Allogene Therapeutics Expands Strategic Partnership with Foresight Diagnostics to Advance Joint Development Activities Outside the US Across Europe, UK, Canada, and Australia

Rhea-AI Summary

Allogene Therapeutics (NASDAQ: ALLO) has expanded its strategic partnership with Foresight Diagnostics to develop minimal residual disease (MRD) assay as a companion diagnostic for cemacabtagene ansegedleucel (cema-cel) treatment in large B-cell lymphoma (LBCL) patients across Europe, UK, Canada, and Australia.

The collaboration focuses on using Foresight's CLARITY™ assay to identify MRD-positive patients in the pivotal ALPHA3 trial, where cema-cel is being studied as a first-line treatment. The assay will help identify high-risk patients who achieve remission but remain MRD positive, offering them a one-time consolidation dose of cema-cel to prevent disease recurrence.

Under the agreement, Allogene will invest $37.3 million for MRD assay development, milestone payments for regulatory submissions, and clinical sample testing. Both companies will work towards obtaining regulatory approvals for their respective products.

Positive

• Geographic expansion of diagnostic capabilities to EU, UK, Canada, and Australia
• Strategic investment of $37.3M demonstrates commitment to product development
• Potential to expand market reach in first-line LBCL treatment
• Development of companion diagnostic may improve patient identification and treatment outcomes

Negative

• Significant capital investment required ($37.3M)
• Regulatory approvals still pending in multiple jurisdictions
• Success dependent on positive clinical trial outcomes

Insights

Financial Analyst

Allogene Therapeutics has strategically expanded its partnership with Foresight Diagnostics to develop a companion diagnostic for its lead CAR T therapy across Europe, UK, Canada, and Australia. This $37.3 million investment—representing approximately 8.5% of Allogene's market capitalization—signals a significant commitment to their allogeneic CAR T platform and global commercialization strategy.

The collaboration centers on integrating Foresight's highly sensitive minimal residual disease (MRD) assay to identify large B-cell lymphoma patients who achieve remission after first-line treatment but remain MRD-positive. This precision medicine approach serves multiple strategic objectives:

• Positions cema-cel as a potential first-line consolidation therapy for LBCL, representing a paradigm shift from current CAR T use in later treatment lines
• Expands the addressable market by potentially moving treatment earlier in the patient journey, where patient volumes are substantially larger
• Creates a competitive differentiation against other cellular therapies by utilizing precision diagnostics to optimize patient selection
• Establishes a coordinated multi-regional regulatory strategy that could accelerate global commercialization

The financial commitment is substantial for a clinical-stage company but reflects management's confidence in their lead program. By identifying patients most likely to benefit from treatment, Allogene could demonstrate improved efficacy metrics in clinical trials, potentially supporting premium pricing and broader reimbursement upon approval.

For investors, this expanded collaboration reinforces Allogene's commitment to its differentiated "off-the-shelf" CAR T approach while addressing a critical challenge in cellular therapy—identifying which patients will derive the greatest benefit. The companion diagnostic strategy could enhance the commercial value proposition of cema-cel while simultaneously expanding its geographical footprint beyond the US market.

The ALPHA3 trial represents a potentially transformative approach in LBCL treatment by using MRD status to guide consolidation therapy decisions, potentially preventing relapses before they occur rather than treating established relapsed disease. If successful, this approach could establish a new standard of care and significantly expand the role of allogeneic CAR T therapy in oncology treatment protocols.

Oncology Expert

Allogene's expanded partnership with Foresight Diagnostics represents a potentially transformative approach to lymphoma treatment that could fundamentally alter how we manage large B-cell lymphoma (LBCL). By integrating ultra-sensitive minimal residual disease (MRD) detection with targeted cellular therapy, this collaboration addresses one of the most critical challenges in lymphoma management: identifying and treating patients at high risk of relapse before clinical recurrence occurs.

The clinical significance of this approach cannot be overstated. Studies consistently show that MRD positivity after first-line therapy is one of the strongest predictors of relapse in LBCL, with approximately 70-80% of MRD-positive patients ultimately relapsing compared to less than 20% of MRD-negative patients. Current standard first-line therapy (typically R-CHOP chemoimmunotherapy) fails to cure approximately 40% of LBCL patients, yet we lack effective strategies to identify and intervene for high-risk patients in first remission.

Foresight's PhasED-Seq technology represents a significant advancement over conventional MRD detection methods, offering sensitivity levels that can detect one cancer cell among a million healthy cells. This exceptional sensitivity could enable intervention at the earliest possible stage of molecular relapse, potentially before resistant clones emerge and expand.

• The ALPHA3 trial design is particularly innovative, using MRD status as a biomarker to guide precision consolidation therapy rather than treating all patients or waiting for clinical relapse
• Allogene's "off-the-shelf" allogeneic approach offers significant advantages in this setting, as treatment can be administered promptly after MRD detection without the manufacturing delays associated with autologous products
• This MRD-guided approach could mitigate concerns about overtreatment and cost-effectiveness by restricting expensive cellular therapies to patients most likely to benefit

From a clinical perspective, this collaboration could establish a new paradigm in lymphoma management—shifting from a "wait and see" approach after first-line therapy to active surveillance with molecular testing and targeted intervention. The multi-regional focus of this expanded partnership suggests Allogene is preparing for global implementation of this strategy, potentially accelerating adoption if clinical data proves favorable.

