Allogene Therapeutics Publishes Preclinical Data on ALLO-316, an AlloCAR T™ Candidate Targeting CD70 for the Treatment of Renal Cell Carcinoma, at AACR’s Annual Meeting and in Cancer Research Journal

Rhea-AI Summary

Allogene Therapeutics (ALLO) announced promising preclinical results for its AlloCAR T therapy, ALLO-316, targeting CD70 to treat renal cell carcinoma (RCC) and other malignancies. Presented at the AACR Annual Meeting, these findings highlight the therapy's potential to address the unmet needs of RCC patients, with a 5-year survival rate below 15%. The FDA granted Fast Track Designation for ALLO-316 in March 2022, supporting its Phase 1 TRAVERSE trial aimed at evaluating safety and efficacy. ALLO-316 demonstrates low off-target binding and effective anti-tumor activity in studies.

Positive

• ALLO-316 shows effective anti-tumor activity against RCC in preclinical studies.
• Fast Track Designation from the FDA highlights the urgency and potential of ALLO-316 for treating RCC.
• Demonstrated low off-target binding in preclinical safety studies.

Negative

• Current therapies for RCC are limited, indicating a challenging market landscape.
• Five-year survival rate for advanced RCC patients remains below 15%, showcasing the severity of the unmet medical need.

• Data Continue to Highlight the Potential of ALLO-316 to Treat Both Solid Tumors and Hematologic Malignancies
  
• ALLO-316, in Phase 1 TRAVERSE Trial for the Treatment of Renal Cell Carcinoma, Granted Fast Track Designation (FTD) by the U.S. FDA in March 2022

SOUTH SAN FRANCISCO, Calif., April 13, 2022 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced that new preclinical findings of ALLO-316, an AlloCAR T therapy targeting CD70 for the treatment of renal cell carcinoma (RCC), were presented in a poster session of the 2022 American Association for Cancer Research (AACR) Annual Meeting. The findings were also published in Cancer Research, a journal of the American Association for Cancer Research.

ALLO-316 targets CD70, which is expressed in a number of malignancies ranging from solid tumors such as RCC, lung cancer and glioblastoma to hematologic cancers including acute myeloid leukemia (AML), diffuse large B-cell lymphoma, T-cell lymphomas, and multiple myeloma.

CD70 has previously been shown to be highly expressed in RCC and several hematological cancers with limited normal tissue expression. The current work illustrates that CAR T cells targeting CD70 could be generated in which expression of CD70 CARs was found to mask the cells own CD70 receptors in cis, providing protection from CAR T-mediated fratricide. Multiple CAR T cell constructs were evaluated for anti-tumor activity against RCC cell line and patient-derived mouse tumor models. Lead candidates were evaluated in preclinical safety studies which indicated limited potential for off-target binding. Lastly, highly functional CD70 allogeneic CAR T cells that were gene-edited with TALEN^® to eliminate TCR expression were produced at large scale. These preclinical data provide support for the ongoing clinical evaluation of ALLO-316 for the treatment of patients with RCC and other CD70 expressing hematological cancers and solid tumors.

“These results add to our strong interest in evaluating the potential of ALLO-316 to treat patients with CD70 expressing malignancies, including RCC and other cancers,” said Rafael G. Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. “Coupled with previously published preclinical data on ALLO-316 in a variety of tumors, these findings reinforce our belief that CD70 is an important target across a broad spectrum of cancers.”

In March, Allogene announced that the FDA granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies. RCC is a disease in need of innovation as current therapies are limited to a few mechanistic targets and complete response rates are low. The five-year survival rate for patients with metastatic kidney cancer is less than 15%. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC.

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. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy 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 @AllogeneTx on 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," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "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 ability to progress the Phase 1 TRAVERSE trial of ALLO-316; the ability to manufacture AlloCAR T™ candidates; and the potential benefits of ALLO-316 and other AlloCAR T product candidates. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 10-K for the year ended December 31, 2021. 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™ are trademarks of Allogene Therapeutics, Inc.
TALEN^® is a registered trademark of Cellectis, S.A.

Allogene’s AlloCAR T™ programs utilize Cellectis technologies. The anti-CD70 AlloCAR T programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs.

Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com

FAQ

What are the recent findings of ALLO-316 presented by Allogene Therapeutics?

Allogene Therapeutics presented preclinical findings at the AACR Annual Meeting showing ALLO-316's effective anti-tumor activity against renal cell carcinoma.

What is the Fast Track Designation for ALLO-316 and why is it important?

The Fast Track Designation from the FDA is granted to expedite the development of ALLO-316 due to its potential to meet an unmet medical need in difficult-to-treat renal cell carcinoma.

What is the TRAVERSE trial for ALLO-316?

The TRAVERSE trial is a Phase 1 clinical study evaluating the safety, tolerability, and activity of ALLO-316 in patients with advanced clear cell renal cell carcinoma.

How does ALLO-316 target CD70 in malignancies?

ALLO-316 is designed to target CD70, which is highly expressed in various solid and hematologic tumors, potentially allowing for targeted treatment.

What implications do the preclinical results have for ALLO-316's market potential?

The preclinical results support the advancement of ALLO-316 in clinical trials, positioning it as a potential treatment option for renal cell carcinoma and other CD70 expressing cancers.