Adicet Bio NASDAQ: ACET outlined its near-term clinical priorities and upcoming data catalysts during a fireside chat at the Jefferies Healthcare Conference in New York, with President and CEO Chen Schor emphasizing the company’s focus on off-the-shelf gamma delta 1 T-cell therapies for autoimmune disease and oncology.
Schor said Adicet’s platform is designed around gamma delta 1 T cells, which he described as having potential advantages over conventional alpha beta T-cell approaches. He said the cells can be administered allogeneically without gene editing and without the need for leukapheresis, which he characterized as a bottleneck limiting cell therapy availability to a small number of specialized centers.
“These are simply completely off the shelf for the patients,” Schor said, adding that the company believes the approach could allow broader use in outpatient settings.
Prula-cel Data Update Expected Across Autoimmune Indications
The company’s lead autoimmune program, prula-cel, also known as ADI-001, is a CD20-targeted gamma delta 1 T-cell therapy. Schor said the asset was initially developed for non-Hodgkin lymphoma before Adicet shifted its focus to autoimmune disease after reviewing emerging data.
Adicet is studying prula-cel across multiple autoimmune cohorts, including lupus nephritis, systemic lupus erythematosus, systemic sclerosis, myositis and ANCA vasculitis. Schor said a small rheumatoid arthritis study is also underway, primarily to evaluate different lymphodepletion regimens.
The company expects its next clinical update to include “a little more than 20 patients,” all with at least six months of follow-up, with some patients followed for nine or 12 months. Schor said the data will primarily focus on lupus nephritis and SLE, with potential inclusion of systemic sclerosis data.
In lupus nephritis, Adicet plans to evaluate SLEDAI scores and kidney-function measures. In SLE, Schor said the company will assess SLEDAI scores as well as whether patients remain on immunosuppressants or steroids. For systemic sclerosis, the company is monitoring lung function, skin scores, MRSS and CRISS.
CEO Addresses CD20 Versus CD19 Debate
Anthea Li, a biotech analyst at Jefferies, asked Schor about investor questions surrounding prula-cel’s CD20 target, given that much of the lupus cell therapy data generated to date has involved CD19-directed approaches.
Schor said Adicet has observed complete depletion of CD19 B cells in blood and lymph node biopsy despite targeting CD20. He said the company has not seen a difference so far in autoimmune patients or oncology patients and described the immune reset as similar to what has been observed with autologous CD19 cell therapy companies.
“When we look at the efficacy overall, it looked in the same ZIP code of the efficacy of the alpha beta T cells,” Schor said.
He also pointed to recently announced data from Artiva, which combines an NK cell approach with rituximab, a CD20-targeting therapy, in rheumatoid arthritis, saying future data will help determine whether there is a meaningful difference between CD20 and CD19 approaches.
Safety Profile and Outpatient Dosing Highlighted
Schor said safety is a central issue for making cell therapies available to more patients. He contrasted gamma delta 1 T cells with alpha beta T cells and bispecifics, saying alpha beta T-cell activation is associated with IL-6 secretion, cytokine release syndrome and ICANS, a neurological toxicity.
According to Schor, Adicet’s clinical experience has shown that gamma delta 1 T cells do not produce a significant IL-6 increase compared with alpha beta T cells. He said that has translated across indications into a lower rate and lower severity of CRS and a very low rate of ICANS.
Schor said the U.S. Food and Drug Administration reviewed Adicet’s data and was “perfectly fine” with the company moving to outpatient dosing, at least in lupus nephritis and SLE, without requiring hospitalization.
Development Priorities: Lupus Nephritis First, SLE and Systemic Sclerosis Under Review
Schor said Adicet currently expects to consider lupus nephritis as the first indication for advancement. He said companies have previously started in lupus nephritis and expanded into SLE as more patients were enrolled, including in pivotal-study contexts.
For SLE, he said Adicet may need to expand the data set and better understand durability before deciding how to proceed. In systemic sclerosis, Schor said even a small single-digit patient data set could potentially support discussions about a pivotal study, depending on the results.
On durability, Schor said six months appears to be an important regulatory timeframe for lupus nephritis and SLE, while systemic sclerosis may require longer follow-up, potentially 12 months. He said physicians would view one-time treatment favorably if patients saw meaningful symptom relief and were able to stop or reduce immunosuppressants and steroids.
ADI-212 IND Planned and Cash Runway Extends Into 2026
Adicet also discussed ADI-212, its oncology program targeting PSMA in solid tumors. Schor said the company recently updated guidance and now expects to file an investigational new drug application in the third quarter.
ADI-212 is a gamma delta T-cell therapy targeting PSMA and includes two additional technologies intended to improve efficacy. Schor said Adicet knocked out MED12 to enhance cytotoxicity and repeat killing capacity, and added membrane-bound IL-12 designed to reshape the tumor microenvironment. He said the company has had early meetings with the FDA and received positive feedback.
Adicet expects to potentially begin enrolling patients in a Phase 1 study in the fourth quarter and generate data next year, Schor said.
The company’s near-term catalysts include data in lupus nephritis and SLE, potential clinical entry for the PSMA program and possible PSMA data next year. Schor said Adicet is “well-funded into the second half of next year.” He also referenced an undisclosed in vivo program, saying Adicet has been working on it for some time and that when the company discusses it publicly, “it’s going to be meaningful.”
About Adicet Bio NASDAQ: ACET
Adicet Bio, Inc NASDAQ: ACET is a clinical‐stage biotechnology company specializing in the development of off‐the‐shelf, allogeneic gamma delta (γδ) T cell therapies for oncology and autoimmune disorders. The company's proprietary platform enables the genetic engineering of γδ T cells with chimeric antigen receptors (CARs) and other molecular modifications to enhance tumor targeting, expansion, and persistence. By leveraging the innate tumor-recognition properties of γδ T cells, Adicet seeks to overcome the manufacturing and safety challenges associated with autologous cell therapies.
Adicet's lead product candidate, ADI-001, is a CAR‐engineered allogeneic γδ T cell therapy directed against CD20 for the treatment of relapsed or refractory B-cell malignancies.
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