Personalized Medicine

As stated in our mission statement, we are dedicated to improving health and quality of life with novel immunotherapeutics for the treatment of cancer, autoimmune and other serious diseases. The challenges in cancer management have been early detection and more effective treatments.

We are addressing these challenges with a multi-pronged approach that involves 3 pathways: (i) early detection and diagnosis before the disease has metastasized, which limits therapy options; (ii) a highly sensitive and specific molecular imaging method to locate sites of tumor in the body, both prior to and following therapy; and (iii) using the same antibody to carry therapeutic agents selectively to the cancer for more specific and individualized therapy.

By first testing for the presence of a specific disease biomarker that the therapeutic agent targets, we think the likelihood of therapeutic success will improve with fewer side effects for the patients. We now have two product candidates that we believe can potentially bring the concept of personalized medicine closer to reality.

While we are heartened by the actual tumor shrinkage and quality-of-life improvements we have witnessed in some patients with advanced pancreatic cancer treated with Clivatuzumab tetraxetan labeled with yttrium-90 in combination with gemcitabine, our excitement with this antibody is with the companion diagnostic blood test we are trying to develop for detecting early stage pancreatic cancer. Clivatuzumab is also being developed as a pretargeted imaging agent, which we hope will pinpoint sites of pancreatic cancer spread and recurrence, using positron emission tomography, or PET, scan. Together, these 3 methods could help us identify patients that will likely respond to therapy with radiolabeled Clivatuzumab, as well as enable us to monitor their response or failure earlier, thereby providing the patient with a personalized treatment.

Thus, the basis of individualized therapy centers on the pre-selection of patients who will likely be more responsive to the therapeutic. This requires the use of the same agent for diagnostic imaging and again for therapy. The major attribute of pretargeting is that by using a “two-step” approach in the delivery of a bispecific antibody and the ensuing radioisotopes, the same bispecific antibody can be used for both activities.

TF2, a bispecific antibody engineered using our patented Dock-and-Lock method, is our lead product candidate from our pretargeting imaging/therapy program. It is currently being evaluated clinically for pretargeted imaging and therapy of colorectal cancer. We plan to use the imaging step as a screening tool to pre-select patients with the lesions that are known to be targeted by TF2. This is a major benefit for the patient, since patients without sufficient targeting will not be subjected to the radiation-based therapy. In addition to the patient benefit, this method provides a significant advancement toward controlling the spiraling cost of healthcare by limiting the expensive therapy to only patients who have shown successful targeting in the imaging step and thus, have a higher probability of therapeutic success.