KZR Kezar Life Sciences Inc.

6.55
-0.03  -0%
Previous Close 6.58
Open 6.55
52 Week Low 2.18
52 Week High 9.79
Market Cap $303,057,201
Shares 46,268,275
Float 38,480,112
Enterprise Value $160,190,249
Volume 218,577
Av. Daily Volume 201,282
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Upcoming Catalysts

Drug Stage Catalyst Date
KZR-616 (MISSION)
Lupus
Phase 2
Phase 2
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KZR-616 - PRESIDIO
Dermatomyositis and polymyositis
Phase 2
Phase 2
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Latest News

  1. Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced members of the executive team will present during upcoming virtual investor conferences. The details of the presentations are as follows:

    Jefferies Virtual London Healthcare Conference
    Wednesday, November 18, 2020, 1:10pm EST (Fireside Chat)
    Presenters: John Fowler, Chief Executive Officer; Christopher Kirk, PhD, Chief Scientific Officer, and Noreen R. Henig, MD, Chief Medical Officer

    2020 Evercore ISI HealthCONx Conference
    Thursday, December 3, 2020, 1:00pm EST (Presentation)
    Presenter: John Fowler, Chief Executive Officer

    The presentations will be…

    Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced members of the executive team will present during upcoming virtual investor conferences. The details of the presentations are as follows:

    Jefferies Virtual London Healthcare Conference

    Wednesday, November 18, 2020, 1:10pm EST (Fireside Chat)

    Presenters: John Fowler, Chief Executive Officer; Christopher Kirk, PhD, Chief Scientific Officer, and Noreen R. Henig, MD, Chief Medical Officer

    2020 Evercore ISI HealthCONx Conference

    Thursday, December 3, 2020, 1:00pm EST (Presentation)

    Presenter: John Fowler, Chief Executive Officer

    The presentations will be webcast live and may be accessed in the "Investors and News" section of the Company's website at www.kezarlifesciences.com. Kezar Life Sciences will maintain an archived replay of the webcasts on its website for 90 days after the conference.

    About Kezar Life Sciences

    Based in South San Francisco, Kezar Life Sciences is combining courage, conviction, and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function and inhibit multiple drivers of disease via a single target. KZR-616, a first-in-class selective immunoproteasome inhibitor, is being evaluated in severe and underserved autoimmune diseases. Additionally, KZR-261, the first clinical candidate for the treatment of cancer from the company's protein secretion program targeting the Sec61 translocon, is undergoing IND-enabling activities.

    View Full Article Hide Full Article
    • FDA grants two Orphan Drug Designations to KZR-616 for the treatment of Dermatomyositis (DM) and Polymyositis (PM)
    • KZR-616 clinical and pre-clinical data continues to support its potential to positively affect multiple drivers of immune-mediated diseases
    • KZR-261 IND submission on-track for Q1 2021

    Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced its third-quarter 2020 financial results and corporate highlights.

    "The third quarter of 2020 saw continued momentum for Kezar, punctuated by the U.S. FDA granting Orphan Drug Designations for our lead candidate KZR-616 for the treatment of polymyositis…

    • FDA grants two Orphan Drug Designations to KZR-616 for the treatment of Dermatomyositis (DM) and Polymyositis (PM)
    • KZR-616 clinical and pre-clinical data continues to support its potential to positively affect multiple drivers of immune-mediated diseases
    • KZR-261 IND submission on-track for Q1 2021

    Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced its third-quarter 2020 financial results and corporate highlights.

    "The third quarter of 2020 saw continued momentum for Kezar, punctuated by the U.S. FDA granting Orphan Drug Designations for our lead candidate KZR-616 for the treatment of polymyositis and dermatomyositis," said John Fowler, Kezar's Co-Founder and Chief Executive Officer. "In addition, our presentations at a number of medical and scientific meetings this fall highlight the compelling therapeutic potential of our two highly novel programs in immunoproteasome inhibition and the protein secretion pathway. With each step forward, our conviction deepens that Kezar's novel small molecule approaches in autoimmunity and oncology could have profound impacts on a wide array of diseases with high unmet need."

    Clinical Highlights & Updates

    KZR-616: Selective Immunoproteasome Inhibitor

    KZR-616 is currently being evaluated for the treatment of severe autoimmune diseases.

