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Novel MAP Kinase Pathway Inhibitors to Treat Pancreatic Ductal AdenoCarcinoma

Award Number: R44CA206663
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/03/2016
PERIOD OF PERFORMANCE END DATE: 05/31/2021

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Novel MAP Kinase Pathway Inhibitors to Treat Pancreatic Ductal AdenoCarcinoma - DESCRIPTION (provided by applicant): Patients diagnosed with advanced pancreatic ductal adenocarcinoma (PDAC) have a 5 year survival rate of less than 5%. These tumors have the highest reported incidence of KRAS mutations among all human cancers. Because of these observations, there has been considerable interest in developing direct inhibitors of RAS mutants such as KRAS. However, attempts to directly inhibit KRAS have to date been unsuccessful. An alternative approach is to target downstream effectors of KRAS on the MAPK pathway. Extracellular Regulated Kinase 1 and 2 (ERK 1/2) are serine-threonine protein kinases which are downstream components of the RAS/RAF/MEK signal transduction pathway. Aberrant activation of ERK has been demonstrated in many human tumors, including pancreatic cancer. ERK inhibitors could prove very useful as therapies to treat tumors with RAS mutations such as PDAC. This proposal aims to determine the potential of Kalyra's novel ERK inhibitors as treatments for PDAC via the following aims. Phase 1: Characterization of Novels Leads in Models of Pancreatic Cancer Aim 1. Evaluate 10 lead molecules in preliminary in vitro ADME and Plasma Protein Binding studies. Aim 2. Confirm efficacy of 5 lead molecules vs. a panel of human RAS mutant pancreatic cancer cell lines. Aim 3. Determine PK and in vivo efficacy of top 3 leads in an in vivo model of KRAS pancreatic cancer. Phase II: Additional studies to enable selection of a Development Candidate Aim 1. Characterize the effects of lead ERK inhibitors in combination studies Aim 2. ADME and Preliminary Toxicology Aim 3. Pharmcokinetics for Species Selection for Toxicology and Pilot Toxicology After completion of the studies outlined in this proposal, we will have selected a drug candidate to enter IND enabling;toxicology studies in support of filing an IND with the FDA to begin human clinical trials for the development of a novel effective treatment for pancreatic ductal adenocarcinoma.


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: 2022 ( Subtotal = $0 )
2022	2019	ZENO MANAGEMENT, INC.	10275 SCIENCE CENTER DR STE 200	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	4	11/4/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2018	KALYRA PHARMACEUTICALS, INC.	10835 ROAD TO THE CURE STE 205	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	2	7/12/2021	EXTENSION WITH OR WITHOUT FUNDS	-$4,076
2021	2018	ZENO MANAGEMENT, INC.	10275 SCIENCE CENTER DR STE 200	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	001	3	7/12/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$4,076
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	ZENO MANAGEMENT, INC.	10835 ROAD TO THE CURE STE 205	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	4	3/25/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $856,578 )
2019	2019	ZENO MANAGEMENT, INC.	10835 ROAD TO THE CURE STE 205	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	003	4	5/31/2019	NON-COMPETING CONTINUATION	$856,578
2019	2018	ZENO MANAGEMENT, INC	10835 ROAD TO THE CURE STE 205	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	001	3	11/14/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,060,799
2019	2018	KALYRA PHARMACEUTICALS, INC.	10835 ROAD TO THE CURE STE 205	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	2	11/14/2018	EXTENSION WITH OR WITHOUT FUNDS	-$1,060,799
2019	2018	KALYRA PHARMACEUTICALS, INC.	10835 ROAD TO THE CURE STE 205	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	002	2	2/7/2019	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $856,578

Issue Date FY: 2018 ( Subtotal = $1,139,689 )
2018	2018	KALYRA PHARMACEUTICALS, INC.	10835 ROAD TO THE CURE STE 205	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	001	2	6/1/2018	EXTENSION WITH OR WITHOUT FUNDS	$1,139,689
2018	2016	KALYRA PHARMACEUTICALS, INC.	10835 ROAD TO THE CURE STE 205	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	1	4/18/2018	NEW	$0
														Subtotal = $1,139,689

Issue Date FY: 2016 ( Subtotal = $297,555 )
2016	2016	KALYRA PHARMACEUTICALS, INC.	6181 CORNERSTONE CT STE 106	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	1	6/3/2016	NEW	$297,555
														Subtotal = $297,555

Grand Total All Awards = $2,293,822

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Novel MAP Kinase Pathway Inhibitors to Treat Pancreatic Ductal AdenoCarcinoma

Award Number: R44CA206663

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/03/2016

PERIOD OF PERFORMANCE END DATE: 05/31/2021

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