Articles from Cabaletta Bio

– FDA meeting to align on myositis registrational trial designs for rese-cel in 1H25 on track –

PHILADELPHIA, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 11:50 a.m. ET in Boston, MA.

– Clinical efficacy continued to deepen over time with three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major TIS improvement; each of these patients discontinued all immunosuppressants and are off or tapering steroids as of the latest follow-up –

– Clinical efficacy continued to deepen over time with three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major TIS improvement; each of these patients discontinued all immunosuppressants and are off steroids as of the latest follow-up –

PHILADELPHIA, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that updated clinical data on resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) will be featured in presentations at the 2025 American Association for the Advancement of Science Annual Meeting, which is being held at the Hynes Convention Center in Boston, MA from February 13-15, 2025, and the 5th International Conference on Lymphocyte Engineering, which is being held at the Holiday Inn Munich – City Center in Munich, Germany from February 20-22, 2025. The presentations will include safety, translational data and clinical outcomes from the first 10 patients dosed with rese-cel across multiple ongoing clinical trials in the RESET™ clinical development program.

PHILADELPHIA, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at Guggenheim’s SMID Cap Biotech Conference on Wednesday, February 5, 2025, at 10:30 a.m. ET in New York, NY.

– Company plans to meet with the FDA to align on registrational trial designs in 1H25 based on emerging clinical profile of resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) and increased pace of enrollment with 44 active clinical trial sites –

PHILADELPHIA, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in the following investor conferences in December:

– CABA-201 safety profile suggests favorable risk-benefit with no CRS or ICANS in the majority of patients; low-grade CRS in three of eight patients and one previously reported ICANS event –

– Clinical data from the RESET-Myositis™ and RESET-SLE™ trials, along with initial clinical data from the RESET-SSc™ trial, to be presented this weekend in oral and poster presentations at ACR Convergence 2024 –

PHILADELPHIA, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at Guggenheim's Inaugural Healthcare Innovation Conference on Monday, November 11, 2024, at 10:00 a.m. ET in Boston, MA.

PHILADELPHIA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced two presentations at the upcoming American College of Rheumatology (ACR) Convergence 2024, which is being held at the Walter E. Washington Convention Center in Washington, D.C. from November 14-19, 2024. The presentations will feature new and updated clinical data on CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, which is being evaluated in multiple ongoing clinical trials in the RESET™ clinical development program.

PHILADELPHIA, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in the following investor conferences in September:

– Nine patients enrolled as of August 5, 2024 across the RESET™ clinical development program, including four since EULAR in June, with 22 U.S. clinical sites now enrolling –

PHILADELPHIA, July 02, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Stifel 2024 Virtual Cell Therapy Forum on Tuesday, July 9, 2024, at 1:00 p.m. ET.

– No CRS, ICANS, infections or serious adverse events observed in either of the first two patients through data cut-off of May 28, 2024 –

PHILADELPHIA, May 29, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 5, 2024, at 11:00 a.m. ET in New York, NY.

– No CRS or ICANS of any grade observed during the 28-day DLT observation window for either of the first patients dosed with CABA-201 in the RESET-Myositis™ and RESET-SLE™ trials –

PHILADELPHIA, May 13, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ on Monday, May 20, 2024 at 9:30 a.m. ET in New York, NY.

– First patient dosed with CABA-201 in the RESET™ (REstoring SElf-Tolerance) clinical trial program –

PHILADELPHIA, March 20, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for the treatment of systemic sclerosis (SSc). CABA-201 is in development as a potential treatment for autoimmune diseases driven by B cells. The RESET™ (REstoring SElf-Tolerance) clinical trial program includes four Phase 1/2 trials advancing for the evaluation of CABA-201 across multiple autoimmune conditions, including the Phase 1/2 RESET-SSc™ trial.

PHILADELPHIA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in two upcoming investor conferences in March:

PHILADELPHIA, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for the treatment of idiopathic inflammatory myopathies (IIM, or myositis). CABA-201 is in development as a potential treatment for autoimmune diseases driven by B cells. Four RESET™ (REstoring SElf-Tolerance) Phase 1/2 trials are advancing for the evaluation of CABA-201 across multiple autoimmune conditions, including the Phase 1/2 RESET-Myositis™ trial.

PHILADELPHIA, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Wednesday, February 7, 2024 at 10:00 a.m. ET in New York, NY.

– Second and third FDA Fast Track Designations for CABA-201, following the systemic lupus erythematosus (SLE) and lupus nephritis (LN) designation, providing the opportunity for expedited development and review of CABA-201 for the treatment of these autoimmune diseases –

PHILADELPHIA, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 5:15 p.m. PT (8:15 p.m. ET) in San Francisco, CA.

PHILADELPHIA, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Wednesday, November 29, 2023 at 8:20 a.m. ET in Miami, FL.

