Cell Theranostics 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.
Cell Theranostics was established in 2021 to license the biopharmaceutical assets of CellPoint L.L.C., which was established in 2001 to develop and commercialize molecular imaging and targeted therapeutics based on platform technologies licensed from The University of Texas MD Cancer Center. These include
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 Theranostics is sponsoring 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/3 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 developing its first three therapeutic compounds, Platinum-Oncardia, 177Lu-Oncardia and 187Re-Oncardia. At M.D. Anderson, Platinum-Oncardia and 187Re-Oncardia have been studied in preclinical as potential therapeutics 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 derivative of Cisplatin. Given the level of interest in 177Lu based therapy, Cell Theranostics is preparing to focus on 177Lu-Oncardia as an essential part of its clinical program to focus on cancer metastases and small tumors under 3 mm.
In addition to Ethylenedicysteine Drug Conjugate Technology platform compounds, Cell Theranostics is planning to increase its commitment to developing product compounds from its other chelation-based technologies to address diabetes, pancreatic cancer, neuroendocrine diseases and disorders, and the ability to perform single dose dual modality imaging and simultaneous chemo/radiation therapy.
Cell Theranostics and its lead product 99mTc-Oncardia have been featured on Fox News, Fox Business Channel, National Public Radio and local Denver Colorado affiliates of ABC, CBS and NBC.
Cancers affecting the lungs, head and neck, breast, lymphoma, liver, prostate, colorectal and kidney.
Oncardia can be used on SPECT and PET cameras. The initial focus was on SPECT due to the significantly greater volume of installed SPECT and SPECT/CT cameras worldwide compared to PET and PET/CT cameras. advantages of imaging on SPECT cameras are access, lower cost and reduced radiation exposure. Currently in the U.S., the installed base of SPECT and SPECT/CT cameras have an approximate 6-fold installed base advantage compared to PET and PET/CT cameras. Over 90% of hospitals worldwide have at least one SPECT or SPECT/CT camera. SPECT imaging reduces radiation exposure to the patient by approximately 64% and the overall cost of SPECT imaging is on average 30% less than PET. In terms of PET imaging, Oncardia can be radiolabeled with gallium-68 (68Ga). Cell Theranostics will be planning the start of 68Ga-Oncardia: PET/CT trial studies after the NDA is filed with the FDA for 99mTc-Oncardia for application in lung cancer.
The early clinical imaging with 99mTc-Oncardia was performed on vintage SPECT cameras and separately each patient was imaged on a CT camera using fiducial markers to align the images from the two separate systems. This was before the introduction of the dual modality SPECT/CT cameras. The software used was not adequate to produce the desired quality of imaging for a radiopharmaceutical like 99mTc-Oncardia. Philips Healthcare, who had been observing the development of Oncardia, stepped in and a collaboration was established which allowed Philips Healthcare to develop a completely new reconstruction software to address imaging with 99mTc-Oncardia as well as other tracer applications. The algorithms in the poisson modeling based Astonish software are used on most of the SPECT cameras and certain PET camera applications in the U.S., Europe and Asia.
It was observed during the Phase I oncology imaging trial that 99mTc-Oncardia also localized in part of the myocardium in a few patients. Investigation revealed that those patients had been receiving chemotherapy. This suggested cardiotoxicity and involvement in the impacted ischemic region of the heart. Because Oncardia does not exhibit uptake in the normal heart, the suggestion was that 99mTc-Oncardia was localizing in the region where ischemia was present. Following extensive heart modeling animal studies at the University of Virginia, it became apparent that 99mTc-Oncardia was a functional target specific agent for diagnosing the presence and extent of myocardial ischemia. Follow-on clinical studies have demonstrated that with 99mTc-Oncardia, the patient can receive a complete diagnostic study by submitting to only a rest study, not the traditional rest and stress studies required by the current standard of care, myocardial perfusion imaging. This will have the potential to eliminate a significant amount of time to perform a nuclear scan cardiac study. In addition, it has been found that the diagnostic accuracy of a rest only 99mTc-Oncardia study compared with a two-part rest and stress 99mTc-sestamibi perfusion study was 95% versus 72%.