Allogene Therapeutics to Present Data from its Anti-CD19 AlloCAR T™ Therapy Program in Relapsed/Refractory Non-Hodgkin Lymphoma at the American Society of Clinical Oncology

Rhea-AI Summary

Allogene Therapeutics (Nasdaq: ALLO) announced the presentation of longer-term data from its Phase 1 ALPHA study on ALLO-501 in relapsed/refractory non-Hodgkin lymphoma, alongside initial findings from the Phase 1 ALLO-501A ALPHA2 study. This presentation will take place during the virtual 2021 ASCO Annual Meeting from June 4-9, 2021. ALLO-501A aims for a pivotal Phase 2 trial and has received FDA Fast Track Designation for DLBCL. Additionally, safety data for ALLO-647 will be presented, further advancing Allogene's AlloCAR T™ platform in cancer treatment.

• Longer Term Data from the ALLO-501 Phase 1 ALPHA Study to be Presented Alongside Initial Data from the Phase 1 ALLO-501A ALPHA2 Study
• Separate Presentation to Include Safety and PK/PD Data on ALLO-647 Used in, Allogene’s Proprietary Lymphodepletion Regimen
• ALLO-501A, Intended for a Potentially Pivotal Phase 2 Trial, Previously Granted FDA Fast Track Designation for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
• Allogene to Host Virtual CD19 Forum to Review ASCO Datasets on May 19, 2021 at 2:30 p.m. PT/5:30 p.m. ET

SOUTH SAN FRANCISCO, Calif. and PARIS, April 28, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, in collaboration with its development partner Servier, an independent international pharmaceutical company, today announced that longer-term follow-up data from Allogene’s dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) will be jointly presented with initial data from the ALPHA2 trial of ALLO-501A at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually June 4 - 9, 2021. A separate poster presentation will detail safety and biomarker findings from ALLO-647, Allogene’s wholly owned antibody used for lymphodepletion with fludarabine (Flu)/cyclophosphamide (Cy) in patients with relapsed/refractory non-Hodgkin lymphoma and multiple myeloma.

These Phase 1 trials are designed to assess the safety and tolerability at increasing dose levels of ALLO-501, ALLO-501A and ALLO-647 in the most common NHL subtypes of relapsed/refractory diffuse large B-cell lymphoma or follicular lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T™ intended for Phase 2 development in diffuse large B cell lymphoma (DLBCL), eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure.

“We are excited to present the first clinical data on ALLO-501A, our anti-CD19 AlloCAR T candidate intended for registrational trials in DLBCL, along with longer-term follow up from ALPHA, our first Phase 1 study of ALLO-501,” said Rafael Amado, MD, Executive Vice President of Research & Development and Chief Medical Officer of Allogene. “Over the past year, we have moved quickly and diligently to advance multiple AlloCAR T programs into the clinic using innovative technologies and across a variety of malignancies. We’re looking forward to discussing our progress in these two foundational studies during our virtual CD19 Forum.”

Allogene will host a virtual CD19 Forum for investors and other interested parties on May 19, 2021 at 2:30 p.m. Pacific Time/5:30 p.m. Eastern Time. The Forum will include data being presented at the virtual 2021 ASCO Annual Meeting along with discussion from clinical investigators and Allogene’s vision for the future of its AlloCAR T platform.

Allogene presentations at the virtual 2021 ASCO Annual Meeting:

First-in-human data of ALLO-501A, an allogeneic chimeric antigen receptor (CAR) T-cell therapy and ALLO-647 in relapsed/refractory large B-cell lymphoma (R/R LBCL): ALPHA2 study.
Presenter: Frederick Locke, MD, H. Lee Moffitt Cancer Center and Research Institute, Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy
Poster Session Title: Developmental Therapeutics—Immunotherapy
Abstract #2529
Session Release Date: June 4, 2021

Safety and PK/PD of ALLO-647, an anti-CD52 antibody, with fludarabine (Flu)/cyclophosphamide (Cy) for lymphodepletion in the setting of allogeneic CAR-T cell therapy.
Presenter: Michael Tees, MD, Colorado Blood Cancer Institute/Sarah Cannon, Associate Member Physician
Poster Session Title: Developmental Therapeutics—Immunotherapy
Abstract # 2527
Session Release Date: June 4, 2021

Virtual CD19 Forum
Additional information on the Virtual CD19 Forum will be made available in a separate press release and on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Materials presented will be available on the Allogene website prior to the start of the event.

About ALLO-501 (Allogene Sponsored)
ALLO-501 is an anti-CD19 allogeneic CAR T (AlloCAR T™) therapy being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier and utilizing Cellectis technologies. Servier grants to Allogene exclusive rights to ALLO-501 in the U.S. while Servier retains exclusive rights for all other countries.

About ALLO-501A (Allogene Sponsored)
ALLO-501A, a next-generation anti-CD19 AlloCAR T™ intended for Phase 2 development, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. Like ALLO-501, ALLO-501A is being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier and utilizing Cellectis technologies. ALLO-501A uses the Cellectis TALEN technology. Servier grants to Allogene exclusive rights to ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries.

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™) therapies for cancer. Led by a world-class 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.

About Servier
Servier is a global pharmaceutical group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2020, Servier employs 22,500 people worldwide. Servier is an independent group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient's voice at the heart of its activities, from research to support beyond the pill.

A leader in cardiology, the ambition of the Servier Group is to become a recognized and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology, and immuno-inflammatory and neurodegenerative diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies. More information: www.servier.com

Servier Group press contacts:
Sonia Marques: presse@servier.com – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13
Jean-Clément Vergeau: presse@servier.com – Tel. +33 (0)1 55 46 16 / +33 6 79 56 75 96

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 timing and ability to progress the ALPHA and ALPHA2 trials, including progressing to the Phase 2 portion of the ALPHA2 trial, and present any data from the trials, clinical outcomes, which may materially change as patient enrollment continues and more patient data become available, and the potential benefits of AlloCAR T™ therapy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation in its Form 10-K for the year ended December 31, 2020. 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.

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

FAQ

What are the key findings from the ALLO-501 Phase 1 ALPHA study presented by Allogene on June 4, 2021?

The key findings include longer-term follow-up data on ALLO-501 for relapsed/refractory non-Hodgkin lymphoma, showcasing the efficacy and safety of the therapy.

What is ALLO-501A and its significance in Allogene's studies?

ALLO-501A is a next-generation AlloCAR T™ therapy intended for a Phase 2 trial in DLBCL and received FDA Fast Track Designation, allowing for expedited development.

When is the virtual CD19 Forum hosted by Allogene, and what will it cover?

The virtual CD19 Forum is set for May 19, 2021, at 2:30 p.m. PT/5:30 p.m. ET, and will review findings presented at ASCO along with Allogene's future plans.

What safety data was shared regarding ALLO-647 in the recent Allogene press release?

Safety and PK/PD data for ALLO-647, used in Allogene's lymphodepletion regimen, will be detailed during a separate poster presentation at the ASCO Annual Meeting.

What are the objectives of the ALLO-501 and ALLO-501A Phase 1 trials?

Both trials aim to evaluate the safety and tolerability of ALLO-501 and ALLO-501A for patients with common NHL subtypes, including DLBCL.