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Kite and Arcellx to start Phase 3 trial for myeloma therapy

Published 10/05/2024, 00:30
©  Reuters

REDWOOD CITY, Calif. & SANTA MONICA, Calif. - Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) have announced their upcoming Phase 3 clinical trial for anitocabtagene autoleucel (anito-cel), a potential treatment for relapsed and/or refractory multiple myeloma. Anito-cel, which utilizes Arcellx’s novel D-Domain binder, is a BCMA CAR T-cell therapy, a type of immunotherapy that engineers a patient's own immune cells to fight cancer.

The global trial, named iMMagine-3, is set to begin in the second half of 2024 and will enroll approximately 450 adult patients. It aims to compare the efficacy and safety of anito-cel with standard of care (SOC) treatments in patients who have received one to three prior lines of therapy, including both an immunomodulatory drug and an anti-CD38 monoclonal antibody.

The Frederick, Maryland facility of Kite will manufacture anito-cel for the trial, marking the completion of a technical transfer from a third-party contract manufacturer. The U.S. Food and Drug Administration has cleared the Investigational New Drug application for anito-cel, allowing the trial to proceed.

Cindy Perettie, Executive Vice President of Kite, emphasized the importance of manufacturing quality and speed for patients with relapsed and/or refractory multiple myeloma, while Rami Elghandour, Chairman and CEO of Arcellx, highlighted the trial's potential to address a significant unmet clinical need.

The primary endpoint of the iMMagine-3 trial is progression-free survival, with key secondary endpoints including complete response rate and overall survival. The trial is expected to provide preliminary data by the end of the year.

The collaboration between Kite and Arcellx also includes co-development and co-commercialization of anito-cel in the United States, with Kite handling commercialization outside the United States. Anito-cel has received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations from the FDA, underscoring its potential as a significant advancement in the treatment of multiple myeloma.

InvestingPro Insights

As Kite, a Gilead Company (NASDAQ: GILD), forges ahead with its Phase 3 clinical trial for anito-cel in collaboration with Arcellx, Inc., investors are keeping a keen eye on Gilead's financial health and market performance. Here are some key insights from InvestingPro that could be of interest to those following the company's journey:

Gilead Sciences (NASDAQ:GILD) has been showing a strong commitment to delivering shareholder value, as evidenced by aggressive share buybacks. This is a signal that management believes the stock is undervalued and is willing to invest in its own equity—a positive sign for investors.

The company has also demonstrated a robust track record of dividend growth, having raised its dividend for 9 consecutive years. This consistency in returning value to shareholders may appeal to income-focused investors, particularly in a volatile market environment.

From a valuation standpoint, Gilead's current P/E Ratio (Adjusted) for the last twelve months as of Q1 2024 stands at 10.89, which points towards a strong free cash flow yield. This could indicate that the stock is trading at an attractive valuation relative to its cash-generating ability.

Investors should note that while some analysts have revised their earnings expectations downwards for the upcoming period, Gilead remains a prominent player in the Biotechnology industry with a solid financial base. Its market capitalization is a substantial 80.53 billion USD, and the company has maintained a gross profit margin of 77.52% over the last twelve months as of Q1 2024, showcasing its efficiency in maintaining profitability.

For those interested in exploring further InvestingPro Tips related to Gilead Sciences, there are additional insights available that could help in making a more informed investment decision. Readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to these valuable tips. There are 18 more InvestingPro Tips available for Gilead Sciences at https://www.investing.com/pro/GILD, offering a comprehensive understanding of the company's financial and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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