Date: 2015-09-08
Type of information: Results
phase: 2
Announcement: results
Company: ImaginAb (USA - CA)
Product: 89Zr-Df-IAB2M
Action
mechanism: Imaging agent/radiopharmaceutical. 89Zr-Df-IAB2M is a radio-labelled antibody fragment (a “Minibody”) under clinical development as a diagnostic imaging agent for use with positron emission tomography/computed tomography (PET/CT) for detection of soft tissue and bone lesions in metastatic prostate cancer. 89Zr-Df-IAB2M targets prostate-specific membrane antigen (PSMA), a transmembrane protein highly expressed in the majority of prostate cancer, both localized and metastatic disease. PSMA has also been shown to be significantly overexpressed in response to androgen depletion, potentially enabling it to be used as a marker of response to anti-androgen therapy in patients with castrate-resistant disease. IAB2M is a hepatically-cleared imaging agent, meaning that there is no renal clearance and no bladder signal to obfuscate small lesions in the prostate bed. Ongoing clinical studies are evaluating the safety of the 89Zr-Df-IAB2M tracer and its ability to accurately determine the extent of disease in several distinct prostate cancer patient populations with unmet clinical need.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology - Technology - Services
Country:
Trial details:
Latest
news: * On September 8, 2015, ImaginAb has released interim results from a Phase 2 clinical trial of IAB2M, the company\'s proprietary imaging agent for management of prostate cancer, demonstrating superior performance in detecting disease compared with ProstaScint® and conventional imaging technologies including CT scans, MRI scans and bone scans. In addition, IAB2M accurately detected metastatic disease in normal-sized lymph nodes, overcoming a major limitation of existing technologies and addressing a key clinical need. The trial data were presented at the World Molecular Imaging Congress 2015 (Honolulu, HI). Results include the first nine of 20 patients in an ongoing, open-label, Phase 2, single-center trial. Patients received IAB2M intravenously prior to a whole-body PET scan. IAB2M detected disease in lymph nodes of 3 of 6 subjects, later confirmed positive for metastasis at surgery. This is in stark contrast to ProstaScint® and conventional imaging, which did not detect metastasis in lymph nodes in any of those subjects. ImaginAb\'s Prostate Imaging Phase I/IIa data will be presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, alongside pre-clinical CD3+ T-cell imaging data.