    • In October 2020, Orphan Drug Designations (ODD) were granted for KZR-616 in both dermatomyositis (DM) and polymyositis (PM) by the U.S. Food and Drug Administration (FDA). Both orphan diseases are autoimmune inflammatory myopathies that are chronic and debilitating diseases characterized by marked morbidity and mortality. The estimated prevalence of DM and PM in the United States is up to 71,000 and 51,000, respectively. Orphan Drug Designation can provide certain benefits for the development of KZR-616, including a period of marketing exclusivity for the first marketing application, if approved for the designated indication, certain tax credits and waiver of certain administrative fees.
    • The MISSION Phase 2 trial in patients with active, proliferative lupus nephritis (LN) opened for enrollment under a new protocol in August 2020. The primary efficacy endpoint for the trial is the number of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at six months.
      • Interim data are expected in late 2021, and topline data are expected in the first half of 2022. To allow for responding patients to continue treatment with KZR-616, a 12-month extension study will also be made available.
      • Updated results from the MISSION Phase 1b portion were presented at the American College of Rheumatology Annual Meeting (ACR Convergence 2020) in November 2020. These results indicate that KZR-616 60mg administrated subcutaneously weekly is well-positioned for development as a long-term treatment option in autoimmune disease.
    • The PRESIDIO Phase 2 trial of KZR-616 in polymyositis (PM) and dermatomyositis (DM) continues to enroll. A 12-month open-label extension study has been initiated for patients completing the placebo-controlled trial.
      • Topline data are expected in the first half of 2022.
      • Pre-clinical results of KZR-616 in a murine model of polymyositis were presented during ACR Convergence 2020. The results provide a rationale for targeting selective immunoproteasome inhibition for the treatment of polymyositis.

    KZR-261: Protein Secretion Program

    • KZR-261, a first-in-class protein secretion inhibitor, targets the Sec61 translocon and has demonstrated broad anti-tumor activity in preclinical models of both solid and hematologic malignancies. Additional preclinical data further detailing the ability of novel small molecule Sec61 inhibitors to target multiple checkpoint proteins on various cell populations, thereby offering the potential of combination therapy in a single compound, are being presented during the 8th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2020) and the Society for the Immunotherapy of Cancer (SITC) in November 2020.
    • An Investigational New Drug (IND) application for KZR-261 is on-track for a planned submission in the first quarter of 2021. The Phase 1 clinical trial will evaluate dose escalation and safety and tolerability in patients with solid tumors to begin shortly after IND acceptance.

    Third-Quarter 2020 Financial Results

    • Cash, cash equivalents and marketable securities totaled $150.0 million as of September 30, 2020, compared to $78.2 million as of December 31, 2019. The increase in cash, cash equivalents and marketable securities was primarily attributable to the net proceeds from Kezar's underwritten public offerings in February and June 2020, net of cash used by the Company in operations to advance its clinical stage programs and preclinical research and development.
    • Research and development expenses for the third quarter of 2020 increased by $1.2 million to $8.3 million, compared to $7.1 million in the third quarter of 2019. This increase was primarily related to advancing both the KZR-616 clinical program in multiple indications and the protein secretion preclinical program.
    • General and administrative expenses for the third quarter of 2020 increased by $0.7 million to $3.3 million, compared to $2.6 million in the third quarter of 2019. The increase was primarily due to an increase in personnel expenses, including non-cash stock-based compensation, legal and professional fees.
    • Net loss for the third quarter of 2020 was $11.3 million, or $0.23 per basic and diluted common share, compared to a net loss of $9.1 million, or $0.48 per basic and diluted common share, for the third quarter of 2019.
    • Total shares of common stock outstanding were 46.3 million as of September 30, 2020. Additionally, there were outstanding pre-funded warrants to purchase 3.8 million shares of common stock at an exercise price of $0.001 per share and outstanding options to purchase 4.5 million shares of common stock at a weighted average exercise price of $6.12 per share as of September 30, 2020.

    About KZR-616

    KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b clinical trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

    About KZR-261

    KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar's research and discovery efforts targeting protein secretion pathways. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company's proprietary platform evaluating Sec61 modulation. As a result, Kezar has established a broad library of protein secretion inhibitors. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent for the treatment of solid and hematologic malignancies. IND-enabling activities are currently underway, and an IND submission in solid tumors is expected to be filed in the first quarter of 2021.

    About Kezar Life Sciences

    Based in South San Francisco, Kezar Life Sciences is combining courage, conviction and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function and inhibit multiple drivers of disease via a single target. KZR-616, a first-in-class selective immunoproteasome inhibitor, is being evaluated in severe and underserved autoimmune diseases. Additionally, KZR-261, the first clinical candidate for the treatment of cancer from the company's protein secretion program targeting the Sec61 translocon, is undergoing IND-enabling activities. For more information, visit www.kezarlifesciences.com.

