Radimmune Therapeutics has selected Goodwin Biotechnology to develop a process and manufacture it’s lead therapeutic oncology candidate for clinical development, a therapeutic grade IgG monoclonal antibody (mAb) conjugate. The conjugate will be radiolabeled with 213Bi and administered to patients in a Phase I clinical study for the treatment of melanoma.
 
“Melanoma is by far the deadliest form of skin cancer,” said Robert Wittig, chief operating officer, Radimmune Therapeutics. “Globally, there are approximately 3.1 million individuals with active disease and nearly 60,000 deaths annually. The rising incidence of melanoma of 170,000 new cases diagnosed each year is expected to accelerate the demand for anticancer agents.” 
 
RadImmune Therapeutics has developed a novel therapeutic approach leveraging its mAb platform as a radioimmunotherapeutic (RIT) agent. This cancer treatment modality utilizes mAbs chemically linked to a radioactive atom (radionuclide), and targeted against a specific antigen in the melanoma cancer cell microenvironment. RadImmune’s treatment is infused, and then binds to the target antigen resulting in systemic administration of focused therapeutic radiation to tumor cells, while sparing normal tissues from the toxic effects of radiation.
 
“One of the most exciting recent advances in Molecular Targeted Radiotherapy has been in the area of Alpha Emitting Radioimmunotherapy,” said David Rickles, chief scientific officer, Radimmune Therapeutics. “Alpha emitting radionuclides can be linked to custom mAbs via a chelator, and then targeted to highly cancer specific antigens for a new, potentially more effective approach to RIT, a form of Molecular Targeted Radiotherapy. The relative biologic effectiveness (RBE) is the standard measure of cytotoxic potency for therapeutic radiation. Remarkably, alpha rays have an RBE 20 times that of any of the other types of radiation therapy (beta, gamma, X-ray photons, and proton beam). Another attractive feature of alpha rays is their extremely short path length in tissue of about 50 microns, or 5 cells diameter. An alpha emitting, cancer specific, targeted drug could therefore offer true micro precision, in terms of normal tissue sparing. By potentially combining very low toxicity with high potency; Alpha emitting RIT holds great promise for future development.”
 
“We selected Goodwin Biotechnology for this important project based in part on experience working with them on similar projects over a number of years, coupled with impressive references from clients for whom they have recently performed high quality work,” said Mr. Wittig. “Being a smaller company, we found them to be flexible in their approach and a very good fit for RadImmune. They transparently develop sound process development, manufacturing, and product characterization strategies, and have a long history of overcoming challenges while maintaining a rapid development timeline.”
 
Karl Pinto, chief executive officer, Goodwin Biotechnology, said, “We’re excited about the opportunity to partner with Radimmune Therapeutics to advance the treatment of melanoma. Our highly skilled scientific staff takes great pride in delivering the highest quality product on time and within the agreed upon budget. Further, our commitment to provide commercial manufacturing capabilities is well underway and the timing for companies such as Radimmune Therapeutics is perfect to meet their need now and well into the future.”