CABA Cabaletta Bio Inc.

14.4
+0.05  (+0%)
Previous Close 14.35
Open 14.26
52 Week Low 5.51
52 Week High 19.63
Market Cap $346,398,725
Shares 24,055,467
Float 19,218,574
Enterprise Value $222,681,639
Volume 59,219
Av. Daily Volume 71,659
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Latest News

  1. PHILADELPHIA, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will participate in two upcoming investor conferences in December:

    • Piper Sandler 32nd Annual Virtual Healthcare Conference on Wednesday, December 2, 2020: A pre-recorded fireside chat with Dr. Nichtberger is now available on the company's website.
    • Evercore ISI 3rd Annual Virtual HealthCONx Conference on Thursday, December 3, 2020: Live fireside chat with Dr. Nichtberger at 9:15 a.m. ET.

    All webcasts of presentations…

    PHILADELPHIA, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will participate in two upcoming investor conferences in December:

    • Piper Sandler 32nd Annual Virtual Healthcare Conference on Wednesday, December 2, 2020: A pre-recorded fireside chat with Dr. Nichtberger is now available on the company's website.
    • Evercore ISI 3rd Annual Virtual HealthCONx Conference on Thursday, December 3, 2020: Live fireside chat with Dr. Nichtberger at 9:15 a.m. ET.

    All webcasts of presentations are available on the News and Events section of the company's website at www.cabalettabio.com. Following the presentations, a replay of the webcasts will be available on the website for 90 days.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies, and exploring their potential to provide a deep and durable, perhaps curative, treatment, for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTesTM phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200



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  2. PHILADELPHIA, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced financial results for the third quarter ended September 30, 2020 and provided a business update.

    "With patient enrollment now underway for our lead program, DSG3-CAART, for patients with mucosal pemphigus vulgaris, we are on track to report acute safety data from the first cohort of patients in the first half of next year. During the quarter, we opened a second site for the trial and also published comprehensive preclinical proof of concept data in The Journal of Clinical Investigation

    PHILADELPHIA, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced financial results for the third quarter ended September 30, 2020 and provided a business update.

    "With patient enrollment now underway for our lead program, DSG3-CAART, for patients with mucosal pemphigus vulgaris, we are on track to report acute safety data from the first cohort of patients in the first half of next year. During the quarter, we opened a second site for the trial and also published comprehensive preclinical proof of concept data in The Journal of Clinical Investigation further validating the mechanism of action of DSG3-CAART," said Steven Nichtberger, M.D., Chief Executive Officer and co-founder of Cabaletta.

    Pipeline Highlights and Anticipated Upcoming Milestones

    DSG3-CAART: Desmoglein 3 chimeric autoantibody receptor (CAAR) T cells as potential treatment for patients with mucosal pemphigus vulgaris (mPV).

    • The Company's open-label Phase 1 clinical trial (DesCAARTes™) to evaluate the safety and tolerability of DSG3-CAART in relapsed/refractory mPV patients is actively recruiting patients at the first two sites in the U.S. The Company expects to report acute safety data from the initial cohort in the study in the first half of 2021.



    • In August 2020, the Company announced that comprehensive preclinical data for DSG3-CAART were published in The Journal of Clinical Investigation. These data demonstrated that DSG3-CAART achieved autoantibody elimination and resolution of blisters in an active immune mouse model of pemphigus vulgaris and that circulating soluble autoantibodies have the potential to enhance DSG3-CAART efficacy and did not demonstrate off-target toxicity.

    MuSK-CAART: Muscle Specific Kinase (MuSK) CAAR T cells as potential treatment for MuSK-associated myasthenia gravis.

    • Investigational New Drug (IND)-enabling studies are ongoing with an IND submission to the U.S. Food and Drug Administration (FDA) anticipated in the second half of 2021.

    Manufacturing

    • Cell processing capacity is contractually secured at the University of Pennsylvania for the Phase 1 study of DSG3-CAART.



    • Two to three years of vector supply for DSG3-CAART is secured, and pilot partnerships have been established for the production of additional vector at commercial grade and scale.



    • Cabaletta expects to initiate validation of cell processing for MuSK-CAART clinical trials with a commercial grade contract manufacturing partner before the end of 2020.

    Upcoming Events

    • Cabaletta will participate in a fireside chat at the Piper Sandler Virtual Conference on December 1-3.



