1. WATERTOWN, Mass., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ:KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced the appointment of John Maraganore, Ph.D. to its Board of Directors. Dr. Maraganore joins Kymera's Board after having led Alnylam Pharmaceuticals as founding CEO and Director and transformed the field of RNA therapeutics for the last nearly 20 years.

    "John has been a true pioneer and an inspiration for the whole biotech industry. As founding CEO of Alnylam, he has built one of the most successful biotech companies, evolving RNA therapeutics into a commercial stage therapeutic reality for…

    WATERTOWN, Mass., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ:KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced the appointment of John Maraganore, Ph.D. to its Board of Directors. Dr. Maraganore joins Kymera's Board after having led Alnylam Pharmaceuticals as founding CEO and Director and transformed the field of RNA therapeutics for the last nearly 20 years.

    "John has been a true pioneer and an inspiration for the whole biotech industry. As founding CEO of Alnylam, he has built one of the most successful biotech companies, evolving RNA therapeutics into a commercial stage therapeutic reality for patients around the globe." said Nello Mainolfi, PhD, Co-Founder, President and Chief Executive Officer of Kymera Therapeutics. "Given our ambitions at Kymera to take a similar path and build a fully integrated global biopharma company based on targeted protein degradation, it is especially fitting and exceptionally exciting to welcome John to our Board of Directors and work with him directly to accomplish our goals and vision."

    "Targeted protein degradation is a very exciting field with real transformative potential. Kymera's differentiated pipeline and deep and unique platform investments across the spectrum of degrader approaches has clearly positioned the company as a true pioneer in the space," said Dr Maraganore. "Kymera has already demonstrated first in class, clear and profound proof-of-mechanism and proof-of-biology with KT-474, and this year is advancing 3 clinical programs in patients across immune-inflammatory and oncology indications. Importantly, the team is advancing a new generation of additional programs, leveraging the company's unique platform capabilities, making now an exciting time to join Kymera's Board and contribute to our path to becoming a disease-agnostic, global degrader medicine company."

    Dr. John Maraganore served as the founding CEO and a Director of Alnylam from 2002 to 2021, where he built and led the company from early platform research on RNA interference through global approval and commercialization of the first four RNAi therapeutic medicines, ONPATTRO®, GIVLAARI®, OXLUMO®, and Leqvio®. At Alnylam, he also led the company's value creation strategy, building $25B in market capitalization, including over 20 major pharmaceutical alliances. He continues to serve on the Alnylam Scientific Advisory Board. Prior to Alnylam, he served as an officer and a member of the management team for Millennium Pharmaceuticals, Inc., where he was responsible for the company's product franchises in oncology, and cardiovascular, inflammatory and metabolic diseases, in addition to leadership of M&A, strategy, and biotherapeutics functions. Before Millennium, he served as Director of Molecular Biology and Director of Market and Business Development at Biogen, Inc. where he invented and led the discovery and development of ANGIOMAX® (bivalirudin) for injection. Previously, he was a scientist at ZymoGenetics, Inc. and the Upjohn Company. Dr. Maraganore received his M.S. and Ph.D. in biochemistry and molecular biology at the University of Chicago. He is currently a Venture Partner at ARCH Venture Partners, a Venture Advisor at Atlas Ventures, and an Executive Partner at RTW Investments. He is also Chair of the Board of Directors of Hemab Therapeutics and a member of the Board of Directors of Agios Pharmaceuticals, Beam Therapeutics and the Biotechnology Industry Organization, where he was Chair from 2017-2019. In addition, he serves on the Board of the Termeer Foundation – committed to continuing the legacy of the late Henri A. Termeer, as Chair of the n-Lorem Foundation Advisory Council – committed to meeting the needs of patients with nano-rare diseases, and as a strategic advisor to SalioGen, SQZ Biotechnologies, and other innovative companies.

    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 lead 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 Fierce Biotech 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.

