WILBUR FRANKLIN, MD
Medical Practice at 16 Ave, Denver, CO

2013000, Jan 3, 2013

Jul 5, 2012

13/542529

Marileila Varella Garcia - Greenwood Village CO, US
Federico Cappuzzo - Bologna, IT
Wilbur A. Franklin - Denver CO, US
Fred R. Hirsch - Denver CO, US

The Regents of the University of Colorado, a body corporate - Denver CO

G01N 33/574

435 723

Disclosed are biomarkers, methods and assay kits for the identification of cancer patients who are predicted to benefit, or not to benefit, from the therapeutic administration of an epidermal growth factor receptor (EGFR) inhibitor. The biomarkers of the present invention include detection of EGFR and HER 2 gene amplification and polysomy, EGFR protein expression, EGFR mutations, phosphorylated Akt protein expression, and various combinations of such biomarkers, as well as the combination of these biomarkers with mutations in the tyrosine kinase domain of the EGFR gene. Increased EGFR gene copy number, increased HER2 gene copy number, increased EGFR protein expression, activated AKT protein expression (phosphorylated AKT) and EGFR mutations are all associated with better outcome for cancer patients treated with EGFR inhibitors. The invention provides a diagnostic paradigm based on each of these tests and combinations of these tests to select cancer patients who will benefit from EGFR inhibitor therapy, as well as a diagnostic paradigm to select cancer patients who will not benefit from EGFR inhibitor therapy.

2012017, Jul 12, 2012

Mar 12, 2012

13/418004

Paul A. BUNN - Evergreen CO, US
Christopher D. COLDREN - Denver CO, US
Wilbur A. FRANKLIN - Denver CO, US
Mark W. GERACI - Aurora CO, US
Barbara A. HELFRICH - Lakewood CO, US
Fred R. HIRSCH - Denver CO, US
Razvan LAPADAT - Denver CO, US
Michio SUGITA - Centennial CO, US
Samir E. WITTA - Greenwood Village CO, US

A61K 39/395, A61K 31/517, A61P 35/00, C40B 30/00, G01N 33/566, G01N 21/64, G01N 21/76, G01N 27/62, A61K 31/5377, C12Q 1/02

4241331, 4241421, 5142345, 5142664, 435 29, 435 723, 506 7

Disclosed is the identification, provision and use of a panel of biomarkers that predict sensitivity or resistance to EGFR inhibitors, and products and processes related thereto. In one embodiment, a method is described for selecting a cancer patient who is predicted to benefit from therapeutic administration of an EGFR inhibitor, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitor. Also described is a method to identify molecules that interact with the EGFR pathway to allow or enhance responsiveness to EGFR inhibitors, as well as a plurality of polynucleotides or antibodies for detection of the expression of genes that are indicative of sensitivity or resistance to EGFR inhibitors, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitors. A method to identify a compound with the potential to enhance the efficacy of EGFR inhibitors is also described.

2010019, Aug 5, 2010

Jul 23, 2008

12/670052

Paul A. Bunn - Evergreen CO, US
Christopher D. Coldren - Denver CO, US
Wilbur A. Franklin - Denver CO, US
Mark W. Geraci - Aurora CO, US
Barbara A. Helfrich - Lakewood CO, US
Fred R. Hirsch - Denver CO, US
Razvan Lapadat - Denver CO, US
Michio Sugita - Centennial CO, US
Samir E. Witta - Greenwood Village CO, US

A61K 39/395, C12Q 1/68, A61K 31/5377, A61K 31/517, A61K 31/497

4241331, 435 6, 5142345, 5142664, 51425218, 4241411

Disclosed is the identification, provision and use of a panel of biomarkers that predict sensitivity or resistance to EGFR inhibitors, and products and processes related thereto. In one embodiment, a method is described for selecting a cancer patient who is predicted to benefit from therapeutic administration of an EGFR inhibitor, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitor. Also described is a method to identify molecules that interact with the EGFR pathway to allow or enhance responsiveness to EGFR inhibitors, as well as a plurality of polynucleotides or antibodies for detection of the expression of genes that are indicative of sensitivity or resistance to EGFR inhibitors, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitors. A method to identify a compound with the potential to enhance the efficacy of EGFR inhibitors is also described.