    • Cabaletta will participate in a fireside chat at the Evercore ISI 3rd Annual HealthconX Conference on December 1-3.

    Third Quarter 2020 Financial Results

    The Company expects that its cash and cash equivalents and investments as of September 30, 2020 will enable it to fund its operating plan through at least the third quarter of 2022.  

    • Research and development (R&D) expenses for the three months ended September 30, 2020 were $5.7 million, compared to $3.2 million for the same period in 2019.



    • General and administrative (G&A) expenses for the three months ended September 30, 2020 were $2.8 million, compared to $1.8 million for the same period in 2019.



    • As of September 30, 2020, cash and cash equivalents and investments totaled $118.1 million, compared to $136.2 million as of December 31, 2019.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies, and exploring their potential to provide a deep and durable, perhaps curative, treatment, for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements" of Cabaletta within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cabaletta's beliefs and expectations regarding its: expectations of the potential impact of COVID-19 on strategy, future operations, IND submissions, contract manufacturing agreements, collaboration, and the timing of its clinical trials, as well as potential impacts on enrollment and initiation; DesCAARTes™ phase 1 clinical trial, including the expected completion of its patient recruitment, the potential timing of the initiation of patient dosing, and the results and expected timing to report clinical acute safety data from the initial cohort by the first half of 2021; MuSK-CAART program, including the completion and expected results of its ongoing IND-enabling studies and plans to submit an IND application or equivalent regulatory filing for MuSK-CAART in the second half of 2021; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2020; expectations regarding the design, implementation, timing and success of its current and planned clinical trials and the successful completion of nonclinical studies; planned potential timing and advancement of its preclinical studies and clinical trials and related regulatory submissions; ability and the potential to successfully maintain or secure the necessary cell processing capacity and supply for its product candidates for clinical trials, including Cabaletta's planned development and timing of next generation T cell engineering tools and process advancement; ability to replicate results achieved in preclinical studies or clinical trials in any future studies or trials; ability to continue its growth and realize the anticipated contribution of the members of its board of directors and executives to its operations and progress; ability to optimize the impact of its collaborations on its development programs; statements regarding the timing of regulatory filings regarding its development programs; use of capital, expenses, future accumulated deficit and other financial results in the future; and ability to fund operations through the third quarter of 2022. 

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; risks related to Cabaletta's ability to protect and maintain its intellectual property position; risks related to Cabaletta's relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta's product candidates will not be successfully developed and commercialized; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Cabaletta's most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

    CABALETTA BIO, INC.

    SELECTED FINANCIAL DATA

    (unaudited; in thousands, except share and per share data)



    Statements of Operations

      Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
       2020   2019   2020   2019 
             
      unaudited unaudited
    Operating expenses:        
    Research and development $           5,650  $3,220  $15,601  $       8,645 
    General and administrative  2,766      1,811      8,902      4,178 
    Total operating expenses  8,416      5,031      24,503      12,823 
    Loss from operations  (8,416)  (5,031)  (24,503)  (12,823)
    Other income:        
    Interest income     23      381   473      1,283 
    Net loss  (8,393)  (4,650)  (24,030)  (11,540)
    Deemed dividend           (5,326)
    Net loss attributable to common stockholders $    (8,393) $(4,650) $     (24,030) $(16,866)
    Net loss per share of voting and non-voting common stock, basic and diluted $(0.36) $(2.17) $    (1.09) $    (9.34)

    Selected Balance Sheet Data

      September 30,

    2020
     December 31,

    2019
       
                              unaudited
         
    Cash, cash equivalents and investments $                             118,074 $136,204
    Total assets                 121,770  141,468
    Total liabilities                      4,265             3,147
    Total stockholders' equity  117,505  138,321
         

    Contacts:

    Anup Marda

    Chief Financial Officer

    Investors:

    Sarah McCabe

    Stern Investor Relations, Inc.

