Kymera Therapeutics Announces Dosing of First Participant in Phase 1 Clinical Trial of KT-621, a First-in-Class Oral STAT6 Degrader, for the Treatment of TH2 Immuno-Inflammatory Diseases

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, Mass., Oct. 24, 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 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.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and objectives on the clinical development of KT-621. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: the results of preclinical studies and clinical trials may not be predictive of future results in connection with current and future clinical trials, uncertainties inherent in the initiation of future clinical trials, the timing and anticipated results of current and future clinical trials, whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with regulatory authorities, and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Quarterly Report on Form 10-Q and in subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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