PHILADELPHIA, Nov. 09, 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 the appointments of Samik Basu, M.D. to Chief Scientific Officer (CSO) and Heather Harte-Hall to Chief Compliance Officer (CCO). In these new roles, Dr. Basu and Ms. Harte-Hall will continue to report to Gwendolyn Binder, Ph.D., Cabaletta Bio’s Executive Vice President of Science & Technology.
“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. Samik has demonstrated superior leadership guiding the preclinical research and translational medicine teams through the discovery and development of our deep pipeline of precision therapies for patients with B cell-mediated autoimmune diseases. Heather has established quality and compliance programs, which along with her insights and strategic guidance, have proven invaluable as we have advanced our pipeline, most notably our lead product candidate DSG3-CAART, in mucosal pemphigus vulgaris,” said Dr. Binder.
“The addition of Samik and Heather to our leadership team positions us well to deliver on the next phase of our growth including the expansion of our laboratories, continued quality and compliance around our expanding manufacturing efforts and multiple clinical and corporate milestones related to our portfolio of potentially curative products for patients with B cell mediated autoimmune diseases,” said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta.
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. Prior to joining Cabaletta, Dr. Basu was Head of Translational Sciences (Medicine) at Adaptimmune Therapeutics, plc, where he led research efforts focused on understanding the mechanisms of resistance and response to T-cell receptor based adoptive immunotherapies to inform next generation approaches and clinical strategies. Before that, Dr. Basu co-led preclinical development efforts for Keytruda® (pembrolizumab) at Merck Research Laboratories. He is a physician-scientist with 17 years of industry and academic experience in adoptive immunotherapy, translational research, autoimmunity, and tumor immunology with prior roles at the National Institutes of Health, Albert Einstein College of Medicine, and the University of Pennsylvania. Dr. Basu holds an M.D. from Temple University and completed residency training in Clinical Pathology.
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. Previously, she was Head of Clinical Quality and Compliance at Adaptimmune Therapeutics, plc, where she built a compliance program and helped establish a culture of integrity to drive ethical behavior in the management and conduct of clinical trials. Ms. Harte-Hall developed and implemented quality and compliance programs focusing on risk management and compliance functions to improve activities such as regulatory monitoring, auditing, and managing alignment with policies, procedures and controls. Ms. Harte-Hall has over 15 years of experience in pharmaceutical and healthcare management and has held various positions in quality and compliance at Centocor Biotech, Inc., Wyeth, LLC and Pfizer Inc. She currently serves as a committee member for the Alliance for Regenerative Medicine (ARM) Accelerator Group and a member of the Society of Corporate Compliance and Ethics (SCCE). Ms. Harte-Hall holds a Master of Science in Psychology from Capella University and B.A. in Business Administration from St. Leo University.
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 Auto Antibody 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 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; Cabaletta Bio’s business plan and objectives; the expectation that Cabaletta Bio may improve outcomes for patients suffering from mucosal pemphigus vulgaris (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; 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 pemphigus vulgaris; 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
Released November 9, 2021