    Cautionary Note on Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "should," "expect," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the company's financial position and the timing and amount of future operating expenses, the design, progress, timing, scope and results of clinical trials, the anticipated timing of disclosure of results of clinical trials, plans for initiating future clinical trials and extension studies, the likelihood data will support future development, the association of data with treatment outcomes, the likelihood of obtaining regulatory approval of Kezar's product candidates, the timing of regulatory filings, and the discovery and development of new product candidates. Orphan Drug Designation does not provide any assurance of regulatory approval or expedite regulatory review. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the company's business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    KEZAR LIFE SCIENCES, INC.

    Selected Balance Sheets Data

    (in thousands)

    September 30, 2020

    December 31, 2019

     

     

    (unaudited)

     

     

    Cash, cash equivalents and marketable securities

    $

    149,954

    $

    78,206

    Total assets

     

    161,210

     

    89,513

    Total current liabilities

     

    6,193

     

    6,003

    Total stockholders' equity

     

    150,323

     

    78,046

    KEZAR LIFE SCIENCES, INC.

    Condensed Consolidated Statements of Operations

    (Unaudited, In thousands except share and per share data)

    Three Months Ended

    Nine Months Ended

    September 30,

    September 30,

    2020

    2019

    2020

    2019

    (unaudited)

    (unaudited)

    Operating expenses:

    Research and development

    $8,259

    $7,080

    $22,864

    $19,932

    General and administrative

    3,292

    2,601

    9,018

    7,413

    Total operating expenses

    11,551

    9,681

    31,882

    27,345

    Loss from operations

    (11,551)

    (9,681)

    (31,882)

    (27,345)

    Interest income

    262

    533

    1,081

    1,837

    Net loss

    ($11,289)

    ($9,148)

    ($30,801)

    ($25,508)

    Net loss per common share, basic and diluted

    ($0.23)

    ($0.48)

    ($0.73)

    ($1.34)

    Weighted-average shares used to compute net loss per common share, basic and diluted

    49,999,239

    19,095,870

    41,964,042

    19,070,937

     

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  2. Clinical and pre-clinical data continues to support potential of KZR-616 to positively effect multiple drivers of immune-mediated diseases

    Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today highlighted the broad therapeutic potential of KZR-616, a first-in-class immunoproteasome inhibitor, in two poster sessions during the American College of Rheumatology Annual Meeting (ACR Convergence 2020). Both posters can be found on Kezar's website under the "Science" section.

    Richard Furie, M.D., Chief, Division of Rheumatology, Northwell Health in New York, is presenting updated results from the MISSION Phase 1b study (NCT03393013…

    Clinical and pre-clinical data continues to support potential of KZR-616 to positively effect multiple drivers of immune-mediated diseases

    Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today highlighted the broad therapeutic potential of KZR-616, a first-in-class immunoproteasome inhibitor, in two poster sessions during the American College of Rheumatology Annual Meeting (ACR Convergence 2020). Both posters can be found on Kezar's website under the "Science" section.

    Richard Furie, M.D., Chief, Division of Rheumatology, Northwell Health in New York, is presenting updated results from the MISSION Phase 1b study (NCT03393013) evaluating KZR-616 in patients with systemic lupus erythematosus (SLE) with and without lupus nephritis (LN). The presentation by Dr. Furie includes additional patient-weeks of safety and tolerability data compared to prior data presentations. Encouraging trends in early efficacy signals continue, including improvement of SLE-specific disease activity scores. No new safety signals have been observed, and KZR-616 administered subcutaneously (SC) once weekly has been consistently well tolerated for 13 weeks. KZR-616 has been studied at doses of 45 mg, 60 mg and 75 mg SC weekly. Previously, Kezar has identified 45 mg and 60 mg as likely therapeutic doses to advance in its clinical development program.

    Kezar's collaborator, Marta Del Rio Oliva, Ph.D. candidate of the University of Konstanz, is presenting an evaluation of KZR-616 in a well-accepted preclinical mouse model of inflammatory myositis. In this model of myositis, KZR-616 treatment was associated with significant improvement in muscle function and reduced levels of muscle tissue damage. It is also demonstrated that an active immunoproteasome is necessary for the disease to occur. These data suggest that selective inhibition of the immunoproteasome with KZR-616 could have a meaningful clinical impact in patients with inflammatory myopathies, such as dermatomyositis (DM) and polymyositis (PM). Kezar is actively enrolling the PRESIDIO Phase 2 study (NCT04033926), a placebo-controlled, cross-over study of patients with DM and PM. The open-label extension study for PRESIDIO is also enrolling.

