This $644,622 federal Project Grant award from the National Cancer Institute (CFDA 93.395 - Cancer Treatment Research) aims to enhance radioligand therapy for prostate cancer through the development of biomarker and dosimetry-guided personalization approaches. The key products and services to be delivered under this grant include: 1) Developing a novel method for bone marrow dosimetry by coupling macro/micro Monte Carlo modeling with imaging data; 2) Building predictive models to estimate...
This $1,063,155 Project Grant award from the National Cancer Institute (CFDA 93.393 - Cancer Cause and Prevention Research) supports the development and clinical testing of a novel quality assurance (QA) device called the RetrieveTM. The goal is to create a more precise, efficient, and comprehensive QA solution for advanced radiation therapy techniques, such as intensity modulated radiation therapy (IMRT), image-guided radiation therapy (IGRT), stereotactic body radiation therapy (SBRT), and...
This Project Grant award from the National Cancer Institute (CFDA 93.395 - Cancer Treatment Research) provides funding to Tripill Biotechnology, Corp. to validate the therapeutic potential of a novel PSMA-targeted radiopharmaceutical agent called NOTA-UNC-PSMA2. The project aims to address the critical issue of high radiation exposure to normal organs, particularly the salivary glands, which can limit the administration of PSMA-targeted radiotherapies for prostate cancer. Specifically, the...
This federal Project Grant award from the National Cancer Institute (CFDA 93.395 - Cancer Treatment Research) provides $545,078 to The Johns Hopkins University to systematically evaluate the effect of prostate-specific membrane antigen (PSMA)-based radiopharmaceutical therapy (PSMA-RPT) on glutaminolysis in experimental models of prostate cancer (PC) and renal cell carcinoma (RCC). The research aims to determine how PSMA-RPT affects glutaminolysis, a critical metabolic pathway for cancer cell...
This Project Grant award from the National Cancer Institute (CFDA 93.394 - Cancer Detection and Diagnosis Research) supports the development of a novel theranostic (therapeutic and diagnostic) approach using chimeric antigen receptor (CAR) T-cell therapy for the treatment of neuroendocrine prostate cancer (NEPC). The key products and services being delivered under this $720,416 award include: Evaluating the therapeutic efficacy of DLL3-specific CAR-T cells in NEPC models and determining the DLL3...
This $393,401 Project Grant award from the National Cancer Institute (NCI) under the Cancer Treatment Research program (CFDA 93.395) aims to develop a PSMA-targeted small-molecule dual drug conjugate (SMDDC) as a new therapeutic strategy for metastatic castration-resistant prostate cancer (mCRPC) and other PSMA-positive malignancies. The key objectives are to: 1) assess the spatiotemporal cargo release of a PSMA-targeted SMDPC (small-molecule dual probe conjugate) with two distinct fluorescent...
This $538,553 Project Grant award from the National Cancer Institute (CFDA 93.394 - Cancer Detection and Diagnosis Research) will fund a longitudinal study to investigate the use of quantitative multiparametric MRI (mpMRI) features and circulating tumor cells (CTCs) as early markers of patient outcomes after radiation therapy (RT) and androgen deprivation therapy (ADT) in prostate cancer patients. The University of Miami will lead this research, which aims to develop a multivariable model that...
This Project Grant award from the National Cancer Institute's Cancer Treatment Research program (CFDA 93.395) supports a Phase 1 clinical trial to assess the safety, tolerability, and anti-tumor activity of the novel ACK1 inhibitor (R)-9B in patients with castration-resistant prostate cancer (CRPC). The total funding amount is $1,304,828 for the project period from August 15, 2024 to July 31, 2029. The key products and services to be delivered under this grant include: 1) Evaluating the safety...
This $636,289 Project Grant award from the National Cancer Institute's Cancer Treatment Research program (CFDA 93.395) supports research by Duke University to develop a novel gene therapy approach for treating metastatic castration-resistant prostate cancer (mCRPC). The key objectives are to: Uncover the molecular and genomic mechanisms by which the transcription factor HOXB13 drives oncogenic transcription and metastasis in mCRPC. Assess the therapeutic efficacy, safety, and molecular impact of...
The U.S. National Cancer Institute (NCI) awarded a $234,889 Project Grant under the Cancer Treatment Research program (CFDA 93.395) to the University of Louisville. The objective of this 2-year grant, awarded from June 2025 to May 2027, is to develop a novel immunotherapy regimen for prostate cancer. The research aims to determine how the hypomethylating agent guadecitabine (GDEC) can augment antigen presentation and increase susceptibility of prostate cancer cells to CD8+ T cell-mediated immune...
