Setting a New Course: A Look Back and the Voyage Ahead for Allogene

By: David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder

As 2024 draws to a close, we reflect on a year marked by challenges and transformation. At the same time, we are at the threshold of a new year brimming with possibility and the promise of breakthroughs for Allogene. Navigating the dynamic and evolving field of cell therapy can feel like sailing through uncharted waters. It requires courage, foresight, and adaptability, paired with an unwavering commitment to our vision and belief in what we can do together – change the field of CAR T and bring transformative products to patients who need them the most.

Drug discovery is not for the faint of heart. In 2024, our industry continued to face significant hurdles. Across the landscape, clinical setbacks, company restructuring and closures, and budget tightening underscored the demanding reality of drug development. We met our own set of challenges, and it made us – and our programs – stronger. Rather than be deterred, we fought back and responded with energy and creativity, showing the industry why we are a force to be reckoned with. ALPHA3 and the work to develop ALLO-329 in record time are shining examples of what is possible when ambition meets purpose.

2025 promises to be a pivotal year where all our hard work and perseverance will begin to pay off. I am especially excited about the potential for our ALPHA3 trial to transform the standard of care for patients with large B-cell lymphoma (LBCL). As the first and only Phase 2 CAR T study in first-line (1L) consolidation in LBCL, this pioneering trial builds on our years of clinical research with allogeneic CAR T products and integrates cutting-edge investigational assays for detecting minimal residual disease (MRD). This innovative trial design was unimaginable even a few years ago.

Today, many LBCL patients live with the looming threat of relapse after 1L treatment, with the standard "watch and wait" approach offering little peace. But what if we could change someone’s life and potentially offer a better chance of cure by intervening earlier and preventing relapse? The ALPHA3 trial is designed to do just that, testing cema-cel as part of the 1L regimen for LBCL patients at high risk of relapse.

ALPHA3 could mark a monumental leap forward in LBCL treatment. For the first time, if successful, a CAR T (cema-cel) could prevent patient relapse, without additional 2L or 3L treatment and all the hardship that accompanies having to deal with cancer again. Its "off-the-shelf" convenience also broadens the availability of CAR T, bringing this innovative treatment to community cancer centers where most 1L LBCL patients receive care.

I am equally excited about the potential of CAR T in the treatment of autoimmune diseases where they hold the promise of achieving long-term remissions and even "cures" for conditions that currently lack effective treatments. In 2025, we plan to launch our ALLO-329 trial. ALLO-329 is not designed to be just a treatment – it’s intended to be a reimagination of how autoimmune diseases can be managed. By combining accessibility, dual targeting, and technological innovation, it has the potential to redefine autoimmune care, providing hope for patients with limited options today. While others in the field hope?to meet the unmet need of patients using largely the same approach, our unique dual-targeting approach combined with cutting-edge Dagger? technology is enabling us to design and develop a CAR T 2.0 product for autoimmune disease that could eliminate or reduce lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy.

We’re not just aiming to demonstrate the potential of ALLO-329, we’re striving to set a new standard for autoimmune care. This program represents more than hope; it embodies the possibility of deep remissions, broader accessibility, and safer treatments for patients.

As we look ahead to 2025, we are poised to unlock Allogene’s full potential. I am confident that the year ahead will bring considerable progress as we continue to build on our foundation and advance our mission to revolutionize cell therapy. Here’s to the voyage ahead as we lead with boldness, resilience, and purpose. Let’s make 2025 a year of transformative breakthroughs – for Allogene, our industry, and, most importantly, the patients we serve.