Arcellx and Kite Continue Momentum with Advances in Anito-Cel Multiple Myeloma Program
Arcellx and Kite, in partnership with Gilead Company, announced updates on their anitocabtagene autoleucel (anito-cel) multiple myeloma program. The global Phase 3 trial, iMMagine-3, will evaluate anito-cel in patients with relapsed and/or refractory multiple myeloma exposed to specific previous treatments. The technical transfer for manufacturing anito-cel is complete, and preliminary data from the iMMagine-1 trial is expected by year-end.
The initiation of the Phase 3 trial, iMMagine-3, is a positive step towards addressing the unmet needs of patients with relapsed and/or refractory multiple myeloma.
The completion of the technical transfer for manufacturing anito-cel from a third-party organization to Kite's facility accelerates the development program.
The presentation of preliminary data from the iMMagine-1 trial by the end of the year reflects progress in the program.
The challenges of capturing a significant patient population for the iMMagine-3 trial due to evolving treatment paradigms and emerging clinical needs could pose a risk.
The reliance on specific previous therapies in the trial design may limit the generalizability of results to broader patient populations.
Insights
The commencement of the iMMagine-3 trial by Arcellx and Kite marks a significant advancement in the field of multiple myeloma treatment—a disease characterized by malignant plasma cells that accumulate in the bone marrow. The focus on anito-cel, a BCMA CAR T-cell therapy, addresses the growing need for innovative treatments in relapsed and/or refractory multiple myeloma (rrMM), especially for patients who have previously received standard treatments such as immunomodulatory drugs and anti-CD38 monoclonal antibodies.
Anito-cel's novel D-Domain binder is designed to enhance T-cell transduction and expression, which could potentially lead to more efficacious outcomes compared to the standard of care (SOC). However, CAR T-cell therapies, while potentially life-saving, also bring considerable logistical complexity and costs, which may affect the financial performance of both companies involved, depending on the therapy's market adoption and reimbursement strategies.
From an investor's perspective, the success of the iMMagine-3 trial could position Arcellx and Kite advantageously within the competitive landscape of multiple myeloma treatments. However, the inherent risks of clinical trials and the high stakes of Phase 3 outcomes are important to consider. This stage will essentially determine anito-cel's efficacy and safety profile compared to current treatment regimens, which will play a pivotal role in FDA approval decisions and subsequent market penetration.
The manufacturing capability updates, with Kite's facility in Frederick, Maryland, taking over production, also point towards a commitment to ensure product quality and supply chain robustness for anito-cel. This is pivotal, as manufacturing challenges have hampered the commercial success of other cell therapies in the past.
The completion of the technical transfer for anito-cel production to Kite's facility is a noteworthy strategic move. This reflects Kite's confidence in their in-house production capabilities and implies a potentially accelerated pathway to commercialization should clinical outcomes be favorable.
In-house manufacturing provides greater control over the CAR T-cell therapy production process, which is vital for maintaining the stringent quality standards required by regulatory bodies. For investors, it suggests a reduction in the reliance on external manufacturers, which can help mitigate risks associated with third-party production delays or quality control issues. The strategic location of the facility may also optimize the logistics, reducing the time from leukapheresis to reinfusion in patients—a critical aspect of CAR T-cell therapy's success.
Moreover, the ownership of manufacturing processes could improve the cost structures in the long term, potentially enhancing profit margins and competitiveness in the market. While there are significant upfront investments associated with establishing such capabilities, it is a positive sign for the scalability of treatment upon successful trial outcomes. Investors should monitor the execution of these manufacturing operations as they can have a profound impact on the therapy's overall success and, consequently, the financial performance of both Arcellx and Kite.
Anito-cel receiving Fast Track, Orphan Drug and Regenerative Medicine Advanced Therapy designations indicates a recognition from the FDA of its potential to address significant unmet needs within the multiple myeloma treatment paradigm. Such designations often come with benefits like expedited review processes and potential market exclusivity, which can be attractive to investors looking for signs of strategic value in a company's pipeline.
However, it is essential to calibrate expectations, as the drug's ultimate approval will hinge on comprehensive clinical data. The primary endpoint of the iMMagine-3 trial, progression-free survival (PFS), will be a key metric to evaluate efficacy. Investors should note that success in meeting or exceeding PFS expectations could propel the therapy to a leading position in the market. On the contrary, failure to meet these endpoints could lead to a reassessment of the therapy's commercial viability.
Furthermore, with the trial set to initiate in the second half of 2024, investors are looking at a relatively long-term horizon before any potential revenue from anito-cel materializes. This necessitates a patient capital approach, with an understanding that investments in biotechnology, especially in the clinical trial phase, are highly speculative and subject to regulatory risk.
-- The companies share design of global Phase 3 trial, iMMagine-3; will evaluate anito-cel in patients exposed to both an immunomodulatory (lMiD) drug and an anti-CD38 monoclonal antibody --
-- Anito-cel will be manufactured from Kite’s
-- Remain on track to present preliminary data from the iMMagine-1 trial by end of the year --
The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.
