By Jim Shrine
The joint venture between Immunomedics Inc. and Beckman Coulter Inc. got its first funding, allowing development of a cancer therapeutic to begin in earnest.
A group consisting of individuals and institutions invested about $2.45 million for a 7 percent stake in the venture, IBC Pharmaceuticals LLC, which was formed to develop a product combining a bi-specific antibody from Immunomedics with a targeting technology from Beckman Coulter.
¿It now has established the necessary funding to take it from basic research into preclinical and clinical development,¿ said Cynthia Sullivan, executive director at Immunomedics. ¿The vision now is to move this product into the clinic, and then the joint venture could continue with the bi-specific approach with other antibodies. But, right now, it is extremely focused [on one product].¿
Bi-Specific Product To Target Solid Tumors
The unnamed product will target solid tumors. The bi-specific part of it will include two binding sites, with the first attaching to the tumor and the second for a therapeutic agent injected afterward that would bind to the free arm of the bi-specific antibody. The targeting technology, called the Affinity Enhancement System, is designed to get more antibodies to the tumor site.
Immunomedics, of Morris Plains, N.J., owned 53 percent of the joint venture before the new investment. Beckman Coulter, of Fullerton, Calif., owned 47 percent. Their ownership positions were reduced proportionately.
Sullivan said the financing should get the joint venture through early clinical trials of the product. More money would be needed for Phase III testing and marketing, she said.
¿It probably will be at least a year before we¿re in either a pilot study or small Phase I/II clinical trial,¿ Sullivan said. ¿The [Affinity Enhancement System] has actually been in the clinic, just not with our antibody through their system.
¿We both believe this is truly a second-generation cancer therapy,¿ Sullivan said. ¿On our own we would not have been able to develop it as rapidly as we could through the joint venture.¿
Meanwhile, Immunomedics is awaiting decision from the FDA regarding its biologics license application for LeukoScan, an in vivo imaging agent for the detection and diagnosis of bone infection, as well as the diagnosis of acute, atypical appendicitis. That product is approved in Europe.
Immunomedics already is selling in Europe and the U.S. its in vivo imaging agent, CEA-Scan, which consists of a monoclonal antibody fragment against the cancer marker carcinoembryonic antigen (CEA), labeled with the isotope technetium-99.
Separately, Immunomedics is developing LymphoCide and CEA-Cide, two radiolabeled humanized antibodies that are in Phase I/II trials. n