ImaginAb Partners with IBA Molecular for Clinical Supply of 89Zr Labeled Drug Product
IBA to Manufacture and Supply 89Zr-Df-IAB2M for Multi-Center Studies in the US
Los Angeles, CA and Dulles, VA – June 9, 2014 – ImaginAb, Inc. (ImaginAb) and IBA Molecular North America, Inc. (IBA Molecular) 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.
89Zr-Df-IAB2M is ImaginAb’s lead drug candidate, under 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 men with high risk prostate cancer. IAB2M is a monoclonal antibody fragment targeting prostate-specific membrane antigen (PSMA). PSMA is a highly promising target in prostate cancer, both because of its ubiquity and its potential as a pharmacodynamic marker of androgen depletion.
“This product has the potential to impact patient care by correctly assessing the extent of disease in several high-risk patient populations so that better clinical decisions can be made,” said Dr. Christian P. Behrenbruch, CEO of ImaginAb. “We are pleased to select IBA Molecular to provide centralized radiopharmaceutical manufacturing and supply of 89Zr-Df-IAB2M to our clinical trial sites. Their experience with biologics and longer half-life isotopes like 89Zr and 124I was central to our decision.”
“We are pleased to have been selected by ImaginAb to conduct the radiopharmaceutical manufacturing for this promising imaging agent” said Lee Karras, President of IBA Molecular North America. “IBA Molecular is well positioned for the supply of this clinical tracer through the combination of large-scale 89Zr isotope production at our Richmond, VA site and cGMP manufacturing and radiolabeling from our Somerset, NJ facility. Our innovative development and manufacturing platforms are helping bring new and potentially impactful diagnostic and therapeutic products to the market, with the ultimate goal of improving patient care.”
89Zr-Df-IAB2M is a radiolabelled antibody fragment (a “minibody”) under 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 89Zr-Df-IAB2M tracer and determine its ability to accurately determine the extent of disease in several distinct prostate cancer patient populations with unmet clinical need. This immunoPET tracer has not yet been submitted for approval by the US Food and Drug Administration for clinical use.
About IBA Molecular North America, Inc.
IBA Molecular North America, Inc. is part of IBA Molecular, a global developer, manufacturer and distributor of radiopharmaceutical products and supporting services used in molecular imaging. IBA Molecular has engineered a strong and unique product portfolio and pipeline of diagnostic and therapeutic tracers aimed at advancing the development of the global movement towards personalized medicine and making molecular imaging/therapy a major discipline in healthcare. The company also provides educational, technical and marketing support to medical specialists worldwide to help better respond to patient needs. Founded in 1986, IBA Molecular, with North American headquarters in Dulles, Virginia, is jointly owned by SK Capital Partners and Ion Beam Applications S.A. The company is a leading manufacturer and distributor of PET agents in North America, and PET and SPECT agents in Europe and Asia, with a network of 49 sites worldwide.
For more information, please visit www.ibamolecular.com.
ImaginAb, Inc. is redefining therapeutic management by harnessing the power of antibody technology for in vivo imaging. The company's proprietary antibody fragment platform yields actionable molecular information to guide treatment decisions in cancer and immunology. ImaginAb also collaborates with select biopharmaceutical partners to design imaging agents as companion diagnostics for therapeutic antibodies. ImaginAb's technology is positioned to deliver on the promise of precision medicine by improving patient outcomes and reducing the cost of healthcare. For more information, visit www.imaginab.com.
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MacDougall Biomedical Communications