Exhibit 99.1
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Kymera Therapeutics Announces Key 2021 Goals and Milestones to Support its
Evolution into a Fully Integrated Degrader Medicines Company
Company plans Phase 1 trial initiations across three novel degrader programs by end of 2021
Initiation of the single ascending dose portion of Phase 1 trial of KT-474 in healthy volunteers anticipated in 1Q 2021
Strong financial position to support pipeline execution with opportunities to accelerate growth and broaden clinical indications
Watertown, Mass. (January 12, 2021) – Kymera Therapeutics, Inc. (NASDAQ: KYMR), a biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced its research and development goals for 2021 as it transitions into a clinical-stage company.
“This promises to be a transformational year for Kymera, as it marks our planned entry into the clinic for multiple novel therapeutic candidates designed to degrade intractable disease targets. Kymera has made tremendous strides in advancing our platform and science, but that work is in service to a larger mission—to invent and deliver new medicines for the patients who need them most,” said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics. “This year, our focus will be demonstrating the clinical potential for our lead programs, expanding our pipeline of innovative therapeutic candidates, advancing our novel E3 ligase-enabled pipeline, and continuing to build toward a fully integrated biotech company. We plan to administer our heterobifunctional degraders for the first time to healthy volunteers, as well as patients with immune-inflammatory diseases and cancer, with a goal of establishing our first proof-of-biology in humans in 2021.”
2021 Pipeline Objectives
Kymera is discovering and developing novel small molecule therapeutics designed to selectively degrade disease-causing proteins by harnessing the body’s own natural protein degradation system, with an initial focus on immune-inflammatory diseases and oncology.
IRAK4 Degrader Program
IRAK4 is a key protein involved in inflammation mediated by the activation of toll-like receptors (TLRs) and IL-1 receptors (IL-1Rs). Aberrant activation of these pathways is the underlying cause of multiple immune-inflammatory conditions. KT-474, a potential first-in-class, highly active and selective, orally bioavailable IRAK4 degrader, is being developed for the treatment of TLR/IL-1R-driven immune-inflammatory diseases with high unmet medical need, such as hidradenitis suppurativa (HS), atopic dermatitis (AD), rheumatoid arthritis, and potentially other indications.
In December 2020, Kymera submitted an Investigational New Drug (IND) application for KT-474 and was recently informed on a call with the U.S. Food and Drug Administration (FDA) Division of Dermatology and Dentistry that, following receipt of official written communication expected in the next week, the Company may initiate dosing of healthy volunteers in the single ascending dose (SAD) portion of its first-in-human Phase 1 randomized, double-blind, placebo-controlled clinical trial in healthy volunteers and patients with HS or AD. This will be the first time that a heterobifunctional small molecule degrader is administered to healthy volunteers. The FDA also informed the Company that the program is on partial clinical hold regarding the multiple ascending dose (MAD) portion of the Phase 1 trial, pending FDA review of interim data in healthy volunteers from the SAD portion of the trial.
The estimated timing of the Company’s expected program milestones remains unchanged:
| • | Initiation of SAD portion of Phase 1 trial of KT-474 in healthy volunteers (1Q 2021) |
| • | Presentation of final Non-Interventional trial results in HS and AD (1H 2021) |