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Predevelopment of VV2003, a Novel CRAC Channel Inhibitor, to Improve Outcomes Associated with Checkpoint Inhibitor Immunotherapy

Award Number: R44CA224454
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/02/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Predevelopment of VV2003, a Novel CRAC Channel Inhibitor, to Improve Outcomes Associated with Checkpoint Inhibitor Immunotherapy - Vivreon Biosciences, LLC NCI Phase 2 SBIR Submission 1R43CA224454-02 Project Summary Vivreon Biosciences is pleased to apply for NCI’s Phase 2 SBIR. Vivreon Biosciences is an innovative life sciences company that is developing a novel small molecule, Ca2+ channel inhibitor, VV2003, to improve outcomes in persons undergoing checkpoint inhibitor immunotherapy. Checkpoint inhibitors have improved overall survival in numerous cancers, but enterocolitis has emerged as the most frequent dose-limiting toxicity associated with these therapies. Checkpoint inhibitor induced colitis is currently treated with immunosuppressive therapy, which blunts the tumor-killing potential of the checkpoint inhibitor immunotherapy. VV2003 is an oral candidate therapeutic designed to selectively and safely block checkpoint inhibitor-induced enterocolitis without systemic immunosuppression side effects. Vivreon seeks NCI funding to bridge the gap between discovery and development. This grant aims to further validate VV2003 as a safe and effective candidate therapeutic by answering key questions regarding VV2003 pharmacokinetics and efficacy prior to advancing VV2003 into full Investigational New Drug (IND)-enabling studies and into first in human clinical evaluation. Upon successful completion of the program, our preclinical candidate will be the first to specifically inhibit Ca2+ release-activated Ca2+ (CRAC) channels for immunosuppression targeted specifically to sites of enterocolitis. Leukocyte CRAC channels facilitate Ca2+ influx, a process that is upstream of numerous enterocolitis disease-causing processes including leukocyte proliferation and inflammatory cytokine secretion. VV2003 has low systemic bioavailability and remains in the gut lumen following oral administration. This permits VV2003 to achieve colon-restricted immunosuppression, avoiding unwanted systemic side effects. We have developed several strategies to confirm that VV2003 can be used in combination with multiple checkpoint inhibitor immunotherapies, including in vitro and in vivo checkpoint inhibitor immunotherapy efficacy assays. The final aim for this proposal is characterization and testing of the first CRAC channel inhibitor to address enterocolitis associated with checkpoint immunotherapy.


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	VIVREON BIOSCIENCES LLC	4940 CARROLL CANYON RD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	2	12/21/2021	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	VIVREON BIOSCIENCES, LLC	4940 CARROLL CANYON RD STE 110	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	2	2/19/2021	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $474,506 )
2020	2020	VIVREON BIOSCIENCES, LLC	4940 CARROLL CANYON RD STE 110	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	2	4/29/2020	SUPPLEMENT FOR EXPANSION	$224,700
2020	2020	VIVREON BIOSCIENCES, LLC	4940 CARROLL CANYON RD STE 110	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	001	2	8/21/2020	SUPPLEMENT FOR EXPANSION	$249,806
														Subtotal = $474,506

Issue Date FY: 2019 ( Subtotal = $1,004,278 )
2019	2019	VIVREON BIOSCIENCES, LLC	7558 TRADE STREET	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Treatment Research	000	2	8/27/2019	COMPETING CONTINUATION	$1,004,278
														Subtotal = $1,004,278

Grand Total All Awards = $1,478,784

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Predevelopment of VV2003, a Novel CRAC Channel Inhibitor, to Improve Outcomes Associated with Checkpoint Inhibitor Immunotherapy

Award Number: R44CA224454

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/02/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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