The biopharma behind the investigational treatment plans to advance it into a potentially pivotal clinical program next year, noted a BTIG report.
Adicet Bio Inc. (ACET:NASDAQ) presented “encouraging” data from its ongoing Phase 1 trial evaluating the company’s lead therapeutic ADI-001, its chimeric antigen receptor (CAR) T-cell therapy, in large B-cell lymphoma, reported BTIG analyst Justin Zelin in a Dec. 12 research note. The data update took place at the American Society of Hematology’s annual meeting on Dec. 10 to 13.
The study showed Adicet’s anti-CD20, allogeneic, gamma delta CAR T-cell therapy to have a six-month complete response rate that is comparable to that of autologous CAR-T therapy as well as key safety advantages, Zelin highlighted.
“An off-the-shelf, allogeneic therapy with [a] differentiated and well-tolerated safety profile carries a strong value proposition in this setting,” Zelin commented.
Next Steps and Possible Catalysts
Massachusetts-based Adicet will continue enrolling patients in the study to gain further insights into durability and the recommended Phase 2 dose selection, noted Zelin. The likely choices are two infusions of DL3 (300 million cells) with one lymphodepletion or one dose of DL4 (1 billion cells).
“We look forward to clinical and regulatory updates from the company next year,” wrote Zelin.
Also, in about Q2/23, Adicet plans to move ADI-001 into a potentially pivotal clinical program, Zelin noted.
This would include two studies, one in post-CAR-T large B cell lymphoma patients and the other in earlier-line large B cell lymphoma patients. Discussions are planned with the U.S. Food and Drug Administration and the European Medicines Agency about the regulatory path forward for this program.
“We look forward to clinical and regulatory updates from the company next year,” wrote Zelin.
Positive Efficacy and Safety
The updated Phase 1 data indicated a potential efficacy signal for ADI-001 in post-CAR-T large B cell lymphoma patients, Zelin wrote. At all ADI-001 dose levels, patients showed a 75% overall response rate and a 69% complete response rate. Five patients, who previously relapsed on anti-CD19 autologous CAR-T therapy, had 100% overall response and complete response rates.
Zelin relayed that Dr. Sattva Neelapu, in the Department of Lymphoma-Myeloma at the MD Anderson Cancer Center, “expressed his excitement of the complete response rate in heavily pretreated patients with few alternative treatment options (estimated median progression-free survival is about two months), especially in post-CAR-T large B cell lymphoma patients. Dr. Neelapu notes a roughly 30% duration of response at six months would be viewed favorably.”
BTIG has a Buy rating and a US$34 per share price target on Adicet, which is currently trading at about US$19.88 per share.
In terms of safety, at the DL3+ dose (DL3: 300 million CAR+ cells; DL4: 1 billion CAR+ cells), at which the complete response rate was 86%, there were no grade 3 or higher side effects, including cytokine release syndrome, immune effector cell associated neurotoxicity, graft versus host disease or dose-limiting toxicities. Infections were minimal despite enhanced lymphodepletion being employed.
The “ability to safely redose with a single lymphodepletion regimen supports outpatient-community dosing as key advantages for Adicet’s allogeneic cell therapy,” Zelin added.
BTIG has a Buy rating and a US$34 per share price target on Adicet, which is currently trading at about US$19.88 per share.
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BTIG Research, Adicet Bio Inc., December 12, 2022
Analyst Certification: I, Justin Zelin, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.
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