Allogene Therapeutics Launches CAR T Together™, a First-of-its-Kind Initiative with Leading Oncologists Nationwide, Focused on Accelerating Development and Clinical Trial Recruitment for “Off-The-Shelf” Allogeneic Cell Therapy Investigational Products

Rhea-AI Summary

Allogene Therapeutics (ALLO) has launched the CAR T Together initiative to enhance access to allogeneic CAR T therapies for cancer patients. A recent survey showed that only 50% of eligible patients receive current autologous CAR T treatments, with significant delays in access, as 40% wait three to six months. The initiative aims to accelerate clinical trials for 'off-the-shelf' CAR T products, addressing the challenges of patient demand and manufacturing capacity.

Positive

• Launch of CAR T Together initiative to improve access to CAR T therapies.
• Collaboration with leading oncologists to expedite clinical trials for allogeneic CAR T products.
• Survey indicating strong support (82%) for CAR T therapies among clinicians.

Negative

• Only 50% of eligible cancer patients receive FDA-approved autologous CAR T therapies.
• Approximately 40% of eligible patients experience treatment delays of three to six months.
• Barriers to adoption include increased patient demand, manufacturing limitations, and extensive wait times.

• New Survey Focused on Access Limitations of Approved Autologous CAR T Therapies Reveals Only 50% of Eligible Cancer Patients Receive Treatment
• Increased Patient Demand, Manufacturing Capacity and Time to Treatment Highlighted as the Top Three Challenges Facing Future CAR T Adoption
• Initiative Aims to Address Access Bottleneck by Accelerating Clinical Trial Enrollment for “Off-the-Shelf” Allogeneic Products
  

SOUTH SAN FRANCISCO, Calif., Oct. 11, 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 launched CAR T Together™, a first-of-its-kind effort comprised of leading clinical trial investigators who represent the field of clinicians committed to supporting the development of “off-the-shelf” (allogeneic) chimeric antigen receptor (CAR) T products to make CAR T therapy scalable and more accessible to patients with certain cancers.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

CAR T Together was created in response to several real-world access challenges that have emerged since the commercial introduction of autologous CAR T five years ago – chief among them, the supply bottleneck created given the complex, individualized manufacturing process inherent in their delivery. This inaugural group aims to support innovation and bring awareness to clinical trials that may ultimately lead to the availability of an allogeneic CAR T product for patients.

A new survey of U.S. based academic centers specializing in the administration of CAR T, found that 82% of respondents agreed that CAR T therapies have changed how they manage aggressive cancers, but extensive wait times and manufacturing limitations keep many eligible patients from receiving treatment.¹

While the vast majority of late-stage cancer patients are eligible for CAR T treatment, only half of patients who are eligible for currently FDA approved autologous CAR T therapies receive treatment, according to the survey.¹ Of those patients eligible for treatment, 12% were able to receive treatment within one month, with approximately 40% waiting three to six months or longer to receive treatment as their disease worsens.¹

To improve access bottlenecks, CAR T Together brings together oncologists from preeminent research institutions nationwide who want to inspire collaboration to move cancer treatment options forward, supporting the advancement of science, the development of next-generation therapies and addressing the limitations of current therapies.

“Many of the physicians who are part of CAR T Together here and behind the scenes were critical in advancing autologous CAR T therapies. These first-generation CAR Ts transformed how we treat certain difficult-to-treat cancers, but the arduous, individualized manufacturing process and complex supply chain have made it hard for drugmakers to keep up with growing demand,” said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene. “This collaboration aims to hasten our efforts to develop an allogeneic CAR T option with the potential to overcome these barriers and significantly expand patient access.”

Equal parts collaboration, innovation and compassion, CAR T Together harnesses the spirit of cooperation needed to bring about the next cell therapy revolution and will collaborate with investigators and institutions in an effort to expedite clinical trial enrollment. The inaugural CAR T Together participants include:

• Maung Myo Htut, M.D., associate professor, Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope
• Fred Locke, M.D., chair, Department of Blood and Marrow Transplant and Cellular Immunotherapy; program co-leader, Immuno-Oncology, Moffitt Cancer Center
• Jeffrey Matous, M.D., member physician, director of the Multiple Myeloma Program, Colorado Blood Cancer Institute
• Javier Munoz, M.D., M.B.A., hematologic oncologist; director of the Lymphoma Program, Mayo Clinic
• Sumanta Kumar Pal, M.D., F.A.S.C.O., professor, Department of Medical Oncology and Therapeutics Research; co-director, Kidney Cancer Program, City of Hope
• Leslie Popplewell, M.D., chief, Division of Lymphoma, Department of Hematology and Hematopoietic Cell Transplantation; associate medical director of the Briskin Center for Clinical Research, City of Hope
• Michael Tees, M.D., MPH, associate member physician, director of the Lymphoma Program, Colorado Blood Cancer Institute
  

“The best treatment is the one patients can get. These findings show us that unfortunately, one of the greatest barriers for patients is access to innovation,” said Rafael Amado, M.D., Executive Vice President of Research & Development at Allogene. “These constraints are not temporary. In fact, we expect these issues will persist and potentially grow as market demand increases and CAR Ts are approved in earlier indications. The solution lies in the problem. How can we open up access? One potential solution is to develop allogeneic CAR T alternatives for patients that reduce the barriers to innovation for eligible patients.”

