Cell>Point is a late stage Phase 3 biotech company specializing in the field of theranostic nuclear medicine through chelation technologies focused in cancer, cardiovascular, neuroendocrine, diabetes and ischemia-based diseases.
The company was established in 2001 to develop and commercialize molecular imaging and targeted therapeutics based on 5 platform technologies licensed from The University of Texas MD Cancer Center.
Cell>Point’s lead product in clinical development is ethylenedicysteine-glucosamine which the company registered under the trademark “Oncardia”. With applications in cancer and cardiovascular disease, Oncardia can be radiolabeled or complexed with cold metals to create a range of nuclear imaging and therapeutic products. Oncardia’s mechanism allows it to target the diseased cell and then deliver its radionuclide or cold metal into the cell nucleus. Cell>Point refers to this as intra-nuclear therapy.
Oncardia can be conveniently labeled with technetium-99m (99mTc) for imaging with SPECT and SPECT/CT camera systems or gallium-68 (68Ga) for imaging with PET and PET/CT camera systems. For therapy, there are two choices. Oncardia can be complexed with a cold metal for intra-nuclear metallic therapy such as platinum or rhenium-187 (187Re), or it can be labeled with radionuclides like lutetium-177 or rhenium-188 for intra-nuclear radiotherapy.
Platform Technologies Acquired from the University of Texas M.D. Anderson Cancer Center
Platform Technologies Are Based on Chelation Chemistry
Molecular Imaging Agents
Targeted Intra-Nuclear Therapeutics
Patents Granted Worldwide
Cell>Point is completing a Phase 3 lung cancer imaging trial for 99mTc-Oncardia under an FDA Letter Agreement based on an approved Special Protocol Assessment (“SPA”), and a Phase 2b cardiovascular imaging trial for 99mTc-Oncardia to diagnose the presence and extent of coronary artery disease focusing specifically on myocardial ischemia in patients who have suffered a myocardial infarction. In therapy, the company is completing preclinical studies on its first two compounds, platinum-Oncardia and 187Re-Oncardia, for the treatment of patients with relapsed aggressive diffuse type B-cell lymphoma. Plans are to expand the Platinum-Oncardia program to address all cancers that are currently being treated with Cisplatin or one of the derivatives of Cisplatin. Given the level of interest in 177Lu based therapy, Cell>Point is preparing to focus on 177Lu-Oncardia as an essential part of its clinical program.
In addition to Ethylenedicysteine Drug Conjugate Technology, Cell>Point is developing a range of potential product compounds from its Beta Cell, N4 and Dual Imaging/Therapeutic Delivery Technologies, all chelation based technologies, which address diseases of the pancreas, neuroendocrine diseases and disorders, and the ability to perform single dose dual modality imaging and simultaneous chemo/radiation therapy. The fifth platform technology, In-Situ Hydrogel, is a high yield direct in-situ therapeutic delivery system specifically developed to address inoperable or non-resectable tumors with a combination radio/chemo therapy.
Cell>Point and its lead product 99mTc-Oncardia have been featured on Fox News, Fox Business Channel, National Public Radio and local affiliates of ABC, CBS and NBC.
Cell>Point is completing a Phase 3 trial for lung cancer imaging under an FDA Special Protocol Assessment and completed a physician IND study for head and neck cancer. In addition to lung cancer, Cell>Point plans to complete trials for head and neck, breast, lymphoma, liver, prostate, colorectal and kidney cancer.
First, Oncardia can be used to image cancer on both PET and SPECT cameras. The advantages of imaging on SPECT cameras is access, lower cost and reduced radiation exposure. Currently the US has over 15,000 installed SPECT cameras compared to just over 2,400 installed PET cameras. Over 90% of worldwide hospitals have a SPECT camera. SPECT imaging reduces radiation exposure by 73% and the overall cost of SPECT imaging is on average 30% less than PET.
Philips Healthcare developed Astonish software with the help of Cell>Point to optimize Tc-99m-Oncardia images. The algorithms used in the Astonish software are on most of the SPECT cameras used in the US, Europe and Asia. The Astonish software allows for a more accurate calculation of dosimetry (mass of the primary and secondary lesion) which allows for Oncardia to measure response to therapy as soon as 4 weeks.
It was observed during oncology imaging trials that 99mTc-Oncardia localized in the area of the myocardium where ischemia was present. What was further found was that 99mTc-Oncardia exhibited very low uptake in the normal unaffected part of the myocardium. This suggested that 99mTc-Oncardia might also be a potential functional imaging agent for cardiovascular disease. Unlike current nuclear cardiology imaging agents that image blood flow and generally requires two separate studies, one for stress and the other for rest and can take 4-5 hours to complete, Oncardia does not image blood flow, eliminating the need for an image at stress in majority of patients. Phase 1b/2a studies for Oncardia imaging for cardiology showed diagnostic accuracy of 95% compared to current MPI cardiology imaging agents that have a diagnostic accuracy of 72%.