FOR IMMEDIATE RELEASE
Contact: Dan Rogers
BAMF Health launches theranostics trial as world’s first site for patients with an advanced form of prostate cancer
Clarity Pharmaceuticals COMBAT Trial used BAMF RapAct program to launch in record time.
[GRAND RAPIDS, Mich., May 23, 2024] – BAMF Health, a world leader in molecular imaging and theranostics, announced activation as the first site in the world for a clinical trial sponsored by Clarity Pharmaceuticals titled, “A Phase I/II Theranostic Study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for Identification and Treatment of GRPR-expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617,” also known as the “COMBAT Trial,” (NCT05633160)1.
The American Cancer Society estimates nearly 288,300 new cases of prostate cancer will be diagnosed in the U.S. this year, and around 34,700 people will die because of the disease.2 BAMF Health is actively treating prostate cancer using theranostics at its Grand Rapids Clinic and has successfully administered hundreds of rounds of therapies since opening in August 2022. The activation of the COMBAT trial brings an additional option to patients, whose cancer would not be impacted by conventional and current theranostic treatment options.
Dr. Harshad Kulkarni, BAMF Health Chief Medical Advisor, said about the trial, “Presently, BAMF Health offers Pluvicto (177Lu-PSMA-617), an FDA-approved PSMA-targeted molecular radiotherapy using the Theranostics approach for patients with advanced prostate cancer whose lesions are ‘PSMA-positive.’ Unfortunately, we know from the VISION and TheraP trials, that 10-20% of patients will not be candidates for Pluvicto because their cancer has low or negative PSMA expression 3,4. Clarity’s 64Cu-SAR-BBN and 67Cu-SAR-BBN products target the Gastrin-Releasing Peptide receptor (GRPR), a different membrane protein that is expressed in up to 100% of prostate cancers.5,6,7,8,9”
“We are thrilled to open this trial and have a theranostics offering for patients where Pluvicto is not an option,” said Dr. Brandon Mancini, BAMF Health Medical Director and Site Principal Investigator for the COMBAT trial. Participation in the COMBAT trial is the second time that Clarity and BAMF Health have partnered in the fight against prostate cancer. The partnership began in early 2023 when BAMF Health launched the SABRE trial (NCT05407311)10, a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer. Dr. Mancini added, “Activation of the COMBAT trial complements the other advanced trials offered at BAMF Health. It is great to have an additional therapy option for patients available so rapidly.”
BAMF Health has built a unique, dedicated, radiopharmaceuticals Clinical Trials Platform that allows for industry-leading fast launches of clinical trials through its rapid activation program (BAMF RapAct). This enables partners the ability to open their trial to enrollment as soon as feasible. BAMF Health works with sponsors and nimble local partners, like University of Michigan Health-West, who mobilize quickly to provide needed clinical, laboratory and radiology services for participants.
For this Clarity COMBAT trial, activation took only seven weeks from initiation of the RapAct program.
Clarity’s Executive Chairman, Dr Alan Taylor, commented, “We are excited to initiate our first theranostic clinical trial of the SAR-BBN product at BAMF Health. Prostate cancer is Clarity’s key focus and an indication that continues to have a high unmet need. SAR-BBN is an exciting new prospect for better treating patients who are PSMA-negative or have low PSMA uptake and have few therapeutic options at present in the face of a devastating diagnosis. We look forward to progressing the COMBAT trial and building on the compelling data from our preclinical studies as well as from three diagnostic trials with SAR-BBN as we hope to confirm its safety and efficacy.”
“Radiopharmaceutical clinical trials are very complicated and include strict regulations for patient and public safety. At most centers around the world, it can take a year or more for a trial to start and unfortunately, many do not even have spare capacity.” said Dan Rogers, Clinical Trials Lead at BAMF Health. Rogers continued, “With the BAMF RapAct program, we can efficiently conduct more trials, tackle more diseases, and help more patients even faster.”
“We know theranostics has incredible potential to impact a wide variety of cancer, but we must have the right radiopharmaceuticals available. BAMF Health built a platform and trained a specialized team to enable clinical trials to be conducted safer and faster,” said Dr. Anthony Chang, Ph.D., founder and CEO of BAMF Health, “Our goal is to make life-saving drugs affordable and accessible to patients as soon as possible.”
BAMF Health leads the field in using molecular imaging and non-invasive molecular targeted radiotherapy to diagnose and effectively treat cancer. Currently, BAMF is treating stage 4 prostate and neuroendocrine cancer patients. Additionally, BAMF’s technology can provide advanced screening, staging and monitoring for cancers including prostate, breast, lung, colon/rectum, lymphoma, melanoma, multiple myeloma, brain and ovarian cancers. Ultimately, BAMF will apply its advanced technology and precision medicine platform to a wide range of cancers, neurodegenerative diseases, heart disease, endometriosis, chronic pain and other diseases and conditions.
If you or someone you love has cancer, BAMF Health can help. Visit www.bamfhealth.com/patients/ to learn more.
- gov NCT05633160, https://www.clinicaltrials.gov/ct2/show/NCT05633160
- American Cancer Society, Cancer Statistics Center, https://cancerstatisticscenter.cancer.org/?_ga=2.79808020.284532473.1620009137-1916069442.1615761164#!/cancer-site/Prostate
- Hofman, Michael S., et al. “[177Lu]Lu-PSMA-617 versus Cabazitaxel in Patients with Metastatic Castration-Resistant Prostate Cancer (TheraP): A Randomised, Open-Label, Phase 2 Trial.” The Lancet. 2021;(10276):797-804. doi:10.1016/s0140-6736(21)00237-3
- Sartor O, de Bono J, Chi KN, et al. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. New England Journal of Medicine. 2021;385(12):1091-1103. doi:10.1056/nejmoa2107322
- Markwalder R, Reubi JC. Gastrin-releasing peptide receptors in the human prostate: relation to neoplastic transformation. Cancer research. 1999;59(5):1152-1159.
- 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.
- 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.
- 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.
- 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.
- gov NCT05407311, https://www.clinicaltrials.gov/ct2/show/NCT05407311