Cabaletta Bio Announces Appointment of Michael Gerard as General Counsel
Cabaletta Bio (CABA) has appointed Michael Gerard as general counsel, a move intended to bolster its executive team as the company advances its clinical development of engineered T cell therapies for autoimmune diseases. Gerard brings extensive legal experience in life sciences, having previously served at Spark Therapeutics and Sandoz. His addition is expected to support the ongoing DesCAARTes™ trial for DSG3-CAART, which targets mucosal pemphigus vulgaris. The FDA granted Fast Track Designation for this candidate in May 2020, highlighting its potential therapeutic value.
- Appointment of Michael Gerard as general counsel, bringing relevant legal expertise.
- Strengthened leadership may enhance operational efficiency and clinical development.
- FDA Fast Track Designation for DSG3-CAART indicates regulatory support for the therapy.
- Need for robust clinical trial outcomes remains a critical concern for future success.
- Potential risks associated with clinical trial enrollment and data interpretation.
PHILADELPHIA, Sept. 07, 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 that Michael Gerard has been appointed general counsel.
“We are very pleased to welcome Mike to the executive team. His experience with a wide range of strategic legal and corporate matters within the life sciences industry will complement the management team as we advance clinical development for DSG3-CAART in our DesCAARTes™ trial, and further develop follow-on candidates from our deep pipeline of precision therapies for patients with B cell-mediated autoimmune diseases,” said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. “In addition to his dynamic and highly relevant legal experience, Mike shares our vision, our values and our passion for the pursuit of cures for patients with autoimmune diseases.”
Mr. Gerard most recently served as Associate General Counsel at Spark Therapeutics, a member of the Roche Group. While at Spark, he supported the global gene therapy Manufacturing, Business Development, Technical Development, Supply Chain, Quality, Alliance Management, Real Estate, IT and Facilities teams. Prior to joining Spark, he worked in roles of increasing responsibility at Sandoz, a division of the Novartis Group, achieving the position of Executive Director, Associate General Counsel, BD&L, Strategy and Portfolio. Mr. Gerard also worked as Assistant General Counsel at Aramark. He began his legal career at K&L Gates LLP, later joining Morrison & Foerster LLP before assuming his roles as in-house counsel. Mr. Gerard holds a J.D. from Cornell Law School and received his B.A. in Political Science from the University of Michigan.
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 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 visit our website (DesCAARTes™ Phase 1 Trial). 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 expectations regarding the progress and results of its DesCAARTes™ Phase 1 trial, including Cabaletta Bio’s ability to enroll the requisite number of patients and dose each dosing cohort in the intended manner; the expectation that Cabaletta Bio may improve outcomes for patients suffering from mPV; the safety, efficacy and tolerability of DSG3-CAART for the treatment of mPV; the impact of COVID-19 on the timing, progress, interpretability of data, and results of ongoing or planned clinical trials; the ability to develop and advance deep pipeline of precision therapies for patients with B cell-mediated autoimmune diseases statements regarding regulatory filings regarding its development programs; and the anticipated contribution of Cabaletta Bio’s executives to its operations and progress.
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: the risk that signs of biologic activity may not inform long-term results; 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 clinical trial site activation or enrollment rates that are lower than expected; risks related to unexpected safety or efficacy data observed during clinical studies; 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 Orphan Drug Designation and 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 initial or interim 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
investors@cabalettabio.com
Sarah McCabe
Stern Investor Relations, Inc.
sarah.mccabe@sternir.com
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