Products/Technology

Cell>Point has licensed five technology platforms from M.D. Anderson. These five platforms form a solid foundation for the development of new universal molecular imaging and intra-nuclear therapeutic agents.

products-technology-1

EC Technology (Oncardia®)

The EC Technology Platform is the lead technology under development by the company. EC Technology functions as a chemical coupler or bridge linking tissue specific ligands (sugar analogues, proteins, peptides, steroids, etc.) or pharmaceutical compounds to radioisotopes (hot or cold) for diagnostic and therapeutic products. The uniqueness of EC Technology is based on its exceptionally stable chelation (binding) chemistry and its mechanism of action when coupled to a target specific ligand. EC Technology provides the opportunity to create several new classes of molecular diagnostic and therapeutic agents. Oncardia utilizes ethylenedicysteine conjugated with glucosamine to mimic N-Acetyl Glucosamine – naturally produced in the cell. When Oncardia is chelated with a gamma emitting radioisotope, such as Tc-99m, hyperactive tumors and cardiac ischemia will show exaggerated uptake of the radiolabeled Oncardia

EC Technology (the chelator for Oncardia) has gone through significant reformulation since first licensed from M.D. Anderson.

products-technology-2
products-technology-3

Additionally, the Company can use EC Technology to label novel as well as FDA approved cancer, cardiovascular, infectious disease and inflammatory disease drugs. For example, by radiolabeling a cancer drug with 99mTc, the oncologist would be able to assess the patient’s tumor uptake profile for the drug in question. This profile will provide valuable information for how the drug should perform when administered to the patient. Conversely, the oncologist may discover that the patient’s tumor uptake of the therapeutic drug is very low which may persuade the oncologist to consider a different therapeutic approach.

EC Technology is a highly flexible platform for developing diagnostic imaging and therapeutic products. EC conjugated to a target specific ligand forms a targeted pharmaceutical compound. The compound remains in the form of a pharmaceutical until it is necessary to convert the compound to a radiopharmaceutical by labeling the compound with 99mTc (SPECT) or 68Ga for imaging.

Intra-Nuclear Therapy

(187Re-Oncardia® and Platinum-Oncardia®)

187Re-Oncardia and Platinum-Oncardia® are the company’s first two therapeutics. Both therapeutics utilize Oncardia (ethylenedicysteine- glucosamine) as their backbone. The company is completing preclinical research for both therapeutics at M.D. Anderson. The Phase 1 imaging trial for 99mTc-Oncardia focused on patients with lymphoma and NSCLC and demonstrated how well the conjugate compound targeted the disease. Dr. Lan V. Pham, Department of Hematopathology at M.D. Anderson, presented the following paper titled “Metabolic Targeted Therapy for Aggressive B-cell Lymphomas: Evaluating Glucose Metabolism and the Potential of 187Rhenium-Ethylenedicysteine – N- AcetylGlucosamine (187Re-EC-G) for Therapy” at the 52nd American Society of Hematology Annual Meeting in Orlando, Florida. Please note EC-G is the same as Oncardia®. Key findings of the presentation show that 187Re-Oncardia enters the nucleus and impacts the DNA which leads to lymphoma cell apoptosis (cell death). An additional finding suggests that 187Re-Oncardia is an excellent potential candidate for targeted therapy in aggressive B-Cell lymphomas. The Company plans to expand clinical trials with Platinum-Oncardia for non-small cell lung cancer. The administration of both therapeutics will utilize imaging with 99mTc-Oncardia®.

products-technology-4

Beta Cell Imaging

The diagnostic objective of the Beta Cell imaging platform is to target beta cell function in the pancreas and thus monitor changes in beta cell function and degeneration. Since beta cells are the predominate cells in the islets of the pancreas and make insulin, it is potentially important to have an imaging modality capable of accurately measuring a reduction or degeneration of beta cells. 99mTc-DTPA-Glipizide is the lead product compound under development from the Beta Cell platform. The first disease focus will be diabetes where the company is evaluating the ability of 99mTc-DTPA-Glipizide to differentiate Type I and Type II diabetes at the University of Chicago Medical Center. 99mTc-DTPA-Glipizide will also be used to diagnose the presence of early onset pancreatic cancer and to evaluate the extent of the disease. To catch patients in the initial stage of the disease, a blood test or marker such as the PAM4 protein blood test will be needed to determine if a patient is a candidate for a 99mTc-DTPA-Glipizide scan.