    Investor Contact:

    Bruce Jacobs

    Chief Financial Officer



    857-285-5300

    Chris Brinzey

    Managing Director, Westwicke



    339-970-2843

    Media Contact:

    Tyler Gagnon

    Director, Corporate Communications



    508-904-9446



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  2. Company plans to establish Proof-of-Mechanism and -Biology in patients in immune-inflammatory and oncology indications across its three ongoing clinical programs: IRAK4, IRAKIMiD and STAT3

    KT-474 completes dose escalation in healthy volunteer portion of Phase 1 trial, plans patient cohort and proof of biology data in 2022

    Planned IND filing for MDM2 degrader program KT-253 in 2H22

    Additional programs entering development, including tissue-restricted E3 ligase-enabled, and further platform expansion expected in 2022

    Strong financial position to support pipeline execution with opportunities to accelerate growth and broaden clinical indications to continue build to fully integrated biotech

    WATERTOWN, Mass., Jan. 10, 2022…

    Company plans to establish Proof-of-Mechanism and -Biology in patients in immune-inflammatory and oncology indications across its three ongoing clinical programs: IRAK4, IRAKIMiD and STAT3

    KT-474 completes dose escalation in healthy volunteer portion of Phase 1 trial, plans patient cohort and proof of biology data in 2022

    Planned IND filing for MDM2 degrader program KT-253 in 2H22

    Additional programs entering development, including tissue-restricted E3 ligase-enabled, and further platform expansion expected in 2022

    Strong financial position to support pipeline execution with opportunities to accelerate growth and broaden clinical indications to continue build to fully integrated biotech

    WATERTOWN, Mass., Jan. 10, 2022 (GLOBE NEWSWIRE) -- 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 and key milestones for 2022.

    "2021 was a transformative year for Kymera, as we very successfully transitioned from a preclinical company into a full R&D organization with three clinical stage programs and first-in-class clinical data that validated our platform and our broader pipeline," said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics. "This year, our focus will be on demonstrating the clinical potential for our lead programs (KT-474, KT-413 and KT-333) in a broad variety of patient populations with debilitating and life-threatening diseases such as HS, AD, lymphomas and leukemias, as we drive toward our mission to change treatment paradigms in a technology- and disease-agnostic manner. We also plan to demonstrate that our research and development organization can deliver successfully on our goal to maintain a pipeline that will add at least one new clinical program annually, as we outlined in our 2021 R&D day (https://investors.kymeratx.com/events-and-presentations). We expect to file an IND for our first-in-class MDM2 degrader, KT-253, in 2022, as well as continue to demonstrate our degraders' biological superiority over small molecule inhibitor targeting in a broad variety of indications. Importantly, we will continue to deliver on our key objective to enable the drugging of all target classes in human cells by advancing tissue-restricted, E3 ligase-enabled development programs, as well as our first set of molecular glue programs."

    2022 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

    In 2021, Kymera disclosed data from the single ascending dose (SAD) and multiple ascending dose (MAD) portions of its Phase 1 randomized, double-blind, placebo-controlled clinical trial in healthy volunteers. The MAD data demonstrated potent, marked IRAK4 reduction in peripheral blood mononuclear cells (PBMC) with steady-state degradation at Day 14 of 92% at the lowest dose level (25 mg) and 96-98% at the two highest dose levels (100-200 mg), where IRAK4 was reduced to near the lower limit of quantitation (LLOQ) of the assay. Proof of mechanism in the skin was established as mean IRAK4 levels were reduced to near the LLOQ by the final day of dosing on Day 14 at the highest dose level (200 mg). The continued decline of IRAK4 in skin on Day 14 in the 50-200 mg cohorts suggested that steady-state degradation in skin had not yet been achieved. Proof-of-biology was demonstrated through inhibition of up to 9 disease relevant cytokines with the 100 mg (MAD3) dose reaching 85% inhibition. KT-474 multi-dosing was safe and well-tolerated. Kymera has now completed dose escalation in the SAD and MAD healthy volunteer portions of KT-474's Phase 1 clinical trial and will review all clinical data prior to initiating the open-label patient portion of the study.

    Expected 2022 Milestones:

    • Commence patient dosing (Part C) of Phase 1 trial
    • Present data from patient cohort showing proof of mechanism and proof of biology

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

    IRAKIMiD Degrader Program

    In 4Q21, Kymera announced IND clearance of KT-413, the company's potent degrader of IRAK4 and IMiD substrates. KT-413's Phase 1 trial will evaluate safety, PK/PD, and preliminary efficacy in MYD88 mutant and MYD88 wild-type relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL). Primary study endpoints will include safety, tolerability and recommended Phase 2 dose, with secondary endpoints of PK and preliminary efficacy. The trial will also explore target (IRAK4/Ikaros/Aiolos) knockdown and downstream effects in PBMC and tumors.

