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Oral nanoformulation for the treatment of BRAF inhibitor resistant melanoma

Award Number: SC2GM130478
ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2020
PERIOD OF PERFORMANCE END DATE: 11/30/2022

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Oral nanoformulation for the treatment of BRAF inhibitor resistant melanoma - Abstract Melanoma is the most aggressive and the deadliest form of skin cancer with very limited treatment options due to resistance to conventional chemotherapy. Discovery of BRAF mutation ( ~60 % of melanoma patients) and BRAF inhibitors in recent years proved to be breakthroughs in the field of melanoma cancer treatment. Unfortunately, patients developed drug resistance and eventually relapsed within an average of 7 months after vemurafenib (VF) therapy. Combination of BRAFi and MEKi is currently in clinical practice and show remarkable tumor response rate and prolong patient survival leading to a new era of melanoma therapy. But Off target toxicities and cross-resistance limits clinical potential of this approach. Consequently, there is a growing and urgent need to develop novel or alternative therapeutic approaches for the treatment of melanoma. Recently, researchers have developed a BET degrading molecules - BRD4 PROTAC (BPRO) (known as ARV-825), which selectively degrades BRD4 protein instead of mere inhibiting it. Bromodomain degraders or any other PROTAC molecules were never investigated on VF resistant melanoma cancer. Preliminary studies in our laboratory have revealed two very interesting findings; (1) We observed that BPRO is significantly more cytotoxic in VF resistant SK-MEL-28 and A375 compared to parent SK-MEL-28 and A375 and (2) BPRO remarkably reduced the IC50 of VF in both the cell lines. Considering the potential of BPRO - alone and in combination with VF in the treatment of BRAFi resistant melanoma, we decided to develop a translational oral nanoformulation co-loaded with VF and BPRO. The main goal of proposed investigation is to develop an orally bioavailable formulation of VF and BPRO for improved treatment of parent and BRAFi resistant melanoma cancer. To achieve this goal, we propose two specific aims; Specific aim 1. Optimization and characterization of formulation for permeability and oral bioavailability. Specific aim 2. In vivo anticancer efficacy study of optimized NANOVB in parent and BRAFi resistant melanoma tumor bearing mice.


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: 2023 ( Subtotal = -$398 )
2023	2021	ST JOHN'S UNIVERSITY, NEW YORK	8000 UTOPIA PWY	JAMAICA	NY	11439	QUEENS	USA	Biomedical Research and Research Training	000	2	2/7/2023	NON-COMPETING CONTINUATION	$0
2023	2021	ST JOHN'S UNIVERSITY, NEW YORK	8000 UTOPIA PWY	JAMAICA	NY	11439	QUEENS	USA	Biomedical Research and Research Training	001	2	8/8/2023	NON-COMPETING CONTINUATION	-$398
														Subtotal = -$398

Issue Date FY: 2021 ( Subtotal = $164,000 )
2021	2021	ST JOHN'S UNIVERSITY, NEW YORK	8000 UTOPIA PWY	JAMAICA	NY	11439	QUEENS	USA	Biomedical Research and Research Training	000	2	2/25/2021	NON-COMPETING CONTINUATION	$164,000
														Subtotal = $164,000

Issue Date FY: 2020 ( Subtotal = $164,000 )
2020	2020	ST JOHN'S UNIVERSITY, NEW YORK	8000 UTOPIA PWY	JAMAICA	NY	11439	QUEENS	USA	Biomedical Research and Research Training	000	1	3/11/2020	NEW	$164,000
														Subtotal = $164,000

Grand Total All Awards = $327,602

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Oral nanoformulation for the treatment of BRAF inhibitor resistant melanoma

Award Number: SC2GM130478

ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/15/2020

PERIOD OF PERFORMANCE END DATE: 11/30/2022

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