Developing Life-Changing Treatments for Blood Cancer

This Blood Cancer Awareness Month, we’re taking a moment to shine a spotlight on the driving force for all that we do — our determination to make a difference for patients and their care teams. 

Allogene’s initial focus has been on blood cancers and we have treated well over 100 patients so far through our clinical trials. But the need for improved therapies remains great: In 2020, it’s estimated that 178,520 people in the U.S. were diagnosed with leukemia, lymphoma or myeloma.¹  

We have those individuals — and their support communities — in mind each day.   

Like others, the pandemic has required us to flex and innovate. But at its onset, I was confident that our team — which is bold, creative and collaborative — would be able to persevere, despite the challenges. My confidence in our teams was well-placed. We have made great strides that have brought us closer to our most important milestone yet – possibly the first industry pivotal trial for an allogeneic CAR T therapy.  

For patients with relapsed or refractory non-Hodgkin lymphoma, this is cheering news. When I worked as an oncologist and hematologist at an academic medical center, or even as recently as one year ago, allogeneic CAR T therapies for blood cancers seemed out of reach, a therapy that may come to pass for younger generations. But now, driven by hope, scientific progress, insights and determination, we are focused firmly on overcoming challenges to get to the finish line — developing and delivering off-the-shelf therapies to treat individuals with blood cancers faster, more reliably and at greater scale. 

Meaningful Progress in Non-Hodgkin Lymphoma and Multiple Myeloma 

Some of our most notable milestones over the past year show that we are moving in the right direction to treat eligible patients with lymphoma and multiple myeloma. As we shared at our CD19 Forum and at the Annual Meeting of the American Society of Clinical Oncology this year, our AlloCAR T™ data indicate that we can achieve deep and durable responses in patients with relapsed or refractory non-Hodgkin lymphoma. These initial results, together with the safety profile, were on par with autologous CAR T therapies.  

We’re also making promising progress toward making a difference in another devastating blood cancer, resistant or refractory multiple myeloma. In the last year, positive initial results from a Phase 1 study demonstrated for the first time the feasibility and safety of an allogeneic CAR T therapy directed at this disease, and we continue to test new strategies to optimize these results.  

Manufacturing Off-the-Shelf Medicine  

One key differentiator of AlloCAR T is the ability to be available off-the-shelf – ready for patients when they are. As you may know, autologous therapies are procedures that require leukapheresis and a costly, time-consuming manufacturing process for each individual patient, which can take up to four weeks or more – time that some patients with advanced disease do not have to spare.  

To create our AlloCAR T products, we don’t need any cells from patients themselves. Instead, we manufacture therapies using cells from healthy donors, engineer them to express chimeric antigen receptors, or CARs, which recognize and target cancer cells, and genetically modify them to reduce autoimmune responses and rejection inside a patient’s body.  

To create off-the-shelf AlloCAR T therapies, transforming living cells into medicines, we began constructing a state-of-the-art manufacturing facility, which we coined Cell Forge 1, two years ago. Cell Forge 1, a facility located in Newark, CA, is designed for clinical and commercial manufacturing, analytical testing and distribution of cell therapies. With onsite manufacturing, we will have the ability to make off-the-shelf AlloCAR T treatment available for an increased patient population in a shorter period of time.  

One Step Closer to Potentially Life-Saving Therapies 

For patients with advanced blood cancers, one year is an eternity. Initial lines of therapy consist of sequential cycles that can be challenging to tolerate, side effects confounding and disease progress dispiriting for many patients. We realize that. Know that we are pressing forward toward our pivotal study, eagerly anticipating the day we are able to offer innovative ways to improve the lives of individuals with these cancers.  

This Blood Cancer Awareness Month, we’re going to be spreading the word about blood cancers and keeping our focus on our mission: to create and lead the next revolution in cancer treatment. Our AlloCAR T therapies have the potential to make a life-changing impact for those with blood cancers. With our patient-first mentality, as one Allogene community, we are confident that we are on the right path.  

Cautionary Note on Forward-Looking Statements 

This article contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The article may, in some cases, use terms such as "believe," “designed,” "potential," "proposed," "estimate," "anticipate," "expect," "plan," "intend," "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 potential initiation of a pivotal trial for an allogeneic CAR T therapy; clinical outcomes; our future manufacturing capabilities with respect to AlloCAR T™ treatments; and the potential benefits of AlloCAR T™ therapy. Various factors may cause differences between Allogene’s expectations and actual results, including: the initiation of a pivotal trial is subject to collection of data and favorable FDA feedback on the design of the trial; our engineered allogeneic T cell product candidates represent a novel approach to cancer treatment that creates significant challenges for us, including manufacturing challenges; initial, interim and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data; and the COVID-19 global pandemic is adversely impacting our business, including our preclinical studies and clinical trials. These and other factors are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as filed with the SEC on August 4, 2021. Any forward-looking statements that are made in this article speak only as of the date of this article. 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 article. 

References

1 https://www.lls.org/facts-and-statistics/facts-and-statistics-overview