Research Project
8314901
DESCRIPTION (provided by applicant): OmniCyte is dedicated to the development of novel targeted treatments for T-Cell malignancies. The company will pursue the development of a commercial diagnostic specifically targeted at a subgroup of T- cell malignancies, including Acute Lymphoblastic Leukemia (ALL). Because T-cell lymphomas and leukemias generally make up the minority of each type of lymphoma and leukemia, and therapeutics are traditionally developed to treat the majority, it is not surprising that T-cell malignancies often do not respond as well to therapeutics. Thus they require more intense treatment that results in worse side effects, and when there is recurrence it is most often deadly. Therefore, not only is there a need for more emphasis on therapeutics for T-Cell cancers, there is a need to improve the arsenal of diagnostics to complement that emphasis. hRgr is a novel oncogene that has been found to be mutated and over-expressed in numerous T- cell cancers. It has also been shown to be transforming in vitro and animal models. When inactivated, hRgr has been shown to reverse transformation in T-cell malignancies. OmniCyte in collaboration with NYU Medical Center, plans to develop a diagnostic, for prognosis, to determine treatment options, and to complement the development of a small molecule therapeutics targeted at hRgr. For the diagnostic we will attempt to develop both a monoclonal antibody that can be used in Flow Cytometry (to detect the presence of the mutant protein in permeablized cells) as well as a monoclonal antibody to be used in immunohistochemistry. Both assays are currently being used for diagnosis and prognosis of hemopoetic malignancies, and the availability of both assays will make testing for the expressed activated oncogene possible at institutions of various sizes and capabilities. For our companion diagnostic, it may be possible to use the RT-PCR assay already employed in our lab. While we have begun to develop a therapeutic to treat these malignancies, the diagnostic assays are of paramount importance to stratify the study subjects of a clinical trial. Additionally the diagnostics will be necessary to target the minority subset of patients that may benefit from a therapeutic. Possibly more importantly, the assay may offer prognosis information and may direct the therapeutics used in treatment of hemopoetic malignancies, particularly to avoid relapse and/or following relapse. It is our great desire to develop a clinical diagnostic to aid in the targeted treatment of cancer. To effectively realize the commercial potential of our efforts we hope to enjoy incentives such as Orphan Drug Status, which provides grant opportunities, FDA approval support, and 7 year market exclusivity. Additionally, the company has already begun to leverage foundation support and that of altruistically interested individuals. Finally, we are positioning the program and its intellectual property so that it will be of interest to pharma companies and other institutional investors when we reach critical clinical milestones. PUBLIC HEALTH RELEVANCE: T-cell malignancies make up the minority of each type of lymphoma and leukemia, and the treatments are traditionally developed to treat the majority, therefore it is not surprising that T-cell malignancies often do not respond as well to the treatments. OmniCyte is pursuing the commercial development of a diagnostic to identify the subset of T-cell patients who express the hRgr mutation. By examining retrospective patient data, we will also attempt to determine the prognosis of these patients and identify the therapeutic options with the greatest chance of success for this underserved subgroup. Finally, we will develop a companion diagnostic for a small molecule therapeutics that we are currently developing to specifically target this subgroup of patients. A companion diagnostic is necessary for a therapeutic that specifically targets the oncogene product to be useful.
