase 1 study ongoing with additional data expected in the second half of 2024
WATERTOWN, Mass., June 01, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ:KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today shared new clinical data from its ongoing KT-253 Phase 1 trial. KT-253, a potent, selective heterobifunctional small molecule degrader of MDM2, demonstrated preliminary signs of efficacy across tumor types at doses that were generally well-tolerated. The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 – June 4, 2024. Results released in an ASCO poster today include a data cut-off of April 9, 2024.
"We're encouraged by the data emerging from the KT-253 Phase 1 dose escalation trial, showcasing the potential of TPD to address this clinically proven but inadequately drugged cancer mechanism. We have demonstrated strong proof of mechanism as well as preliminary signs of efficacy in both solid tumors and AML, with translation from our preclinical models to patient populations, without the hematological toxicity typically seen with traditional small molecule inhibitors," said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. "These findings continue to support our therapeutic hypothesis for MDM2 degradation and the potential to improve the therapeutic index compared to small molecule inhibitors. We look forward to sharing the full Phase 1 data set, as well as our biomarker strategy and guidance on the program's next development steps, later this year."
"I am pleased to see responses in both liquid and solid tumor patients being treated with KT-253 at doses that do not cause neutropenia or diarrhea," said Naval Daver, MD, of The University of Texas MD Anderson Cancer Center and clinical investigator of the KT-253 Phase 1 study. "The responses in post-MPN AML are especially encouraging, as these patients are often refractory to multiple different therapies and therefore represent a subset of AML with high unmet medical need."
KT-253 Clinical Update
The Phase 1 study of KT-253 is evaluating the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and clinical activity of KT-253 in patients with relapsed or refractory high grade myeloid malignancies, including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), lymphomas, and solid tumors.
The poster provides a clinical update from the ongoing KT-253 Phase 1 trial from 24 patients including 16 patients in Arm A (solid tumors and lymphomas) at dose levels (DL) 1-5, and 8 patients in Arm B (high grade myeloid malignancies) at DL1-3 as of April 9, 2024. The most common ...