logo
Arcellx Announces New Positive Data for Its iMMagine-1 Study in Patients with Relapsed and/or Refractory Multiple Myeloma

Arcellx Announces New Positive Data for Its iMMagine-1 Study in Patients with Relapsed and/or Refractory Multiple Myeloma

Business Wire14-05-2025

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM). These data will be presented during an oral presentation at the EHA2025 Congress in Milan on June 14, 2025. Anito-cel is partnered with Kite, a Gilead Company.
The Phase 2 iMMagine-1 data are from a May 1, 2025 data cutoff date, including all 117 patients with a median follow-up of 12.6 months and a minimum follow-up of four months after treatment with anito-cel. All patients received a single infusion of anito-cel (target dose of 115×10 6 CAR+ viable T cells). 101 of 117 patients (86%) were triple refractory, and 48 of 117 patients (41%) were penta refractory. Patients received a median of three prior lines of therapy, with 60 of 117 patients (51%) having received three prior lines.
Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at the time of this data cut, 93.3% (70/75) achieved MRD negativity at a minimum of 10 -5 sensitivity. Six-month progression-free survival (PFS) and overall survival (OS) rates were 91.9% and 96.6%, respectively, and 12-month PFS and OS rates were 78.8% and 95.2%, respectively. Median PFS and median OS have not been reached.
No delayed or non-immune effector cell-associated neurotoxicity syndrome (ICANS) neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed to date with anito-cel. No additional treatment- or therapy-related deaths or Grade ≥3 cytokine release syndrome (CRS) or ICANS events have occurred since the previous data presentation in December 2024.
Conclusions
Preliminary results from the Phase 2 iMMagine-1 study demonstrate deep and durable responses with a predictable and manageable safety profile in a fourth-line or higher (4L+) RRMM population, including triple- and penta-class refractory disease. Notably, no delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed with anito-cel to date.
'These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them,' said Rami Elghandour, Arcellx's Chairman and Chief Executive Officer. 'There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible. Anito-cel has the unique potential to address these needs thanks to our differentiated technology, our incredible and entrepreneurial team, the robust clinical data generated to date, and our strong partnership with Kite. Our 2026 commercial launch plans for anito-cel with our partners at Kite are well underway and we are excited for the opportunity to advance anito-cel in support of the myeloma community. We look forward to sharing these data with the clinical community at EHA and are honored that the iMMagine-1 data will be presented during an oral presentation on Saturday, June 14.'
EHA2025 Presentation Details
Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Preliminary Results from the iMMagine-1 Trial
Speaker: Gurbakhash Kaur, M.D., Assistant Professor of Internal Medicine, Mount Sinai Health System
Session Title: s431 Treatment of relapsed and/or refractory multiple myeloma (RRMM)
Session Date: June 14, 2025
Session Time: 17:00-18:15 CEST
Publication Number: S201
Presentation Title: S201 Phase 2 Registrational Study of Anitocabtagene Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1
About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient's immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.
About Anitocabtagene Autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx's novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.
About Arcellx and Kite Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with multiple myeloma. Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a global Phase 3 randomized controlled study for relapsed and/or refractory multiple myeloma (RRMM). Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States.
About Arcellx, Inc.
Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. For more information on Arcellx, please visit www.arcellx.com. Follow Arcellx on X @arcellx and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding the safety and efficacy of anito-cel, the promising clinical profile of anito-cel, the expectation of anito-cel to be a differentiated CAR-T treatment option for RRMM, the potential of anito-cel as an outpatient therapy, and the planned commercial development of anito-cel both inside and outside the United States. The forward-looking statements contained herein are based upon Arcellx's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission (SEC) on May 8, 2025, and the other documents that Arcellx may file from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Ardian and ROYC Announce Partnership
Ardian and ROYC Announce Partnership

