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Autolus Therapeutics to Present Clinical Data Update at the American College of Rheumatology (ACR) Convergence 2025

MWN-AI** Summary

Autolus Therapeutics plc, a pioneering biopharmaceutical company focused on cutting-edge programmed T cell therapies, has announced that it will present an update on its clinical research at the American College of Rheumatology (ACR) Convergence 2025, scheduled for October 24-29 in Chicago. The presentation will feature updated data from the CARLYSLE study, which investigates the efficacy of its novel therapy, obe-cel, in patients suffering from severe refractory systemic lupus erythematosus (srSLE).

The abstract titled "Obecabtagene autoleucel (obe-cel), a CD19-targeting autologous chimeric antigen receptor T-cell therapy (CAR T) with a fast off-rate binding domain, in patients with severe, refractory systemic lupus erythematosus (srSLE): preliminary results from the Phase I CARLYSLE study" is set for a poster presentation on Tuesday, October 28, 2025, with Dr. Maria Leandro as the presenting author.

Early results highlight a favorable safety profile for obe-cel, showcasing no dose-limiting toxicities (DLTs), immune effector cell-associated neurotoxicity syndrome (ICANS), or severe cytokine release syndrome (CRS). Clinically meaningful improvements were observed amongst participants, evidenced by reductions in the SLEDAI-2K score and three patients achieving a complete renal response.

Autolus Therapeutics continues to advance its mission to develop therapies for cancer and autoimmune diseases through innovative T cell programming technologies. The company currently markets the therapy AUCATZYL® and has a robust pipeline targeting both hematological malignancies and solid tumors. As it prepares for the upcoming ACR event, Autolus remains committed to delivering scientifically innovative treatment options to patients in need. For additional information, please visit their official website at www.autolus.com.

MWN-AI** Analysis

As Autolus Therapeutics plc (Nasdaq: AUTL) prepares to present updated clinical data from the CARLYSLE study at the ACR Convergence 2025, investors should closely monitor this pivotal moment for the company, especially given the promising early results showing a manageable safety profile and notable clinical benefits in patients with severe refractory systemic lupus erythematosus (srSLE). The focus on obe-cel, the CD19-targeting autologous CAR T-cell therapy, positions Autolus in a niche market where effective treatments for srSLE continue to be limited.

The presentation, scheduled for October 28, 2025, should shed further light on the therapy's efficacy, safety measures, and potential for commercialization. The absence of dose-limiting toxicities and the observed clinical improvement—evident by reductions in the SLEDAI-2K score—are encouraging signs that align with regulatory and market expectations for innovative biopharmaceutical treatments. This could enhance investor confidence in Autolus as a burgeoning leader in autoimmune therapy.

Investors should also consider the broader implications of the data presented. Positive outcomes may drive stock price momentum, providing opportunities for both short- and long-term gains. However, market conditions leading up to the conference will also necessitate vigilance; biopharmaceutical stocks often experience volatility based on clinical trial results and investor sentiment.

Moreover, with the company already having a marketed therapy in AUCATZYL and a pipeline that aims to address hematological malignancies and solid tumors, Autolus is diversifying its risk across multiple therapeutic areas. For investors, holding a position in Autolus could be seen as a long-term play with potential upside, contingent on the upcoming data, which could catalyze significant movements in stock performance.

In conclusion, while there are inherent risks within the biotech sector, the upcoming clinical data at ACR presents a compelling opportunity for stakeholders to evaluate Autolus Therapeutics’ growth trajectory and potential market impact.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

LONDON and GAITHERSBURG, Md., Sept. 16, 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 the online publication of an abstract submitted to the American College of Rheumatology (ACR) Convergence 2025, to be held October 24-29, 2025, in Chicago. Autolus will have a poster presentation, which will include updated follow up from the CARLYSLE study in patients with severe refractory systemic lupus erythematosus (srSLE).

Abstract: 2458
Title: Obecabtagene autoleucel (obe-cel), a CD19-targeting autologous chimeric antigen receptor T-cell therapy (CAR T) with a fast off-rate binding domain, in patients with severe, refractory systemic lupus erythematosus (srSLE): preliminary results from the Phase I CARLYSLE study
Session date and time: Tuesday, October 28, 2025; 10:30am - 12:30pm Central Time
Presenting Author: Maria Leandro, MD

Summary: Initial findings from the ongoing CARLYSLE study of obe-cel in srSLE show a manageable safety profile, with no dose limiting toxicities (DLTs), immune effector cell-associated neurotoxicity syndrome (ICANS) or Grade ?2 cytokine release syndrome (CRS). SLEDAI-2K score reduction and clinical benefit were observed in all patients. In addition, three patients who had a complete renal response. Updated data will be presented at the conference.

About Autolus Therapeutics plc
Autolus Therapeutics plc?(Nasdaq: AUTL) is an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies and candidates for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted and controlled T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a marketed therapy, AUCATZYL ® , and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com .

Contact:

Amanda Cray
+1 617-967-0207
a.cray@autolus.com


FAQ**

How does Autolus Therapeutics plc AUTL plan to utilize the findings from the CARLYSLE study in advancing next-generation T cell therapies for systemic lupus erythematosus?
Autolus Therapeutics plc plans to leverage insights from the CARLYSLE study to enhance the development of next-generation T cell therapies by optimizing their approaches in targeting and treating systemic lupus erythematosus.
What implications might the results presented at ACR Convergence 20have for future treatment options within the portfolio of Autolus Therapeutics plc AUTL in autoimmune diseases?
The results presented at ACR Convergence 2025 could significantly enhance Autolus Therapeutics plc's portfolio by providing compelling evidence for innovative CAR-T cell therapies, paving the way for novel treatment strategies in autoimmune diseases and expanding their market potential.
In what ways could the insights gained from the obe-cel therapy in the CARLYSLE study enhance Autolus Therapeutics plc AUTL's overall approach to developing treatments for other conditions beyond srSLE?
The insights from the OBE-Cel therapy in the CARLYSLE study could inform Autolus Therapeutics' strategies in optimizing CAR T-cell therapies, broadening their application to other autoimmune and hematological conditions through enhanced efficacy and safety profiles.
What strategies does Autolus Therapeutics plc AUTL have in place to maintain a manageable safety profile for its therapies, particularly in light of findings from the ongoing CARLYSLE study presented at the upcoming conference?
Autolus Therapeutics plc employs rigorous safety monitoring, adaptive trial designs, and thorough data analysis from the CARLYSLE study to ensure a manageable safety profile for its therapies while continuously optimizing treatment protocols.

**MWN-AI FAQ is based on asking OpenAI questions about Autolus Therapeutics plc (NASDAQ: AUTL).

Autolus Therapeutics plc

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