Allogene Therapeutics to Present Pre-Clinical Data Highlighting the Potential of ALLO-329, an Allogeneic CD19/CD70 Dual CAR T for the Treatment of Autoimmune Diseases, at the American College of Rheumatology (ACR) Convergence

Rhea-AI Summary

Allogene Therapeutics (Nasdaq: ALLO) will present pre-clinical data for ALLO-329, its next-generation investigational AlloCAR T candidate for autoimmune indications, at the ACR Convergence 2024. ALLO-329 is a CD19/CD70 dual AlloCAR T product designed to target both B-cells and T-cells implicated in autoimmune diseases. It utilizes CRISPR-based site-specific integration and incorporates the Dagger® technology to potentially reduce or eliminate the need for lymphodepletion.

The company aims to address challenges in CAR T therapy for autoimmune diseases by making it available off-the-shelf and potentially reducing chemotherapy conditioning. Allogene plans to file an IND application in Q1 2025 and expects proof-of-concept by year-end 2025.

Positive

• Development of ALLO-329, a novel dual CAR T product for autoimmune diseases
• Potential to reduce or eliminate lymphodepletion in CAR T therapy
• Off-the-shelf availability to meet potential demand
• Planned IND application filing in Q1 2025
• Expected proof-of-concept by year-end 2025

Negative

• None.

Insights

Medical Research Analyst

This news highlights Allogene Therapeutics' advancement in developing ALLO-329, a novel allogeneic CAR T therapy for autoimmune diseases. Key points include:

• ALLO-329 targets both CD19+ B-cells and CD70+ activated T-cells, addressing multiple aspects of autoimmune diseases.
• The therapy incorporates the Dagger® technology, potentially reducing or eliminating the need for lymphodepletion, a significant barrier in CAR T adoption for autoimmune indications.
• It utilizes CRISPR-based site-specific integration for dual CAR expression, potentially enhancing safety by reducing secondary malignancy risks.
• Allogene plans to file an IND in Q1 2025 and expects proof-of-concept by end of 2025.

This represents a significant step in expanding CAR T therapy beyond oncology into autoimmune diseases, potentially opening a vast new market. However, it's important to note that this is still in pre-clinical stages and success in human trials is yet to be demonstrated.

Biotechnology Investor

From an investor's perspective, ALLO-329 presents an intriguing opportunity in the $130 billion autoimmune disease market. Key investment considerations include:

• First-mover advantage: Allogene is positioning itself as a pioneer in allogeneic CAR T for autoimmune diseases, potentially capturing significant market share if successful.
• Addressable market expansion: Success could dramatically increase Allogene's total addressable market beyond oncology.
• Technological differentiation: The dual-targeting approach and Dagger® technology provide competitive advantages.
• Near-term catalysts: IND filing in Q1 2025 and proof-of-concept results by end of 2025 are important milestones to watch.

However, investors should be cautious. The 545 million market cap suggests high risk and success is not guaranteed. The timeline to potential commercialization is long and significant capital may be needed to fund clinical development.

• The CD19/CD70 Dual CAR is Specifically Designed to Address Both the B-cell and T-cell Dysfunction Implicated in Autoimmune Diseases
• ALLO-329, is an Investigational Product Built on a New Gene Editing Platform that Features Site-Specific Integration, Intended to Reduce the Risk of Secondary Malignancies, and Leverage the Clinically Validated Dagger^® Effect Aimed at Reducing or Eliminating Lymphodepletion, a Potential Barrier in the Adoption of CAR T in Autoimmune Indications

SOUTH SAN FRANCISCO, Calif., Sept. 26, 2024 (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 that it will present pre-clinical data for its next-generation investigational AlloCAR T candidate for autoimmune indications, ALLO-329, at the American College of Rheumatology's annual meeting, ACR Convergence 2024, being held from November 14-19 in Washington, D.C.

ALLO-329, the Company’s CD19/CD70 dual AlloCAR T product is the first CAR T designed to both reduce or eliminate the need for lymphodepletion while also targeting CD19+ B-cells and CD70+ activated T-cells, both of which are likely to play a role in autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression.

