 PHILADELPHIA, Aug. 06, 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 second quarter ended June 30, 2020 and provided a business update. The recent initiation of patient recruitment in the DesCAARTesTM Phase 1 trial is an important milestone for Cabaletta that reflects the commitment of our outstanding team and academic partners to patients suffering with mucosal pemphigus vulgaris. This trial, evaluating the safety and tolerability of DSG3-CAART, is the first trial exploring whether a highly specific targeted cellular therapy can provide a deep and durable, perhaps curative, treatment for patients with a B cell-mediated autoimmune disease. We look forward to reporting acute safety data from the initial cohort by the first half of 2021, said Steven Nichtberger, M.D., Chief Executive Officer and co-founder of Cabaletta. Our lead preclinical program targeting patients with the MuSK form of myasthenia gravis is currently advancing with IND-enabling studies ongoing. We remain on track to submit an IND in the second half of 2021. Based on progress with our two lead programs, we recently added three new undisclosed disease targets to our pipeline through the expansion of our Sponsored Research Agreement with the University of Pennsylvania. In addition, the recent announcement of our gene editing research and collaboration agreement with Artisan Bio may potentially allow us to expand and enhance our product portfolio by creating the next-generation of CAAR T cell therapies for B cell-mediated autoimmune diseases.Pipeline Highlights and Anticipated Upcoming MilestonesDSG3-CAART: Desmoglein 3 chimeric autoantibody receptor CAAR T cells as potential treatment for patients with mucosal pemphigus vulgaris mPV. The Companys open-label Phase 1 clinical trial DesCAARTesTM to evaluate the safety and tolerability of DSG3-CAART in relapsedrefractory mPV patients is now open for recruitment with clinical acute safety data from the initial cohort expected by the first half of 2021. In May 2020, the Company announced that the U.S. Food and Drug Administration FDA granted Fast Track Designation to DSG3-CAART, which provides independent validation of mPV as a serious and unmet medical need in patients.MuSK-CAART: Muscle Specific Kinase MuSK CAAR T cells as potential treatment for MuSK-associated myasthenia gravis. Investigational New Drug IND-enabling studies are ongoing with an IND submission to the FDA anticipated in the second half of 2021. In May 2020, in vivo target engagement data was presented at the American Academy of Neurology 2020 Science Highlights Virtual Platform. The data demonstrated in vitro cytotoxicity towards a B cell line expressing anti-MuSK antibodies, but no observed cytotoxicity when the anti-MuSK antibody was not expressed. MuSK CAAR T cells also targeted and eliminated a panel of B cells targeting different MuSK epitopes. In an in vivo mouse model, MuSK CAAR T cells, but not control CAAR T cells, showed biological activity by blocking the growth of B cell lines expressing an anti-MuSK antibody. This study demonstrated that MuSK CAAR T cells were able to deplete B cells expressing anti-MuSK antibodies.Manufacturing Cell processing capacity is contractually secured at the University of Pennsylvania for the Phase 1 study of DSG3-CAART. Pilot partnerships with two commercial grade contract manufacturers have been initiated to support later-stage clinical development. Two to three years of vector supply for DSG3-CAART is secured, and pilot partnerships have been established for the production of additional vector at commercial grade and scale. Cabaletta expects to initiate validation of cell processing for MuSK-CAART clinical trials with a commercial grade contract manufacturing partner in the second half of 2020.Corporate Highlights In August 2020, Dr. Carl June, M.D., joined the Companys Scientific Advisory Board. Dr. June led the research team that discovered and developed the first FDA-approved Chimeric Antigen Receptor CAR T cell therapy. He is the Richard W. Vague Professor of Immunotherapy in the Department of Pathology and Laboratory Medicine at the University of Pennsylvania, Director of the Center for Cellular Immunotherapies at the Perelman School of Medicine and Director of the Parker Institute for Cancer Immunotherapy at the University of Pennsylvania. In July 2020, the Company signed a gene editing research and collaboration agreement with Artisan Bio, Inc., a precision cell therapy engineering company, to accelerate development of next-generation CAAR T cell therapies with the potential for improved manufacturing andor clinical outcomes for patients with B-cell mediated autoimmune diseases. In May 2020, the Company expanded its Sponsored Research Agreement with the University of Pennsylvania. The agreement expands the scope of sponsored research to include three additional B cell-mediated autoimmune diseases under the direction of Aimee Payne, M.D., Ph.D., a Professor of Dermatology in the Perelman School of Medicine at the University of Pennsylvania, Director of the Penn Clinical Autoimmunity Center of Excellence, and a co-founder of Cabaletta and co-chair of the Scientific Advisory Board.Upcoming August Events Cabaletta will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 10, 2020 at 1:00 p.m. ET. Cabaletta will participate in a fireside chat at the Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 8:35 a.m. ET. Cabaletta will participate in a fireside chat at the 40th Annual Canaccord Genuity Growth Conference on Wednesday, August 12, 2020 at 11:30 a.m. ET.Second Quarter 2020 Financial Results Research and development RD expenses for the three months ended June 30, 2020 were 5.3 million, compared to 2.7 million for the same period in 2019. General and administrative GA expenses for the three months ended June 30, 2020 were 2.9 million, compared to 1.1 million for the same period in 2019. As of June 30, 2020, cash and cash equivalents and investments totaled 123.2 million, compared to 136.2 million as of December 31, 2019.The Company expects that its cash and cash equivalents and investments as of June 30, 2020 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 Cabalettas 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 Companys lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTesTM 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 clinical trial, please see The Companys 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 Statements This press release contains forward-looking statements of Cabaletta within the meaning of the Private Securities Litigation Reform Act of 1995. 