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Bastyr/UW Oncomycology Translational Research Center

Award Number: U19AT006028
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/29/2010
PERIOD OF PERFORMANCE END DATE: 08/31/2015

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Bastyr/UW Oncomycology Translational Research Center - DESCRIPTION (provided by applicant): Purpose: To assess the effects of combining the TLR agonist activity of PSK to HER-2/neu (HER2) directed monoclonel antibody therapy using a HER2 specific vaccine for the treatment of patients with advanced stage breast cancer. We will conduct pre-clinical gene-signature biomarker work in year 1 and 2 then conduct a placebo-controlled phase II randomized controlled clinical trial in years 3 and 4. Hypothesis: PSK, when added to a HER2 vaccine will improve immune response and Survival in women with advanced HER2 overexpressing breast cancer. Methods: 1) Determine whether PSK administered concurrently with HER2-targeted vaccine can enhance tumor antigen-specific immune response and prevent or delay disease progression in neu-transgenic mice; 2) Identify a gene signature that predicts clinical response in neu-transgenic mice receiving PSK, trastuzumab, and a HER2-tergeted vaccine; and 3) Determine the safety and immunogenicity of PSK as a component of combination immunotherapy in patients with advanced stage (stage IV) breast cancer. Clinical Trial Design: 30 women with advenced HER-2/neu overexpressing breast cancer who receive trastuzumab + HER2 peptide vaccine therapy will be randomized to receive PSK or placebo orally (3000 mg/day) concomitant with vaccine therapy. Primary endpoints will be intermolecular epitope spreading, changes in TGF-b serum levels and peripheral blood biomarkers identified in neu-transgenic mice as predictive of clinical response in breast cancer patients receiving HER2 ICD vaccine.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2014 ( Subtotal = $784 )
2014	2013	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	4	3/10/2014	NON-COMPETING CONTINUATION	$784
														Subtotal = $784

Issue Date FY: 2013 ( Subtotal = $300,784 )
2013	2013	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	4	9/12/2013	NON-COMPETING CONTINUATION	$300,000
2013	2013	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	001	4	3/10/2014	NON-COMPETING CONTINUATION	$784
														Subtotal = $300,784

Issue Date FY: 2012 ( Subtotal = $1,349,565 )
2012	2012	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	001	3	9/13/2012	NON-COMPETING CONTINUATION	$1,207,565
2012	2012	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	2	6/14/2012	SUPPLEMENT FOR EXPANSION	$142,000
														Subtotal = $1,349,565

Issue Date FY: 2011 ( Subtotal = $1,241,098 )
2011	2011	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	001	2	8/30/2011	SUPPLEMENT FOR EXPANSION	$134,898
2011	2011	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	2	8/26/2011	NON-COMPETING CONTINUATION	$1,106,200
														Subtotal = $1,241,098

Issue Date FY: 2010 ( Subtotal = $1,147,443 )
2010	2010	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	1	9/23/2010	NEW	$1,147,443
														Subtotal = $1,147,443

Grand Total All Awards = $4,039,674

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Bastyr/UW Oncomycology Translational Research Center

Award Number: U19AT006028

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/29/2010

PERIOD OF PERFORMANCE END DATE: 08/31/2015

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