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Drug and energy dose-escalation study of SONALA-001 sonodynamic therapy in the treatment of diffuse intrinsic pontine glioma

Award Number: R01FD007538
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2022
PERIOD OF PERFORMANCE END DATE: 10/31/2024

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Drug and energy dose-escalation study of SONALA-001 sonodynamic therapy in the treatment of diffuse intrinsic pontine glioma - PROJECT SUMMARY Diffuse Intrinsic Pontine Gliomas (DIPG) are rare and deadly pediatric brain tumors. They are extremely aggressive tumors that are found in the pons, which controls many of the body's most vital functions such as breathing, blood pressure, and heart rate. There is no currently effective means of treatment for DIPG, and the median survival is 7-11 months after diagnosis. Thus, there is significant need for a method to effectively treat DIPG. To address this unmet need, SonALAsense is developing sonodynamic therapy (SDT), a non-invasive drug-device combination, to treat DIPG. SDT uses an MRI-Guided Focused Ultrasound (MRgFUS) device in combination with a drug called 5-aminolevulinic acid (ALA; SONALA-001). Three independent laboratories have demonstrated the safety and efficacy of ALA SDT in animal glioma models where the animals were dosed first with ALA and then treated with MRgFUS at energies that do not raise brain temperature. MRgFUS activated Protoporphyrin IX (PpIX), a metabolite of ALA, created singlet oxygen that induced necrosis and apoptosis in the glioma in a process similar to photodynamic therapy. Activation of PpIX non-invasively caused regression of the gliomas and extended survival. We also have data that support that ALA SDT is safe and well-tolerated in adult patients with recurrent glioblastoma multiforme, and leads to targeted oxidative stress and accompanying apoptosis in tumor tissue, in the absence of a thermal effect, similar to the animal model results. SONALA-001 is Orphan Drug designated for the treatment of all malignant gliomas and an Investigational New Drug (IND) application was cleared to proceed by the FDA. The goal of this R01 is to execute a Phase 2 clinical trial to provide safety and efficacy data for subsequent trials of ALA SDT in DIPG. As one of three clinical trial sites participating in this trial, the Ivy Brain Tumor Center will enroll 12 DIPG patients in up to 9 cohorts. This trial will be uncontrolled for ethical reasons. First, we will determine blood plasma PK of ALA metabolism and PpIX synthesis as this is the first intravenous (IV) formulation of ALA. Second, we will determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of MRgFUS energy combined with IV ALA. Third, we will determine safety and efficacy of ALA SDT by following patients for up to 12 months. Successful completion of this trial will identify a safe dose to proceed to the next stage of clinical development, in which DIPG patients will receive SDT therapy on a monthly basis to attempt to maximize effects on survival of these patients using a safe IV dose of ALA in combination with an optimal dose of MRgFUS. The goal of this development program is to obtain the clinical data necessary for FDA marketing approval and to commercialize this combination therapy for DIPG patients who have no therapeutic options. ALA SDT has the potential to be the first successful treatment for DIPG and for the first time in medical history parents of children with DIPG would not only have hope that the life of their child could be extended, but also the comfort that the combination therapy used is noninvasive and has extremely tolerable side effects.


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: 2025 ( Subtotal = $0 )
2025	2024	SONALASENSE, INC.	904 ALVARADO RD	BERKELEY	CA	94705	ALAMEDA	USA	Food and Drug Administration Research	000	2	4/9/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2024	SONALASENSE, INC.	1111 BROADWAY	OAKLAND	CA	94607	ALAMEDA	USA	Food and Drug Administration Research	000	2	7/23/2024	NON-COMPETING CONTINUATION	$488,085
2024	2024	SONALASENSE, INC.	1111 BROADWAY	OAKLAND	CA	94607	ALAMEDA	USA	Food and Drug Administration Research	003	2	9/4/2024	NON-COMPETING CONTINUATION	$0
2024	2024	SONALASENSE, INC.	1111 BROADWAY	OAKLAND	CA	94607	ALAMEDA	USA	Food and Drug Administration Research	002	2	8/21/2024	NON-COMPETING CONTINUATION	-$488,084
2024	2024	SONALASENSE, INC.	1111 BROADWAY	OAKLAND	CA	94607	ALAMEDA	USA	Food and Drug Administration Research	001	2	7/24/2024	NON-COMPETING CONTINUATION	-$1
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	SONALASENSE, INC.	1111 BROADWAY	OAKLAND	CA	94607	ALAMEDA	USA	Food and Drug Administration Research	000	1	7/19/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $477,006 )
2022	2022	SONALASENSE INC	2600 10TH ST STE 435	BERKELEY	CA	94710	ALAMEDA	USA	Food and Drug Administration Research	000	1	9/22/2022	NEW	$477,006
														Subtotal = $477,006

Grand Total All Awards = $477,006

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Drug and energy dose-escalation study of SONALA-001 sonodynamic therapy in the treatment of diffuse intrinsic pontine glioma

Award Number: R01FD007538

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/20/2022

PERIOD OF PERFORMANCE END DATE: 10/31/2024

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