IP Library › Granted Patent US 12,566,181
Granted Patent B2
US 12,566,181 · App. 15/913,520 · Granted Mar 3, 2026

Methods and compositions for determining the potency of a therapeutic cellular composition

Inventors: Suzanne T. Ildstad (Prospect, KY); Andreas Katopodis (Basel, CH); Vladimir Senyukov (Basel, CH); Margit Jeschke (Basel, CH)
Assignees: ImmunoFree, Inc.; University of Louisville Research Foundation
G01N33/6872C07K16/18C07K16/2809C07K16/2815G01N33/5005G01N2333/4703G01N2458/00
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Quick Facts
Patent No.
US 12,566,181
App. No.
15/913,520
Granted
Mar 3, 2026
Kind
B2
Abstract

This disclosure provides a potency assay for evaluating the potency of facilitating cells and/or alpha beta TCR+ T cells.

Claims (13)

1 . A method of preparing a therapeutic cellular composition, the method comprising:

providing a therapeutic cellular composition comprising FCs and/or alpha beta TCR+ T cells;

contacting a sample of the therapeutic cellular composition with a mitogenic stimulus for a period of time from about 5 minutes to about 60 minutes, wherein the sample comprises about 100,000 to about 2,000,000 FCs and/or alpha beta TCR+ T cells;

determining a number of FCs and/or alpha beta TCR+ T cells in the sample in which ribosomal S6 protein is phosphorylated (pS6 + ); and

preparing the therapeutic cellular composition for delivery to a patient when at least 30% of the FCs and/or the alpha beta TCR+ T cells in the sample are pS6 + .

2 . The method of claim 1 , wherein the mitogenic stimulus is selected from the group consisting of phorbol 12-myristate 13-acetate (PMA) with ionomycin, phytohaemagglutinin (PHA), concanavalin A (conA), and pokeweed mitogen (PWM).

3 . The method of claim 1 , wherein the sample is contacted with the mitogenic stimulus for a period of time from about 20 mins to about 30 mins.

4 . The method of claim 1 , where the number of FCs and/or alpha beta TCR+ T cells in the sample in which pS6 is phosphorylated is determined using a fluorescently-labeled antibody against pS6.

5 . The method of claim 4 , wherein binding of the fluorescently-labeled antibody is detected using FACS.

6 . The method of claim 1 , wherein at least 30% of the FCs in the sample are pS6+.

7 . The method of claim 1 , wherein at least 30% of the alpha beta TCR+ T cells in the sample are pS6+.

8 . The method of claim 1 , wherein the method is performed prior to freezing the FCs and/or alpha beta TCR+ T cells.

9 . The method of claim 1 , wherein the method is performed on FCs and/or alpha beta TCR+ T cells that have been frozen.

Assignments (8)
TRANSFER OF OWNERSHIP. Recorded Dec 30, 2025
From: TALARIS THERAPEUTICS, INC.
To: IMMUNOFREE, INC.
Reel/Frame 073455/0819 →
CHANGE OF NAME Recorded Dec 17, 2020
From: REGENEREX, INC.
To: TALARIS THERAPEUTICS, INC.
Reel/Frame 054794/0695 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 5, 2018
From: NOVARTIS AG
To: REGENEREX, LLC
Reel/Frame 047412/0738 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2018
From: ILDSTAD, SUZANNE T.
To: UNIVERSITY OF LOUISVILLE RESEARCH FOUNDATION
Reel/Frame 045129/0448 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2018
From: KATOPODIS, ANDREAS; JESCHKE, MARGIT
To: NOVARTIS PHARMA AG
Reel/Frame 045129/0541 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2018
From: SENYUKOV, VLADIMIR
To: NOVARTIS PHARMACEUTICALS CORPORATION
Reel/Frame 045129/0566 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2018
From: NOVARTIS PHARMACEUTICALS CORPORATION
To: NOVARTIS AG
Reel/Frame 045129/0667 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2018
From: NOVARTIS PHARMA AG
To: NOVARTIS AG
Reel/Frame 045129/0795 →
Continuity (2)
Provisional Application 62467420 · Mar 6, 2017
Related Publication 20180252729A1 · Sep 6, 2018
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