IRAK4 oral degrader KT-474 (SAR444656) expected to complete enrollment in both Phase 2 HS and AD studies in fourth quarter of 2024, with topline data expected in first half of 2025
STAT6 oral degrader KT-621, with dupilumab-like activity, expected to enter Phase 1 clinical trial in the second half of 2024
TYK2 oral degrader KT-294, with a TYK2 loss-of-function profile and expected biologics-like activity, planned to enter Phase 1 clinical trial in the first half of 2025
STAT3 degrader KT-333 and MDM2 degrader KT-253 expected to complete Phase 1a studies in 2024 and deliver additional proof-of-concept data defining path to late-stage development
Well-capitalized, with cash in excess of $745 million1 and expected runway into the first half of 2027, enabling expansion into areas with large clinical and commercial opportunities
Kymera to present company update and 2024 outlook at J.P. Morgan Annual Healthcare Conference on Tuesday, January 9, 2024, at 9:00 a.m. PT/12:00 p.m. ET
WATERTOWN, Mass., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced its corporate goals for 2024, including anticipated progress on its best-in-class pipeline of immunology and oncology programs.
“Kymera has taken important steps toward our goal of building a fully integrated, global biotechnology company, demonstrating our ability to consistently deliver first- and best-in-class programs that target validated pathways with the potential to address large, underserved disease areas and create significant value for patients and shareholders,” said Nello Mainolfi, Ph.D., Founder, President and CEO, Kymera Therapeutics. “We’re building an industry-leading oral immunology portfolio, beginning with our IRAK4 degrader, KT-474, which we expect to complete enrollment in two Phase 2 studies later this year, and continuing with our recently announced oral STAT6 and TYK2 degrader programs, which have the potential to revolutionize how we treat many immuno-inflammatory diseases using oral medicines with biologics-like efficacy. In addition, we are advancing our two novel oncology programs targeting STAT3 and MDM2, both of which we expect to deliver additional proof-of-concept data and comprehensive Phase 1 data in 2024, giving us multiple clinical catalysts in the year ahead.”
Dr. Mainolfi continued, “Importantly, we have in excess of $745 million of cash1, providing expected runway now into the first half of 2027. This will enable us to deliver the next stage of the company’s growth and is expected to take the company past our Phase 2 data for KT-474, our oncology proof-of concept readouts, and several clinical inflection points for our two recently-announced immunology programs, STAT6 and TYK2.”
Kymera’s corporate goals for 2024 include:
Immunology Portfolio
Kymera is working to build an industry-leading oral immunology pipeline by leveraging its disease agnostic discovery platform, deep expertise gained through the development of its first-in-class IRAK4 program, and unique target selection strategy that focuses on genetically and clinically validated pathways, to build a portfolio of oral medicines with efficacy comparable to in-pathway biologics.
- Collaborate with Sanofi to complete enrollment of the KT-474/SAR444656 (IRAK4) Phase 2 hidradenitis suppurativa and atopic dermatitis clinical trials, with topline data expected to be reported in the first half of 2025
KT-474 (SAR444656) is an oral IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven complex inflammatory diseases. Sanofi, which is collaborating with Kymera on the development of KT-474 outside of the oncology and immune-oncology fields, is conducting the Phase 2 studies. Kymera has an option after Phase 2 and prior to the first Phase 3 study to opt in and equally share development and commercialization costs and profits in the U.S. while retaining tiered royalties in the rest of the world.
- Initiate dosing in the KT-621 (STAT6) Phase 1 trial in the second half of 2024, with Phase 1 data expected to be reported in 2025
KT-621 has shown in preclinical studies to be a potent (picomolar), oral degrader of STAT6, the only specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation in allergic diseases, with in vitro and in vivo efficacy similar or superior to dupilumab. KT-621 has potentially broad utility across a number of allergic diseases, including atopic dermatitis, asthma and chronic obstructive pulmonary disorder, among others.
