SOUTH SAN FRANCISCO – Allogene Therapeutics, Inc. (NASDAQ:ALLO), a biotech firm focused on developing allogeneic CAR T therapies, has been awarded a $15 million grant from the California Institute for Regenerative Medicine (CIRM). The funding is earmarked to support the Phase 1 TRAVERSE trial, which is evaluating the safety and efficacy of ALLO-316, an investigational AlloCAR T™ product targeting CD70, in patients with advanced or metastatic renal cell carcinoma (RCC).
The TRAVERSE trial follows the Fast Track Designation granted by the U.S. Food and Drug Administration in March 2022, recognizing the potential of ALLO-316 to meet the significant need for new treatments in RCC after standard therapies have failed. RCC, a prevalent form of kidney cancer, presents a dire prognosis, with a less than 17% five-year survival rate for advanced cases.
Initial findings from the TRAVERSE trial, presented at AACR 2023, have shown promising response rates and anti-tumor activity. The grant is expected to aid in completing the Phase 1 segment of the trial and expanding clinical sites to diversify patient access. It will also support translational and clinical analyses to formulate a recommended Phase 2 regimen.
The Dagger® technology, utilized in ALLO-316, aims to enhance CAR T cell expansion and persistence by selectively eliminating CD70 positive, alloreactive host immune cells, potentially delaying or preventing premature rejection of AlloCAR T cells by the patient's immune system.
Allogene's ALLO-316 has demonstrated notable expansion and persistence in both preclinical and clinical settings, even when paired with less-intense lymphodepletion regimens. The company anticipates publishing details on a safety algorithm discovered during the trial that could broaden the use of CAR T therapies in solid tumors, with a more extensive data update from the ongoing trial expected later in 2024.
Allogene Therapeutics, headquartered in South San Francisco, is pioneering the development of "off-the-shelf" CAR T cell products for cancer and autoimmune diseases, aiming to offer cell therapy more reliably and at a larger scale to a broader patient population.
The information in this article is based on a press release statement from Allogene Therapeutics.
InvestingPro Insights
Allogene Therapeutics (NASDAQ:ALLO) is navigating a critical phase as it progresses with its TRAVERSE trial. The recent grant from CIRM underscores the potential of its investigational AlloCAR T™ therapy. However, a closer look at the company's financial health and market performance through InvestingPro provides additional context for investors.
InvestingPro data reveals a market capitalization of $482.76 million, indicating a moderate size within the biotech industry. Despite the promise of ALLO-316, the company's revenue over the last twelve months as of Q4 2023 stands at just $0.1 million, with a significant revenue decline of -39.1%. The gross profit margin over the same period is alarmingly negative at -255598.95%, highlighting operational challenges and the cost-intensive nature of biotech research and development.
InvestingPro Tips suggest a mixed outlook. On the positive side, Allogene holds more cash than debt, a crucial factor for sustainability in the biotech sector, and liquid assets exceed short-term obligations, indicating a solid short-term financial position. On the other hand, analysts anticipate a sales decline in the current year and do not expect the company to be profitable this year. Moreover, the stock has experienced a significant hit over the last week and month, with a one-week price total return of -17.72% and a one-month return of -32.19%, reflecting investor concerns and market volatility.
For investors considering Allogene Therapeutics, these insights underline the importance of careful analysis and the inherent risks and opportunities within the biotech sector. To explore further, investors can find additional InvestingPro Tips for Allogene, offering a more comprehensive view of the company's financials and market performance. Take advantage of the exclusive offer by using coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, which includes a total of 14 InvestingPro Tips for Allogene Therapeutics at https://www.investing.com/pro/ALLO.
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