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  3. PHILADELPHIA, Sept. 25, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will present at the following three upcoming investor conferences in October:

    • Stifel 2020 Immunology and Inflammation Virtual Summit: "The Potential for Treg Modifying and CAR T Therapies in Immunology" panel on Thursday, October 1, 2020 at 3:00 p.m. ET.
    • Jefferies Virtual Cell Therapy Summit: Fireside chat on Monday, October 5, 2020 at 8:30 a.m. ET.
    • Chardan 4th Annual Genetic Medicines Conference: Fireside chat…

    PHILADELPHIA, Sept. 25, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will present at the following three upcoming investor conferences in October:

    • Stifel 2020 Immunology and Inflammation Virtual Summit: "The Potential for Treg Modifying and CAR T Therapies in Immunology" panel on Thursday, October 1, 2020 at 3:00 p.m. ET.
    • Jefferies Virtual Cell Therapy Summit: Fireside chat on Monday, October 5, 2020 at 8:30 a.m. ET.
    • Chardan 4th Annual Genetic Medicines Conference: Fireside chat on Tuesday, October 6, 2020 at 11:30 a.m. ET.

    A live webcast of these presentations will be available on the News and Events section of the company's website at www.cabalettabio.com. Following the presentations, a replay of the webcast will be available on the website for 90 days.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ Phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the DesCAARTes™ Phase 1 clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.

    Primary Logo

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  4. PHILADELPHIA, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced its participation in fireside chats at the following upcoming September investor conferences:

    • Morgan Stanley 18th Annual Global Healthcare Conference on Monday, September 14, 2020 at 3:00 p.m. ET.
    • H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 4:30 p.m. ET.

    A live webcast of the presentations will be available on the News and Events section of the company's website at www.cabalettabio.com. Following the presentations, a replay of the webcast…

    PHILADELPHIA, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced its participation in fireside chats at the following upcoming September investor conferences:

    • Morgan Stanley 18th Annual Global Healthcare Conference on Monday, September 14, 2020 at 3:00 p.m. ET.
    • H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 4:30 p.m. ET.

    A live webcast of the presentations will be available on the News and Events section of the company's website at www.cabalettabio.com. Following the presentations, a replay of the webcast will be available on the website for 90 days.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ Phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the DesCAARTes™ Phase 1 clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

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    • DSG3-CAART achieved autoantibody elimination and resolution of blisters in active immune mouse model of pemphigus vulgaris
    • Soluble autoantibodies demonstrated potential to enhance DSG3-CAART efficacy and did not demonstrate off-target toxicity
    • DesCAARTes™ Phase 1 clinical trial actively recruiting patients

    PHILADELPHIA, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced comprehensive preclinical study results evaluating DSG3-CAART (Desmoglein 3 chimeric autoantibody receptor T cells), its lead product candidate for patients with mucosal pemphigus…

    • DSG3-CAART achieved autoantibody elimination and resolution of blisters in active immune mouse model of pemphigus vulgaris
    • Soluble autoantibodies demonstrated potential to enhance DSG3-CAART efficacy and did not demonstrate off-target toxicity
    • DesCAARTes™ Phase 1 clinical trial actively recruiting patients

    PHILADELPHIA, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced comprehensive preclinical study results evaluating DSG3-CAART (Desmoglein 3 chimeric autoantibody receptor T cells), its lead product candidate for patients with mucosal pemphigus vulgaris (mPV), were published in The Journal of Clinical Investigation. The manuscript, titled "Antigen-specific B-cell depletion for precision therapy of mucosal pemphigus vulgaris," includes the preclinical data that enabled the DSG3-CAART IND submission and opening of the DesCAARTesTM clinical trial. The paper can be accessed online at: https://www.jci.org/articles/view/138416/pdf.

    The preclinical studies, conducted at the Perelman School of Medicine at the University of Pennsylvania and led by the laboratory of Aimee Payne, MD, PhD, assessed the potential toxicity and specific target engagement of DSG3-CAART in inducing antigen-specific B cell depletion. In vitro results of DSG3-CAART demonstrated specific killing of anti-DSG3 B cell receptor (BCR) expressing cell lines, as well as killing of desmoglein 3 (DSG3) specific B cells from patients with pemphigus vulgaris (PV) while sparing normal B cells. No off-target cytotoxic interactions were detected, and no DSG3-CAART activity against known binding partners to DSG3 was detected. Together the data demonstrate specific anti-DSG3 BCR killing along with a lack of on-target and off-target toxicity for DSG3-CAART. 

    In vivo studies included use of an active immune PV model, characterized by a PV clinical phenotype, including skin blistering and physiologic anti-DSG3 IgG levels. In these mice, DSG3-CAART reduced serum levels of pathogenic anti-DSG3 antibodies, as well as tissue bound antibodies in the epithelium, a hallmark of PV disease. Clinical and histologic resolution of blisters was observed in DSG3-CAART treated animals.