Radio/Chemotherapy Delivery System

In-Situ Hydrogel was initially developed as a high yield radio/chemotherapy delivery system that enables the physician to treat inoperable or surgically nonresectable tumors. The clinical purpose of In-Situ Hydrogel is to deliver a therapeutic radionuclide (such as 188Re) and a chemotherapeutic drug in the same dose directly into large highly vascularized tumors. This delivery system involves the use of a dual barrel syringe with one barrel containing a specific polymer to carry and dispense the radionuclide and chemotherapeutic drug. The other barrel contains a cross-linking compound. The polymer containing the radionuclide and chemotherapeutic drug is first injected directly into the tumor mass. Then the cross-linking compound is injected into the tumor to generate the hydrogel complex. The hydrogel complex encapsulates the radionuclide and chemotherapeutic drug. The radionuclide remains trapped within the hydrogel complex while the chemotherapeutic drug is slowly released. This results in minimal impact to healthy surrounding tissue thus significantly reducing adverse toxicity normally associated with systemic chemotherapy agents or external beam radiation. In radioactive seed implant therapy for prostate cancer, the radioactive seeds sometimes migrate away from the specific region of interest in the prostate. As a result, the effectiveness of the treatment can be diminished. Seed implant therapy cannot be repeated. In-Situ Hydrogel therapy would not have this problem. More than one dose of In-Situ Hydrogel therapy could be given to a patient.

In 2016, Vyripharm Biopharmaceuticals licensed the use of In-Situ Hyrdrogel from the company to develop a transdermal hydrogel patch for use in delivering cannabis-based therapy to patients suffering Post-Traumatic Stress Disorder and Epilepsy.

N4 Technology

N4 Technology is being used to develop new SPECT as well as a new class of PET imaging agents that will be labeled with generator-based radioisotopes (as opposed to cyclotron-based radioisotopes such as 18F that is currently the radioisotope used with FDG). The company believes that generator-based radioisotopes will be more cost effective and provide greater flexibility in the development of new agents. The first product under development is a SPECT imaging agent, 99mTc-N4-tyrosine. This product will be used to assess tyrosine kinase activity to help determine which patients with lung or breast cancer, for example, will benefit from anti-EGFR-tyrosine kinase therapy. In addition, N4 Technology compounds are being evaluated for imaging and treating neuroendocrine tumors and for diagnosing, assessing and potentially treating patients with Parkinson’s, Huntington’s and Alzheimer’s as well as certain other diseases affecting the central nervous system. In 2016, Vyripharm Biopharmaceuticals licensed the use of the N4 Technology from the company to be used with cannabidiol/cannabinoids in neurological disorders including epilepsy, and PTSD.

Dual Agent Technology

The Dual Agent Technology was developed to combine in a single compound, a diagnostic radiopharmaceutical for either SPECT or PET imaging with a contrast media agent for either CT or MRI imaging. Today, the medical camera companies are moving toward dual modality cameras such as SPECT/CT or PET/CT. In the future, the combination cameras may evolve to SPECT/MRI and PET/MRI. The preclinical work with the dual technology platform is focused on the development of the delivery of combination radio-chem-cannabinoids therapy. The Company is also developing a SPECT/CT diagnostic imaging agent, EC-Oligosaccharide-Diatrizoic Acid (“EC-OS2-DZ”) labeled with the radioisotope 99mTc, and a radio-chemotherapeutic EC-OS-Methotrexate. In 2016, Vyripharm Biopharmaceuticals licensed the use of the Dual Agent Technology from the company.