    "These two presentations strengthen our understanding of how KZR-616 can be an effective treatment for patients with a variety of autoimmune diseases. The preclinical data show the importance of the immunoproteasome in the pathology of myositis and the ability of KZR-616 to selectively inhibit this important regulator of immune function for therapeutic benefit. The clinical data continues to show that KZR-616 is well- tolerated and improves multiple signs and symptoms of SLE. We continue to build a strong foundation for KZR-616 as a novel and important therapeutic for patients living with LN, dermatomyositis and polymyositis and other immune-mediated diseases," said Noreen Henig, M.D., Kezar's Chief Medical Officer.

    About MISSION

    MISSION (NCT03393013) is a Phase 1b/2 clinical trial evaluating KZR-616 in SLE patients with and without nephritis. The study consists of two parts. The Phase 1b portion is an open-label dose escalation study which is evaluating doses up to 75 mg of KZR-616 across 6 cohorts, which has completed enrollment. The primary objective of the Ph1b portion of MISSION is to assess safety and tolerability. Secondary objectives include evaluating pharmacokinetics (PK) and pharmacodynamics (PD) and selecting dose levels for the Phase 2 trials. Several exploratory efficacy measures are also being assessed: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), Cutaneous Lupus Erythematosus Severity Index-Activity (CLASI-A), Tender and Swollen Joint Counts (TJC/SJC), Physician Global Assessment (PhGA), Patient Global Assessment (PtGA) and Patient Assessment of Pain (PtP). The Phase 2 portion of the MISSION study evaluating KZR-616 in patients with LN is currently enrolling.

    About PRESIDIO

    PRESIDIO (NCT04033926) is a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, PK and PD of treatment with KZR-616 in patients with active polymyositis or dermatomyositis. During the 32-week treatment period, patients will receive either KZR-616 or placebo subcutaneously once weekly for 16 weeks followed by a crossover to the other treatment arm for an additional 16 weeks. The study is expected to enroll 24 patients. An open-label extension study of PRESIDIO is now also enrolling.

    About KZR-616

    KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

    About Kezar Life Sciences

    Based in South San Francisco, Kezar Life Sciences is combining courage, conviction and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function and inhibit multiple drivers of disease via a single target. KZR-616, a first-in-class selective immunoproteasome inhibitor, is being evaluated in severe and underserved autoimmune diseases. Additionally, KZR-261, the first clinical candidate for the treatment of cancer from the company's protein secretion program targeting the Sec61 translocon, is undergoing IND-enabling activities. For more information, visit www.kezarlifesciences.com, and follow us on Twitter at @KezarBio, Facebook and LinkedIn.

    Cautionary Note on Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "should," "expect," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the likelihood that data will support future development, the association of data with treatment outcomes, the design, progress, timing, scope and results of clinical trials, the anticipated timing of disclosure of results of clinical trials and the likelihood of obtaining regulatory approval of Kezar's product candidates. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the company's business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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  3. Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced that the U.S. Food and Drug Administration has granted Orphan Drug Designations (ODD) for KZR-616 for the treatment of polymyositis (PM) and dermatomyositis (DM). Both orphan diseases are autoimmune inflammatory myopathies that are chronic and debilitating diseases characterized by marked morbidity and mortality. The estimated prevalence of PM and DM in the United States is up to 51,000 and 71,000, respectively.

    KZR-616 is a first-in-class selective immunoproteasome inhibitor with the potential to impact multiple drivers of immune-mediated diseases and…

    Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced that the U.S. Food and Drug Administration has granted Orphan Drug Designations (ODD) for KZR-616 for the treatment of polymyositis (PM) and dermatomyositis (DM). Both orphan diseases are autoimmune inflammatory myopathies that are chronic and debilitating diseases characterized by marked morbidity and mortality. The estimated prevalence of PM and DM in the United States is up to 51,000 and 71,000, respectively.

    KZR-616 is a first-in-class selective immunoproteasome inhibitor with the potential to impact multiple drivers of immune-mediated diseases and inflammation. PRESIDIO, a Phase 2 placebo-controlled cross-over clinical trial to evaluate KZR-616 for the treatment of PM and DM, is currently enrolling subjects.

