Celebrating Three Years of Allogene

Three years ago on May 1, 2018, we launched Allogene. Dr. Arie Belldegrun and I co-founded Allogene along with other well-respected colleagues, all of whom were eager to bring to life our collective vision for the next revolution in cell therapy: an “off-the-shelf” platform that could improve upon the autologous CAR T therapies we helped bring to patients in a previous life.

 In 2021, our founding vision is one step closer to creating a new reality for patients. We continue to advance our AlloCAR T? platform in the clinic and we continue to strengthen and expand our platform to lead innovation, which we believe is necessary to best serve patients and move the field forward. Our Research team is rapidly identifying ways to increase cell potency, overcome tumor microenvironment challenges and delay immune rejection, with the goal to make our therapies effective for patients.

Our proprietary TurboCAR? technology leads the pack in this new wave of technological breakthroughs as we harness the power of programmable cytokine signaling designed to control T cell exhaustion, improve T cell function, and potentially reduce the dosing requirement of AlloCAR T cells, opening the door to investigate difficult-to-treat hematologic malignancies and solid tumors.

But our desire to lead this CAR T revolution does not stop there. Pre-clinical research for future generation TurboCARs is already driving forward as we design our therapeutic candidates to overcome immune suppressive factors in the tumor microenvironment, particularly in solid tumors, by engineering T cell stimulatory domains that are activated by certain factors that normally inhibit T cell functions.

Not only are we advancing our technologies; more importantly, we are advancing them into the clinic. This year, we continue to mark many “firsts,” not just for Allogene but for the industry at large.

The First TurboCAR Trial: ALLO-605, which targets BCMA in multiple myeloma, received Investigational New Drug clearance from the FDA just weeks ago, and we plan to launch the IGNITE trial in mid-2021.

Our First Solid Tumor Trial: ALLO-316 is the beginning of our work in solid tumors. Solid tumors have yet to benefit from the potential of cell therapies and we aim to change that with our TRAVERSE trial targeting CD70 for the treatment of advanced or metastatic clear cell renal cell carcinoma.

Two Firsts in Multiple Myeloma:  In December 2020 we reported initial data from the UNIVERSAL trial demonstrating for the first time that an allogeneic CAR T therapy directed at BCMA could achieve meaningful clinical responses in patients with relapsed/refractory multiple myeloma while eliminating both the need for bridging therapy as well as the delays in treatment associated with autologous CAR T cell therapy manufacturing. Based on our data, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715. We’ve also initiated a combination study exploring ALLO-715 plus nirogacestat, gamma secretase inhibitor developed by SpringWorks. This multifaceted approach is key to our strategy as we recognize in multiple myeloma, the majority of patients continue to relapse and experience progressive disease.

Our First Potential Pivotal Trial: Today, we look ahead to the American Society of Clinical Oncology Annual Meeting where we will present data from our anti-CD19 AlloCAR T program in relapsed/refractory non-Hodgkin lymphoma. We plan to share longer term data from the ALLO-501 Phase 1 ALPHA trial alongside initial data from our ALLO-501A ALPHA2 study. As we further progress the trials and collect data, we may have the potential to initiate our first pivotal trial by the end of this year. 

As we look at what’s to come in 2021, we never stop looking to the future. Whether it’s our work with Notch Therapeutics as we develop induced pluripotent stem cells (iPSC), or our joint venture with Overland Pharmaceuticals – Allogene Overland Biopharm – to bring AlloCAR T therapies to China and other parts of Asia, we won’t stop.

Today, more patients have been treated with our AlloCAR T therapies than any other allogeneic CAR T in clinical development. On our third anniversary, we celebrate the success we’ve achieved today through teamwork with our partners, our academic collaborators, our investigators and many others.

 Today, we celebrate the potential to help even more patients tomorrow.

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Allogene Forward-Looking Statements

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, ALPHA2, UNIVERSAL and TRAVERSE 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; the timing and ability to initiate a clinical trial of ALLO-605; the ability of ALLO-605 to improve efficacy, overcome exhaustion, and reduce cell dose requirements; the ability to expand the TurboCAR platform; the ability to manufacture AlloCAR T? therapies, including for use in clinical trials; 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-Q for the quarter ended March 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?, AlloCAR ? and TurboCAR? are trademarks of Allogene Therapeutics, Inc.