Kymera Therapeutics Receives FDA Clearance for KT-621, an Oral STAT6 Degrader

Kymera Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing small molecule medicines through targeted protein degradation (TPD), has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KT-621. KT-621 is an oral degrader of STAT6, a transcription factor involved in T helper type 2 (TH2) inflammation associated with allergic diseases. This approval marks a significant advancement, allowing Kymera to be the first company to bring a STAT6-targeted medicine to clinical trials.

Starting in October 2024, Kymera plans to initiate dosing in a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of KT-621 in healthy volunteers. The company expects to have data from this study by the first half of 2025. Dr. Nello Mainolfi, the Founder, President, and CEO of Kymera Therapeutics, emphasized the importance of this milestone, noting that KT-621 has the potential to combine the benefits of upstream biologics with the convenience of oral administration, possibly transforming treatment for atopic and allergic diseases.

KT-621 has shown dupilumab-like activity in various preclinical models of TH2 diseases and was well tolerated. Dupilumab, an injectable monoclonal antibody, is currently approved for several allergic and atopic conditions. STAT6, the target of KT-621, plays a crucial role in the IL-4/IL-13 signaling pathways, which are central to the inflammation seen in allergic diseases. Traditional small molecule inhibitors have struggled to effectively and selectively inhibit STAT6 due to its essential protein-protein and protein-DNA interactions. However, Kymera believes that TPD can overcome this challenge by driving degradation through a binding event.

Kymera's approach with KT-621 is to provide a first-in-class, once-daily oral STAT6 degrader that can address various allergic and atopic diseases, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease. The Phase 1 trial will compare different doses of KT-621 against a placebo to establish its safety and efficacy profile.

Kymera Therapeutics, founded in 2016 and headquartered in Watertown, Massachusetts, is a leader in the field of TPD. The company aims to develop medicines that can offer new therapeutic options for diseases that are currently difficult to treat with conventional approaches. In addition to its work on immunological diseases, Kymera is also advancing degrader programs in oncology, targeting proteins that are currently undrugged or inadequately addressed by existing treatments. This innovative approach has the potential to create new methods for combating cancer.

Kymera has been recognized for its groundbreaking work and has been named one of the top workplaces in Boston for several consecutive years. The company remains committed to developing highly effective, convenient therapies that can greatly improve the quality of life for patients with severe health conditions.

In summary, the FDA's clearance of Kymera's IND application for KT-621 represents a significant step forward in the development of new treatments for allergic and atopic diseases. With the initiation of Phase 1 clinical trials imminent, Kymera is poised to advance its mission of bringing innovative, orally administered therapies to patients in need.