    "We are very pleased to have received orphan drug designations for both polymyositis and dermatomyositis. This recognition spotlights the significant unmet need for patients living with these autoimmune myopathies. KZR-616 has potential to truly modify the underlying pathophysiology of these two diseases," said Noreen R. Henig, MD, Kezar’s Chief Medical Officer. "We will share more detail on the preclinical scientific rationale for the use of selective immunoproteasome inhibition to treat these rare and debilitating diseases during the 2020 American College of Rheumatology Conference next month."

    Orphan Drug Designation is intended to advance drug development for rare diseases. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States. Orphan Drug Designation can provide certain benefits and incentives for KZR-616, including a period of marketing exclusivity for the first marketing application, if regulatory approval is received for the designated indication, potential tax credits for qualified clinical testing and waiver of certain administrative fees.

    About KZR-616

    KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

    About Polymyositis and Dermatomyositis

    Polymyositis (PM) and Dermatomyositis (DM) are two of the five types of autoimmune myositis diseases. Both are chronic, debilitating, inflammatory autoimmune myopathies that are distinguished by inflammation of the muscles as well as the skin (in DM). Up to ~120,000 people in the United States are living with these severe and progressive inflammatory myopathies that are characterized by marked morbidity and associated mortality. While debilitating muscle weakness is the hallmark of these myopathies, including compromised muscles of respiration, other internal organ system dysfunctions can be equally disabling. The aim of treatment for these diseases is to suppress inflammation, increase muscle strength and prevent long-term damage to muscles and extramuscular organs; however, treatment options are limited for DM, and there are currently no approved treatments for PM.

    About Kezar Life Sciences

    Based in South San Francisco, Kezar Life Sciences is combining courage, conviction and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function and inhibit multiple drivers of disease via a single target. KZR-616, a first-in-class selective immunoproteasome inhibitor, is being evaluated in severe and underserved autoimmune diseases. Additionally, KZR-261, the first clinical candidate for the treatment of cancer from the company's protein secretion program targeting the Sec61 translocon, is undergoing IND-enabling activities.

    Cautionary Note on Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "should," "expect," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to estimates of the prevalence of polymyositis and dermatomyositis, the potential of KZR-616 to modify the underlying pathophysiology of polymyositis and dermatomyositis, statements about the likelihood that pre-clinical data will support the scientific rationale to develop KZR-616 in polymyositis and dermatomyositis, the design, progress, timing, scope and results of clinical trials, the anticipated timing of disclosure of results of clinical trials and the likelihood and timing of obtaining regulatory approval of KZR-616. Orphan Drug Designation does not provide any assurance of regulatory approval or expedite regulatory review. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the company’s business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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  4. ACR and ASN presentations provide updated interim results from the Phase 1b MISSION study and highlight the broad immunomodulatory potential of KZR-616 to treat severe autoimmune diseases

    Cytokines 2020 and SITC presentations to showcase Sec61 inhibition as a novel mechanism for blocking expression of therapeutically relevant targets such as cytokines and immune checkpoints

    Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced six presentations during four upcoming medical and scientific conferences.

    "The growing body of data around KZR-616, our first-in-class selective immunoproteasome inhibitor, support…

    ACR and ASN presentations provide updated interim results from the Phase 1b MISSION study and highlight the broad immunomodulatory potential of KZR-616 to treat severe autoimmune diseases

    Cytokines 2020 and SITC presentations to showcase Sec61 inhibition as a novel mechanism for blocking expression of therapeutically relevant targets such as cytokines and immune checkpoints

    Kezar Life Sciences, Inc. (NASDAQ:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced six presentations during four upcoming medical and scientific conferences.

    "The growing body of data around KZR-616, our first-in-class selective immunoproteasome inhibitor, support its unique and powerful immunomodulatory mechanism to tackle severe immune-mediated diseases where treatment options are limited," said Noreen Henig, MD, Kezar's Chief Medical Officer.

    "We're thrilled to highlight our Protein Secretion Drug Discovery program as a novel way to target immune checkpoints in oncology and cytokine pathways in inflammatory disorders," said Christopher Kirk, PhD, Kezar's President and Chief Scientific Officer. "Our novel compounds highlight the potential of targeting the protein secretion pathway and the Sec61 translocon, as a means to induce inhibition of multiple therapeutically relevant targets."

    Following is an overview of Kezar's upcoming scientific and clinical presentations, which will also be made available on the company's website:

    The American Society of Nephrology's Kidney Week 2020

    Dr. Samir Parikh will present accumulated interim results of the MISSION Phase 1b study of KZR-616 for the treatment of systemic lupus erythematosus (SLE) with or without nephritis in a poster presentation. In an oral abstract presentation, Kezar will share preclinical data further illustrating the mechanism of action and broad immunomodulatory potential of KZR-616 in lupus nephritis.

