Kymera Therapeutics Receives FDA Orphan Drug Designation

WATERTOWN, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical firm advancing focused protein degradation to ship novel small molecule protein degrader medicines, at this time introduced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to KT-333 for the remedy of Cutaneous T-cell Lymphoma (CTCL).

KT-333 is a first-in-class degrader of the transcriptional regulator STAT3. Deregulation of STAT3 signaling has been implicated within the pathogenesis of a wide range of cancers, together with CTCL. There are at present no accredited therapies for CTCL that concentrate on this pathway. KT-333 acquired orphan drug designation for the remedy of Peripheral T-cell Lymphoma (PTCL) earlier this 12 months.

“This second orphan drug designation reinforces the potential of KT-333 to impact the lives of a broad range of patients with hematological and solid tumors by targeting STAT3, a protein that has been considered undruggable,” stated Nello Mainolfi, Co-Founder, President and CEO of Kymera Therapeutics. “We have a significant opportunity to deliver an important new medicine with this first-in-class heterobifunctional degrader, and we look forward to working with the lymphoma community to rapidly advance KT-333 in CTCL and exploring its potential in other cancers.”

The security, tolerability and PK/PD of escalating doses of KT-333 are at present being evaluated in an ongoing Phase 1 medical trial in grownup sufferers with relapsed/refractory liquid and strong tumors, together with aggressive lymphomas.

The FDA’s Orphan Drug Designation program gives orphan standing to medication outlined as these supposed for the remedy, prognosis or prevention of uncommon illnesses that have an effect on fewer than 200,000 folks in the United States. Orphan drug designation qualifies the sponsor of the drug for sure growth incentives, together with tax credit for certified medical testing, prescription drug person price exemptions and seven-year advertising exclusivity upon FDA approval.

About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma (CTCL) is a common time period for non-Hodgkin’s T-cell lymphomas which are primarily characterised by an irregular accumulation of T-cells within the pores and skin and which account for roughly 25 % of T-cell lymphomas within the U.S. CTCL can contain the blood, lymph nodes and different inside organs. CTCL is a uncommon and usually slow-growing most cancers with signs corresponding to dry pores and skin, probably extreme itching, rashes and enlarged lymph nodes. Since signs and pores and skin biopsy findings are just like different pores and skin situations, early-stage prognosis will be tough.

About Kymera Therapeutics
Kymera Therapeutics (Nasdaq: KYMR) is a biopharmaceutical firm pioneering the sphere of focused protein degradation, a transformative method to deal with illness targets and pathways inaccessible with typical therapeutics. Kymera’s Pegasus platform is a robust drug discovery engine, advancing novel small molecule therapies that harness the physique’s innate protein recycling equipment to degrade dysregulated, disease-causing proteins. With a deal with undrugged nodes in validated pathways, Kymera is advancing a pipeline of novel therapeutics designed to deal with essentially the most intractable pathways and supply new remedies for sufferers. Kymera’s preliminary packages goal IRAK4, IRAKIMiD, and STAT3 inside the IL-1R/TLR or JAK/STAT pathways, offering the chance to deal with sufferers with a broad vary of immune-inflammatory illnesses, hematologic malignancies, and strong tumors. For extra info, go to www.kymeratx.com.

Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a “Fierce 15” biotechnology firm by Fierce Biotech and has been acknowledged by the Boston Business Journal as considered one of Boston’s “Best Places to Work.” For extra details about our folks, science, and pipeline, please go to www.kymeratx.com or observe us on Twitter or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This press launch accommodates forward-looking statements inside the that means of the Private Securities Litigation Reform Act of 1995, as amended, together with, with out limitation, implied and specific statements concerning its: technique, business plans and targets for the STAT3 degrader program; and plans and timelines for the medical growth of Kymera Therapeutics’ product candidates, together with the therapeutic potential and medical advantages thereof. The phrases “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and comparable phrases or expressions are supposed to establish forward-looking statements, though not all forward-looking statements include these figuring out phrases. Any forward-looking statements on this press launch are based mostly on administration’s present expectations and beliefs and are topic to quite a lot of dangers, uncertainties and necessary elements that will trigger precise occasions or outcomes to vary materially from these expressed or implied by any forward-looking statements contained on this press launch, together with, with out limitation, dangers related to: the affect of COVID-19 on international locations or areas through which now we have operations or do business, in addition to on the timing and anticipated outcomes of our present preclinical research and future medical trials, technique and future operations; the delay of any present preclinical research or future medical trials or the event of Kymera Therapeutics’ drug candidates; the chance that the outcomes of present preclinical research will not be predictive of future ends in reference to future medical trials; Kymera Therapeutics’ capacity to efficiently show the security and efficacy of its drug candidates; the timing and consequence of the Company’s deliberate interactions with regulatory authorities; and acquiring, sustaining and defending its mental property. These and different dangers and uncertainties are described in higher element within the part entitled “Risk Factors” within the Annual Report on Form 10-Ok for the interval ended December 31, 2021 and most up-to-date Quarterly Report on Form 10-Q, in addition to discussions of potential dangers, uncertainties, and different necessary elements in Kymera’s subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements signify Kymera Therapeutics’ views solely as of at this time and shouldn’t be relied upon as representing its views as of any subsequent date. Kymera Therapeutics explicitly disclaims any obligation to replace any forward-looking statements. No representations or warranties (expressed or implied) are made concerning the accuracy of any such forward-looking statements.

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