Arcellx Announces New Positive Data for Its iMMagine-1 Study in Patients with Relapsed and/or Refractory Multiple Myeloma
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Insider
an hour ago
- Business Insider
Nvidia or Palantir: Morgan Stanley Selects the Superior AI Stock to Buy
A smart investor is always on the lookout for growth sectors, places where the economy is primed to boom and where consequent opportunities are riding high. Right now, few sectors are offering the strong growth potential of artificial intelligence (AI). Confident Investing Starts Here: In just a few short years, AI – and particularly generative and agentic AI – has become the 'shiny new thing' on the cutting edge of high-tech. The entry of AI is rapidly transforming the tech industry, and it is making inroads into numerous other areas. Data management, content creation, publishing – we've only begun to find out what AI can do, and we can only imagine what it will do. A report from UN Trade & Development points out that the world's AI market, which was estimated at $189 billion in 2023, will expand 25x by 2033 to reach $4.8 trillion. AI's growth will bring with it gains for companies across a wide spectrum of fields, including development, applications, hardware, infrastructure, and power generation. Such rapid growth is creating new opportunities for investors. The challenge won't be finding one – it'll be choosing the right one. That's where Morgan Stanley's analysts come in. They've zeroed in on two tech titans that have become synonymous with AI innovation: Nvidia (NASDAQ:NVDA) and Palantir (NASDAQ:PLTR). Both are riding the AI wave, but Morgan Stanley is making a clear call on which one stands out as the better buy right now. Let's take a closer look. Nvidi a Nvidia stands at the forefront of Wall Street's tech revolution. As a dominant force among the 'Magnificent 7' and boasting a $3.45 trillion market cap, it's not only the largest of the tech mega-cap – it's the biggest publicly traded company in the U.S. The AI boom, which took off in late 2022 with the debut of ChatGPT, put Nvidia in the spotlight. As the top supplier of high-performance GPUs, the company was well-positioned to meet the explosive demand for AI-capable chips – and that sent NVDA shares soaring 660% over the past three years. However, even a juggernaut like Nvidia isn't immune to shifting market dynamics. After an extraordinary run, the company's stock momentum has started to cool amid rising volatility this year. One key challenge stems from the lingering effects of President Trump's tariff policies. The chip industry is deeply intertwined with global supply chains, and Nvidia's exposure to East Asia has made it vulnerable to tariff risks. That may be easing now, as both China and the EU have entered into trade talks with the White House. Yet, Nvidia isn't standing still. The company continues to push the boundaries of innovation, doubling down on emerging technologies to maintain its leadership in the AI race. This past May, Nvidia unveiled the world's largest dedicated quantum computing research supercomputer, the ABCI-Q, hosted at the Global Research and Development Center for Business by Quantum-AI Technology (G-QuAT). The new system is already integrated with Nvidia's open-source hybrid computing platform CUDA-Q. A second new development was made public last week. Nvidia announced that its Blackwell architecture, designed to power the latest AI platforms, showed superior performance on the latest rounds of the MLPerf Training, a key benchmark used to rate the capabilities of new AI systems. In Nvidia's last earnings report, covering fiscal 1Q26, company CEO Jensen Huang noted that the company's breakthrough Blackwell products are in full production and went on to outline the potential for AI to continue supporting strong results: 'Global demand for NVIDIA's AI infrastructure is incredibly strong. AI inference token generation has surged tenfold in just one year, and as AI agents become mainstream, the demand for AI computing will accelerate.' Turning to the company's financial results for the quarter, we find that Nvidia's revenue came in at $44.1 billion, up 69% year-over-year and $810 million better than had been expected. The company's non-GAAP EPS figure, at 81 cents, was 6 cents per share above the forecasts. Data center revenue, at $39.1 billion, was the main revenue driver and was up 73% year-over-year. Nvidia's gross margin for the quarter was reported at approximately 61%. For 5-star analyst Joseph Moore, the key point for investors to remember about Nvidia is that the future looks good. The Morgan Stanley analyst writes in his note on this chip maker: 'Racks get better from here. China is entirely derisked, at least for direct shipments, and we are optimistic that there will be some path to monetize at least a portion of that demand. Gross margins have bottomed and are improving to the mid 70s, sustainably. And every customer commentary confirms that customers waiting for these new technologies have left demand on the table. So our confidence in durable demand drives is quite high. We think that our numbers are conservative given the variables at play, and we see a high probability of continued upward revisions.' Moore's comments support his Overweight (i.e., Buy) rating on NVDA stock, while his $170 price target points toward a one-year upside potential of 20%. (To watch Moore's track record, click here) Overall, Nvidia has earned a Strong Buy consensus rating from the Street's analysts, based on 40 reviews that include 35 Buys, 4 Holds, and 1Sell. The stock is priced at $141.72 and its $172.36 average