Express targets a variety of solid tumors, and clinical trials of allogeneic CAR-T therapy have been approved by the FDA

▎ WuXi AppTec content team editor today, Poseida Therapeutics announced that the US FDA has approved a new drug clinical trial application (IND) for the allogeneic CAR-T cell therapy P-MUC1C-ALLO1 to treat multiple solid tumor indications
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 Poseida's platform technology focuses on stem memory T cells (TSCM)
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Such cells have the characteristics of long life, self-renewal and pluripotency, and can reconstruct the entire lineage of T cell subsets including effector T cells
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Clinical trials have shown that they may survive for several years after treatment, providing the possibility of long-term efficacy
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P-MUC1C-ALLO1, developed based on this type of platform technology, is the second completely allogeneic CAR-T candidate product approved by Poseida in 2021 and has the potential to treat a variety of epithelial cell-derived solid tumors, such as breasts.
Cancer, colorectal cancer, lung cancer, ovarian cancer, pancreatic cancer, and kidney cancer, as well as other cancers that express the cancer-specific form of mucin 1 protein (MUC1C)
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P-MUC1C-ALLO1 is designed to be completely allogeneic, eliminating or reducing the reaction between the host and the graft through gene editing
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Poseida has demonstrated in preclinical models that P-MUC1C-ALLO1 can eliminate triple-negative breast and ovarian cancer tumor cells to undetectable levels
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▲Part of Poseida’s R&D pipeline (picture source: Poseida’s official website) The therapy will be evaluated in a multi-center, open-label, dose-escalation phase 1 clinical trial.
The research object will be locally advanced or refractory to current standard treatments.
Adult patients with metastatic epithelial solid tumors, or such patients who are considered unsuitable/rejected by another existing treatment option
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The trial will evaluate the safety, tolerability and preliminary efficacy of P-MUC1C-ALLO1, and follow the 3+3 design of the dose-escalation cohort
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After the subjects are enrolled, they will be given P-MUC1C-ALLO1 allogeneic CAR-T cells in accordance with the pretreatment regimen based on standard chemotherapy
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In addition, the research protocol allows for the exploration of other dosing options, including re-dosing after the initial safety has been determined
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Dr.
Eric Ostertag, CEO of Poseida, said: “We are pleased to initiate a clinical trial evaluating the allogeneic CAR-T candidate product P-MUC1C-ALLO1
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It is expected to treat a wide range of solid tumors, including breast, ovarian and other cancers
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P- The gene editing in MUC1C-ALLO1 has been shown to reduce or completely eliminate alloreactivity
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Our proprietary production process, including our booster molecule, has the potential to treat many patients with one production
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We We look forward to starting this trial in 2022 and providing preliminary clinical data
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"Reference: [1] Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-MUC1C-ALLO1, a Fully Allogeneic CAR-T Targeting Multiple Solid Tumors.
Retrieved December 20, 2021, from https://investors.
poseida.
com/news-releases/news-release-details/poseida-therapeutics-announces-fda-clearance-investigational-0 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
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