PHILADELPHIA, May 12, 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 first quarter ended March 31, 2020.

“Following the recent Fast Track Designation from the FDA for our lead product candidate, DSG3-CAART, for the treatment of patients with mucosal pemphigus vulgaris (mPV), our Phase 1 DesCAARTes™ trial is ready to launch as soon as COVID-19 related clinical trial activity restrictions are lifted. mPV is a rare, serious, and sometimes fatal disease for which patients have limited treatment options. We are eager to explore the potential of our engineered T cell therapy to fulfill this unmet need,” said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. “We continue to closely monitor the unprecedented challenges and impact of the COVID-19 pandemic while working to ensure that patients, our employees and collaborators remain safe. As evidenced by the recent Fast Track designation, despite working from home over the past two months, our dedicated team continues to make progress across our portfolio wherever possible as we strive to develop potential cures for patients with severe autoimmune diseases.”

Pipeline Highlights and Anticipated Upcoming Milestones

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

• In May 2020, the Company announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to DSG3-CAART. This follows the January 2020 granting of Orphan Drug Designation from the FDA for the treatment of PV.
• The Company is prepared to initiate an open-label Phase 1 clinical trial (DesCAARTes™) to evaluate the safety and tolerability of DSG3-CAART in relapsed/refractory mPV patients in 2020.

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

• Cabaletta plans to initiate Investigational New Drug (IND)-enabling studies in 2020.
• In vivo target engagement data were selected for oral presentation at the 72nd American Academy of Neurology (AAN) Annual Meeting and will now be made available online via a virtual presentation, following the cancellation of the in-person conference.

Manufacturing

• Ample cell processing capacity is contractually secured for the Phase 1 study of DSG3-CAART.
• Two to three years of vector supply for DSG3-CAART has been secured through partnerships established for process development of additional vector at commercial grade and scale.
• Cabaletta expects to initiate validation of cell processing for MuSK-CAART clinical trials with a contract manufacturing partner in 2020, barring additional COVID-19 related delays.

Corporate Highlights

• In April, Dr. Iain McInnes, PhD, FRCP, FRSE, FMedSci, joined the Company’s Scientific Advisory Board. Dr. McInnes has extensive experience in leading multicenter clinical trials for novel immune therapies, and has built an internationally recognized research program that aims to understand the cellular and molecular pathways behind the development of inflammatory and immune-mediated diseases. His work has been widely published and he has been influential in supporting development efforts for novel therapeutics in the field. Dr. McInnes is currently the Muirhead Chair of Medicine, Versus Arthritis Professor of Rheumatology and Director of Institute of Infection, Immunity and Inflammation at the University of Glasgow.

Upcoming Events

• MuSK-CAART in vivo target engagement data to be presented on Monday, May 18, 2020 via a virtual presentation at the AAN 2020 Virtual Forum
• The company will host its virtual Annual Meeting on Tuesday, June 2, 2020 at 10:00 AM Eastern Time.
• Cabaletta will give a corporate presentation at the Jefferies Virtual Global Healthcare Conference on Wednesday, June 3, 2020 at 3:30 PM Eastern Time.

First Quarter 2020 Financial Results

• Research and development (R&D) expenses for the three months ended March 31, 2020 were $4.6 million.
• General and administrative (G&A) expenses for the three months ended March 31, 2020 were $3.3 million.
• As of March 31, 2020, cash and cash equivalents totaled $131.0 million.

The Company expects that its current cash and cash equivalents will enable it to fund its operating plan through at least the third quarter of 2022.

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 in development as a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris. For more information, visit www.cabalettabio.com.