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REDWOOD CITY, Calif. & BOSTON - Adicet Bio, Inc. (NASDAQ:ACET), a biotech firm in the clinical stage, has initiated a Phase 1 trial for its novel CAR T cell therapy, ADI-270, aimed at treating advanced clear cell renal cell carcinoma (ccRCC). The trial marks a significant step in addressing solid tumors, which have historically shown resistance to existing CAR T cell therapies primarily successful in hematologic cancers.
The open-label study will evaluate the safety, tolerability, and preliminary efficacy of ADI-270 as a monotherapy in adults with relapsed or refractory ccRCC. Participants in the trial, following a lymphodepletion process, may receive up to two doses of ADI-270, starting with 3E8 CAR+ cells.
ADI-270 is an "off-the-shelf" gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. It is engineered to resist the immunosuppressive environment typically found within tumors, aiming to improve durability and effectiveness in the patient's body. The therapy utilizes a third-generation CAR that targets CD70 with its natural receptor CD27 and includes a dominant negative form of the transforming growth factor-β receptor II to enhance its resilience.
Renal cell carcinoma represents the majority of kidney cancers, with ccRCC being the most aggressive subtype. It's known for its high metastatic potential, often spreading to lungs, liver, and bones. The prognosis for advanced ccRCC remains dire, with a 5-year survival rate sitting at a mere 15% for metastatic cases.
Adicet Bio anticipates sharing the initial clinical data from this trial in the first half of 2025. The company's focus is on developing gamma delta T cell therapies for autoimmune diseases and cancer, with a pipeline of engineered chimeric antigen receptors (CARs) designed to facilitate durable activity in patients.
This press release contains forward-looking statements regarding the potential of ADI-270 as a treatment for solid tumors, including ccRCC. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. The company cautions that positive preclinical results may not necessarily predict future clinical outcomes.
The information presented here is based on a press release statement from Adicet Bio, Inc.
In other recent news, Adicet Bio has made notable strides in its clinical trials and financial operations. The biotechnology company has kicked off a Phase 1 clinical trial for lupus nephritis patients, with preliminary data expected in the first half of 2025. The trial is part of a broader research effort by Adicet Bio to explore the potential of its investigational therapy ADI-001. The U.S. Food and Drug Administration (FDA) has granted ADI-001 Fast Track Designation for the potential treatment of relapsed/refractory class III or class IV lupus nephritis.
Adicet Bio has also modified its loan agreement with Pacific Western Bank, providing more flexibility in managing its financial resources and investments in its Shanghai subsidiary. The company has received approval from the FDA to expand its Phase 1 trial of ADI-001 to include two additional autoimmune diseases: idiopathic inflammatory myopathy and stiff person syndrome. This broadens the scope of Adicet Bio's clinical program to six autoimmune indications.
Analyst firms Guggenheim and H.C. Wainwright have maintained their respective Buy and Neutral ratings on Adicet Bio, while Canaccord Genuity and Jones Trading have adjusted their price targets for the company. Adicet Bio is also preparing for a Phase I study of another promising candidate, ADI-270, targeting metastatic or advanced clear cell renal cell carcinoma. Preliminary data for this study is anticipated in the first half of 2025. Lastly, Adicet Bio has expanded its board with the appointment of Dr. Lloyd Klickstein, an expert in rheumatology, immunology, and drug development. These are the most recent developments for Adicet Bio.
InvestingPro Insights
As Adicet Bio (NASDAQ:ACET) embarks on its Phase 1 trial for ADI-270, investors should be aware of the company's current financial position and market performance. According to InvestingPro data, Adicet Bio has a market capitalization of $80.01 million, reflecting its status as a small-cap biotech firm. The company's stock has experienced significant volatility recently, with a 24.85% decline in the past week and a 34.7% drop over the last month.
InvestingPro Tips highlight that Adicet Bio holds more cash than debt on its balance sheet, which could be crucial for funding its ongoing clinical trials and research. However, the company is quickly burning through cash, a common characteristic of clinical-stage biotech firms investing heavily in R&D.
The stock's recent performance has pushed it near its 52-week low, with the price currently at 25.68% of its 52-week high. This decline aligns with the broader market's perception of risk associated with early-stage biotech companies. Despite these challenges, analysts have set a fair value target of $7 per share, significantly higher than the current trading price.
It's worth noting that Adicet Bio is not currently profitable, with a negative P/E ratio and operating income of -$128.44 million for the last twelve months. This is not unusual for companies in the clinical trial phase, as they typically prioritize research and development over immediate profitability.
For investors interested in a deeper analysis, InvestingPro offers 13 additional tips on Adicet Bio, providing a more comprehensive view of the company's financial health and market position.
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