Kite’s facility in
“Our global iMMagine-3 trial will evaluate anito-cel as a second through fourth line treatment in patients with multiple myeloma who were previously exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “The iMMagine-3 study allows us to maximize the impact of anito-cel as it captures what will become the largest second line patient population based on the current treatment paradigm, as anti-CD38 therapies move to front line treatment. This population represents an emerging significant unmet clinical need allowing us to provide access to a unique patient population. In addition, the completion of the technical transfer to Kite allowed us to accelerate our development program and launch iMMagine-3 globally, which will enable broader and earlier patient access to anito-cel.”
“We are pleased to start the Phase 3 pivotal trial, iMMagine-3, in the second half of this year given the tremendous unmet need that remains in patients with relapsed and/or refractory multiple myeloma,” said Cindy Perettie, Executive Vice President, Kite. “As we prepare for this pivotal program, we look forward to leveraging our manufacturing expertise to further position anito-cel as a potential best-in-class cell therapy. We know manufacturing quality, reliability, and speed are critically important as every day matters for these patients.”
About iMMagine-3 Global Phase 3 Randomized Controlled Clinical Trial
iMMagine-3 is a phase 3, randomized controlled trial designed to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with SOC in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.
iMMagine-3 will enroll approximately 450 adult patients. Prior to randomization, investigator’s choice of SOC regimens include: pomalidomide, bortezomib, and dexamethasone (PVd); daratumumab, pomalidomide, and dexamethasone (DPd); carfilzomib, daratumumab and dexamethasone (KDd); or carfilzomib and dexamethasone (Kd). Patients in the anito-cel arm will undergo leukapheresis and optional bridging therapy (with the SOC regimen selected by the investigator prior to randomization) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T cells) on Day 1.
The primary endpoint is progression free survival (PFS) per blinded independent review according to the 2016 IMWG uniform response criteria for MM with the hypothesis that anito-cel will prolong PFS compared to SOC. Key secondary endpoints include complete response rate (CR/sCR), minimal residual disease negativity, overall survival, and safety.
The iMMagine-3 trial is expected to initiate in the second half of 2024 at ~130 study sites across
About Arcellx and Kite Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and co-commercialize Arcellx's anito-cel candidate for the treatment of patients with relapsed or refractory multiple myeloma currently in a pivotal Phase 2 trial. Kite and Arcellx will jointly develop and commercialize the anito-cel asset in
About anitocabtagene autoleucel (anito-cel)
Anito-cel is a BCMA CAR T that utilizes a novel binder (or CAR) known as the D-Domain. Its small size (8kDa) facilitates high T-cell transduction and expression, resulting in more CAR positive cells and more CARs expressed per T-cell.
Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in
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. Arcellx's lead product candidate, anito-cel (formerly CART-ddBCMA), is being developed for the treatment of relapsed or refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial.
Arcellx is also developing its dosable and controllable CAR T therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. For more information on Arcellx, please visit www.arcellx.com. Follow Arcellx on X (Twitter) at @arcellx and LinkedIn.
Arcellx 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 Arcellx's expectations regarding the timing, design and outcomes of clinical trials for its product candidates, including expected timing of presentation on clinical data and the breadth and uniqueness of the patient population being addressed; expectations around manufacturing; and the potential impact of its product candidates and platforms on patients and cell therapy. 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 risks that may be found in the section entitled “Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the Securities and Exchange Commission (SEC) on May 9, 2024, and other documents that Arcellx files from time to time with the SEC. 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.
Gilead Forward-Looking Statements
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to realize the anticipated benefits from the collaboration with Arcellx; Gilead and Kite’s ability to increase its CAR T-cell therapy manufacturing capacity, timely manufacture and deliver such therapies (or otherwise reduce the time to manufacture such therapies), or produce an amount of supply sufficient to satisfy demand for such therapies, including the production of anito-cel for the iMMagine-3 clinical trial and any future commercial manufacturing; the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving anito-cel; uncertainties relating to regulatory applications and related filing and approval timelines, including FDA approval of anito-cel for treatment of multiple myeloma; the risk that CAR T-cell therapy will not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508860197/en/
Arcellx Contacts:
Investors:
Myesha Lacy
ir@arcellx.com
510-418-2412
Media:
Andrea Cohen
Sam Brown Inc.
andreacohen@sambrown.com
917-209-7163
Gilead/Kite Contacts:
Investors:
Jacquie Ross
investor_relations@gilead.com
Media:
Tracy Rossin
trossin@kitepharma.com
Source: Arcellx, Inc.
FAQ
<p>What is the Phase 3 trial announced by Arcellx and Kite?</p>
The Phase 3 trial is named iMMagine-3 and aims to evaluate anito-cel in patients with relapsed and/or refractory multiple myeloma who have received specific prior treatments.
<p>When is the iMMagine-1 trial's preliminary data expected to be presented?</p>
The preliminary data from the iMMagine-1 trial is expected to be presented by the end of the year.
<p>What is the manufacturing status of anito-cel for the iMMagine-3 trial?</p>
Anito-cel will be manufactured at Kite's facility in Frederick, Maryland, following the completion of the technical transfer from a third-party organization.
<p>What is the unique feature of anito-cel as a BCMA CAR T therapy?</p>
Anito-cel utilizes Arcellx's novel D-Domain binder, making it the first BCMA CAR T therapy in multiple myeloma to use this innovative technology.
