Claims for Patent: 9,835,616

Summary for Patent: 9,835,616

Title:	In vitro method for assessing cytokine storm responses
Abstract:	The present disclosure an in vitro method of assaying the stimulation of a cytokine storm response comprising the steps of: a. co-culturing PBMCs and matched differentiated endothelial cells to provide a system representative of human responses in vivo, and b. exposing the co-cultured cell system to a test agent, c. analyzing the system for the presence of one or more cytokines released after exposing the co-culture system to said test agent, and d. optionally evaluating the response to the test agent in comparison to a response to one or more control agents.
Inventor(s):	Mitchell; Jane Alison (London, GB)
Assignee:	Imperial Innovations Ltd. (London, GB)
Application Number:	14/778,729
Patent Claims:	1. An in vitro method of assaying the stimulation of a cytokine storm response comprising: (a) co-culturing peripheral blood mononuclear cells (PBMCs) and matched differentiated endothelial cells to provide a cell system representative of human responses in vivo; (b) exposing the co-cultured cell system to a test agent; (c) analyzing the system for presence of one or more cytokines released after exposing the co-culture system to the test agent; and (d) optionally evaluating the response to the test agent in comparison to a response to one or more control agents; wherein the endothelial cells are autologous to the PBMCs; and wherein the endothelial cells are derived from blood outgrowth endothelial cells. 2. The method of claim 1, wherein the endothelial cells are capable of being cultured to provide a phenotype; wherein the phenotype is characterized as elongated and aligned. 3. The method of claim 1, wherein the response of the test agent is evaluated in comparison to one or more control agents. 4. The method of claim 3, wherein the control agent is a TGN1412 anti-CD28 antibody or an anti-CD52 antibody. 5. The method of claim 4, wherein the anti-CD52 antibody is alemtuzumab. 6. The method of claim 1, wherein the analyzed cytokine is CXCL8. 7. The method of claim 1, wherein exposing the co-cultured cell system to a test agent comprises exposing the co-cultured cell system to an agent which induces cytokine storm in the system, followed by the exposure of the system to a test inhibitor the induced response. 8. The method of claim 7, further comprising identifying an inhibitor of cytokine storm in the in vitro co-cultured cell system. 9. The method of claim 4, wherein the endothelial cells are from a biopsy.

Details for Patent 9,835,616

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2033-03-22
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2033-03-22
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2033-03-22