REDWOOD CITY, Calif. & BOSTON - Adicet Bio, Inc. (NASDAQ: ACET), a biotechnology firm at the clinical stage, has 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 (IIM) and stiff person syndrome (SPS). The company aims to start patient enrollment for these conditions in the first quarter of 2025.
This development broadens the scope of Adicet Bio's clinical program to six autoimmune indications, building upon the FDA's recent consent to evaluate ADI-001 for three other diseases beyond lupus nephritis (LN). These include systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).
Chen Schor, President and CEO of Adicet Bio, expressed optimism about the potential of ADI-001, citing recent clinical biomarker data that showed significant B-cell depletion and preferential trafficking to tissues and organs. The company anticipates initial clinical data from the Phase 1 study in multiple autoimmune diseases to be reported in the first half of 2025.
The Phase 1 trial will have four separate arms, each targeting a different set of autoimmune diseases. Patients will receive a single dose of ADI-001, and their response and safety will be assessed at various intervals, with the primary objective being to evaluate the therapy's safety and tolerability.
IIM, also known as myositis, encompasses a variety of disorders characterized by chronic muscle inflammation and weakness, often affecting other organs and leading to significant disability. SPS, a rare neurological disorder, causes severe muscle stiffness and spasms, impacting mobility and daily activities.
ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20, which has shown promise in the treatment of autoimmune diseases. It has been granted Fast Track Designation by the FDA for the treatment of LN.
Adicet Bio is focused on developing gamma delta T cell therapies for autoimmune diseases and cancer. The information in this article is based on a press release statement from Adicet Bio, Inc.
In other recent news, Adicet Bio has been making significant strides in its clinical developments and has received attention from various analyst firms. The company has recently opened enrollment for a Phase 1 trial of ADI-001, targeting autoimmune diseases such as lupus nephritis, systemic lupus erythematosus, systemic sclerosis, and anti-neutrophil cytoplasmic autoantibody associated vasculitis. H.C. Wainwright has maintained its neutral rating on Adicet Bio, indicating it will reevaluate its rating upon the release of clinical data in autoimmune indications.
Adicet Bio has also 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. Despite promising results, H.C. Wainwright has maintained a neutral rating on the company's shares.
In response to these developments, Canaccord Genuity and Jones Trading have adjusted their price targets for Adicet Bio. The U.S. Food and Drug Administration has granted Fast Track Designation to ADI-001 and clearance for a Phase 1 clinical trial of ADI-270, another potential therapy candidate. Lastly, Adicet Bio has expanded its board with the appointment of Dr. Lloyd Klickstein, an expert in rheumatology, immunology, and drug development, expected to advance its autoimmune programs.
InvestingPro Insights
As Adicet Bio (NASDAQ: ACET) expands its clinical trials for ADI-001, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at $115.36 million, reflecting its position as a clinical-stage biotechnology firm.
InvestingPro Data reveals that Adicet Bio's price-to-book ratio is 0.49, suggesting that the stock may be undervalued relative to its book value. This could be particularly interesting for value investors considering the company's potential in the autoimmune disease treatment market.
However, it's important to note that Adicet Bio is currently not profitable, with an adjusted operating income of -$128.08 million over the last twelve months. This aligns with an InvestingPro Tip indicating that the company is quickly burning through cash, which is not uncommon for biotechnology firms in the clinical trial phase.
On a positive note, another InvestingPro Tip highlights that Adicet Bio holds more cash than debt on its balance sheet. This financial cushion could be crucial as the company progresses through its expanded clinical trials and aims for data readouts in 2025.
Investors should be aware that the stock price movements are quite volatile, as noted by an InvestingPro Tip. This volatility is reflected in the company's price performance, with a 9.38% return over the past three months but a -36.07% return over six months.
For those interested in a more comprehensive analysis, InvestingPro offers 10 additional tips for Adicet Bio, providing a deeper understanding of the company's financial health and market position.
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