    The potential impact of anti-DSG3 antibodies on DSG3-CAART toxicity and target engagement was also evaluated. The researchers studied whether anti-DSG3 antibodies could serve as a "cytotoxic bridge" enabling DSG3-CAART to kill cells which express antibody receptors on their surface, and no such cross reactivity was detected. Building on prior evidence that DSG3-CAART function is not meaningfully inhibited by anti-DSG3 antibodies, and that proliferation of DSG3-CAART in response to polyclonal PV serum IgG is observed (as previously reported in the 2016 publication in Science), the recently published studies demonstrated functional activation of DSG3 CAAR T cells in response to anti-DSG3 antibodies. This may improve the potential efficacy of DSG3-CAART in targeting rare B cells. The potential risk for CRS or other inflammatory responses resulting from DSG3-CAART interaction with soluble anti-DSG3 autoantibodies post-infusion is being mitigated in the DesCAARTesTM Phase 1 trial design through a conservative fractionated-dose approach where increasing fractions of the target dose are infused, enabling for safety monitoring between infusions while preserving the opportunity for the patient to receive a full dose.

    "We believe these comprehensive preclinical data for DSG3-CAART, published in The Journal of Clinical Investigation, support our approach to develop a durable, potentially curative, treatment for patients with mucosal pemphigus vulgaris," said Steven Nichtberger, M.D., Chief Executive Officer and co-founder of Cabaletta. "CAAR T cells represent a precision therapy approach designed to eliminate the underlying cause of B cell-mediated autoimmune diseases. The data also inform development of the multiple additional CAAR T therapies for B cell-mediated diseases that are in our pipeline."

    The safety and tolerability of DSG3-CAART in targeting pathogenic B cells in patients with mPV is currently being evaluated in the DesCAARTes™ clinical trial, which recently started recruiting. The FDA granted Fast Track Designation to DSG3-CAART in May 2020.

    About Pemphigus Vulgaris

    PV is a rare autoimmune blistering disease that is characterized by the loss of adhesion between cells of the skin or mucous membranes. PV is caused by the production of autoantibodies that disrupt structural proteins within the skin and/or mucosa that connect with other proteins to enable the skin and/or mucosal cells to connect with each other. The autoantibodies can target DSG3 and/or desmoglein 1 (DSG1), which are primarily expressed in the mucosal membranes and skin, respectively. mPV is characterized by autoantibodies against DSG3 only whereas mucocutaneous PV is characterized by autoantibodies against DSG3 and DSG1.

    About CAAR T Cell Therapy

    Chimeric AutoAntibody Receptor (CAAR) T cells are designed to selectively bind and eliminate only disease-causing B cells, while sparing the normal B cells that are essential for human health. CAAR T cells are based on the chimeric antigen receptor (CAR) T cell technology. While CAR T cells typically contain a CD19-targeting molecule, CAAR T cells express an autoantibody-targeted antigen on their surface. The co-stimulatory domain and the signaling domain of both a CAR T cell and a CAAR T cell carry out the same activation and cytotoxic functions. Thus, Cabaletta Bio's CAARs are designed to direct the patient's T cells to kill only the pathogenic cells that express disease-causing autoantibodies on their surface, potentially leading to complete and durable remission of disease while sparing all other B cell populations that provide beneficial immunity from infection.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTesTM Phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the DesCAARTes™ Phase 1 clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com

    Forward-Looking Statements

    This press release contains "forward-looking statements" of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding the safety, effectiveness and timing of product candidates that Cabaletta Bio may develop, including in collaboration with academic partners; the safety, efficacy and tolerability of DSG3-CAART for the treatment of mPV; the impact of preclinical data on the future development of CAAR T therapies in our pipeline portfolio; expectations regarding the intended incentives conferred by Fast Track Designation for DSG3-CAART for the treatment of mPV; expectations of the potential impact of COVID-19 on strategy, future operations, and the timing of its clinical trials, including the potential impacts on enrollment and initiation of its DesCAARTes™ Phase 1 trial; and statements regarding regulatory filings regarding its development programs.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Cabaletta Bio's ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical and clinical trials of DSG3-CAART; risks related to the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19; Cabaletta's ability to retain and recognize the intended incentives conferred by Fast Track Designation for DSG3-CAART for the treatment of PV; risks related to Cabaletta's ability to protect and maintain its intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Cabaletta's most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.  

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.

     

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