Pemphigus vulgaris

Cabaletta Bio Strengthens Executive Leadership Team with Promotions of Gwendolyn Binder, Ph.D. to President of Science and Technology and Arun Das, M.D. to Chief Business Officer

Retrieved on: 
Tuesday, January 11, 2022 - 1:00pm

In these new roles, Dr. Binder and Dr. Das will continue to report to Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta.

Key Points: 
  • In these new roles, Dr. Binder and Dr. Das will continue to report to Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta.
  • In her elevated position as President of Science and Technology, with the recently announced promotions of our Chief Scientific Officer and Chief Compliance Officer, we look forward to leveraging her expertise for broader strategic insight and leadership.
  • Arun has made key strategic contributions to the business, including establishing many of the collaborations in our network of academic and industry partners.
  • Dr. Binder was one of Cabalettas first employees, joining in February 2019, and was most recently Executive Vice President of Science and Technology.

SinoMab Awared the "Best Small and Mid-Cap Company" and "Best CEO" in the Selection of the "6th Hong Kong Golden Stocks Awards" and the "Listed Company with the Most Growth Potential" in the Selection of "2021 Sina Finance Golden Unicorn Best Hong Kong an

Retrieved on: 
Tuesday, January 11, 2022 - 7:55am

The Company was also previously awarded the "Listed Company with Most Growth Potential" in the selection of "2021 Sina Finance Golden Unicorn Best Hong Kong and US Listed Companies".

Key Points: 
  • The Company was also previously awarded the "Listed Company with Most Growth Potential" in the selection of "2021 Sina Finance Golden Unicorn Best Hong Kong and US Listed Companies".
  • In addition, SN1011, a key product of the Company, completed its phase I last subject last visit in China in July last year.
  • That reflects the capital market's recognition of the value, management and growth potential of the Company and is a great encouragement to the Company.
  • The selection of the "6th Hong Kong Golden Stocks Awards" was jointly organized by Zhitongcaijing.com, a leading Hong Kong and US stock information platform in China, with RoyalFlush Finance and China Galaxy Securities.

Cabaletta Bio Reports Top-line Biologic Activity Data from Two Lowest Dose Cohorts in DesCAARTes™ Trial in Patients with Mucosal Pemphigus Vulgaris

Retrieved on: 
Tuesday, December 14, 2021 - 12:00pm

The systemic therapies may have impacted clinical scores and DSG3 levels, both of which improved between screening and infusion.

Key Points: 
  • The systemic therapies may have impacted clinical scores and DSG3 levels, both of which improved between screening and infusion.
  • Additional data on the initial cohorts in the DesCAARTes trial are anticipated to be presented at medical meetings and/or scientific sessions in 2022.
  • Cabalettas DesCAARTes Phase 1 trial is an open-label, multi-center study of DSG3-CAART in adults with mucosal-dominant pemphigus vulgaris (mPV).
  • For more information about the DesCAARTes Phase 1 clinical trial, please visit our website ( DesCAARTes Phase 1 Trial ).

Zai Lab Announces First Patient Dosed in Greater China in Global Registrational Clinical Trial of Efgartigimod in CIDP

Retrieved on: 
Tuesday, November 16, 2021 - 12:30pm

The ADHERE trial is a registrational, prospective, multi-center study to investigate the safety and efficacy ofweekly subcutaneous (SC) efgartigimod in adult patients with CIDP.

Key Points: 
  • The ADHERE trial is a registrational, prospective, multi-center study to investigate the safety and efficacy ofweekly subcutaneous (SC) efgartigimod in adult patients with CIDP.
  • Diagnosis of CIDP will be confirmed by an independent panel of experts prior to enrollment into Stage A.
  • In Stage B, patients are randomized to either SC efgartigimod or placebo for up to 48 weeks.
  • The primary endpoint is event-driven and based on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) overall disability score.

Zai Lab Announces First Patient Dosed in Greater China in Global Registrational Clinical Trial of Efgartigimod in Pemphigus

Retrieved on: 
Monday, November 15, 2021 - 12:30pm

ADDRESS is a randomized, double-blind, placebo-controlled, multi-center trial evaluating the safety and efficacy of efgartigimod in approximately 150 patients with PV or PF.