    Expected 2022 Milestones

    • Present first proof of mechanism clinical data to de-risk further development
    • Present new preclinical data to enable indication expansions in new oncology indications

    STAT3 Degrader Program

    In 4Q21, Kymera announced IND clearance of KT-433, the company's potent degrader of STAT3. KT-333's Phase 1 trial will evaluate safety, PK/PD, and preliminary efficacy in peripheral T cell lymphoma (PTCL), cutaneous T cell lymphoma (CTCL), large granular lymphocytic leukemia (LGL-L) and solid tumors. Primary study endpoints will include safety, tolerability and recommended Phase 2 dose, with secondary endpoints of PK and preliminary efficacy. The trial will also explore STAT3 knockdown and downstream effects in PBMC and tumors.

    Expected 2022 Milestones

    • Present first proof of mechanism clinical data to de-risk further development
    • Present new preclinical data to enable indication expansions in new oncology indications
    • Present new preclinical data to demonstrate relevance of STAT3 degradation in immunology and fibrosis

    MDM2 Degrader Program

    At last month's R&D Day, Kymera announced its new development program and development candidate, KT-253, a potent and selective degrader of MDM2 with potential to be a best-in-class P53 stabilizer. Degradation of MDM2, rather than inhibition, has the ability to block the feedback loop which up-regulates MDM2 production and in doing so more effectively drives tumor cells to rapid apoptosis. KT-253 inhibits tumor cell growth with picomolar potency that is more than 200-fold greater than clinically active MDM2 small molecule inhibitors. This leads to sustained tumor regression in vivo in leukemia models following just a single dose. As wild-type p53 is present in >50% of tumors, KT-253 represents another program with broad franchise potential in liquid and solid tumors. Kymera is focused on indications with specific sensitivity to this mechanism of action, such as AML, lymphomas, uveal melanoma and others through a focused biomarker strategy.

    Expected 2022 Milestones

    • Present additional preclinical data that outline the biomarker strategy as well as new indications for KT-253
    • File IND for KT-253

    Discovery and Platform

    Kymera is also actively advancing a broad pipeline of preclinical programs across a wide variety of diseases, both internally and in collaboration with existing partners Vertex Pharmaceuticals and Sanofi. The internal programs continue to be focused on undrugged or inadequately drugged nodes within highly validated pathways. Kymera is committed to drugging all high value target classes in human cells in a technology- and disease-agnostic manner with particular focus on using tissue-selective or -restricted E3 ligase and molecular glue degraders where needed to elicit the best clinical response.

    Key 2022 Objectives

    • Nominate first Development Candidate using a tissue restricted E3 ligase
    • Continue pipeline expansion by advancing early-stage discovery programs toward IND-enabling studies
    • Further expand the capabilities of Kymera's Pegasus™ platform to identify the optimal pairing of disease-causing protein targets with E3 ligases to generate novel degrader product candidates
    • Leverage Kymera's E3 Ligase Whole-Body Atlas of over 600 unique E3 ligases to identify previously unliganded E3 ligases, including tissue-restricted or -selective, as well as new small molecule molecular glue degraders to unlock new opportunities across broad therapeutic applications.

    2022 Corporate Objectives

    Kymera's mission is to discover, develop, and commercialize transformative therapies while leading the evolution of targeted protein degradation. The Company's goal is to become a fully integrated biopharmaceutical company with a pipeline of novel medicines targeting disease-causing proteins that were previously intractable. In 2022, Kymera plans to continue to grow and strengthen its organizational capabilities in order to deliver on the potential of inventing a new class of protein degrader medicines for patients.

    Key Objectives

    • Continue to foster company culture of transparency, inclusion, communication, problem solving, and innovation
    • Scale organization with continued growth in key functional areas, including clinical development, manufacturing, drug discovery, preclinical development, and G&A functions to support Kymera's growth
    • Continue to advance existing collaborations, or execute additional strategic partnerships that can contribute complementary capabilities in disease areas both within and outside of Kymera's core areas of therapeutic focus to further extend the potential impact of protein degrader therapies to even more patients and diseases

    J.P. Morgan Healthcare Conference

    Kymera will present at the virtual 40th Annual J.P. Morgan Healthcare Conference at 9:00 a.m. ET on Tuesday, January 11, 2022. Nello Mainolfi, PhD, Co-Founder, President and CEO of Kymera, will provide an overview of the Company's progress and anticipated milestones for 2022.

