Originally posted on LinkedIn by BAMF Health
Contact: Dan Rogers dan.rogers@bamfhealth.com 616-330-3886
Grand Rapids, Mich. – BAMF Health announces that it has commenced enrollment of participants in Clarity Pharmaceuticals SABRE Clinical Trial (NCT05407311). SABRE is a Phase II Positron Emission Tomography imaging trial of participants with prostate specific membrane antigen protein (PSMA)-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy. The primary objectives of the trial are to investigate the safety and tolerability of 64Cu-SAR-BBN as well as its ability to correctly detect recurrence of prostate cancer.
To best serve prostate cancer patients with a wide array of diagnoses, BAMF Health recognizes the need to provide as many patient-first resources as possible. BAMF Health began treating metastatic prostate cancer in August 2022 using the FDA approved imaging tracer, Illuccix (68Ga-PSMA-11) for use on their uExplorer Total Body PET-CT. BAMF also offers the FDA approved molecular targeted radiation therapy, Pluvicto (177Lu-PSMA-617). Shortly after opening, BAMF initiated its first clinical trial in late October, treating the first trial patient on December 6, 2022. Bringing the SABRE trial to patients at their flagship facility provides prostate cancer patients and their care team the opportunity to gain additional critical information in their fight to overcome this deadly disease.
The success of PSMA-targeted products—such as Illuccix for imaging, or Pluvicto for therapy—both depend upon cancer cells having the PSMA protein on their cell surface. Approximately 20% of prostate cancers with BCR are PSMA-PET negative1-4 and approximately 25% of mCRPC patients have low or no uptake of a PSMA-targeting tracer5. These patients are therefore unlikely to show uptake of PSMA-targeted imaging and therapy products, and currently have very limited radiopharmaceutical options available to them. Given that prostate cancer is one of the most common cancers, there is a significant unmet medical need. However, there is another cancer surface protein commonly on the surface of prostate and many other types of cancer cells: the Gastrin-Releasing Peptide Receptor (GRPR). GRPR protein levels are independent of PSMA and can be targeted by SAR-BBN. Therefore, this product (64Cu-SAR-BBN) could offer valuable imaging and therapeutic options for not only PSMA negative prostate cancer patients, but also the large number of patients with other cancers who have GRPR on their cancer cells.
“Our clinical care team is proud to offer this much needed imaging resource to the patients for which we do not have a clear picture of how their prostate cancer is evolving” said Dr. Brandon Mancini, MD, FACRO, BAMF Health Medical Director. “This might therefore be future potential for therapeutic impact for these patients, as they could be offered treatment using the copper-67 (Cu-67 or 67Cu) counterpart in case of metastases, like the current approach for PSMA-positive patients using the so-called “Theranostics Twins” Gallium-68 (Ga-68 or 68Ga) and Lutetium-177 (Lu-177 or 177Lu)”, added Dr. Harshad R. Kulkarni, MD, BAMF Health Chief Medical Advisor. “This is part of our ongoing effort to ensuring the most optimum and personalized care for patients across all stages and types of cancer.”
BAMF Health’s novel infrastructure, positioned at the crossroads of education, research, and patient care on the Medical Mile in Grand Rapids, Michigan allows for running multiple trials simultaneously. The team at BAMF Health, combined with their key partnerships and collaboration with the embracing local medical community, enables patient focused care across their platform. At present, BAMF is focused on expanding clinical trial portfolio to include offerings for any patient with prostate cancer and soon to other cancers.
“Hosting a wide variety of clinical trials gives patients options for them and their care team to better understand their disease or therapy options” said Dan Rogers, MBA, CCRC, Clinical Trials Lead at BAMF Health. “Our team has built the most advanced infrastructure in the world to partner with industry, academia, and health care partners to bring clinical trials to patients faster and more efficiently than ever before.”
For more information about this trial and others open at BAMF Health, please visit https://www.bamfhealth.com/clinical-trials/.
