Strategic Expansion of Allogene and Foresight Diagnostics Partnership
Allogene Therapeutics Expands Strategic Collaboration with Foresight Diagnostics
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a pioneering company in the biotechnology sector focused on innovative allogeneic CAR T (AlloCAR T™) products for both cancer and autoimmune diseases, has recently enhanced its strategic collaboration with Foresight Diagnostics, Inc. This partnership is set to include the development of a companion diagnostic tool aimed at improving patient treatment in large B-cell lymphoma (LBCL) cases.
Development of Enhanced Diagnostic Tools
Under the newly amended strategic collaboration agreement, Allogene and Foresight are poised to work closely on advancing Foresight's minimal residual disease (MRD) assay. This advanced diagnostic tool will be crucial in identifying patients who are best suited for treatment with cemacabtagene ansegedleucel (cema-cel).
As part of its clinical studies, Allogene is currently conducting the pivotal ALPHA3 trial, which aims to provide first-line therapies that could potentially elevate cure rates among patients with LBCL. One innovative aspect of this study involves utilizing Foresight's high-sensitivity ctDNA-based Foresight CLARITY™ assay, powered by PhasED-Seq™, to detect MRD in patients who have achieved remission. Those remaining MRD positive, as indicated by the assay, may be considered high-risk for relapse and thus potentially eligible for cema-cel as a critical one-time consolidation treatment.
Investment and Commitment to Joint Development
In total, Allogene has committed around $37.3 million towards the development of the MRD assay, including milestone payments related to regulatory submissions both in the U.S. and internationally. Both Allogene and Foresight Diagnostics are dedicated to pursuing regulatory approvals and executing their collaborative plan effectively, aiming to facilitate the joint development activities as outlined in their agreement.
Cemacabtagene Ansegedleucel: A Breakthrough in LBCL Treatment
Cemacabtagene ansegedleucel (cema-cel) represents a groundbreaking new generation of therapy designed to treat LBCL. Following its recent designation by the U.S. Food and Drug Administration as a Regenerative Medicine Advanced Therapy (RMAT) for relapsed/refractory LBCL, cema-cel is currently being explored in the Phase 2 ALPHA3 trial targeting first-line consolidation treatments beginning in 2024. This strategic focus ensures that Allogene holds significant oncology rights for cema-cel across multiple regions including the U.S., EU, and UK, with future opportunities in China and Japan as well.
The Importance of the ALPHA3 Trial
The ALPHA3 trial stands to treat a substantial portion of the over 60,000 patients diagnosed with LBCL each year across the U.S., EU, and UK. Although first-line treatments such as R-CHOP have shown effectiveness, there remains a concerning relapse rate of approximately 30%. In response, the ALPHA3 trial incorporates cema-cel as a timely intervention that can be administered immediately following the discovery of MRD after the standard treatment cycles. This technique positions cema-cel as a prospective standard treatment, or “7th cycle,” for eligible patients facing the risk of disease recurrence.
About Allogene Therapeutics
Allogene Therapeutics, headquartered in South San Francisco, is notable for its innovative approach toward the production of allogeneic chimeric antigen receptor T-cell (AlloCAR T™) therapies designed specifically for oncology and autoimmune conditions. The company’s experienced management team, deeply rooted in cell therapy, continually strives to develop a range of “off-the-shelf” CAR T cell product candidates. The aim is to facilitate on-demand cell therapy access more effectively and at a larger scale for patients across the globe.
Frequently Asked Questions
What is the focus of Allogene Therapeutics' partnership with Foresight Diagnostics?
The partnership aims to develop Foresight's MRD assay as a companion diagnostic tool for identifying patients suitable for cema-cel treatment for LBCL.
What does cemacabtagene ansegedleucel (cema-cel) aim to treat?
Cema-cel is designed to treat large B-cell lymphoma (LBCL) and is currently being evaluated in pivotal clinical trials.
What is the significance of the ALPHA3 trial?
The ALPHA3 trial is pivotal in determining the effectiveness of cema-cel as a treatment option, particularly for patients who are at high risk of relapse following initial therapy.
How much is Allogene investing in the development of the MRD assay?
Allogene plans to invest approximately $37.3 million into the development of the MRD assay and related regulatory efforts.
What are Allogene's future goals regarding its products?
Allogene aims to achieve regulatory approvals for its products and ultimately provide accessible, on-demand therapies focused on improving patient outcomes.
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