    A live webcast of the presentation can be accessed under "Events and Presentations" in the Investors section of the Company's website at www.kymeratx.com. An archived webcast recording of the presentation will be available on the website for approximately 30 days.

    An updated corporate overview presentation is available on the Investors section of the Company's website at https://investors.kymeratx.com/events-and-presentations.

    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 lead 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 Fierce Biotech 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 by Kymera Therapeutics regarding its: strategy, business plans and objectives for 2022 and beyond, including for the IRAK4, IRAKIMiD,STAT3 and MDM2 degrader programs; plans and timelines for the clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof; and expectations regarding its existing collaborations. 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 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 future clinical trials; 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. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the Quarterly Report on Form 10-Q for the period ended September 30, 2021, filed on November 10, 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



    857-285-5300

    Chris Brinzey

    Managing Director, Westwicke



    339-970-2843

    Media Contact:

    Tyler Gagnon

    Director, Corporate Communications



    508-904-9446



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  3. WATERTOWN, Mass., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ:KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced the Company will present at the virtual 40th Annual J.P. Morgan Healthcare Conference at 9:00 a.m. ET / 6:00 a.m. PT on Tuesday, January 11, 2022. Nello Mainolfi, PhD, Co-Founder, President and CEO of Kymera, will provide an overview of the Company's progress and anticipated milestones for 2022 and beyond.

    A live webcast of the presentation can be accessed under "Events and Presentations" in the Investors section of the Company's website at www.kymeratx.com. An archived webcast recording of the…

    WATERTOWN, Mass., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ:KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced the Company will present at the virtual 40th Annual J.P. Morgan Healthcare Conference at 9:00 a.m. ET / 6:00 a.m. PT on Tuesday, January 11, 2022. Nello Mainolfi, PhD, Co-Founder, President and CEO of Kymera, will provide an overview of the Company's progress and anticipated milestones for 2022 and beyond.

    A live webcast of the presentation can be accessed under "Events and Presentations" in the Investors section of the Company's website at www.kymeratx.com. An archived webcast recording of the presentation will be available on the website for approximately 30 days.

    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 lead 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 Fierce Biotech 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.

    Investor Contact:

    Bruce Jacobs

    Chief Financial Officer



    857-285-5300

    Chris Brinzey

    Managing Director, Westwicke



    339-970-2843

    Media Contact:

    Tyler Gagnon

    Director, Corporate Communications



    508-904-9446



    Primary Logo

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  4. Multiple Ascending Dose (MAD) data from KT-474 Phase 1 trial demonstrates near complete IRAK4 degradation in PBMC and skin, robust ex vivo inhibition of multiple disease-relevant cytokines, and favorable safety profile

    KT-253, a first-in-class potent and selective MDM2 degrader targeting the P53 pathway for the treatment of liquid and solid tumors, disclosed as Kymera's new development program

    First tissue restricted E3 ligase achieves in vivo POC, leading to tissue sparing biology​

    Novel approach to molecular glue for undrugged/unliganded targets​

    Five-year vision to build a fully integrated, global biotech company with a disease- and technology-agnostic pipeline

    Additional Insights on KT-474 development opportunities from Kymera partner…

    Multiple Ascending Dose (MAD) data from KT-474 Phase 1 trial demonstrates near complete IRAK4 degradation in PBMC and skin, robust ex vivo inhibition of multiple disease-relevant cytokines, and favorable safety profile

    KT-253, a first-in-class potent and selective MDM2 degrader targeting the P53 pathway for the treatment of liquid and solid tumors, disclosed as Kymera's new development program

    First tissue restricted E3 ligase achieves in vivo POC, leading to tissue sparing biology​

    Novel approach to molecular glue for undrugged/unliganded targets​

    Five-year vision to build a fully integrated, global biotech company with a disease- and technology-agnostic pipeline

    Additional Insights on KT-474 development opportunities from Kymera partner, Sanofi, with special guest speaker

    Kymera to webcast R&D Day today at 8:30am EST

    WATERTOWN, Mass., Dec. 16, 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 significant advances across its clinical stage pipeline, new programs and platform investments at its first R&D Day.

