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REDWOOD CITY, Calif. & BOSTON - Adicet Bio, Inc. (NASDAQ:ACET), a biotechnology firm specializing in gamma delta T cell therapies, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational treatment ADI-001, targeting systemic sclerosis (SSc) in adults.
Fast Track Designation aims to expedite the development and review of drugs that address serious conditions and fulfill an unmet medical need. ADI-001 is a chimeric antigen receptor (CAR) T cell therapy that has also been fast-tracked for other autoimmune diseases, including lupus nephritis and systemic lupus erythematosus with extrarenal involvement. InvestingPro data reveals that while the company holds more cash than debt on its balance sheet, it is currently burning through cash rapidly, a common characteristic of early-stage biotech companies.
Currently, ADI-001 is being evaluated in a Phase 1 study for lupus nephritis, with patient enrollment ongoing. The company plans to initiate enrollment for additional autoimmune conditions, such as systemic sclerosis, idiopathic inflammatory myopathy, and stiff person syndrome, in the second quarter of 2025. Enrollment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis is slated for the second half of the year. With the stock trading near $0.90, down over 60% in the past year, InvestingPro’s Fair Value analysis suggests the stock may be undervalued despite its current challenges.
In the Phase 1 GLEAN trial, ADI-001 demonstrated the ability to target B-cells through an anti-CD20 CAR, achieving complete depletion of CD19+ B-cells in blood and secondary lymphoid tissue.
Adicet Bio is advancing a portfolio of "off-the-shelf" gamma delta T cells engineered with CARs to potentially provide durable activity in patients. The company’s focus is on developing treatments for autoimmune diseases and cancer.
The statements made in the press release regarding the progress and potential benefits of ADI-001 are forward-looking and are based on management’s current expectations. These statements involve risks and uncertainties that could cause actual results to differ significantly. Adicet Bio cautions that positive results from earlier studies may not predict future study outcomes, and the drug’s safety and efficacy must be demonstrated in ongoing clinical trials to gain regulatory approval.
This news is based on a press release statement from Adicet Bio, Inc. and does not include any speculative or promotional content. For more information, please visit Adicet Bio’s website.
In other recent news, Adicet Bio, Inc. has announced updates on its clinical trial enrollments, notably for its ADI-001 and ADI-270 programs. The company is actively enrolling patients in a Phase 1 trial for Lupus Nephritis with ADI-001, having dosed three patients since November 2024, and plans to expand this trial to other autoimmune diseases in early 2025. Additionally, Adicet Bio has initiated a Phase 1 clinical trial for its ADI-270 therapy targeting metastatic/advanced clear cell renal cell carcinoma, with early clinical data anticipated in the first half of 2025. In a strategic move, the company has also appointed Dr. Julie Maltzman as its new Chief Medical (TASE:BLWV) Officer to lead its clinical development strategy. Dr. Maltzman brings extensive experience from her previous roles at IconOVir Bio and Roche/Genentech. Furthermore, Adicet Bio has successfully settled its outstanding debts with Banc of California (NYSE:BANC), marking a significant step in its financial management. This recent development involved a payoff agreement and the establishment of cash collateral accounts to cover ongoing services. These updates reflect Adicet Bio’s ongoing efforts in clinical advancements and financial restructuring.
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