SOUTH SAN FRANCISCO, Calif. - Allogene Therapeutics, Inc. (NASDAQ:ALLO), a biotechnology firm specializing in the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for its ALLO-316 product. This designation is for the treatment of adult patients with CD70 positive advanced or metastatic renal cell carcinoma (RCC) who have not responded to standard therapies.
The RMAT designation, granted on October 29, 2024, is based on positive data from the ongoing Phase 1 TRAVERSE trial, indicating ALLO-316's potential to meet the unmet medical needs of patients with difficult-to-treat RCC. These patients have previously undergone treatment with an immune checkpoint inhibitor and a VEGF-targeting therapy without success.
ALLO-316, which targets CD70, a marker highly expressed in RCC, employs Dagger® technology designed to optimize CAR T cell expansion and persistence, potentially enhancing the efficacy of a single infusion in solid tumors. The product was previously granted Fast Track Designation by the FDA in March 2022.
The RMAT designation aims to expedite the development and review process for promising investigational products like ALLO-316. It facilitates early and frequent dialogue with the FDA regarding surrogate or intermediate endpoints and post-approval requirements, potentially smoothing the pathway to market approval.
Allogene Therapeutics plans to present updated Phase 1 data from the TRAVERSE trial at the upcoming Society for Immunotherapy of Cancer (SITC) annual meeting. The company continues to explore the broader applicability of ALLO-316 across various hematologic malignancies and solid tumors.
This announcement is based on a press release statement from Allogene Therapeutics. The company, headquartered in South San Francisco, is committed to advancing its pipeline of "off-the-shelf" CAR T cell product candidates to provide cell therapy on-demand to a broader patient population.
In other recent news, Allogene Therapeutics has announced its intention to present pre-clinical data for ALLO-329, an innovative AlloCAR T candidate targeting autoimmune diseases, at the upcoming ACR Convergence 2024. This investigational therapy is designed to address B-cell and T-cell dysfunctions implicated in autoimmune disorders and uses CRISPR-based site-specific integration for dual CAR expression. This approach aims to reduce the risk of secondary malignancies associated with traditional CAR T therapies.
Allogene's proprietary Dagger® technology is also incorporated into ALLO-329, which could potentially eliminate the need for chemotherapy conditioning, often a barrier to treatment adoption due to its toxicity. The company plans to file an investigational new drug application with the U.S. Food and Drug Administration in the first quarter of 2025, with proof-of-concept data expected by the end of the same year.
In addition, reputable financial firm Piper Sandler has maintained its Overweight rating on Allogene following a study published in the Cell journal. The research detailed the use of allogeneic CD19 CAR-T treatment in patients with autoimmune diseases, who reported improvements in their conditions. Piper Sandler views these results as promising for Allogene's future prospects, potentially paving the way for broader applications of CAR-T therapy beyond oncology. ALLO-329, highlighted in the study, is expected to enter Phase 1 clinical trials in the first half of 2025. These are the recent developments that investors and stakeholders in Allogene Therapeutics are likely to monitor closely.
InvestingPro Insights
As Allogene Therapeutics (NASDAQ:ALLO) celebrates this regulatory milestone for ALLO-316, investors should consider some key financial metrics that provide context to the company's current position. According to InvestingPro data, Allogene's market capitalization stands at $560.42 million, reflecting the market's valuation of its potential in the competitive biotechnology landscape.
An InvestingPro Tip highlights that Allogene holds more cash than debt on its balance sheet, which could be crucial for funding ongoing clinical trials and potential commercialization efforts for ALLO-316. This financial cushion may provide some reassurance to investors as the company navigates the capital-intensive process of drug development.
However, it's important to note that Allogene is currently not profitable, with a negative P/E ratio of -2.17 for the last twelve months as of Q2 2024. This is not uncommon for biotechnology companies in the development stage, but it underscores the importance of the RMAT designation in potentially accelerating the path to market for ALLO-316.
Another InvestingPro Tip indicates that Allogene is quickly burning through cash, which is typical for companies investing heavily in R&D. This burn rate will be a critical factor to watch as the company progresses through clinical trials and regulatory processes.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights that could be valuable in assessing Allogene's financial health and market position. In fact, there are 8 more InvestingPro Tips available for Allogene Therapeutics, providing a deeper dive into the company's financial metrics and market performance.
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