    "At Kymera, we have an unwavering commitment to our vision to be a disease- and technology-agnostic, fully integrated global biopharmaceutical company, using targeted protein degradation to deliver medicines that will transform patients' lives. Today we look forward to sharing our plans to accomplish these ambitious goals," stated Nello Mainolfi, Founder, President and Chief Executive Officer. "This past year has been marked by strong execution, most notably the delivery of two new development candidates and three cleared INDs in 2021, enabling 3 clinical stage programs. These programs include: our potential best-in-class, oral anti-inflammatory drug, KT-474, which has shown proof-of-mechanism and proof-of-biology in the TPD industry's first randomized, placebo-controlled trial in healthy volunteers; the first degrader program (KT-333) targeting an undrugged transcription factor (STAT3); and the first program (KT-413) targeting a genetically- defined subset of diffuse large B cell lymphoma. Today, we also disclosed our new development candidate, KT-253, a first-in-class MDM2 degrader, which we believe has the potential to be the best-in-class p53 stabilizer for a wide variety of solid and liquid tumors, with an IND filing expected in 2022. Additionally, we demonstrated the first in vivo proof-of-concept data on tissue sparing degradation. We are also unveiling today our strategically complementary molecular glue discovery unit. We are excited to share these advances at our first R&D Day today, as well as our vision for Kymera over the next five years."

    Key Portfolio Updates and Progress:

    KT-474 (IRAK4)

    Multiple Ascending Dose (MAD) data included results from the first four KT-474 multiple ascending dose cohorts at doses ranging from 25 to 200 mg, comprising 48 healthy volunteer subjects randomized 9:3 to either 14 daily oral doses of KT-474 or placebo. The data demonstrated potent, marked IRAK4 reduction in peripheral blood mononuclear cells (PBMC) measured by mass spectrometry at doses substantially lower than those required in the single ascending dose (SAD), with steady-state degradation at Day 14 of 92% at the lowest dose level (25 mg) and 96-98% at the two highest dose levels (100-200 mg), where IRAK4 was reduced to near the lower limit of quantitation (LLOQ) of the assay (Table 1).

    Table 1: Percent IRAK4 Change from Baseline in PBMC at Day 14 using Mass Spectrometry

    CohortPlacebo

    (n=12)
    Cohort 1

    (n=9)
    Cohort 2

    (n=9)
    Cohort 3

    (n=9)
    Cohort 4

    (n=9)
    KT-474 dose-  25 mg 50 mg 100 mg 200 mg
    Mean IRAK4 Change, Day 14-23%-92%-95%-98%-96%
    p-value (relative to placebo) <0.0001<0.0001<0.0001<0.0001

    Proof of mechanism in the skin was established for the first time through demonstration of dose-dependent IRAK4 degradation, as measured by mass spectrometry. At the top dose of 200 mg, mean IRAK4 levels were reduced to near the LLOQ by the final day of dosing on Day 14, where continued decline in IRAK4 suggested that steady-state degradation had not yet been achieved.

    Proof-of-biology, established previously in the SAD portion through inhibition of ex vivo cytokine induction by toll-like receptor (TLR) agonists LPS and R848, was observed in MAD cohorts at considerably lower doses, with the 100 mg (MAD3) dose reaching 85% inhibition.

    Prolonged suppression of IRAK4 in blood and skin for at least 14-21 days with KT-474 multi-dosing was safe and well-tolerated.

    The study is on track to initiate an open-label cohort in up to 20 HS and AD patients in 1Q22 with data read-outs planned for mid-year, followed thereafter by the start of Phase 2 studies in multiple indications.

    Additional information on this clinical trial can be found on www.clinicaltrials.gov.

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

    KT-413 (IRAKIMiD)

    Kymera recently announced IND clearance of KT-413, the company's potent degrader of IRAK4 and IMiD substrates. KT-413's Phase 1 trial will evaluate safety, PK/PD, and preliminary efficacy in MYD88 mutant and MYD88 wild-type relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL). Primary study endpoints will include safety, tolerability and maximum tolerated dose (MTD) and recommended Phase 2 Dose, with secondary endpoints of PK and preliminary efficacy. The trial will also explore target (IRAK4/Ikaros/Aiolos) knockdown and downstream effects in PBMC and tumors.

    KT-333 (STAT3)

    In November, Kymera announced IND clearance of KT-433, the company's potent degrader of STAT3. KT-333's Phase 1 trial will evaluate safety, PK/PD, and preliminary efficacy in peripheral T cell lymphoma (PTCL), cutaneous T cell lymphoma (CTCL), large granular lymphocytic leukemia (LGL-L) and solid tumors. Primary study endpoints will include safety, tolerability and maximum tolerated dose (MTD) and recommended Phase 2 dose, with secondary endpoints of PK and preliminary efficacy. The trial will also explore STAT3 knockdown and downstream effects in PBMC and tumors.

