SOUTH SAN FRANCISCO - Allogene Therapeutics, Inc. (NASDAQ:ALLO), a biotech firm specializing in allogeneic CAR T-cell therapies, has reported promising results from its Phase 1 TRAVERSE trial evaluating ALLO-316 in patients with advanced renal cell carcinoma (RCC). The data, presented at the International Kidney Cancer Symposium (IKCS) and The Society for Immunotherapy of Cancer's (SITC) Annual Meeting, demonstrated that a single infusion of ALLO-316 led to a 50% overall response rate and a 33% confirmed response rate in patients with a CD70 tumor proportion score (TPS) greater than 50%.
The trial included 39 patients, with 26 confirmed to have CD70 positive RCC and evaluable for efficacy. The median time from enrollment to therapy start was five days. The Phase 1b expansion cohort, which is part of the study, is currently evaluating the safety and efficacy of ALLO-316 at a specific dose following a standard lymphodepletion regimen. This cohort is expected to include around 20 patients, with additional data anticipated by mid-2025.
The most common adverse events reported were cytokine release syndrome, fatigue, neutropenia, decreased white blood cell count, anemia, and nausea. No cases of graft-versus-host disease were observed. The safety profile was deemed manageable, with a newly implemented diagnostic and management algorithm effectively abating immune effector cell-associated neurotoxicity syndrome without compromising the efficacy of the CAR T treatment.
ALLO-316, which targets CD70, a marker highly expressed in RCC, is being developed not only for RCC but also for a range of hematologic malignancies and solid tumors. The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for advanced or metastatic RCC, following a Fast Track Designation received in March 2023.
Allogene Therapeutics is also supported by a $15 million award from the California Institute for Regenerative Medicine (CIRM) to aid the ongoing TRAVERSE trial. The company aims to provide off-the-shelf CAR T cell product candidates, potentially offering more accessible and scalable cell therapy options. This press release statement serves as the basis for the reported facts in this article.
In other recent news, Allogene Therapeutics has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration for ALLO-316. This designation, based on positive data from the Phase 1 TRAVERSE trial, is for the treatment of adult patients with CD70+ advanced or metastatic renal cell carcinoma who have not responded to standard therapies. H.C. Wainwright has maintained a Buy rating on Allogene shares, following this development.
In addition, Allogene has announced plans to present pre-clinical data for ALLO-329, an AlloCAR T candidate targeting autoimmune diseases, at the upcoming ACR Convergence 2024. The company is scheduled to file an investigational new drug application with the FDA in the first quarter of 2025, with proof-of-concept data expected by the end of that year.
Financial firm Piper Sandler has maintained its Overweight rating on Allogene, following a study published in the Cell journal detailing the use of allogeneic CD19 CAR-T treatment in patients with autoimmune diseases. These recent developments provide investors with insights into Allogene Therapeutics' ongoing projects and potential future directions.
InvestingPro Insights
As Allogene Therapeutics (NASDAQ:ALLO) continues to make strides in its clinical trials for ALLO-316, investors may find additional context from recent financial data and analyst insights valuable. According to InvestingPro, Allogene has experienced a significant return over the last week, with a 26.03% price increase, and strong returns of 24.81% and 30.36% over the last month and three months, respectively. This positive momentum could be attributed to the promising trial results and the company's progress in developing innovative cell therapies.
However, it's important to note that Allogene is currently in a pre-revenue stage, which is reflected in its financial metrics. An InvestingPro Tip highlights that the company is quickly burning through cash, a common situation for biotech firms investing heavily in research and development. This is further supported by the data showing an operating income of -$270.81 million for the last twelve months as of Q2 2024.
Despite the cash burn, another InvestingPro Tip reveals that Allogene holds more cash than debt on its balance sheet, which could provide some financial flexibility as it continues its clinical trials and pursues regulatory approvals. This strong cash position aligns with the company's ability to secure additional funding, such as the $15 million award from CIRM mentioned in the article.
For investors interested in a deeper analysis, InvestingPro offers 12 additional tips for Allogene Therapeutics, providing a more comprehensive view of the company's financial health and market position.
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