`US007402431B2
`
`c12) United States Patent
`Har-Noy
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 7,402,431 B2
`*Jul. 22, 2008
`
`(54) T-CELL THERAPY FORMULATION
`
`(75)
`
`Inventor: Michael Har-Noy, Modi'in (IL)
`
`(73) Assignee: Immunovative Therapies, Ltd.,
`Shoham (IL)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 160 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21)
`
`Appl. No.: 11/069,010
`
`(22)
`
`Filed:
`
`Mar.1, 2005
`
`(65)
`
`Prior Publication Data
`
`US 2005/0214274 Al
`
`Sep.29,2005
`
`Related U.S. Application Data
`
`(60)
`
`Provisional application No. 60/549,032, filed on Mar.
`1, 2004.
`
`(51)
`
`(52)
`(58)
`
`(56)
`
`Int. Cl.
`C12N 5106
`(2006.01)
`C12N 16100
`(2006.01)
`U.S. Cl. ................................. 435/372.3; 530/391.1
`Field of Classification Search ....................... None
`See application file for complete search history.
`
`References Cited
`
`U.S. PATENT DOCUMENTS
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`6,352,694 Bl
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`2002/0115214 Al
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`3/2002 June et al ................. 424/93.71
`3/2003 June et al ................. 424/93.71
`8/2002 June et al ................. 435/372.3
`9/2002 Waller et al .............. 424/93.21
`11/2004 Har-Noy .................. 424/93.71
`
`FOREIGN PATENT DOCUMENTS
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`WO
`WO
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`WO 03/038062
`WO 03024989
`
`10/2002
`* 3/2003
`
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`(Continued)
`
`Primary Examiner-Michail A Belyavskyi
`(74) Attorney, Agent, or Firm-Z. Peter Sawicki; Westman,
`Champlin & Kelly, P.A.
`
`(57)
`
`ABSTRACT
`
`Ex-vivo prepared T-cells are harvested from cell culture con(cid:173)
`ditions and formulated in medium suitable for infusion. The
`formulation is made by labeling the cells with one or more
`agents which have reactivity for T-cell surface moieties
`capable of delivery activation signals upon cross-linking and
`mixing the labeled cells with biodegradable nanospheres or
`microspheres coated with a material capable of cross-linking
`the agents attached to the T-cell surface moieties. Alterna(cid:173)
`tively, the formulation may be made by mixing a population
`of T-cells with biodegradable nanospheres or microspheres
`coated with a first material and one or more second materials.
`The first material binds the second material and the second
`material has reactivity for surface moieties on the T-cells and
`the interaction of the second materials with the T-cells causes
`the activation of the T-cells. In either method, the mixture of
`T-cells and biodegradable spheres are suspended in a medium
`suitable for infusion, and the mixture is packaged in a con(cid:173)
`tainer.
`
`3 Claims, No Drawings
`
`UPenn Ex. 2042
`Miltenyi v. UPenn
`IPR2022-00855
`
`
`
`US 7,402,431 B2
`Page 2
`
`OTHER PUBLICATIONS
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`
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