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Autolus Therapeutics Highlights Advancing Autoimmune Pipeline at R&D Investor Event
Newsfilter· 2025-04-23 20:05
Core Insights - Autolus Therapeutics plc is advancing its development pipeline, particularly focusing on the expansion of its programmed T cell therapy, obe-cel, into autoimmune diseases such as lupus nephritis (LN) and multiple sclerosis (MS) [1][2][5] Development Plans - The company aims to establish a potential registrational path for obe-cel in LN, supported by insights from key opinion leaders in the field [2][3] - Preliminary data from the Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE) indicate a strong rationale for progressing to a pivotal Phase 2 study, with the first patient expected to be dosed by the end of 2025 [5][6] Clinical Data - In the Phase 1 CARLYSLE trial, three out of six patients achieved complete renal response by month three, and all patients showed normalization of complement levels by month one [6] - The trial reported no dose-limiting toxicities or severe neurotoxicity, with only mild cytokine release syndrome observed in some patients [6] Future Trials - Autolus plans to initiate a Phase 1 trial for obe-cel in progressive forms of MS, with the first patient expected to be dosed by year-end 2025 [5][6] - The company has aligned with the U.S. FDA on the Phase 2 trial design and anticipates further data presentation at a medical conference in the second half of 2025 [6] Regulatory Updates - Autolus is awaiting notifications from the UK MHRA and EU EMA regarding the approval of obe-cel for adult patients with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL) in 2025 [7][11] - The company is actively launching AUCATZYL, its FDA-approved product, with 38 centers fully activated as of April 2025 [11][13] Market Potential - The company believes that obe-cel represents a significant opportunity for value creation across multiple B cell-driven malignancies and autoimmune diseases, addressing substantial unmet medical needs [3][5]
Autolus Therapeutics Highlights Advancing Autoimmune Pipeline at R&D Investor Event
Globenewswire· 2025-04-23 20:05
Company outlined potential for value creation driven by obe-cel across multiple B cell driven malignancies and autoimmune diseases, including acute lymphoblastic leukemia (ALL), lupus nephritis (LN) and multiple sclerosis (MS)Preliminary data in initial six patient cohort treated in Phase 1 trial in systemic lupus erythematosus (SLE) support progressing obe-cel into a planned Phase 2 pivotal study in lupus nephritis; first patient expected to be dosed in Phase 2 trial by year-end 2025Company plans to advanc ...
Autolus Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Globenewswire· 2025-04-02 11:00
LONDON, April 02, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the Company will participate in the 24th Annual Needham Virtual Healthcare Conference. Autolus Chief Executive Officer Dr. Christian Itin will present in a Fireside Chat on Wednesday, April 9, 2025 at 9:30am EDT / 14:30pm BST. A webcast of the fireside chat will be available ...
Nkarta to Participate in an April Investor Conference
Newsfilter· 2025-04-01 12:01
Company Overview - Nkarta, Inc. is a clinical-stage biotechnology company focused on developing engineered natural killer (NK) cell therapies for autoimmune diseases [2] - The company utilizes a combination of cell expansion, cryopreservation platforms, proprietary cell engineering technologies, and CRISPR-based genome engineering to create its therapies [2] Upcoming Events - Nkarta will participate in the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025, at 11:00 a.m. ET, featuring a fireside chat [1] - A simultaneous webcast of the event will be available on Nkarta's website, with a replay archived for approximately 90 days [1]
Mustang Bio Regains Compliance with Nasdaq Capital Market Requirement
Globenewswire· 2025-03-05 21:15
Group 1 - Mustang Bio, Inc. has regained compliance with Nasdaq's minimum stockholders' equity requirement as per Nasdaq Listing Rule 5550(b)(1) [1][2] - The company previously satisfied the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing, thus meeting all Nasdaq Capital Market listing requirements [2] - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers, aiming to license or acquire technologies to fund research and development [3] Group 2 - Mustang Bio has partnered with leading medical institutions to advance CAR-T therapies [3] - The company's common stock is registered under the Securities Exchange Act of 1934 and it files periodic reports with the SEC [3]
Mustang Bio Announces Sale of Fixed Assets and Exit of Facility
Globenewswire· 2025-02-27 21:05
Core Viewpoint - Mustang Bio, Inc. has exited its lease for a manufacturing facility in Worcester, Massachusetts, and divested certain fixed assets to AbbVie for $1.0 million, while relocating its corporate headquarters to Waltham, Massachusetts [1][2]. Group 1: Financial Implications - The termination of the lease is expected to result in approximately $2.0 million in cash expense savings over the next 24 months [2]. - The divestment of fixed assets to AbbVie Bioresearch Center Inc. was completed for a total of $1.0 million [1]. Group 2: Strategic Focus - The company remains committed to advancing its existing portfolio and plans to initiate a novel clinical trial with MB-109, targeting recurrent glioblastoma and high-grade astrocytomas in the second half of 2025 [3]. - MB-109 is a combination therapy that includes MB-101 (IL13Rα2-targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus), aimed at enhancing the efficacy of CAR-T cell therapy by modifying the tumor microenvironment [4]. Group 3: Company Overview - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers, partnering with leading medical institutions to advance CAR-T therapies [5].