IBA to develop, distribute PSMA PET/CT agent for ImaginAb
ImaginAb announced earlier this month that IBA Molecular will be taking on radiochemistry, manufacturing and distribution of the diagnostic immunoPET agent for prostate cancer, Zr-89 Df-IAB2M, as U.S. clinical trials roll out.
The development and distribution of Zr-89 Df-IAB2M will be happening out of IBA’s Richmond, Va., and Somerset, N.J., radiopharmaceutical facilities.
"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 Christian P. Behrenbruch, MBA, PhD, CEO of ImaginAb, in a press release. "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 Zr-89 and I-124 was central to our decision."
Zr-89 Df-IAB2M is ImaginAb’s banner PET/CT radiotracer candidate and is comprised of a radio-cc antibody fragment—what the company calls a "Minibody." This drug candidate is currently being evaluated for the detection of metastatic prostate cancer in soft tissue and bone. The IAB2M monoclonal antibody fragment seeks out prostate-specific membrane antigen (PSMA), which the company says could be ideal as a biomarker for androgen depletion.
"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 in the release. "IBA Molecular is well positioned for the supply of this clinical tracer through the combination of large-scale Zr-89 isotope production at our Richmond, Va. site and [good current manufacturing practices] and radiolabeling from our Somerset, N.J. 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."