NuView’s leading technology, NV-VPAC1 consists of a series of peptide analogs that target the vasoactive intestinal peptide receptor type 1 (VPAC1). The VPAC1 receptor becomes overexpressed in certain key malignancies including breast, prostate, colon, bladder, and endometrial cancer. Attaching a molecular imaging or therapeutic component to a NV-VPAC1 peptide enables NuView to develop a series of precisely targeted products that may be used in the diagnosis and treatment of cancer.
NV-VPAC1-PET Imaging agent
NuView is currently developing the NV-VPAC1 technology as a Positron Emission Tomography (PET) imaging agent for the in vivo diagnosis of breast and prostate cancer by combining an NV-VPAC1 peptide with a medical imaging isotope.
NV-VPAC1-PET in Breast Cancer
In the United States, breast cancer is the most common cancer among women of all races and ethnicities. An estimated 249,260 new cases of breast cancer with 40,890 deaths are forecasted in 2016. Approximately 12.3% of women will be diagnosed with breast cancer at some point in their lifetime.
The primary imaging modality used in breast cancer screening is mammography and every year, women undergo 40 million mammograms in the United States alone. During screening, if a woman has an abnormal mammographic finding, additional imaging and a biopsy may be recommended. Approximately 1.7 million breast biopsies are performed every year as a result of the observation of suspicious lesions. Approximately 1.3 million of these biopsies result in a benign diagnosis (approximately 80%). The estimated annual cost of negative biopsies in the U.S. is approximately $4B.
Since the VPAC1 receptor is highly expressed on breast cancer cells with minimal expression on nonmalignant tissues, the utilization of NV-VPAC1 technology to improve the specificity of the early stage diagnosis of breast cancer has the potential to significantly reduce the number of negative breast biopsies that are done annually as part of the breast cancer screening process. NuView estimates that from 20% to 50% of women who are scheduled for a breast biopsy may have the option to undergo a NV-VPAC1-PET scan to improve the image-based diagnosis of breast cancer and avoid the necessity of a breast biopsy.
For example, the NV-VPAC1-PET technology can potentially be used in patients who have had a mammogram with suspicious findings and in whom a breast biopsy is indicated. Such patients could undergo an NV-VPAC1-PET scan post-mammography and prior to the biopsy. NuView is in the process of designing clinical trials to demonstrate the benefit of the NV-VPAC1-PET technology in this setting.
NV-VPAC1 in vitro diagnostic agent
NuView is currently developing the NV-VPAC1 technology as an in vitro diagnostic kit by attaching a fluorophore to an NV-VPAC1 peptide that may be used for detecting shed cancer cells in voided urine.
NV-VPAC1 in vitro Diagnostic in Prostate Cancer
Prostate cancer is the leading cause of cancer death among men of all races and populations. In 2016, approximately 180,890 men in the U.S. are expected to be diagnosed with prostate cancer, and approximately 26,120 men will die from the disease. Approximately 30 million prostate-specific antigen (PSA) tests are conducted annually to measure the level of protein produced by cells of the prostate gland.
A urine sample from an at-risk patient can be collected and processed with an NV-VPAC1 peptide so that any cancer cells expressing the VPAC1 receptor can be visualized microscopically. As in the image above, cancer cells appear as illuminated red blooms when viewed in a laboratory under a confocal fluorescent microscope via a standard testing method.
There are many factors that can confound the result of a PSA test including i) medical conditions other than prostate cancer that can cause PSA levels to rise including benign prostatic hyperplasia (BPH) and prostatitis, and ii) PSA-lowering factors such as certain drugs used to treat BPH or urinary conditions, large doses of chemotherapy medications, and obesity.
Due to the simple and convenient nature of the NV-VPAC1 urine screen diagnostic test, it has the potential to complement or replace the PSA test as part of routine screening of prostate cancer, given that the NV-VPAC1 urine screen diagnostic test specifically tests for the presence of cancer cells that have a very high level of VPAC1 receptor expression.
Applications in Therapy Delivery
NuView intends to develop therapeutic applications of the NV-VPAC1 technology by bringing forward peptide analogs that link cytotoxic agents (chemotherapy) or beta-emitting isotopes (cancer killing isotopes). One example of an isotope that may be used for the treatment of cancer is Copper-67. Targeted therapeutics have the potential to improve efficacy and reduce patient toxicity.
Applications of Liquid Biopsies
NuView intends to evaluate the diagnostic potential of the NV-VPAC1 technology for detecting cancer in other biological fluids including blood, cerebral spinal fluid, and saliva. The NV-VPAC1 technology also has the potential to be applied as a non-invasive diagnostic to detect colon cancer given the high level expression of the VPAC1 receptor on colon cancer cells.