The integration of companion diagnostics with cellular therapy also addresses a key limitation of current CAR T approaches: identifying which patients will derive the greatest benefit. By restricting treatment to MRD-positive patients, Allogene could demonstrate improved efficacy metrics in clinical trials while simultaneously addressing healthcare resource utilization concerns that have broader adoption of cellular therapies.

SOUTH SAN FRANCISCO, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T^™) products for cancer and autoimmune disease, today announced an expanded strategic collaboration with Foresight Diagnostics, Inc. to include the development of Foresight’s minimal residual disease (MRD) assay as a companion diagnostic to identify patients with large B-cell lymphoma (LBCL) for treatment with cemacabtagene ansegedleucel (cema-cel).

Under the Amended and Restated Strategic Collaboration Agreement, Allogene and Foresight will work together to support the development of Foresight Diagnostics’ MRD assay as a companion diagnostic in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel. Cema-cel is being studied in the groundbreaking randomized controlled pivotal ALPHA3 trial as part of a first-line (1L) treatment to potentially improve the cure rate in patients with LBCL. In the ALPHA 3 trial, patients who achieve remission following initial treatment but remain positive for MRD will be identified by using Foresight Diagnostics’ ultra-sensitive ctDNA-based Foresight CLARITY™ investigational use only (IUO) assay, powered by PhasED-Seq™. Patients who remain MRD positive may be at high-risk of relapse, and therefore will have an opportunity to receive cema-cel as a one-time consolidation dose to prevent disease recurrence.

“The continued collaboration with Foresight Diagnostics strengthens our commitment to advancing next-generation cancer therapies by integrating MRD detection as a powerful tool in patient care,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “We believe that this strategic expansion will help accelerate the development and potential approval of cema-cel as we continue our mission to transform the LBCL treatment landscape for patients beyond the United States.”

As part of this agreement, Allogene will invest approximately $37.3 million for MRD assay development, milestone payments for U.S., and certain international regulatory submissions and clinical sample testing. Both companies have committed to use commercially reasonable efforts to obtain regulatory approvals of their respective products and execute the agreed-upon work plan to support and enable the joint development activities.

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T^™ investigational product for the treatment of large B-cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first-line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first-line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to “watch and wait” to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, “off-the-shelf” treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD.

About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T^™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn.

Cautionary Note on Forward-Looking Statements for Allogene
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release may, in some cases, use terms such as “develop,” “potential,” “advance,” “expect,” “can,” “see if,” “positioning,” “become,” “be identified,” “powered,” “help,” “accelerate,” “continue,” “may,” “could,” “believe,” “improve,” “support,” “enable,” “improve,” “designed to,” “predict,” or “will,” including alternative forms thereof, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: ALPHA3 being a pivotal trial and the extent to which it will support regulatory approval of cema-cel; the ability for Foresight’s minimal residual disease test to identify patients with LBCL who are likely to relapse following standard 1L treatment; the potential for the ALPHA3 trial and an investigational minimal residual disease test to identify patients with LBCL who are likely to relapse following standard 1L treatment; the potential for cema-cel to become the standard “7th cycle” of frontline treatment; the design of the ALPHA3 trial and expected benefits therefrom; that cema-cel could be a promising therapeutic option for patients with MRD; that cema-cel can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy; the timing for completion of ALPHA3 enrollment or cema-cel BLA submission; the incidence of LBCL including the extent to which patients will relapse and require subsequent treatment; the potential for our product candidates to be approved; the potential benefits of the ALPHA3 trial and of AlloCAR T™ products; our ability to deliver cell therapy on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: the limited nature of our Phase 1 data from the ALPHA/ALPHA2 trial and the extent to which such data may or may not be validated in the ALPHA3 trial and any future clinical trials; the ability for Foresight to develop and obtain regulatory approval for its MRD assay as a companion diagnostic to identify patients with LBCL; the ability and extent that cema-cel will be administered only to patients at high risk for relapse as a one-time consolidation dose before disease recurrence; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; and challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation under the “Risk Factors” heading in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T^™ is a trademark of Allogene Therapeutics, Inc.
CLARITY™ and PhasED-Seq™ are trademarks of Foresight Diagnostics.

Allogene’s investigational AlloCAR T^™ oncology products utilize Cellectis technologies. These anti-CD19 products are developed based on an exclusive license granted by Cellectis to Servier. Servier, which has an exclusive license to the anti-CD19 AlloCAR T^™ investigational products from Cellectis, has granted Allogene exclusive rights to these products in the U.S., all EU Member States and the United Kingdom.

Allogene Media/Investor Contact:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
Christine.Cassiano@allogene.com

FAQ

What is the purpose of Allogene's expanded partnership with Foresight Diagnostics for ALLO stock?

The partnership aims to develop MRD assay as a companion diagnostic for cema-cel treatment in LBCL patients across Europe, UK, Canada, and Australia, potentially expanding ALLO's market reach.

How much is ALLO investing in the Foresight Diagnostics partnership?

Allogene is investing $37.3 million for MRD assay development, milestone payments, and clinical sample testing.

What is the significance of the ALPHA3 trial for ALLO's cema-cel treatment?

ALPHA3 is a pivotal randomized controlled trial studying cema-cel as a first-line treatment to improve cure rates in LBCL patients, using Foresight's CLARITY assay to identify suitable candidates.

How will the Foresight CLARITY assay be used in ALLO's LBCL treatment?

The assay will identify MRD-positive patients who achieve remission but remain at high risk of relapse, making them eligible for a one-time consolidation dose of cema-cel.