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Kymera Therapeutics to Present Pharmacokinetic and Pharmacodynamic Data, including Cytokines, from the Single Ascending Dose Portion of KT-474 Phase 1 Trial in Healthy Volunteers at the 4th Annual Targeted Protein Degradation Summit

Oct 13, 2021
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WATERTOWN, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today announced that the Company will be giving multiple presentations at the 4th Annual Targeted Protein Degradation Summit, taking place from October 26 - 29, 2021. A Keynote Plenary Session presentation will include safety, pharmacokinetic (PK) and pharmacodynamic (PD) data, including cytokines, from the Single Ascending Dose (SAD) portion of the KT-474 Phase 1 trial in healthy volunteers that has recently completed dose escalation. KT-474 is a potential first-in-class, orally bioavailable IRAK4 degrader being developed for the treatment of TLR/IL-1R-driven immune-inflammatory diseases including hidradenitis suppurativa, atopic dermatitis, rheumatoid arthritis, and others.

“We look forward to presenting PK and PD data, including IRAK4 levels and cytokine results, from the SAD portion of the KT-474 Phase 1 randomized, placebo-controlled trial in healthy volunteers. This represents the most comprehensive assessment to date of PKPD for heterobifunctional small molecule protein degraders in humans, highlighting KT-474’s potential as a best-in-class anti-inflammatory oral agent, as well as further validating Kymera’s TPD platform,” said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics. “Additionally, while we have completed Single Ascending Dose escalation, the Multiple Ascending Dose (MAD) portion of the trial continues in healthy volunteers. We plan to present data from the MAD portion of our healthy volunteer Phase 1 study before year-end.”

Keynote Plenary Presentation:

  • Title: Safety, PK and PD from Single Ascending Dose Portion of KT-474 Phase 1 Trial in Healthy Volunteers
    • Presenter: Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics
    • Time: 8:30 a.m. ET on Wednesday, Oct. 27, 2021

  • KT-474 Phase 1 SAD highlights to include data from seven dose levels showing:
    • Pharmacokinetic profile
    • Effects on IRAK4 levels in peripheral blood mononuclear cells (PBMC) and on ex vivo induction of proinflammatory cytokines
    • Safety and tolerability

Additional Presentations and Sessions:

  • Presentation Title: Pre-Conference Workshop: De-risking Clinical Development of Protein Degraders
    • Presenter: Alice McDonald, Director, Translational Medicine, Kymera Therapeutics
    • Time: 8:30 a.m. ET on Tuesday, Oct. 26, 2021
  • Industry Leaders Panel Discussion: 2021 in Review
    • Panel participation by Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics
    • Time: 9:30 a.m. ET on Wednesday, Oct. 27, 2021
  • Presentation Title: Impact of Understanding PKPD for Development of a STAT3 Targeted Protein Degrader
    • Presenter: Chris De Savi, PhD, Vice President, Head of Drug Discovery, Kymera Therapeutics
    • Time: 4:15 p.m. ET on Wednesday, Oct. 27, 2021

For more information and to register for the 4th Annual Targeted Protein Degradation Summit, please visit: www.proteindegradation.com. Copies of the presentations will be available for download at: www.kymeratx.com/scientific-resources/.

About IRAK4 and KT-474
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, 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 atopic dermatitis, hidradenitis suppurativa, rheumatoid arthritis, and potentially others. KT-474 is designed to block TLR/IL-1R-mediated inflammation more broadly compared to monoclonal antibodies targeting single cytokines, and to enable pathway inhibition that is superior to IRAK4 kinase inhibitors by abolishing both the kinase and scaffolding functions of IRAK4. In February 2021, Kymera initiated the first-in-human Phase 1 Single and Multiple Ascending Dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered KT-474 in adult healthy volunteers and patients with atopic dermatitis and hidradenitis suppurativa.

Kymera is collaborating with Sanofi on the development of degrader candidates targeting IRAK4, including KT-474 (SAR444656), outside of the oncology and immuno-oncology fields.

About Pegasus™
Pegasus™ is Kymera Therapeutics’ proprietary protein degradation platform, created by its team of experienced drug hunters to improve the effectiveness of targeted protein degradation and generate a pipeline of novel therapeutics for previously undruggable diseases. The platform consists of informatics-driven target identification, novel E3 ligases, proprietary ternary complex predictive modeling capabilities, and degradation tools.

About Kymera Therapeutics
Kymera Therapeutics (Nasdaq: KYMR) is a clinical-stage biopharmaceutical company founded with the mission to discover, develop, and commercialize transformative therapies while leading the evolution of targeted protein degradation, a transformative new approach to address previously intractable disease targets. Kymera’s Pegasus™ platform enables the discovery of novel small molecule degraders designed to harness the body’s natural protein recycling machinery to degrade disease-causing proteins, with a focus on undrugged nodes in validated pathways currently inaccessible with conventional therapeutics. Kymera’s initial programs are IRAK4, IRAKIMiD, and STAT3, each of which addresses high impact targets within the IL-1R/TLR or JAK/STAT pathways, providing the opportunity to treat a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors. Kymera’s goal is to be a fully integrated biopharmaceutical company at the forefront of this new class of protein degrader medicines, with a pipeline of novel degrader medicines targeting disease-causing proteins that were previously intractable.

Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a “Fierce 15” biotechnology company by FierceBiotech and has been recognized by the Boston Business Journal as one of Boston’s “Best Places to Work.” For more information about our people, science, and pipeline, please visit www.kymeratx.com or follow us on 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 regarding its: strategy, business plans and objectives for the KT-474 and STAT3 degrader programs; and plans and timelines for the clinical development of Kymera Therapeutics' product candidates, including the therapeutic potential and clinical benefits thereof. 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 those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our current preclinical studies and future clinical trials, strategy and future operations; the delay of any current preclinical studies or future clinical trials or the development of Kymera Therapeutics' drug candidates; the risk that the results of current preclinical studies may not be predictive of future results in connection with future clinical trials; Kymera Therapeutics' ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Company’s planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the Annual Report on Form 10-Q for the period ended June 30, 2021, filed on August 6, 2021, as well as discussions of potential risks, uncertainties, and other important factors in Kymera Therapeutics' subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Kymera Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Kymera Therapeutics explicitly disclaims 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:
Bruce Jacobs
Chief Financial Officer
investors@kymeratx.com
857-285-5300

Chris Brinzey
Managing Director, Westwicke
chris.brinzey@westwicke.com
339-970-2843

Media Contact:
Tyler Gagnon
Director, Corporate Communications
tgagnon@kymeratx.com
508-904-9446