    KT-253 (MDM2)

    Kymera announced today its new development program and development candidate KT-253, a potent and selective degrader of MDM2 with potential to be a best-in-class P53 stabilizer. Degradation of MDM2, rather than inhibition, has the ability to block the feedback loop which up-regulates MDM2 production and in doing so more effectively drives tumor cells to rapid apoptosis. KT-253 inhibits tumor cell growth with picomolar potency that is more than 200-fold greater than clinically active MDM2 small molecule inhibitors. This leads to sustained tumor regression in vivo in leukemia models following just a single dose. As wild-type p53 is present in >50% of tumors, KT-253 represents another program with broad franchise potential in liquid and solid tumors. Kymera is focused on indications with specific sensitivity to this mechanism of action, such as AML, lymphomas, uveal melanoma and others through a focused biomarker strategy. Kymera expects to file an IND for KT-253 in 2022.

    New, Tissue Restrictive E3 Ligase

    Kymera disclosed for the first-time in vivo proof-of-concept of tissue selective degradation utilizing an E3 ligase with selective expression. With this E3 ligase, Kymera has demonstrated in vivo degradation of an oncology target in tumor but not in the blood cell type where the E3 ligase has little or no expression, thereby avoiding well-characterized on-target hematologic toxicity and potentially enabling broader clinical development. This program is projected to nominate a development candidate in 2022.

    Molecular Glues

    Kymera is reinforcing its commitment to drugging all target classes. Alongside its continued investments in heterobifunctional molecules to unlock inadequately drugged targets such as IRAK4 and MDM2, undrugged but ligandable targets such as STAT3 and targets in a tissue-restricted fashion, Kymera is expanding its reach into undrugged and un-ligandable targets, in which Kymera believes the most valuable application of a molecular glue approach resides. Going beyond the Cereblon/IMiD scaffold, Kymera is focused on prospectively identifying the best matched pairs between genetically validated but undrugged and unliganded targets and E3 ligases, exploiting natural affinities between the two proteins augmented by small molecule glues. Kymera has multiple programs in discovery stage and has formed partnerships with companies and academic institutions, including A-Alpha Bio, the University of Washington and New York University. These collaborations will accelerate technology development and translate discoveries into new degrader medicines.

    Five-Year Vision

    Kymera also shared its five-year vision through 2026 which includes: 8 or more clinical stage programs across different disease areas; a pipeline positioned to deliver at least 1 new IND per year; clinical proof-of-concept of tissue-selective/restricted degradation and undrugged targets; and the development of an industry-leading platform that is disease and technology agnostic while wholistically addressing the undrugged proteome.

    Kymera R&D Day Details:

    Kymera will host a webcast from 8:30-11:00 a.m. ET, Thursday, December 16. A live webcast of the event, as well as a replay, will be available at: https://investors.kymeratx.com/RD-Day.

    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 lead 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 Fierce Biotech 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 Kymera Therapeutics': plans to present results from the ongoing Phase 1 study of the KT-474 trial; platform and approach to drug development; including with respect to previously undruggable targets, business plans and objectives for the KT-474, KT-413, KT-333 and KT-253 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 clinical trials and 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 Quarterly Report on Form 10-Q for the period ended September 30, 2021, filed on November 10, 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



    857-285-5300

    Chris Brinzey

    Managing Director, Westwicke



    339-970-2843

    Media Contact:

    Tyler Gagnon

    Director, Corporate Communications



    508-904-9446



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  5. Two presentations demonstrated Kymera's STAT3 degraders can reduce STAT3 expression, modify STAT3-dependent signaling, and suppress the growth of tumors in multiple preclinical models of lymphoma and solid tumors

    WATERTOWN, Mass., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ:KYMR), a biopharmaceutical company advancing targeted protein degradation to deliver novel, small molecule protein degrader therapeutics, today announced the company presented new preclinical data for its STAT3 degraders, including its first-in-class KT-333 STAT3 degrader, at the virtual 63rd American Society of Hematology (ASH) Annual Meeting taking place from December 11 – 14, 2021 in Atlanta, GA and virtually.

