[GRAND RAPIDS, Mich., May 9, 2023] — BAMF Health, a world leader in molecular imaging and theranostics, today announced activation of its site as a new site in a SOFIE sponsored trial, “A Phase 2, Multicenter, Single- Arm, Open-Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients with resectable or borderline resectable Pancreatic Ductal Carcinoma (PDAC),” NCT05262855. The study sponsor, SOFIE Biosciences, is leading the development of its highly valued intellectual property, FAPI family of compounds licensed from Heidelberg university, towards diagnostic and companion diagnostic approval. Together SOFIE and BAMF are launching this and future trials with incredible speed, reducing the time and cost required to bring new radiopharmaceutical diagnostics and therapeutics to patients.
“Pancreatic cancer is a notorious cancer that is commonly discovered late, and currently there is no effective treatment,” said Dr. Anthony Chang, PhD, founder and CEO of BAMF. “By leveraging the potential of novel targets for PET imaging and theranostics, we can significantly enhance our ability to catch the disease in earlier stages and to treat it effectively. This project shows BAMF is continuing to fulfill our commitment to push the boundaries of medicine with world-leading partners.”
“There is a lot of excitement in the field of Theranostics about Fibroblast Activation Protein Inhibitor (FAPI) as a class of novel radio-labeled small molecules, for its potential to diagnose at least 28 types of cancers and other diseases. We are thrilled to partner with SOFIE in this study offering FAPI-46 PET to pancreatic cancer patients,” said Dr. Harshad Kulkarni, MD, BAMF Principal Investigator for the FAPI-46 study and Chief Medical Advisor. “We recognize the urgency for pancreatic cancer patients and their care teams to access better tools to understand their cancer so that ultimately it can be better treated. We are hopeful that FAPI-46 PET imaging will be such a tool.”
BAMF Health began treating metastatic prostate cancer and neuroendocrine tumor (NET) patients with theranostics in August 2022. Their advanced radiopharmacy and clinical infrastructure were designed as a platform to serve companies like SOFIE and their patients by manufacturing radiopharmaceuticals and conducting clinical trials for a wide variety of diseases. “BAMF has attracted the attention of pharma companies with our infrastructure combined with unique expertise, dedication, and nimbleness. SOFIE is the first to experience the benefits of this dedicated platform and together we have lined up another clinical trial using a SOFIE pipeline product, expected to open at BAMF this summer,” said Matt DeLong, PharmD, BAMF Health VP of Radiopharmacy.
“SOFIE has been a great partner to test how swiftly we can move,” said Dan Rogers, MBA, CCRC, Clinical Trials Lead at BAMF. “We worked hand-in-hand with SOFIE from concept to opening the clinical trial in less than five months; that might take up to a year or longer at an academic medical center.”
“We are excited to add BAMF Health as our fourth [68Ga]FAPI-46 trial site in the US, which includes Mayo, UCLA, and NYU Langone,” said Dr. Sherly Mosessian, PhD, Chief Scientific Officer of SOFIE. “It has been a pleasure to combine our expertise with BAMF’s for the launch of this trial in Michigan and we are looking forward to further expanding this partnership to [18F]FAPI-74, NCT05641896. BAMF’s purpose-built clinical trials platform enables rapid technology transfer for radiopharmaceutical manufacturing, efficient study startup, and high quality of data simultaneously, which allows us to focus on our mission.”
By joining forces, BAMF Health and SOFIE Biosciences are providing a much-needed diagnostic opportunity for patients and ensure that they receive the highest quality of care at BAMF throughout the clinical-trial process. Additionally, physicians will have a trusted partner to refer their patients to, knowing that they will receive the best possible care.
More information about this study can be found at bamfhealth.com/clinical-trials/.
About BAMF Health:
BAMF Health leads the field in using molecular imaging and non-invasive molecular therapy 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/rectal, 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.
About SOFIE Biosciences:
SOFIE Biosciences is improving patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With a robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value radiopharmaceutical intellectual property, they are poised to deliver on the promise of radiopharmaceuticals.