“We are at the beginning of understanding what may be possible for CAR T in autoimmune disease. However, the only way to fully realize the potential of the modality is to develop product candidates designed to meet the specific needs of this vast patient population and allow for greater implementation in real-world practice. This is how we have designed ALLO-329,” said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development of Allogene. “We believe the first and most important factor for the potential success of CAR T in autoimmune disease is being available off-the-shelf to meet potential demand. Next, we have addressed lymphodepletion by incorporating our proprietary and clinically validated Dagger^® technology, which is designed to enable cells to expand and persist in patients without or with potentially reduced chemotherapy conditioning. Lastly, our dual CAR targets both the B- and T-cell components of autoimmune disease, which we believe may allow for a broader application of CAR T across a multitude of indications.”

Allogene Abstract:
Title: Preclinical Evaluation of ALLO-329: Allogeneic CD19 CAR T Cells Expressing an Anti-Rejection CD70 CAR for the Treatment of Autoimmune Diseases
Presenter: Kristen Zhang, Research Scientist, Allogene Therapeutics
Abstract Number: 1841
Poster Session: T Cell Biology & Targets in Autoimmune & Inflammatory Disease Poster
Date and Time: Monday, November 18, 10:30 a.m-12:30 p.m. ET

The abstract can be found on the American College of Rheumatology’s website.

The Company plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration in the first quarter of 2025 and expects to have proof-of-concept by year-end 2025.

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 (formerly Twitter) 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. The press release may, in some cases, use terms such as “predicts,” “projects,” “believes,” “potential,” “proposed,” “advance,” “making,” “continue,” “likely,” “designed to,” “estimates,” “anticipates,” “expects,” “envision,” “plans,” “intends,” “look to,” “may,” “could,” “might,” “will,” “should” 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: the timing of filing Investigational New Drug applications, achieving proof-of-concept relating to autoimmune disease, and the progress and success of such clinical program; the ability to reduce or eliminate lymphodepletion in autoimmune disease; the potential for our dual CAR targeting B- and T-cell components of autoimmune disease will allow for broader application of CAR T across a multitude of indications; the potential for our product candidates to be approved; the potential benefits of AlloCAR T products; the ability of our product candidates to treat autoimmune disease; our ability to meet the specific needs of the patient population and allow for greater implementation; the extent to which our clinical trials will support regulatory approval of our product candidates; 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 extent to which Dagger-endowed cells expand and persist in patients with less reliance on chemotherapy conditioning; our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; 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, including initiation of 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 SEC, including without limitation under the “Risk Factors” heading in its Quarterly Report on Form 10-Q for the quarter ended June 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™ and Dagger^® are trademarks of Allogene Therapeutics, Inc.

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

Additional Allogene Media Contacts:
Leslie Bryant
Leslie.Bryant@allogene.com

Madeleine Goldstein
Madeleine.Goldstein@allogene.com

FAQ

What is ALLO-329 and how does it differ from other CAR T therapies?

ALLO-329 is a CD19/CD70 dual AlloCAR T product designed for autoimmune diseases. It targets both B-cells and T-cells, uses CRISPR-based site-specific integration, and incorporates Dagger® technology to potentially reduce or eliminate lymphodepletion, setting it apart from traditional CAR T therapies.

When will Allogene Therapeutics (ALLO) file the IND application for ALLO-329?

Allogene Therapeutics plans to file an Investigational New Drug (IND) application for ALLO-329 with the U.S. Food and Drug Administration in the first quarter of 2025.

What are the potential advantages of ALLO-329 for autoimmune disease treatment?

ALLO-329 offers potential advantages including off-the-shelf availability, reduced need for lymphodepletion, and targeting of both B-cells and T-cells involved in autoimmune diseases. This may allow for broader application across multiple autoimmune indications.

When does Allogene Therapeutics (ALLO) expect to have proof-of-concept for ALLO-329?

Allogene Therapeutics expects to have proof-of-concept for ALLO-329 by year-end 2025.