Desmoglein-3

Cabaletta Bio Appoints Biopharmaceutical Leader Scott Brun, M.D. to Board of Directors

Retrieved on: 
Monday, June 28, 2021

His expertise will be particularly valuable to Cabaletta as we advance our lead program, DSG3-CAART, in mucosal pemphigus vulgaris, said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta.

Key Points: 
  • His expertise will be particularly valuable to Cabaletta as we advance our lead program, DSG3-CAART, in mucosal pemphigus vulgaris, said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta.
  • We welcome him to the Board of Directors and look forward to his contributions to our strategic and operational objectives as we seek to increase shareholder value.
  • Earlier in his career, he held positions of increasing leadership responsibility in drug development within the R&D organization at Abbott Laboratories.
  • Dr. Brun will succeed Brian Daniels, M.D., who resigned from the Board of Directors effective June 24, 2021, and subsequently joined the Scientific Advisory Board.

Cabaletta Bio Announces First Patient Dosed in Landmark DesCAARTes™ Trial of DSG3-CAART for Treatment of Mucosal-Dominant Pemphigus Vulgaris

Retrieved on: 
Tuesday, December 8, 2020

We believe this is the first time a highly targeted, antigen specific cell therapy has been dosed in a patient with autoimmune disease.

Key Points: 
  • We believe this is the first time a highly targeted, antigen specific cell therapy has been dosed in a patient with autoimmune disease.
  • Currently available therapies for mPV patients, including steroids, typically induce broad immunosuppression, offer modest efficacy and/or are associated with frequent relapses.
  • Cabaletta Bios DesCAARTes Phase 1 trial is an open-label, multi-center study of DSG3-CAART in adults with mucosal-dominant pemphigus vulgaris (mPV).
  • The trial is expected to enroll approximately 30 subjects across multiple clinical sites throughout the United States.

Cabaletta Bio Announces Publication of Comprehensive Preclinical Study Results for DSG3-CAART in Pemphigus Vulgaris

Retrieved on: 
Tuesday, August 25, 2020

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.

Key Points: 
  • 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.
  • 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.
  • 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.

Cabaletta Bio Receives FDA Fast Track Designation for DSG3-CAART for the Treatment of Mucosal Pemphigus Vulgaris

Retrieved on: 
Wednesday, May 6, 2020

We believe that this Fast Track Designation, coming shortly after the Orphan Drug Designation for DSG3-CAART, further demonstrates that mPV is a devastating, rare disease for which patients have limited treatment options resulting in a large unmet need.

Key Points: 
  • We believe that this Fast Track Designation, coming shortly after the Orphan Drug Designation for DSG3-CAART, further demonstrates that mPV is a devastating, rare disease for which patients have limited treatment options resulting in a large unmet need.
  • The Fast Track Designation represents an important next step in our clinical development plans, said David J. Chang, M.D., Chief Medical Officer of Cabaletta.
  • The FDA grants Fast Track Designation to drugs or biologics to facilitate the expedited development and review for therapeutics intended to treat serious or life-threatening conditions and to address unmet medical needs.
  • The Companys lead product candidate, DSG3-CAART, is in development as a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris.

FDA Grants DSG3-CAART Orphan Drug Designation for the Treatment of Pemphigus Vulgaris

Retrieved on: 
Wednesday, January 29, 2020

The FDA grants Orphan Drug Designation to drugs or biologics intended to treat or prevent rare diseases or conditions that affect fewer than 200,000 individuals in the United States.

Key Points: 
  • The FDA grants Orphan Drug Designation to drugs or biologics intended to treat or prevent rare diseases or conditions that affect fewer than 200,000 individuals in the United States.
  • This designation qualifies Cabaletta for certain incentives, which may include partial tax credit for clinical trial expenditures, waived user fees and potential eligibility for seven years of marketing exclusivity.
  • mPV is characterized by autoantibodies against DSG3 only whereas mucocutaneous PV (mcPV) is characterized by autoantibodies against DSG3 and DSG1.
  • The Companys lead product candidate is being studied in a phase 1 clinical trial as a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris.

Cabaletta Bio Receives IND Clearance from FDA to Initiate First Clinical Trial of DSG3-CAART in Patients with Mucosal Pemphigus Vulgaris

Retrieved on: 
Tuesday, October 1, 2019

DSG3-CAART has the potential to generate persistent complete remission off therapy while avoiding the adverse effects of chronic and generalized immunosuppression.

Key Points: 
  • DSG3-CAART has the potential to generate persistent complete remission off therapy while avoiding the adverse effects of chronic and generalized immunosuppression.
  • Approximately 4,250 patients suffer from mPV in the United States and 6,250 patients in Europe, which accounts for approximately 25% of all PV cases.
  • The autoantibodies can target desmoglein 3 (DSG3) and/or desmoglein 1 (DSG1), which are primarily expressed in the mucosal membranes and skin, respectively.
  • The Companys lead product candidate is being studied as a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris (mPV).