Yahoo

time13 minutes ago

  • Yahoo

Ardian and ROYC Announce Partnership

STOCKHOLM, June 10, 2025--(BUSINESS WIRE)--ROYC, the leading global Platform-as-a-Service provider for alternative investments, and Ardian, one of Europe's largest private investment firms managing and advising $180 billion in AuM, are today happy to announce a partnership. ROYC will act as a key partner for Ardian in the rapidly growing private wealth segment in Europe. "We are proud to partner with Ardian, sharing the belief that technology and a data-driven approach are essential for enabling more LPs to invest in Ardian's funds cost-effectively", said Mathias Leijon, Founder & President of ROYC. Erwan Paugam, Head of Private Wealth Solutions at Ardian, added, "ROYC has made a strong impression on us with its technological platform and professionalism. They will be an important partner to expand our activities in private wealth and in particular for the fundraising of our Ardian Secondary Infrastructure Fund IX". About ROYC ROYC is the leading European B2B financial technology company that provides a complete private markets operating system, empowering private equity firms, banks, wealth managers, and multi-family offices to seamlessly access, distribute, and manage private investments at scale. As private markets expand, financial institutions require scalable, technology-driven solutions to manage complexity, optimizing fund operations, and delivering exceptional client experiences. ROYC combines state-of-the-art private markets technology with tailored fund structuring and investment solutions. Its intuitive, scalable platform replaces manual processes with automation and real-time data access, transforming how private market investments are managed across the entire fund lifecycle. About Ardian Ardian is a world-leading private investment firm, managing or advising $180bn of assets on behalf of more than 1,850 clients globally. Our broad expertise, spanning Private Equity, Real Assets and Credit, enables us to offer a wide range of investment opportunities and respond flexibly to our clients' differing needs. Through Ardian Customized Solutions we create bespoke portfolios that allow institutional clients to specify the precise mix of assets they require and to gain access to funds managed by leading third-party sponsors. Private Wealth Solutions offers dedicated services and access solutions for private banks, family offices and private institutional investors worldwide. Ardian's main shareholding group is its employees and we place great emphasis on developing its people and fostering a collaborative culture based on collective intelligence. Our 1,050+ employees, spread across 19 offices in Europe, the Americas, Asia and Middle East are strongly committed to the principles of Responsible Investment and are determined to make finance a force for good in society. Our goal is to deliver excellent investment performance combined with high ethical standards and social responsibility.

Infobip Unveils CXOP: The Next Generation of AI-Powered Customer Conversations
Infobip Unveils CXOP: The Next Generation of AI-Powered Customer Conversations

Yahoo

time14 minutes ago

  • Yahoo

Infobip Unveils CXOP: The Next Generation of AI-Powered Customer Conversations

Built on agentic AI, CXOP delivers intelligent, hyper-personalized experiences across the full customer journey VODNJAN, Croatia, June 10, 2025--(BUSINESS WIRE)--Global cloud communications platform Infobip today announced its Conversational Experience Orchestration Platform (CXOP) — a game-changing solution that places agentic AI at the heart of every customer interaction. CXOP enables brands to move beyond static, rules-based workflows to deliver dynamic, goal-oriented conversations across marketing, sales, and support — at scale. The announcement builds on Infobip's AI Hub, marking a major step forward by natively infusing agentic AI across Infobip's entire award-winning product stack — unifying channels, data, and automation into a single intelligent platform. Built on Microsoft Azure OpenAI in Foundry Models, CXOP uses intelligent AI agents to orchestrate personalized customer journeys across channels like WhatsApp, RCS, and web chat. These agents understand context, act autonomously, and seamlessly collaborate with human teams when needed — reducing time to resolution, improving loyalty, and cutting costs. Today's consumers expect instant, relevant, and seamless interactions no matter what the channel. CXOP meets this demand by unifying messaging, automation, and AI-powered assistance within a single, intelligent platform that adapts to behavior, sentiment, and intent in real time. With CXOP, businesses can: Deliver empathetic, goal-driven AI interactions across channels Slash response times and reduce service costs through automation Increase lead conversion and campaign performance with real-time personalization Support hybrid teams with human-in-the-loop for complex cases Launch fast with no-code or full-code deployment options At its core, CXOP leverages a network of intelligent, agentic AI assistants that understand user intent and execute context-sensitive workflows. These agents don't just answer — they guide, solve, and act, creating fluid, human-like experiences from lead generation to retention. "CXOP enables enterprises to move beyond static workflows and deliver intelligent, empathetic interactions at scale," said Ivan Ostojić, Chief Business Officer at Infobip. "It's a foundational step toward building AI-first customer experiences that drive measurable business impact." "Using agentic AI instead of a rules-based automation, Infobip's new CXOP is an enhancement for customer experiences," said Myladie Stoumbou, Sr Director ISV Partnerships, at Microsoft. "Available within the Microsoft Azure Marketplace, clients can access such certified products and eliminate the complexity of managing individual vendor relationships." About Infobip Infobip is a global cloud communications platform that enables businesses to build connected experiences across all stages of the customer journey. Accessed through a single platform, Infobip's omnichannel engagement, identity, user authentication and contact center solutions help businesses and partners overcome the complexity of consumer communications to grow business and increase loyalty. View source version on Contacts Marcelo Bojana Mandić Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Helping UK construction SMEs stay compliant – with KMS and Resco Inspections+
Helping UK construction SMEs stay compliant – with KMS and Resco Inspections+

