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Development of synthetic sphingolipids for prostate cancer therapy

Award Number: R44CA257568
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/24/2020
PERIOD OF PERFORMANCE END DATE: 12/31/2023

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Development of synthetic sphingolipids for prostate cancer therapy - PROJECT SUMMARY The objective of this project is to develop the synthetic sphingolipid SGE-893 (893) into an FDA-approved cancer therapy, with the ultimate goal of reducing mortality and morbidity rates in end-stage, drug-resistant prostate cancer. 893 shows promising pharmacological characteristics and potent anti-cancer activity in pre-clinical models while sparing normal tissues. 893 and related molecules have a novel mechanism of action, simultaneously engaging two validated oncology targets. This dual-target approach is deadly to cancer cells and predicted to reduce the risk of resistance. Despite its pleiotropic actions, 893 is well-tolerated by normal proliferating cells. Thus, 893 shows potential as a single-agent therapy that could produce a durable response even in hard-to-treat cancers like late-stage prostate, for which systemic chemotherapy remains the standard- of-care (SOC) and high recurrence and mortality rates are driven by resistance. As 893’s mechanism of action further suggests that it could sensitize drug-resistant tumors to FDA-approved agents, 893 may have additional clinical applications as a component of combination therapy. With key de-risking studies completed, we are proposing a Direct-to-Phase II approach. The objectives of Aim 1 are to extend the Target Product Profile by evaluating efficacy in combination with FDA-approved agents and to validate pharmacodynamics markers that can be used to measure target engagement in a phase 1 trial. Aim 2 proposes toxicology studies required for an IND application. The expected results would become part of a strong portfolio demonstrating acceptable toxicity to share with the FDA. Were it to be approved for patient use, this innovative molecule would become a first-in- class compound, offering hope and reducing mortality in PC patients whose tumors fail to respond to or become resistant to SOC.


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: 2024 ( Subtotal = $0 )
2024	2021	SIEGE PHARMACEUTICALS, INC.	5270 CALIFORNIA AVE STE 300	IRVINE	CA	92617	ORANGE	USA	Cancer Treatment Research	000	2	5/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	SIEGE PHARMACEUTICALS INC	5270 CALIFORNIA AVE	IRVINE	CA	92617	ORANGE	USA	Cancer Treatment Research	001	2	12/1/2022	NON-COMPETING CONTINUATION	$0
2023	2021	SIEGE PHARMACEUTICALS, INC.	5270 CALIFORNIA AVE STE 300	IRVINE	CA	92617	ORANGE	USA	Cancer Treatment Research	000	2	11/3/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $989,405 )
2021	2021	SIEGE PHARMACEUTICALS, INC.	5270 CALIFORNIA AVE STE 300	IRVINE	CA	92617	ORANGE	USA	Cancer Treatment Research	001	2	6/11/2021	NON-COMPETING CONTINUATION	$989,405
2021	2020	SIEGE PHARMACEUTICALS, INC.	5270 CALIFORNIA AVE STE 300	IRVINE	CA	92617	ORANGE	USA	Cancer Treatment Research	000	1	12/11/2020	NEW	$0
														Subtotal = $989,405

Issue Date FY: 2020 ( Subtotal = $1,008,833 )
2020	2020	SIEGE PHARMACEUTICALS, INC.	93 MURASAKI ST	IRVINE	CA	92617	ORANGE	USA	Cancer Treatment Research	000	1	9/24/2020	NEW	$1,008,833
														Subtotal = $1,008,833

Grand Total All Awards = $1,998,238

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Development of synthetic sphingolipids for prostate cancer therapy

Award Number: R44CA257568

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/24/2020

PERIOD OF PERFORMANCE END DATE: 12/31/2023

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