2008011, May 15, 2008

Jul 23, 2007

11/781946

Paul A. BUNN - Steamboat Springs CO, US
Christopher D. COLDREN - Denver CO, US
Wilbur A. FRANKLIN - Denver CO, US
Mark W. GERACI - Aurora CO, US
Barbara A. HELFRICH - Lakewood CO, US
Fred R. HIRSCH - Denver CO, US
Razvan LAPADAT - Indianapolis IN, US
Michio SUGITA - Centennial CO, US
Samir E. WITTA - Greenwood Village CO, US

THE REGENTS OF THE UNIVERSITY OF COLORADO - Boulder CO

C40B 30/04, G01N 33/574, C12Q 1/68

506 9, 435 723, 435 6

Disclosed is the identification, provision and use of a panel of biomarkers that predict sensitivity or resistance to EGFR inhibitors, and products and processes related thereto. In one embodiment, a method is described for selecting a cancer patient who is predicted to benefit from therapeutic administration of an EGFR inhibitor, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitor. Also described is a method to identify molecules that interact with the EGFR pathway to allow or enhance responsiveness to EGFR inhibitors, as well as a plurality of polynucleotides or antibodies for detection of the expression of genes that are indicative of sensitivity or resistance to EGFR inhibitors, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitors. A method to identify a compound with the potential to enhance the efficacy of EGFR inhibitors is also described.

2008009, Apr 17, 2008

May 26, 2005

11/568760

Marileila Varella Garcia - Greenwood Village CO, US
Paul A. Bunn - Evergreen CO, US
Federico Cappuzzo - Bologna, IT
Wilbur A. Franklin - Denver CO, US
Fred R. Hirsch - Denver CO, US

THE REGENTS OF THE UNIVERSITY OF COLORADO - Boulder CO

C12Q 1/68, C12Q 1/00, G01N 33/483

435 6, 435 4, 435 405

Disclosed are biomarkers, methods and assay kits for the identification of cancer patients who are predicted to benefit, or not to benefit, from the therapeutic administration of an epidermal growth factor receptor (EGFR) inhibitor. The biomarkers of the present invention include detection of EGFR and HER 2 gene amplification and polysomy, EGFR protein expression, EGFR mutations, phosphorylated Akt protein expression, and various combinations of such biomarkers, as well as the combination of these biomarkers with mutations in the tyrosine kinase domain of the EGFR gene. Increased EGFR gene copy number, increased HER2 gene copy number, increased EGFR, protein expression, activated AKT protein expression (phosphorylated AKT) and EGFR mutations are all associated with better outcome for cancer patients treated with EGFR inhibitors. The invention provides a diagnostic paradigm based on each of these tests and combinations of these tests to select cancer patients who will benefit from EGFR inhibitor therapy, as well as a diagnostic paradigm to select cancer patients who will not benefit from EGFR inhibitor therapy.

8017321, Sep 13, 2011

Jan 24, 2005

10/587052

Christopher D. Coldren - Denver CO, US
Wilbur A. Franklin - Denver CO, US
Mark W. Geraci - Aurora CO, US
Barbara A. Helfrich - Lakewood CO, US
Fred R. Hirsch - Denver CO, US
Razvan Lapadat - Denver CO, US
Michio Sugita - Centennial CO, US
Samir E. Witta - Greenwood Village CO, US

The Regents of the University of Colorado, A Body Corporate - Denver CO

C12Q 1/68

435 6

Disclosed is the identification, provision and use of a panel of biomarkers that predict sensitivity or resistance to gefitinib and other EGFR inhibitors, and products and processes related thereto. Specifically, a method is described for selecting a cancer patient who is predicted to benefit from therapeutic administration of an EGFR inhibitor, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitor. Also described is a method to identify molecules that interact with the EGFR pathway to allow or enhance responsiveness to EGFR inhibitors, as well as a plurality of polynucleotides or antibodies for the detection of the expression of genes that are indicative of sensitivity or resistance to EGFR inhibitors, an agonist thereof, or a drug having substantially similar biological activity as EGFR inhibitors. A method to identify a compound with the potential to enhance the efficacy of EGFR inhibitors is also described.