price target implies a ~22% upside in the next 12 months. (See NVDA stock forecast) Palantir Technologies Palantir is another standout in the AI space. Founded in 2003 by venture capitalist Peter Thiel, the company has built a strong reputation as a leader in data analytics and software solutions. Like Nvidia, Palantir has leveraged its unique capabilities to ride the wave of the AI boom, and the results have been striking. Over the past three years, its stock has skyrocketed 1,291%, including a 69% gain year-to-date. These gains haven't come by chance. Palantir stock's growth is rooted in the strength of its data management and analysis tools, which are used by businesses, non-profits, and government agencies alike. At the center of its offerings is the AI Platform (AIP), a solution that blends advanced AI capabilities with human-driven decision-making. One of its key strengths lies in its accessibility – users can interact with the platform using natural language, without needing coding expertise. AIP also supports multilingual inputs and translation frameworks, making it easier for users around the world to engage with its tools. Palantir can currently boast more than 760 customers, from both the public and private sectors. The company's AI-powered data platforms are popular with big businesses, and Palantir can count such names as Stellantis and BP among its users, as well as the US Department of Defense. In May, Palantir received a $795 million contract modification to its Maven Smart System agreement with the Army, extending support through 2029. The company is also among the short‑listed firms – alongside SpaceX, Lockheed Martin – and others, being considered for President Trump's $175 billion Golden Dome missile defense program. On the financial side, Palantir has been singularly successful at generating strong revenues and earnings. In 1Q25, the last period reported, the company had a top line of $883.9 million, representing 39% year-over-year growth and beating the forecast by $21.72 million. At the bottom line, Palantir's EPS came to 13 cents in non-GAAP terms, matching analyst expectations. The company proved successful at closing large deals during the quarter, including 31 deals worth at least $10 million. Despite this strength, some caution is warranted. Morgan Stanley's Sanjit Singh remains confident in Palantir's fundamentals but cautions that the valuation may be stretched after such a strong run. 'Palantir continues to prove out that it is one of the clear AI winners in software which has translated to accelerating top-line growth of 30%+ and a rule of 40 score (revenue growth + operating margin) of 83%. While this represents elite level performance in software, the current valuation of ~95x CY27 FCF makes underwriting a return on Palantir shares extremely challenging. As a result, we remain EW and await a better entry point before getting more bullish,' Singh noted. Singh's Equal Weight (i.e., Hold) rating comes with a $98 price target, implying a potential 25% drop from current levels. It's safe to say that his ideal entry point lies somewhere south of that. (To view Singh's track record, click here) Morgan Stanley's view aligns with the broader Street consensus. Palantir holds a Hold rating overall, based on 18 recent analyst recommendations: 3 Buys, 11 Holds, and 4 Sells. The stock is currently trading at $127.72, while the average price target stands at $100.13, implying a potential ~22% downside over the coming year. (See PLTR stock forecast) With the facts laid out, the Morgan Stanley analysts come to a clear conclusion: Both of these AI stocks are solid performers, but Nvidia is the superior choice to buy right now. To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights.
Business Wire
an hour ago
- Business Wire
'AI-First' Hype Gives Way to Reality: New Speechmatics Report Reveals What's Actually Working in AI
CAMBRIDGE, UK--(BUSINESS WIRE)--After a wave of bold 'AI-first' announcements from major tech players, many are now scaling back. Rather than betting on speculative demos, successful enterprises are treating Voice AI as critical infrastructure. Share As the AI gold rush slows, a new report from Speechmatics explores what's actually working — and where the real value lies. Titled The Voice AI Reality Check: Frontline Perspectives for Enterprise in 2025, the report zeroes in on one of the fastest-evolving areas of AI: Voice AI. Built on interviews with leaders across healthcare, compliance, media, public services, and research, it reveals a clear shift from flashy demos to embedded, operational AI — where tools assist humans, deliver measurable ROI, and quietly power core infrastructure. Report highlights include: Assistive over autonomous: The most effective deployments augment people rather than replace them. Assistive agents are driving real ROI. Multilingual as standard: Real-time code-switching is now a baseline requirement, not a bonus. Accuracy is make-or-break: With growing global concerns over AI hallucinations, precision is essential — especially in compliance-heavy environments. Voice as infrastructure: Quietly embedded tools are outperforming headline-grabbing features. Rather than betting on speculative demos, successful enterprises are treating Voice AI as critical infrastructure. It's being embedded into workflows that demand speed, accuracy, and trust — from noisy control rooms to multilingual contact centres. The report closes with future-looking predictions, outlining the rise of emotionally intelligent, adaptive, and natively multilingual voice systems — and offers guidance on what enterprises must prioritise next.