Business Wire

time14 minutes ago

  • Business Wire

Helping UK construction SMEs stay compliant – with KMS and Resco Inspections+

LONDON--(BUSINESS WIRE)--Staying compliant with building regulations is becoming more demanding, especially for smaller construction companies. The Building Safety Act, along with the Golden Thread of Information, means that every project must now come with a clear, traceable record of decisions, inspections, and data. For many small to medium-sized businesses, that's easier said than done. Let's face it: construction SMEs are under pressure. Regulations are stricter than ever. Teams are busy. Resources are limited. But the need to collect, manage, and share accurate project data hasn't gone away – in fact, it's now critical. Share That's why Resco partnered with KMS – a specialist in project-centric CRM for the construction industry – to bring a new digital solution to the UK market. Together, they are making compliance easier, faster, and far less stressful. Why this matters Let's face it: construction SMEs are under pressure. Regulations are stricter than ever. Teams are busy. Resources are limited. But the need to collect, manage, and share accurate project data hasn't gone away – in fact, it's now critical. One mistake or missing document can lead to costly delays, fines, or reputational damage. The recent partnership brings together KMS' construction CRM with Resco Inspections+, a mobile-first solution built for capturing field data. The result? A connected, user-friendly platform that helps construction teams stay on top of compliance requirements – without adding extra admin or complexity. What you can do with KMS + Resco solution Stay compliant with the Building Safety Act With clear documentation and up-to-date data, you can meet the Golden Thread of Information requirements confidently. Capture field data easily Whether it's site surveys, safety checks, or inspections, your team can log it all on the spot – even offline. No paper forms, no duplicated work. Keep everything in one place The integration syncs field data directly with KMS CRM. That means your records are always up to date and easy to access. Maintain a strong audit trail Every task is linked to your project records, so you can prove compliance when it matters – from planning approvals to final sign-offs. Built for real construction projects KMS + Resco solution offers a straightforward, cost-effective solution that helps UK construction SMEs stay compliant with the Building Safety Act. It's designed for the way construction teams actually work – out in the field, under pressure, juggling deadlines, and often without a reliable data connection. With real-time updates, seamless task scheduling, and automated reporting, it cuts down on manual tasks and gives you a clearer picture of your project status at all times. Want to see it in action? By integrating Resco's Inspections+ with KMS' CRM, construction teams can easily capture and manage key project data, ensuring compliance and reducing risks. This solution streamlines workflows, provides an audit trail, and helps businesses meet regulatory standards without the complexity. Learn how this partnership can simplify compliance and improve project management. Request a demo of Resco Inspections+ to see how it can benefit your team.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store