| Item 7.01 | Regulation FD Disclosure. |
On May 1, 2023, Cabaletta Bio, Inc. (the “Company” or “Cabaletta”) posted to the “Investors & Media” section of the Company’s website at www.cabalettabio.com an updated corporate presentation providing a corporate overview and updated development plan (the “Corporate Presentation”). A copy of the Corporate Presentation is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.
On May 1, 2023, the Company issued a Press Release announcing that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to deplete CD19-positive B cells and improve disease activity in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN) (the “Press Release”). A copy of the Press Release is attached hereto as Exhibit 99.2 and is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
On May 1, 2023, the Company issued the Press Release announcing that the FDA has granted Fast Track Designation for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, designed to deplete CD19-positive B cells and improve disease activity in patients with SLE and LN. Cabaletta has been cleared to initiate a Phase 1/2 clinical trial of CABA-201 for the treatment of 6 SLE patients with active LN, and in a separate parallel cohort, 6 patients with active SLE without renal involvement.
SLE is a chronic, potentially severe, autoimmune disease in which the immune system attacks healthy tissue throughout the body, most commonly impacting young women between the ages of 15 and 40 with higher frequency and greater severity in people of color. It is characterized by abnormal B cell function and autoantibody production resulting in a range of clinical manifestations including end organ damage and an increased risk of death. SLE affects an estimated 160,000-320,000 patients in the U.S, with LN as the most common end-organ manifestation, affecting approximately 40% of SLE patients. Among these patients, the risk of end-stage renal disease is approximately 17% and the risk of death is approximately 12%, each within 10 years of diagnosis.
CABA-201 is designed to be given as a one-time infusion, to evaluate its potential to transiently, but fully, eliminate B cells, enabling an “immune system reset” with durable remission in patients with SLE. The Phase 1/2 clinical trial is an open-label study designed to evaluate CABA-201 in SLE subjects with active LN or active SLE without renal involvement. CABA-201 will be administered at a dose of 1.0 x 106 cells/kg. This study will enroll 6 subjects in an active LN cohort and 6 subjects in an active SLE without renal involvement cohort, in parallel. Subjects will be treated with a standard preconditioning regimen consisting of fludarabine and cyclophosphamide prior to CABA-201 infusion. This represents the first trial assessing Cabaletta’s CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy.
Forward-Looking Statements
This 8-K contains “forward-looking statements” of Cabaletta within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding: expectations regarding: Cabaletta’s ability to retain and recognize the intended incentives conferred Fast Track Designation for CABA-201 to deplete CD19-positive B cells and improve disease activity in patients with SLE and LN; Cabaletta’s ability to grow its autoimmune-focused pipeline; the Company’s business plans and objectives; Cabaletta Bio’s expectations around the potential success and therapeutic benefits of CABA-201, including its belief that CABA-201 may enable an “immune system reset” and provide deep and durable responses for patients with SLE and potentially for patients diagnosed with other autoimmune disease; the Company’s plans to initiate a Phase 1/2 clinical trial of CABA-201 in patients with SLE, including its anticipated progress, clinical trial design, ability to leverage its experience in autoimmune cell therapy and lupus product development; Cabaletta’s ability to enroll the requisite number of patients, dose each dosing cohort in the intended manner and advance the trial as planned in its Phase 1/2 clinical trial of CABA-201; and the ability to accelerate Cabaletta’s pipeline and develop meaningful therapies for patients, including in collaboration with academic and industry partners and the ability to optimize such collaborations on its development programs.
