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Immuno-Oncology Resource Center

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December 22, 2021
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FDA clears IND application for allogeneic CAR-T to treat certain solid tumors

Source:

Press Release

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The FDA cleared an investigational new drug application for P-MUC1C-ALLO1, a chimeric antigen receptor T-cell therapy designed to treat adults with locally advanced or metastatic epithelial-derived solid tumors.

The IND clearance applies to patients who are refractory to standard-of-care therapy, or those who are ineligible for or refused another existing treatment option.

Sign outside FDA HQ in Washington, DC.
Source: Adobe Stock.

P-MUC1C-ALLO1 (Poseida Therapeutics) is an allogeneic, gene-edited CAR T-cell therapy that targets tumors that express a cancer-specific form of the Mucin 1 (MUC1C) protein on the surface of cancer cells. The agent includes gene edits aimed at preventing host-versus-graft and graft-versus-host alloreactivity, according to the manufacturer.

The IND clearance will allow Poseida to start enrollment for a clinical trial that will evaluate P-MUC1C-ALLO1 for patients with advanced or metastatic epithelial-derived solid tumors, including breast, colorectal, lung, ovarian, pancreatic and renal cancers, as well as other malignancies that express MUC1C.

P-MUC1C-ALLO1 will be assessed as part of a multicenter phase 1 dose-escalation study that will evaluate the investigational therapy’s safety, tolerability and efficacy.

Patients will receive a standard chemotherapy-based conditioning regimen followed by a single dose of P-MUC1C-ALLO1. Additional dosing regimens — including repeat dosing — will be permitted as part of the study protocol once initial safety of the regimen has been established, according to the manufacturer.

“The genetic edits in P-MUC1C-ALLO1 have been shown to reduce or fully eliminate alloreactivity, and our proprietary manufacturing process — which includes our booster molecule — has the potential to treat many patients from a single manufacturing run,” Eric Ostertag, MD, PhD, CEO of Poseida Therapeutics, said in a company-issued press release. “We look forward to beginning this trial and to presenting initial clinical data in 2022.”