First-in-human Phase 1 trial evaluating KT-485 (SAR447971) initiated, triggering a $20 million milestone payment from Sanofi
WATERTOWN, Mass., June 09, 2026 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that the first participant has been dosed in the first-in-human Phase 1 clinical trial evaluating KT-485 (SAR447971), an oral, potent and selective IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa (HS) patients. The Phase 1 trial (NCT07629336) is being conducted by the Company's partner Sanofi. Under the terms of the collaboration, dosing of the first participant triggered a $20 million milestone payment to Kymera from Sanofi.
Per the collaboration, Sanofi is leading development, regulatory, and commercial efforts for the program. Kymera is eligible to receive up to $975 million of potential clinical, regulatory and commercial milestones related to KT-485.
"Advancing KT-485, our second generation IRAK4 degrader, into the clinic is an important milestone for our collaboration with Sanofi and our efforts to ultimately bring this important oral therapy to patients," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "There remains a significant need for novel oral options that can address key inflammatory pathways implicated in several immuno-inflammatory conditions, and we are excited to collaborate with Sanofi on this work."
The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and additional exploratory endpoints of orally administered KT-485. The three-part study includes double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as an open-label MAD cohort.
About KT-485/SAR447971
KT-485 is a second generation, oral degrader of IRAK4, that demonstrated increased potency and specificity with a favorable safety profile in preclinical testing. IRAK4 is a scaffolding kinase and key protein of the myddosome complex that mediates signaling through IL-1 and toll-like receptors. IRAK4 acts at the interface of the innate and adaptive immune responses with a variety of functions depending on its kinase activity and scaffolding function. Eliminating IRAK4 completely through degradation impacts both the kinase and scaffolding functions, therefore having the potential to achieve a broad, well-tolerated, anti-inflammatory effect providing a novel oral therapeutic approach for a variety of immuno-inflammatory diseases. KT-485 is being developed under Kymera's collaboration with Sanofi for IRAK4 degraders outside of oncology and immuno-oncology. Kymera has the option to participate in future development and commercialization, and 50/50 profit split, in the United States and double-digit tiered royalties in ROW.
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 building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. 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 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 development of KT-485, including the therapeutic potential, clinical benefits and safety thereof. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target," "upcoming" 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 timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of Kymera Therapeutics' drug candidates; the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including for KT-485; Kymera Therapeutics' ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Kymera Therapeutics' planned interactions with regulatory authorities; obtaining, maintaining and protecting its intellectual property; and Kymera Therapeutics' relationships with its existing and future collaboration partners, the timing and outcome of planned interactions with and submissions to regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements 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 SEC. 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.
Investor Contact:
Justine Koenigsberg
investors@kymeratx.com
857-285-5300
Media Contact:
Matthew Henson
media@kymeratx.com
857-285-5300