    Kymera's first presentation, "A…

    Two presentations demonstrated Kymera's STAT3 degraders can reduce STAT3 expression, modify STAT3-dependent signaling, and suppress the growth of tumors in multiple preclinical models of lymphoma and solid tumors

    WATERTOWN, Mass., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ:KYMR), a biopharmaceutical company advancing targeted protein degradation to deliver novel, small molecule protein degrader therapeutics, today announced the company presented new preclinical data for its STAT3 degraders, including its first-in-class KT-333 STAT3 degrader, at the virtual 63rd American Society of Hematology (ASH) Annual Meeting taking place from December 11 – 14, 2021 in Atlanta, GA and virtually.

    Kymera's first presentation, "A First-in-Class STAT3 Degrader KT-333 in Development for Treatment of Hematologic Cancers" showcased how its clinical compound KT-333 induced growth arrest and cell death in multiple models of anaplastic large cell lymphoma (ALCL). This resulted in eradication of ALK+ ALCL tumor xenografts with weekly or every other week dosing associated with >90% STAT3 knockdown in tumors and modulation of STAT3-dependent signaling. In addition, KT-333 reduced mediators of immune suppression in an ex vivo, co-culture model of the tumor microenvironment in non-small cell lung cancer and led to tumor regressions in the mouse CT-26 colorectal cancer syngeneic tumor model when coupled with an anti-PD1 antibody, demonstrating the potential for this combination immunodulatory approach in solid tumors.

    "KT-333 is a potent and selective STAT3 degrader targeting a high priority, previously undruggable transcription factor that has the potential to address a range of hematologic and solid cancers based on a growing body of preclinical studies described to date," said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics. "We are excited about the development opportunities as a monotherapy in STAT3-dependent T and NK cell hematologic malignancies and in combination with immune checkpoint inhibitors in solid tumors as we are about to initiate our Phase 1 trial in liquid and solid tumors."

    The second presentation, "Selective STAT3 Degraders Dissect Peripheral T-Cell Lymphomas Vulnerabilities Empowering Personalized Regimens" highlights results from a research collaboration with Georgio Inghirami, MD, Weill Cornell Medical College. In primary patient-derived tumor xenograft (PDTX) models of anaplastic large cell lymphoma (ALCL), selective STAT3 degraders were shown to potently degrade STAT3 and modify STAT3-dependent signaling, leading to tumor growth inhibition and cell death in an ALK- ALCL model characterized by STAT3 activation via STAT3 and Jak1 mutations. STAT3 degraders were also shown to synergize with other targeted agents, such as venetoclax, in various peripheral T-cell lymphoma (PTCL) PDTX models.

    "Taken together, these findings help to identify STAT3-dependent hematologic malignancies based on pathogenic mutations, as well as gene expression signatures, potentially enabling the selection of patients most likely to respond to STAT3 degraders," said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. "Our Phase 1 trial of KT-333 will further aid in defining tumor biomarkers of response to STAT3 degradation that will inform the design of subsequent trials in PTCL."

    KT-333 Presentation Details:

    • Title: A First-in-Class STAT3 Degrader KT-333 in Development for Treatment of Hematologic Cancers
    • Poster Session: 802. Chemical Biology and Experimental Therapeutics: Poster 1
    • Abstract Number: 1865
    • Session Time: 5:30 p.m. – 7:30 p.m. ET on Saturday, Dec. 11, 2021
    • Location: Hall B5, Georgia World Congress Center, Atlanta, GA
    • Presenter: Phillip Liu, Executive Director, Oncology Biology, Kymera Therapeutics

    KTX-105 and KTX-154 Presentation Details:

    • Title: Selective STAT3 Degraders Dissect Peripheral T-Cell Lymphomas Vulnerabilities Empowering Personalized Regimens
    • Oral Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Novel Targets and Therapeutics
    • Session Time: 6:15 p.m. – 7:45 p.m. ET on Monday, Dec. 13, 2021
    • Location: B302-B303, Georgia World Congress Center, Atlanta, GA
    • Presenter: Giorgio Inghirami, MD, Professor of Pathology and Laboratory Medicine, Weill Cornell Medicine

    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 STAT3 degrader program; 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 ofKymera 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 Quarterly Report on Form 10-Q for the period ended September 30, 2021, filed on November 10, 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  

     

    857-285-5300 

    Chris Brinzey 

    Managing Director, Westwicke 

     

    339-970-2843 

    Media Contact: 

    Tyler Gagnon 

    Director, Corporate Communications 

      

    508-904-9446



    Primary Logo

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