Survey Findings
Extensive wait times for FDA-approved CAR T have become increasingly common and resulted in many physicians making hard decisions – which of their eligible patients will get a scarce manufacturing slot versus who will need to go on a waiting list as their disease continues to progress. A new in-depth survey of 50 U.S.-based hematologist-oncologists, physician assistants, nurse practitioners, and registered nurses from academic centers with CAR T therapy capabilities sheds new light on the evolving landscape and underscores the growing unmet need.

The survey results revealed:

• Only half of late-stage cancer patients who are eligible for currently FDA approved autologous CAR T therapies receive treatment.
• While 82% of respondents agree that CAR T therapies have changed how they manage aggressive cancers, extensive wait times and manufacturing limitations keep many eligible patients from receiving treatment.
• Of those patients eligible for treatment, only 12% are able to receive treatment within one month, with approximately 40% waiting up to six months or longer to receive treatment as their disease worsens.
• For eligible patients, disease progression, manufacturing capacity and comorbidities were the top barriers.
• Increased patient demand, manufacturing capacity and time to treatment are cited by respondents as the three biggest challenges facing CAR T adoption in the future.
  

The survey was sponsored by Allogene Therapeutics and conducted by an independent third-party research organization. The survey did not assess the treatment status of individual patients.

For more information about CAR T Together, visit www.CARTTogether.com.

Limitations of Today’s CAR Ts
Today’s approved CAR Ts, referred to as autologous, are manufactured by taking T cells from a patient and engineering them in a central manufacturing facility to target and attack certain cancer cells before being reinfused back into the patient. Despite successful patient outcomes for many, autologous CAR T therapies have certain limitations associated with their delivery – time to treatment and supply limitations. For an autologous CAR T to treat thousands of patients, thousands of manufacturing runs must be successfully executed. Unlike autologous CAR Ts, allogeneic CAR T products utilize cells from healthy donors, making them “off-the-shelf” in nature and able to be efficiently manufactured in large batches and kept frozen for on-demand delivery to patients. Allogeneic CAR T products have the potential to treat approximately 100 patients with a single manufacturing run, possibly treating 20,000 patients annually from one manufacturing facility at scale. While experts are hopeful that allogeneic CAR T products will help address this patient need, advancing clinical trials are the next step toward making this potential revolution a reality.

About CAR T Together™
CAR T Together™ is a first-of-its-kind initiative that brings together oncologists from preeminent research institutions to harness the spirit of cooperation needed to make the next revolution for cell therapy a reality – potentially turning the promise of scalable, off-the-shelf (allogeneic) CAR T products into a reality and expanding access to cancer patients. For more information, visit www.CARTTogether.com.

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 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: expectations regarding the future demand for CAR T products and the supply of autologous CAR T products; the ability to develop allogeneic CAR T products; the ability to enroll patients in clinical trials of allogeneic CAR T products; the results from the survey, which may not be representative of all CAR T treatment providers and may change as the treatment landscape evolves; and the potential benefits of allogeneic CAR T. 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 8-K filed on September 21, 2022 and Form 10-Q for the quarter ended June 30, 2022. 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 CAR T Together™ are trademarks of Allogene Therapeutics, Inc.

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

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

Madeleine Goldstein
madeleine.goldstein@allogene.com

¹ Allogene data on file.

FAQ

What is the purpose of the CAR T Together initiative launched by Allogene Therapeutics?

The CAR T Together initiative aims to improve access to allogeneic CAR T therapies and accelerate clinical trial enrollment.

What challenges are facing the adoption of CAR T therapies according to the recent survey?

The survey highlighted increased patient demand, manufacturing capacity, and extensive wait times as key challenges.

What percentage of eligible patients currently receive CAR T therapy?

Only 50% of eligible patients receive treatment with currently approved autologous CAR T therapies.

How long do eligible patients typically wait for treatment with CAR T therapies?

Many eligible patients wait three to six months or longer for treatment.

What is the significance of the survey conducted by Allogene Therapeutics?

The survey sheds light on access challenges, revealing that extensive wait times and manufacturing limitations hinder treatment for eligible patients.