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Bringing 4π radiation therapy to the clinic

Award Number: R44CA183390
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/06/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2025

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Bringing 4π radiation therapy to the clinic - Significance/Innovation: Utilizing non-coplanar beams in radiotherapy can significantly improve dosimetry for better normal organ sparing and tumor targeting. However, the optimality of such therapy requires extensive and efficient utilization of non-coplanar beams that are incompatible with existing radiotherapy platforms. The widely available C-arm gantry systems are collision prone, cumbersome, and require undesirable patient couch motion to achieve the non-coplanar angles. The existing robotic system lacks posterior beams and a planning system to integrally optimize beam orientation and fluence, making it extremely limited in achievable dosimetry, target sizes, applicable disease sites, and throughput. Motivated by these clinical and market needs UCLA and RadiaBeam are developing a new robotic radiotherapy platform called Polaris that overcomes the limitations of existing radiotherapy systems, with the following innovative advantages: 1. A super compact 6MV linear accelerator enables unobstructed access to 4π solid angle, including posterior beams. 2. A mathematical framework for integrated beam orientation, source-to-tumor distance, and fluence map optimization, which can efficiently create substantially better plans than the clinical state-of-the-art. 3. A 3D image guidance system will be implemented for the first time on a robotic radiotherapy system without impeding the degrees of freedom in non-coplanar delivery. 4. The combination of hardware and software allows superior dosimetry to be efficiently delivered to targets of all sizes, making our system a superior replacement of all C-arm gantry systems and the existing robotic radiotherapy system as a general-purpose radiotherapy machine. During the SBIR project (NIH Phase II 5R44CA183390-04), Celestial Oncology Inc. was founded to bring the Polaris system to market, and received a $6M series A investment in 2020. This NIH SBIR Phase IIB bridge project will accelerate the completion of the last technical, regulatory, and clinical steps required to bring this life-saving therapy to the clinic. We propose the following aims: Aims: 1a: Mechanically synchronize the X-ray source and detector robots. 1b. Collect projections for circular and helical trajectories for CBCT reconstruction. 1c. Integrate the imaging component for end-to-end IGRT accuracy validation. 2a. Complete the design, manufacturing, verification, and validation of the clinical system. 2b. Submit for US market clearance. 2c. Establish and certify a Quality Management System. 3a. Installation and acceptance tests of the 4π radiotherapy system at UCLA. 3b. Early phase clinical study. Impact: Polaris will serve as a superior replacement of all general-purpose machines with advantages in dose conformity, automation, and throughput. These advantages will drive rapid adoption. The success of this project will clear the last hurdles between the current level of technical development and what is needed to be commercially and clinically ready.


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 = $1,579,292 )
2024	2024	CELESTIAL ONCOLOGY INC.	1735 STEWART ST	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	7	5/20/2024	NON-COMPETING CONTINUATION	$1,579,292
														Subtotal = $1,579,292

Issue Date FY: 2023 ( Subtotal = $1,199,674 )
2023	2023	CELESTIAL ONCOLOGY INC	1735 STEWART ST	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	6	4/25/2023	NON-COMPETING CONTINUATION	$1,199,674
														Subtotal = $1,199,674

Issue Date FY: 2022 ( Subtotal = $1,132,278 )
2022	2022	CELESTIAL ONCOLOGY INC.	1735 STEWART ST STE A	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	000	5	5/6/2022	COMPETING CONTINUATION	$1,132,278
2022	2022	CELESTIAL ONCOLOGY INC.	1735 STEWART ST STE A	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Treatment Research	001	5	5/12/2022	COMPETING CONTINUATION	$0
														Subtotal = $1,132,278

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	RADIABEAM TECHNOLOGIES, LLC	1717 STEWART ST	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Cause and Prevention Research	000	4	9/20/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $432,270 )
2019	2019	RADIABEAM TECHNOLOGIES, LLC	1717 STEWART ST	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Cause and Prevention Research	000	4	3/12/2019	NON-COMPETING CONTINUATION	$432,270
														Subtotal = $432,270

Issue Date FY: 2018 ( Subtotal = $753,117 )
2018	2018	RADIABEAM TECHNOLOGIES, LLC	1717 STEWART ST	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Cause and Prevention Research	001	3	5/17/2018	NON-COMPETING CONTINUATION	$3,090
2018	2018	RADIABEAM TECHNOLOGIES, LLC	1717 STEWART ST	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Cause and Prevention Research	000	3	3/22/2018	NON-COMPETING CONTINUATION	$750,027
														Subtotal = $753,117

Issue Date FY: 2017 ( Subtotal = $750,390 )
2017	2017	RADIABEAM TECHNOLOGIES, LLC	1717 STEWART ST	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Cause and Prevention Research	001	2	7/31/2017	COMPETING CONTINUATION	$0
2017	2017	RADIABEAM TECHNOLOGIES, LLC	1717 STEWART ST	SANTA MONICA	CA	90404	LOS ANGELES	USA	Cancer Cause and Prevention Research	000	2	3/22/2017	COMPETING CONTINUATION	$750,390
														Subtotal = $750,390

Grand Total All Awards = $5,847,021

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Bringing 4π radiation therapy to the clinic

Award Number: R44CA183390

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/06/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2025

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