About BAMF Health:
BAMF Health is a health innovation company employing molecular imaging and non-invasive molecular therapy to pinpoint and effectively treat cancer and neurodegenerative diseases. Currently, BAMF is providing advanced screening, staging and monitoring for cancers including prostate, breast, lung, colon/rectal, lymphoma, melanoma, multiple myeloma, brain and ovarian. Additionally, BAMF is treating stage 4 prostate cancer patients and neuroendocrine cancer patients. Ultimately, BAMF will apply their advanced technology and precision medicine platform to diagnose and treat a wide range of cancers, neurodegenerative diseases, heart disease, endometriosis, chronic pain and other diseases and conditions.
The BAMF Health headquarters in Grand Rapids, Michigan, houses the most advanced dual cyclotron-equipped radiopharmacy, molecular imaging clinic, and non-invasive molecular treatment clinic in the world. When employing their technology and AI capabilities to the fullest in the years ahead, BAMF will be the first entity anywhere in the world to provide same-day onsite AI-based precision cancer diagnosis and treatment outside of a clinical trial setting. If you or a loved one has cancer, visit www.bamfhealth.com/patients to learn more.
About Clarity Pharmaceuticals
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.
www.claritypharmaceuticals.com
About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)6-10. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide11. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease12.
References
1. Afshar-Oromieh A, Holland-Letz T, Giesel FL, et al. Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) PET/ CT in patients with recurrent prostate cancer: evaluation in 1007 patients. Eur J Nucl Med Mol Imaging. 2017 Aug;44(8):1258-1268.
2. Ferraro DA, Rüschoff JH, Muehlematter UJ, et al. Immunohistochemical PSMA expression patterns of primary prostate cancer tissue are associated with the detection rate of biochemical recurrence with 68Ga-PSMA-11-PET. Theranostics. 2020;10(14):6082-6094.
3. Baratto L, Song H, Duan H, et al. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021;62(11):1545-1549.
4. Mapelli P, Ghezzo S, Samanes Gajate AM, et al. 68Ga-PSMA and 68Ga-DOTA-RM2 PET/MRI in Recurrent Prostate Cancer: Diagnostic Performance and Association with Clinical and Histopathological Data. Cancers (Basel). 2022;14(2):334.
5. Vlachostergios PJ, Niaz MJ, Sun M, et al. Prostate-Specific Membrane Antigen Uptake and Survival in Metastatic Castration-Resistant Prostate Cancer. Frontiers in oncology. 2021;11.
6. Markwalder R, Reubi JC. Gastrin-releasing peptide receptors in the human prostate: relation to neoplastic transformation. Cancer research. 1999;59(5):1152-1159.
7. Fleischmann A, Waser B, Reubi JC. High expression of gastrin-releasing peptide receptors in the vascular bed of urinary tract cancers: promising candidates for vascular targeting applications. Endocrine-related cancer. 2009;16(2):623-633.
8. Ananias HJ, van den Heuvel MC, Helfrich W, de Jong IJ. Expression of the gastrin-releasing peptide receptor, the prostate stem cell antigen and the prostate-specific membrane antigen in lymph node and bone metastases of prostate cancer. The Prostate. 2009;69(10):1101-1108.
9. Reubi JC, Wenger S, Schmuckli-Maurer J, Schaer JC, Gugger M. Bombesin receptor subtypes in human cancers: detection with the universal radioligand (125)I-[D-TYR(6), beta-ALA(11), PHE(13), NLE(14)] bombesin(6-14). Clin Cancer Res. 2002;8(4):1139-1146.
10. Sun B, Halmos G, Schally AV, Wang X, Martinez M. Presence of receptors for bombesin/gastrin-releasing peptide and mRNA for three receptor subtypes in human prostate cancers. The Prostate. 2000;42(4):295-303.
11. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries <https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660>
12. American Cancer Society, Cancer Statistics Center, <https://cancerstatisticscenter.cancer.org/?_ga=2.79808020.284532473.1620009137-1916069442.1615761164#!/cancer-site/Prostate>