Business Wire
2 hours ago
- Business Wire
FIA President Mohammed Ben Sulayem Looking Forward to Visiting ‘Iconic' Macau for the 2025 FIA Annual Conference
MACAU--(BUSINESS WIRE)--The Fédération Internationale de l'Automobile (FIA), the global governing body for motorsport and the federation for mobility organisations worldwide, will shortly be in Macau for the 2025 FIA Extraordinary General Assembly and Annual Conference. Marking the first time this event has ever taken place in this diverse region, the conference will be hosted in partnership with the Automobile General Association Macao-China (AAMC) and Galaxy Entertainment Group and held at the Galaxy International Convention Centre. The event will welcome over 500 senior FIA delegates across mobility and motorsport from 149 countries, offering the opportunity to address key initiatives in road safety, sustainable mobility, regional sporting growth, and innovation in transport, with the FIA President Mohammed Ben Sulayem in attendance. Speaking ahead of his visit to Macau, FIA President Mohammed Ben Sulayem said: 'Global gatherings like this are vital to the health of our federation. Bringing our community together allows us an invaluable opportunity for engagement and participation, particularly within a pivotal election year. 'The Members of the FIA are at the heart of everything we do, and I am looking forward to being inspired by and connected to them over the next few days, strengthening the link between sport and mobility, expanding our reach, and continuing to impact the global stage. 'I am incredibly proud of the progress we have made together during my first term in office and look forward to continuing that partnership going forward. I am committed to the transformation of the FIA, so it can be an even more positive force for society. Globally, we remain committed to growing motorsport participation through grassroots initiatives and accessibility programmes such as the Affordable Cross Car and the Global Karting Plan. 'At the same time, we continue to empower all regions through our mobility capabilities, maintaining a central role in the automotive industry and leading the dialogue on the future of sustainable cities, safety, and transport.' Commenting on the location of this year's conference, Ben Sulayem said: 'Macau is iconic within the world of motorsport and a fitting location for the FIA to host one of the most important weeks of our calendar. I look forward to seeing much of what this unique destination has to offer.' The conference follows the FIA's recent announcement regarding the FIA's significant financial turnaround and strongest results in almost ten years. Reporting a profit of €4.7m, and an operating income of €182m for 2024, this puts the FIA back in the black following the inheritance of a €-24.0m deficit in 2021 from the previous administration. The conference will be attended by representatives from the 245 FIA Member Clubs. This structure forms the backbone of the federation's governance and operations, with each full Member Club holding voting rights across the FIA's elections and regulatory decisions. Clubs are grouped into two primary categories, with some serving in both roles: Mobility Clubs – provide mobility services and represent the interest of road users, with a focus on road safety, travel and tourism, consumer rights, and sustainable mobility National Sporting Authorities (ASNs) – govern and develop motorsport at a national level, are responsible for sporting events, issuing licenses, and engagement across regulations The Fédération Internationale de l'Automobile (FIA) is the governing body for world motor sport and the federation for mobility organisations globally. It is a non-profit organisation committed to driving innovation and championing safety, sustainability and equality across motor sport and mobility. Founded in 1904, with offices in Paris, London and Geneva, the FIA brings together 245 Member Organisations across five continents, representing millions of road users, motor sport professionals and volunteers. It develops and enforces regulations for motor sport, including seven FIA World Championships, to ensure worldwide competitions are safe and fair for all. The 2025 FIA Conference is hosted in association with Galaxy Entertainment Group and will be held at the International Convention Centre from 10-12 June. The Galaxy International Convention Centre is situated within the Galaxy Macau Integrated Resort which regularly plays host to world class sporting and conference events, and international exhibitions.
