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Development of personalized ex vivo predictive technology for rapidly matching patient tumors with chemotherapy regimens before treatment.

Award Number: R43CA254493
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Development of personalized ex vivo predictive technology for rapidly matching patient tumors with chemotherapy regimens before treatment. - Project Summary/Abstract Pancreatic ductal adenocarcinoma (PDAC) is among the deadliest cancers with <9% five-year survival rate and an estimated 60,000 deaths/year by 2030. PDAC is often diagnosed at an advanced stage thereby precluding surgical resection for most patients. While new systemic therapy regimens have improved survival, availability of multiple options, without tools to select an optimal regimen from these (on an individualized basis), has created a frustrating paradox in clinical decision-making. Due to a lack of personalized predictive tools, current standard of care treatment strategy is based on prognostic factors such as age, stage, performance status, serum albumin, etc. There is a critical, urgent and unmet need to develop predictive tools that can identify optimal systemic therapy regimens and eliminate from consideration ineffective options, on an individualized basis, to improve quality of life and reduce overtreatment. CerFlux, Inc. is developing such predictive technology with its low-cost and rapid Personalized Oncology Efficacy Test (POET) to match each patient with the right treatment – before treatment – to transform pancreatic cancer treatment in the near-term and make a difference in the lives of patients and providers around the world. Our personalized medicine approach is unique and further enhanced by a commercial-academic collaboration between CerFlux, Inc. and the O’Neil Comprehensive Cancer Center at the University of Alabama at Birmingham. The proposed project will build on recent work by our team including a patented (US 10,114,010B1) biomimetic in vitro platform for pharmacological transport and pancreatic microtissue tumor models. The commercial goal of this proposal is to identify best practices for using POET in personalized therapy. Our hypothesis is that response to treatment observed in POET will approximate the response in the corresponding patient. Our objective is to predict both effective and ineffective treatments for each patient prior to initiating treatment. We propose the following aims to achieve our objective: Aim 1: Calibrate and optimize POET for evaluating therapeutics using human PDAC cell-line xenografts for subsequent testing with patient tissue. Aim 2: Evaluate efficacy of various systemic therapy agents in POET on an individualized basis to establish protocols and best practices for using POET in personalized therapy. We envision substantial continuing commercial-academic collaboration between CerFlux, Inc. and the O’Neil Comprehensive Cancer Center at the University of Alabama at Birmingham including the integration of machine learning to derive a “POET Score” – a personalized quantitative efficacy score – based on a combination of factors. Data from POET and the POET Score will help clinical teams rank treatments for individual patients before the first drug infusion. If successful, this SBIR-driven study has the potential to transform pancreatic cancer treatment in the near-term and make a positive impact around the world.


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	2020	CERFLUX INC	215 RICHARD ARRINGTON JR BLVD N	BIRMINGHAM	AL	35203	JEFFERSON	USA	Cancer Treatment Research	000	1	12/17/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $52,000 )
2021	2021	CERFLUX, INC.	2140 11TH AVE S STE 308	BIRMINGHAM	AL	35205	JEFFERSON	USA	Cancer Treatment Research	000	1	5/24/2021	SUPPLEMENT FOR EXPANSION	$52,000
														Subtotal = $52,000

Issue Date FY: 2020 ( Subtotal = $249,148 )
2020	2020	CERFLUX, INC.	2140 11TH AVE S STE 308	BIRMINGHAM	AL	35205	JEFFERSON	USA	Cancer Treatment Research	000	1	9/10/2020	NEW	$249,148
														Subtotal = $249,148

Grand Total All Awards = $301,148

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Development of personalized ex vivo predictive technology for rapidly matching patient tumors with chemotherapy regimens before treatment.

Award Number: R43CA254493

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/10/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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