RADIO-IMMUNOTHERAPY DOSE-PAINTING (RAID) TREATMENT FOR HORMONAL RESISTANT PROSTATE CANCER - ABSTRACT PROSTATE CANCER, RATHER INDOLENT BY NATURE, HAS SPECIFIC SUBTYPES PRESENT WITH AGGRESSIVE LOCOREGIONAL DISEASE THAT ARE QUICKLY BECOMING HORMONAL RESISTANT. PATIENTS WITH CASTRATE-RESISTANT DISEASE (CRPC) ARE GENERALLY YOUNGER AND NON-CAUCASIAN, AND MANY SUFFER FROM LOCAL PROGRESSION, EDEMA, AND PAIN. RADIOTHERAPY (RT) IS OFFERED BUT LIMITED BY THE EXTENT, FORMER EXPOSURE, AND RESISTANCE OF DISEASE. SEQUENTIAL MULTIPLE CHEMOTHERAPY OR RT TREATMENTS, OFFERED AS STANDARD OF CARE, ARE HARD TO COMPLY TO, ESPECIALLY IN LOW-RESOURCE POPULATIONS. TREATMENT OF THIS SYMPTOMATIC POPULATION IS OFTEN TERMINATED PREMATURELY, OR NEVER STARTED, DUE TO FINANCIAL AND TIME RESTRICTIONS. INNOVATIVE, SHORTER MORE EFFICIENT TREATMENTS ARE NEEDED, ESPECIALLY TO REDUCE DISPARITIES IN COMPLIANCE AND OUTCOMES OF GLOBAL CANCER CARE. IN EXTENSIVE PRECLINICAL WORK, THE COMBINATION OF RT WITH IMMUNOGENIC SMART RADIOTHERAPY MATERIALS (ISRBS), ADDRESSED AS RADIO-IMMUNOTHERAPY DOSE-PAINTING (RAID) TECHNOLOGY, BRINGS INTRA-TUMORAL SLOW-RELEASE ANTICD40 PAYLOAD IN THE TARGET THAT GETS IRRADIATED AND HAS SHOWN TO PRIME THE IMMUNE SYSTEM AND CREATE SUSTAINABLE TUMOR CONTROL BY IN SITU-VACCINATION, EVEN AFTER DIFFERENT THERAPEUTIC OPTIONS HAVE FAILED. MOREOVER, THIS COMBINATION TREATMENT CAN IMPROVE QUALITY OF LIFE (QOL) FAST BY A SHORT SIMPLE INTERVENTION WITH FEWER SIDE EFFECTS, HAVING AN ANTICD40 PAYLOAD FAR SMALLER THAN NEEDED IN INTRAVENOUS (IV) IMMUNOTHERAPY. THE OVERALL GOAL OF THIS PROJECT - PROPOSED BY NANOCAN THERAPEUTICS CORPORATION IN COLLABORATION WITH JOHN HOPKINS MEDICINE, DANA-FARBER CANCER INSTITUTE AND NORTHWELL HEALTH - IS TO BRIDGE PRECLINICAL WORK TO THE FIRST CLINICAL TRIAL WITH THE INNOVATIVE RAID TECHNOLOGY AND CONFIRM ITS POTENTIAL FOR IN SITU-VACCINATION THAT CAN EXTEND THE USE OF RADIOTHERAPY (RT) FROM PALLIATIVE LOCAL TREATMENT TO SYSTEMIC DISEASE CONTROL IN ONE SESSION. THE ISRBS ARE AS SEED-LIKE FIDUCIAL MARKERS ADMINISTERED DIRECTLY IN THE PROSTATE TUMOR BY ULTRASOUND GUIDED NEEDLES. THE ISRBS CREATE CONTRAST ON CT AND KV IMAGING MAKING RT SET-UP FAST; ISRBS SLOWLY RELEASE (20MCG PER UNIT OVER 15 DAYS) ANTI-CD40 PAYLOAD DIRECTLY THE TARGET WHICH GETS IRRADIATED, TRIGGERING IN SITU-VACCINATION. THE PURPOSE OF THIS PROJECT IS TO TRANSLATE EXTENSIVE SAFETY AND EFFICACY DATA FROM SMALL ANIMAL STUDIES OF SINGLE FRACTION RT COMBINED WITH SLOW RELEASED INTRA-TUMORAL ANTICD40 DELIVERY TO A FIRST HUMAN TRIAL FOR CRPC PATIENTS. THE FIRST PART WILL BE USED TO OPTIMIZE ISRBS INTO A CGMP PRODUCT, AND CONFIRMATION OF LARGER VOLUME TESTING IN MONKEYS TO CONFIRM SAFETY, IMMUNOGENICITY, AND PHARMACOKINETICS ALREADY PERFORMED IN EXTENSIVE SMALL ANIMAL WORK. MILESTONES WILL COMPLETE IND FILLING BY NANOCAN THERAPEUTICS. AFTER FDA APPROVAL, SECOND PART OF THE PROJECT WILL ENCOMPASS THE PHASE 1 SINGLE ARM OPEN LABEL CLINICAL TRIAL SEEKING CONFIRMATION OF SAFETY AND NUMBER OF ISRBS AS WELL AS RT DOSE NEEDED IN CRPR PATIENTS. THIS PROJECT CAN PROVIDE ALL NEEDED DATA FOR PLANNED PHASE II CLINICAL WORK IN AIMS OFFERING A NOVEL TREATMENT PARADIGM FOR CRPR PATIENTS.