Key Points: 
  • ADDRESS is a randomized, double-blind, placebo-controlled, multi-center trial evaluating the safety and efficacy of efgartigimod in approximately 150 patients with PV or PF.
  • We are excited about the therapeutic potential of efgartigimod in pemphigus, based on its mode of action in clearing IgGs.
  • We look forward to advancing the China portion of this registrational Phase 3 study and to bringing such an innovative treatment option to patients with pemphigus in China.
  • Treatment of pemphigus vulgaris and foliaceus with efgartigimod, a neonatal Fc receptor inhibitor: a phase 2 multicentre, open-label feasibility trial.

Zai Lab Announces First Patient Dosed in Greater China in Global Registrational Clinical Trial of Efgartigimod in Primary Immune Thrombocytopenia

Retrieved on: 
Thursday, November 11, 2021 - 12:30pm

The company announced today that the first patient with primary immune thrombocytopenia (ITP) was treated with efgartigimod in Greater China (mainland China, Hong Kong, Macau, and Taiwan) as part of the global registrational ADVANCE-SC Phase 3 study.

Key Points: 
  • The company announced today that the first patient with primary immune thrombocytopenia (ITP) was treated with efgartigimod in Greater China (mainland China, Hong Kong, Macau, and Taiwan) as part of the global registrational ADVANCE-SC Phase 3 study.
  • Also, efgartigimod appears to be well tolerated, potentially because of its unique structure and ability to bind to the FcRn receptor.
  • The prevalence of primary ITP in Greater China is estimated at 120,000 patients.
  • Phase 2 study of efgartigimod, a novel FcRn antagonist, in adult patients with primary immune thrombocytopenia.

Cabaletta Bio Expands Executive Leadership Team with Appointments of Samik Basu, M.D. to Chief Scientific Officer and Heather Harte-Hall, MSc. to Chief Compliance Officer

Retrieved on: 
Tuesday, November 9, 2021 - 1:00pm

to Chief Scientific Officer (CSO) and Heather Harte-Hall to Chief Compliance Officer (CCO).

Key Points: 
  • to Chief Scientific Officer (CSO) and Heather Harte-Hall to Chief Compliance Officer (CCO).
  • Samik and Heather are both highly respected and accomplished leaders at Cabaletta and we are thrilled to announce their well-deserved promotions to these new roles.
  • Dr. Basu joined Cabaletta in December 2019 and was most recently Vice President of Preclinical Research and Translational Medicine before assuming his new role as Chief Scientific Officer.
  • Ms. Harte-Hall joined Cabaletta in March 2019 and was most recently Vice President of Quality and Compliance before assuming her new role as Chief Compliance Officer.

Cabaletta Bio Reports Clinical Data from the Third Dose Cohort in DesCAARTes™ Trial in Patients with mPV

Retrieved on: 
Monday, November 1, 2021 - 11:00am

PHILADELPHIA, Nov. 01, 2021 (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 28-day clinical data from the third dose cohort using 500 million DSG3-CAART cells in the DesCAARTes™ Phase 1 clinical trial for the treatment of patients with mucosal-dominant pemphigus vulgaris (mPV).

Key Points: 
  • The rapid pace of the clinical trial has been possible due to the enthusiasm and engagement of patients, investigators and patient advocacy groups.
  • Dosing of patients in the fourth cohort at a treatment dose of 2.5 billion DSG3-CAART cells has been initiated.
  • The Company anticipates announcing 28-day safety data for the fourth dose cohort in the first quarter of 2022.
  • For more information about the DesCAARTes Phase 1 clinical trial, please visit our website ( DesCAARTes Phase 1 Trial ).

Sanofi provides update on Phase 3 study evaluating rilzabrutinib for the treatment of pemphigus

Retrieved on: 
Thursday, September 9, 2021 - 6:00am

The Phase 3 study, which is the first placebo-controlled trial of a BTK inhibitor in pemphigus, enrolled adult patients with moderate-to-severe pemphigus vulgaris or pemphigus foliaceus.

Key Points: 
  • The Phase 3 study, which is the first placebo-controlled trial of a BTK inhibitor in pemphigus, enrolled adult patients with moderate-to-severe pemphigus vulgaris or pemphigus foliaceus.
  • We are committed to investigating rilzabrutinib further and progressing our clinical programs forward to deliver new treatment options for patients.
  • Currently options for the treatment of pemphigus (including pemphigus vulgaris and pemphigus foliaceus) are limited and systemic corticosteroid treatment remains the standard of care.
  • Rilzabrutinib is being investigated in a Phase 3 trial for the treatment of immune thrombocytopenia, a rare blood disorder, and in a Phase 2 study for the autoimmune condition IgG4-related disease.

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

Retrieved on: 
Monday, June 28, 2021 - 1:00pm

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.