- Complete activities to enable IND filing and initiate dosing in the KT-294 (TYK2) Phase 1 clinical trial in the first half of 2025, with Phase 1 data expected to be reported in 2025
KT-294 has shown in preclinical studies to be a potent oral degrader of TYK2, a member of the Janus Kinase (JAK) family required for Type I interferon (IFN), IL-12 and IL-23 signaling with both genetic and clinical validation in autoimmune and inflammatory diseases. Degradation of TYK2 has the potential to overcome the challenges of small molecule inhibitors, which have limitations due to lack of selectivity, limited target engagement, and/or lack of potent activity. KT-294, with a potential biologic-like efficacy profile, has the opportunity to address conditions such as inflammatory bowel disease, psoriasis, psoriatic arthritis and lupus, among others.
Oncology Portfolio
Kymera is progressing degrader programs in oncology that target undrugged or poorly drugged proteins in an effort to create new ways to fight cancer that improve the standard of care and have the potential treat both solid and liquid tumors.
- Complete the KT-333 (STAT3) Phase 1a study and deliver additional proof-of-concept data to inform the program’s next development steps in 2024
KT-333 is designed as a potent degrader of STAT3, a transcriptional regulator that has been linked to numerous cancers as well as to inflammatory and autoimmune diseases. KT-333 is being developed for the treatment of STAT3-dependent hematological malignancies and solid tumors. At the American Society of Hematology annual meeting, the Company disclosed the first proof-of-concept data for single agent KT-333 anti-tumor activity in hematological malignancies as well as potential anti-tumor immuno-modulatory effects in both tumor biopsies and blood.
- Complete the KT-253 (MDM2) Phase 1a study and deliver proof-of-concept data, which will inform a patient stratification strategy for the program in 2024
KT-253 is a highly potent and selective degrader that targets MDM2, the crucial regulator of the most common tumor suppressor, p53. A Phase 1 study of KT-253 is ongoing, with one arm in patients with relapsed or refractory solid tumors and lymphomas, and a second arm focused on patients with high grade myeloid malignancies and acute lymphocytic leukemia (ALL). Interim data from the study demonstrated evidence of target engagement and p53 pathway activation, as well as initial antitumor activity and a lack of the traditional hematological toxicity seen with small molecule inhibitors. Kymera is working to develop a biomarker-based patient selection strategy for subsequent development beyond Phase 1a.
Research and Platform
- Continue to advance, from early discovery through preclinical development, a series of high value programs in areas of unmet need with large patient populations and target classes best suited for TPD
J.P. Morgan Healthcare Conference Webcast
Kymera will present its 2024 outlook at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, at 9:00 a.m. PT (12:00 p.m. ET). A live webcast of the presentation and Q&A breakout session will be available by visiting the Investors section of Kymera’s website at www.kymeratx.com. A replay of the webcast will be archived on Kymera’s website for 30-days following the presentation.
Additional information about Kymera’s pipeline product opportunities is available in the Pipeline section of the Company’s corporate website.
1Unaudited, estimated cash as of January 9, 2024, inclusive of $301 million of net proceeds from the company’s recently-closed equity offering and a $15 million payment received from Sanofi for a Phase 2 dosing milestone achieved in 4Q23.
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 delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. 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 (formerly 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 by Kymera Therapeutics regarding its: strategy, business plans and objectives for its clinical programs; plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof; expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials; the ability to initiate new clinical programs; and Kymera's financial condition and expected cash runway into the first half of 2027. 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 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 those for KT-474 (SAR444656), KT-621, KT-294, KT-333 and KT-253; 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; the risks associated with pandemics or epidemics; and Kymera Therapeutics' relationships with its existing and future collaboration partners. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the Annual Report on Form 10-K for the period ended December 31, 2022, and most recent Quarterly Report on Form 10-Q, 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: Justine Koenigsberg Vice President, Investor Relations investors@kymeratx.com 857-285-5300 | Media Contact: Todd Cooper Senior Vice President, Corporate Affairs media@kymeratx.com 857-285-5300 |
