Date: 2014-06-09
Type of information: Production agreement
Compound: 89Zr-Df-IAB2M
Company: ImaginAb (USA - CA) IBA Molecular (Belgium)
Therapeutic area: Cancer - Oncology - Technology - Services
Type agreement: manufacturing production
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
Details: * On June 9, 2014, ImaginAb and IBA Molecular North America announced that IBA Molecular has been selected to provide radiochemistry manufacturing and clinical distribution of 89Zr-Df-IAB2M, an immunoPET tracer for imaging prostate cancer, to support multi-center clinical studies in the US. IBA Molecular will manufacture 89Zr-Df-IAB2M under US FDA cGMPs and will supply the required doses to select clinical sites. The company’s radiopharmaceutical development and manufacturing sites in Richmond, VA and Somerset, NJ will be utilized for this project.
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