KT-621, an oral degrader, is the first STAT6 targeted medicine to enter clinical development, with the potential to address multiple immuno-inflammatory diseases
KT-621 has demonstrated dupilumab-like activity and was well tolerated in a wide variety of preclinical models of TH2 diseases
Phase 1 healthy volunteer data expected to be reported in the first half of 2025
WATERTOWN, MA, USA I October 24, 2024 I Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that it recently initiated dosing in the Phase 1 clinical trial in the US evaluating KT-621, a potent, selective, oral degrader of STAT6, in adult healthy volunteers. The Company expects to report Phase 1 data in the first half of 2025.
“KT-621 is the first oral STAT6 targeted medicine to advance into the clinic, showcasing Kymera’s drug discovery capabilities that address previously undrugged disease-causing proteins that have been elusive for existing modalities,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “We believe KT-621 can provide the convenience of a once daily oral pill with the potential to deliver biologic-like activity for patients suffering from highly prevalent allergic and atopic diseases around the world. We generated a comprehensive preclinical package for KT-621 that demonstrated that STAT6 degradation leads to the same level of pathway blockade as an injectable IL-4Rα antibody like dupilumab, with an excellent tolerability profile. We are excited to progress this wholly-owned asset through this Phase 1 healthy volunteer study, and subsequently into patients.”
The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered KT-621 in healthy volunteers. The study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. More information on the KT-621 Phase 1 study will be available on www.clinicaltrials.gov.
About STAT6 Degrader
STAT6 is a historically undrugged essential transcription factor in the IL-4/IL-13 signaling pathways and the central driver of T helper type 2 (TH2) inflammation in allergic diseases. Multiple gain of function mutations of STAT6 were identified to cause severe allergic diseases in humans. Dupilumab, an injectable monoclonal antibody that blocks IL-4/IL-13 signaling, is an approved therapy for multiple allergic and atopic diseases. STAT6 targeting is therefore supported by both human genetics and clinical pathway validation. STAT6 functions through protein-protein and protein-DNA interactions, and it has been challenging to selectively and potently inhibit STAT6 with small molecule inhibitors. However, we believe it is well suited for a targeted protein degradation approach, where a binding event is sufficient to drive degradation. KT-621 is an investigational first-in-class once daily, oral STAT6 degrader with dupilumab-like activity in preclinical models and the potential to address multiple allergic and atopic diseases including atopic dermatitis, asthma, and chronic obstructive pulmonary disease, among others. Kymera has initiated dosing in the KT-621 Phase 1 trial and expects data from the study to be reported in the first half of 2025.
About Kymera Therapeutics
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (previously Twitter) or LinkedIn.
SOURCE: Kymera Therapeutics
Post Views: 2,764
KT-621, an oral degrader, is the first STAT6 targeted medicine to enter clinical development, with the potential to address multiple immuno-inflammatory diseases
KT-621 has demonstrated dupilumab-like activity and was well tolerated in a wide variety of preclinical models of TH2 diseases
Phase 1 healthy volunteer data expected to be reported in the first half of 2025
WATERTOWN, MA, USA I October 24, 2024 I Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that it recently initiated dosing in the Phase 1 clinical trial in the US evaluating KT-621, a potent, selective, oral degrader of STAT6, in adult healthy volunteers. The Company expects to report Phase 1 data in the first half of 2025.
“KT-621 is the first oral STAT6 targeted medicine to advance into the clinic, showcasing Kymera’s drug discovery capabilities that address previously undrugged disease-causing proteins that have been elusive for existing modalities,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “We believe KT-621 can provide the convenience of a once daily oral pill with the potential to deliver biologic-like activity for patients suffering from highly prevalent allergic and atopic diseases around the world. We generated a comprehensive preclinical package for KT-621 that demonstrated that STAT6 degradation leads to the same level of pathway blockade as an injectable IL-4Rα antibody like dupilumab, with an excellent tolerability profile. We are excited to progress this wholly-owned asset through this Phase 1 healthy volunteer study, and subsequently into patients.”
The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered KT-621 in healthy volunteers. The study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. More information on the KT-621 Phase 1 study will be available on www.clinicaltrials.gov.
About STAT6 Degrader
STAT6 is a historically undrugged essential transcription factor in the IL-4/IL-13 signaling pathways and the central driver of T helper type 2 (TH2) inflammation in allergic diseases. Multiple gain of function mutations of STAT6 were identified to cause severe allergic diseases in humans. Dupilumab, an injectable monoclonal antibody that blocks IL-4/IL-13 signaling, is an approved therapy for multiple allergic and atopic diseases. STAT6 targeting is therefore supported by both human genetics and clinical pathway validation. STAT6 functions through protein-protein and protein-DNA interactions, and it has been challenging to selectively and potently inhibit STAT6 with small molecule inhibitors. However, we believe it is well suited for a targeted protein degradation approach, where a binding event is sufficient to drive degradation. KT-621 is an investigational first-in-class once daily, oral STAT6 degrader with dupilumab-like activity in preclinical models and the potential to address multiple allergic and atopic diseases including atopic dermatitis, asthma, and chronic obstructive pulmonary disease, among others. Kymera has initiated dosing in the KT-621 Phase 1 trial and expects data from the study to be reported in the first half of 2025.
About Kymera Therapeutics
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (previously Twitter) or LinkedIn.
SOURCE: Kymera Therapeutics
Post Views: 2,764
