REDWOOD CITY, Calif. & BOSTON - Adicet Bio, Inc. (NASDAQ: ACET), a biotechnology firm focused on developing therapies for cancer and autoimmune diseases, has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1 clinical trial of ADI-270, a pioneering gamma delta CAR T cell therapy candidate, for the treatment of relapsed or refractory renal cell carcinoma (RCC). The company aims to launch this trial in the second half of 2024.
ADI-270 stands out as the first gamma delta 1 CAR T cell therapy candidate to be evaluated in clinical trials for solid tumors, specifically targeting CD70+ cancers. This innovative therapy is designed to address the challenges of the tumor microenvironment by improving specificity, exposure, and tumor infiltration. The Phase 1 study will assess its safety and anti-tumor efficacy in adult patients with clear cell RCC, the most prevalent form of kidney cancer, following a lymphodepletion preparatory regimen.
The planned multicenter, open-label trial will explore the pharmacokinetics and anti-tumor activity of ADI-270, with initial dosing set at 3E8 CAR+ cells. Eligible patients may receive a second dose based on specific protocol criteria. Key endpoints include overall response rate, duration of response, and disease control rate.
ADI-270's engineering incorporates a third-generation CAR design targeting CD70 with CD27 as the binding component and is further enhanced with a dominant negative form of the TGF-β receptor to counteract the immunosuppressive tumor environment. Additionally, it is designed to evade host vs. graft elimination, potentially leading to better clinical outcomes for patients with RCC and other CD70+ tumors.
RCC poses a significant clinical challenge due to its aggressive nature and limited treatment options. With a stark contrast in survival rates between localized and advanced disease stages, new therapies like ADI-270 could offer hope to those with advanced RCC.
The information regarding ADI-270 and its upcoming clinical trial is based on a press release statement from Adicet Bio, Inc.
In other recent news, Adicet Bio, a clinical-stage biotechnology firm, has made significant strides in the medical field. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the company's investigational therapy ADI-001, intended for treating relapsed or refractory lupus nephritis. This designation accelerates the development and review of drugs for severe conditions and unmet medical needs. Adicet Bio plans to commence a Phase 1 clinical study of ADI-001, which has shown promise in depleting CD19+ B-cells in non-Hodgkin’s lymphoma.
Simultaneously, Adicet Bio reported encouraging progress on its cancer therapy ADI-270. Preclinical results revealed promising anti-tumor activity in various cancer models, leading the company to prepare for filing an investigational new drug application for ADI-270. This therapy targets CD70-positive cancers and has shown effectiveness in mixed populations of CD70 negative and positive tumor cells.
These recent developments underscore Adicet Bio's commitment to advancing its research and development efforts in the field of cancer therapy and autoimmune diseases. The company's pipeline includes off-the-shelf gamma delta T cells engineered with chimeric antigen receptors (CARs) to potentially provide durable activity in patients.
InvestingPro Insights
Adicet Bio, Inc. (NASDAQ: ACET) is making strides in the biotechnology sector with its innovative gamma delta CAR T cell therapy candidate, ADI-270, which is set to enter Phase 1 clinical trials. As investors and stakeholders keep a close eye on the company's progress, certain financial metrics and expert tips provide additional context to Adicet's market position and future prospects.
InvestingPro Data shows that Adicet Bio has a market capitalization of $112.58 million, indicating its size within the biotech industry. The company's P/E ratio stands at -0.51, reflecting that it is not currently profitable—a detail that aligns with the challenges often faced by biotech firms in the development stage. Additionally, the Price / Book ratio as of the last twelve months, ending Q1 2024, is 0.43, suggesting that the stock may be undervalued relative to the company's assets, a potential point of interest for value investors.
Two key InvestingPro Tips highlight the financial nuances of Adicet Bio. Firstly, the company holds more cash than debt on its balance sheet, which is a positive sign of financial stability and may provide a buffer as it advances its clinical trials. However, it is important to note that the company is quickly burning through cash, which is not uncommon in the biotech sector due to high research and development costs. This rapid cash burn could be a concern for the company's long-term financial health if additional funding is not secured or if its therapies do not advance successfully through clinical trials.
For those looking to delve deeper into the financial health and future outlook of Adicet Bio, there are additional InvestingPro Tips available at https://www.investing.com/pro/ACET. These include insights on gross profit margins, stock price volatility, and anticipated profitability. With the use of coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these insights and make more informed investment decisions.
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