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REDWOOD CITY, Calif. & BOSTON - Adicet Bio, Inc. (NASDAQ: ACET), a biotechnology company focused on the development of allogeneic gamma delta T cell therapies, has commenced a Phase 1 clinical trial for lupus nephritis (LN) patients, with the first participant now dosed. The company, known for its work in autoimmune diseases and cancer, anticipates preliminary data from the trial in the first half of 2025.
This trial is part of a broader research effort by Adicet Bio to explore the potential of its investigational therapy ADI-001, an allogeneic gamma delta CAR T cell therapy targeting B-cells via an anti-CD20 CAR. 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, highlighting the urgent need for new therapeutic options in this area.
The Phase 1 study is structured with four separate arms, enrolling patients with various autoimmune conditions. Alongside lupus nephritis, the trial will also include systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV). The primary objectives are to evaluate the safety and tolerability of ADI-001, with secondary objectives including measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and disease activity scores.
Adicet Bio expects to initiate enrollment for SLE, SSc, IIM, and SPS in the first quarter of 2025 and for AAV patients in the second half of 2025. Clinical sites are currently open for enrollment, with additional sites anticipated to join shortly.
The company's strategy aims to leverage ADI-001's demonstrated potential in non-Hodgkin’s lymphoma, where it showed robust tissue trafficking and complete CD19+ B cell depletion in peripheral blood and secondary lymphoid tissue, to offer a transformative off-the-shelf treatment for several autoimmune diseases.
This announcement is based on a press release statement from Adicet Bio, Inc. and does not include any promotional content or endorsement of the company's claims. The information presented reflects the current stage of the clinical trial and the company's regulatory milestones.
In other recent news, Adicet Bio has made notable strides in its clinical trials and financial operations. The company has revised its loan agreement with Pacific Western Bank, providing more flexibility in managing its financial resources and investments in its Shanghai subsidiary. Adicet Bio has also received approval from the U.S. Food and Drug Administration (FDA) to expand its Phase 1 trial of ADI-001 to include two additional autoimmune diseases: idiopathic inflammatory myopathy and stiff person syndrome.
The expansion broadens Adicet Bio's clinical program to six autoimmune indications. Additionally, the company reported positive biomarker data from a Phase 1 GLEAN study, showing that ADI-001 led to the depletion of B cells, a promising development for the treatment of autoimmune diseases. 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 recent developments for Adicet Bio.
InvestingPro Insights
As Adicet Bio (NASDAQ: ACET) embarks on this promising Phase 1 clinical trial for lupus nephritis, investors should be aware of some key financial metrics and market trends. According to InvestingPro data, Adicet Bio's market capitalization stands at $78.03 million, reflecting its current position in the biotechnology sector.
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 efforts. This financial stability is particularly important given the company's focus on developing novel therapies in the competitive autoimmune disease space.
However, it's worth noting that the company is not currently profitable, with a negative operating income of $128.44 million over the last twelve months as of Q3 2023. This is not uncommon for biotechnology companies in the research and development phase, but it underscores the importance of successful clinical trials for the company's future prospects.
The stock's recent performance has been challenging, with InvestingPro data showing a one-month price total return of -34.7% and a year-to-date return of -49.9%. This volatility may be attributed to various factors, including market conditions and investor sentiment surrounding the company's clinical progress.
For investors considering Adicet Bio, it's important to note that InvestingPro offers 13 additional tips that could provide further insights into the company's financial health and market position. These additional tips could be valuable for those looking to make informed investment decisions in the biotechnology sector.
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