    Title: Treatment of SLE with or without nephritis with the Immunoproteasome Inhibitor KZR-616: Initial Results of the MISSION Study

    Abstract N°: PO1913 (e-poster presentation)

    Presenters: Samir Parikh, MD, Assistant Professor of Medicine, The Ohio State University Wexner Medical Center

    Session: Glomerular Diseases: Clinical, Outcomes, and Trials - 3

    Date and Time: October 22, 10:00 am – 12:00 pm ET

    Title: KZR-616, A Selective Inhibitor of the Immunoproteasome: Preclinical and Clinical Mechanism of Action Studies in Lupus Nephritis

    Abstract N°: FR-OR38

    Presenter: Tony Muchamuel, MS, Director of Pharmacology and Toxicology, Kezar Life Sciences

    Session: Glomerular Diseases: Charting New Territory [OR1202]

    Date and Time: October 23, 2020, 5:00 – 7:00pm ET

    8th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2020)

    Kezar's presentation will focus on the potential use of narrow-spectrum inhibitors of Sec61 for attenuation of the secretion of multiple pro-inflammatory cytokines in vitro and in vivo, with limited cytotoxicity.

    Title: Blockade of Cytokine Production and Attenuation of Experimental Arthritis Progression by Novel Small Molecule Inhibitors of Sec61-Dependent Protein Secretion

    Session: Lightning Talk Session 2: Autoinflammation and autoimmunity

    Presenter: Janet L. Anderl, MS, Senior Scientist, Kezar Life Sciences

    Date: November 2, 2020, 6:15 – 8:15 pm ET

    American College of Rheumatology's Convergence 2020

    Dr. Richard Furie will present updated interim results of the MISSION Phase 1b study of KZR-616 in SLE patients with and without nephritis in a poster session. Additionally, Marta Del Rio Olivia will give an oral presentation featuring preclinical data on the mechanism of KZR-616 in a murine model of polymyositis.

    Title: Treatment of SLE with or without Nephritis with the Immunoproteasome Inhibitor KZR-616: Updated Results of the MISSION Study

    Abstract N°: 0855

    Session: SLE – Treatment Poster I

    Presenter: Richard Furie, M.D., Chief of the Division of Rheumatology at Northwell Health

    Date: November 7, 2020, 9:00 – 11:00 am ET

    Title: KZR-616, a First-in-class Selective Inhibitor of the Immunoproteasome, Ameliorates Polymyositis in a Murine Model

    Abstract N°: 1916

    Session: Systemic Sclerosis & Related Disorders – Basic Science Poster

    Presenter: Marta Del Rio Oliva, Ph.D. candidate, Clinical Immunology, University of Konstanz

    Date: November 9, 2020 at 9:00 – 11:00 am ET

    The Society for Immunotherapy of Cancer's Annual Meeting

    Kezar Life Sciences will present a scientific poster demonstrating that Sec61 inhibitors can block the expression of CD47, a phagocytosis checkpoint protein, on tumor cells and subsequently modulate macrophage phagocytic activity.

    Title: Small molecule inhibitors of Sec61 co-translational translocation regulate the phagocytosis checkpoint molecule CD47

    Abstract N°: 207

    Session: Checkpoint Blockcade Therapy - poster session

    Presenter: Jennifer Whang, Ph.D., Senior Scientist, Kezar Life Sciences

    Date: November 11, 5:15 – 5:45pm ET; November 13, 4:40-5:10pm ET

    About KZR-616

    KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

    About KZR-261

    KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar's research and discovery efforts targeting protein secretion pathways. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered at Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company's proprietary platform evaluating Sec61 modulation. As a result, Kezar has established a broad library of protein secretion inhibitors. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent for the treatment of solid and hematologic malignancies. IND-enabling activities are currently underway, and an IND submission in solid tumors is expected to be filed in the first quarter of 2021.

    About Kezar Life Sciences

    Based in South San Francisco, Kezar Life Sciences is combining courage, conviction and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function and inhibit multiple drivers of disease via a single target. KZR-616, a first-in-class selective immunoproteasome inhibitor, is being evaluated in severe and underserved autoimmune diseases. Additionally, KZR-261, the first clinical candidate for the treatment of cancer from the company's protein secretion program targeting the Sec61 translocon, is undergoing IND-enabling activities.

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