– Initial clinical data from CABA-201 treated patients in Phase 1/2 trials for lupus and/or myositis expected in the first half of 2024, with the first lupus clinical site actively recruiting patients –

– First cleared CD19-CAR T IND application for generalized myasthenia gravis announced in the U.S. and fourth IND clearance for CABA-201 across a broad range of autoimmune diseases –

PHILADELPHIA, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in three upcoming investor conferences in November:

– Third IND application clearance for CABA-201 within the past 6 months across a broad range of autoimmune diseases –

PHILADELPHIA, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in two upcoming investor conferences in September:

PHILADELPHIA, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company will participate in four upcoming investor conferences in September:

– Agreement expansion facilitates preparation for commercial readiness for CABA-201, enabling treatment of patients in multiple planned clinical trials with separate parallel cohorts –

– Received second IND application clearance for CABA-201 in myositis as well as Fast Track Designation in SLE and LN –

– Ms. Tomasello created and led global commercial and medical affairs functions at Kite Pharma from pre-launch through its acquisition by Gilead Sciences –

PHILADELPHIA, May 31, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present a company presentation at the Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 10:30 a.m. ET in New York, NY.

PHILADELPHIA, May 22, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, announced today the closing of an underwritten public offering of 8,337,500 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,087,500 shares, at the public offering price of $12.00 per share. The gross proceeds raised in the offering, before underwriting discounts and commissions and estimated expenses of the offering, were approximately $100 million.

PHILADELPHIA, May 17, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced the pricing of an underwritten public offering of 7,250,000 shares of its common stock at a public offering price of $12.00 per share. Cabaletta also granted the underwriters a 30-day option to purchase up to an additional 1,087,500 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $87 million, excluding any exercise of the underwriters' option to purchase additional shares. All of the shares in the offering are to be sold by Cabaletta. The offering is expected to close on May 22, 2023, subject to customary closing conditions.

PHILADELPHIA, May 17, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, announced today that it has commenced an underwritten public offering of its common stock. All of the shares are being offered by Cabaletta. In addition, Cabaletta intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

– Phase 1/2 trial for CABA-201 planned to initiate in patients with myositis at an initial dose that is equivalent to the dose used in a patient with myositis as reported in the recent Lancet Rheumatology publication –

– IND application cleared within 30 days for clinical trial of CABA-201 in patients with LN and SLE and Fast Track Designation granted by the FDA for CABA-201 to deplete CD19-positive B cells and improve disease activity in patients with LN and SLE –

PHILADELPHIA, May 02, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Samik Basu, M.D., Chief Scientific Officer at Cabaletta Bio, will deliver an invited, oral presentation titled “CD 19 CAR T-cells for SLE” as part of the session titled “Immune Effector Cells: 2023 and Beyond!” on Tuesday, May 16, 2023, at 11:05 a.m. PT at the upcoming American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting, which is being held at the Los Angeles Convention Center in Los Angeles, CA from May 16-20, 2023. In addition, new preclinical data for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, and updated clinical and translational data from the ongoing DesCAARTes™ trial for DSG3-CAART in adults with mucosal-dominant pemphigus vulgaris (mPV) will be presented in poster presentations.

PHILADELPHIA, May 01, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced 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, designed to deplete CD19-positive B cells and improve disease activity in patients with systemic lupus erythematosus (SLE) and lupus nephritis (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, with an initial dose that is equivalent to the dose used in the September 2022 Nature Medicine publication of a 4-1BB containing CD19-CAR T construct evaluated in patients with SLE.

PHILADELPHIA, April 25, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference at NASDAQ on Tuesday, May 2, 2023 at 1:30 p.m. ET in New York, NY.

PHILADELPHIA, April 13, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present a company presentation at the 22nd Annual Needham Virtual Healthcare Conference on Thursday, April 20, 2023 at 9:30 a.m. ET.

– IND application cleared within 6 months of in-licensing CABA-201 binder –

– Company expecting Investigational New Drug (IND) clearance in the first half of 2023 for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell therapy, with potential to generate initial clinical data by the first half of 2024 –

PHILADELPHIA, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will participate in a fireside chat at the Cowen 43rd Annual Health Care Conference on Tuesday, March 7, 2023 at 2:10 p.m. ET in Boston, MA.

PHILADELPHIA, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., Chief Executive Officer, will present at the 41st Annual J.P. Morgan Conference being held in San Francisco, CA on Thursday, January 12th at 7:30 a.m. PT (10:30 a.m. ET).

PHILADELPHIA, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that it has agreed to sell, by way of an underwritten public offering, pre-funded warrants, in lieu of common stock, to purchase 6,213,776 shares of common stock at a price of $5.51999 per pre-funded warrant and 126,815 shares of its common stock at a price of $5.52 per share, for expected aggregate gross proceeds of approximately $35 million, before deducting underwriting discounts and commissions and other estimated offering expenses. The purchase price per share of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.00001 per share exercise price of such pre-funded warrant. The offering is expected to close on December 12, 2022, subject to customary closing conditions. All of the securities are being offered by Cabaletta.

PHILADELPHIA, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will participate in a virtual fireside chat at the 5th Annual Evercore ISI HealthCONx Conference on Wednesday, November 30, 2022 at 9:40 a.m. ET.

PHILADELPHIA, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today reported financial results for the third quarter ended September 30, 2022, and provided a business update.

– Company has obtained exclusive worldwide license for a fully human CD19 binder with clinical tolerability data that support potential clinical development in autoimmune diseases –

PHILADELPHIA, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of targeted cell therapies for patients with autoimmune diseases, today announced that it will present clinical and translational data from the DesCAARTes™ trial of DSG3-CAART in adults with mucosal-dominant pemphigus vulgaris (mPV) in a poster presentation at the upcoming 29th Annual Congress of the European Society of Gene & Cell Therapy (ESGCT), which is being held at the Edinburgh International Conference Centre in Edinburgh, Scotland from October 11-14, 2022.