On June 14, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage immuno-oncology drug development company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer, reported results from its Phase 1 clinical trial of its ImmunoPET imaging agent, MVT-2163, for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies (Press release, MabVax, JUN 14, 2017, View Source [SID1234519548]). Results from the Phase 1 clinical trial were presented in a poster session and podium talk at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting held in Denver, CO June 10-14, 2017.

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The poster was presented by Joseph O’Donoghue, Ph.D., Associate Attending Physicist, Department of Medical Physics at Memorial Sloan Kettering Cancer Center and the podium talk was presented by Lars Guenter Christian Lohrmann, M.D., Assistant Member and Assistant Attending Radiologist at Memorial Sloan Kettering Cancer Center and the lead investigator in the MVT-2163 Phase 1 clinical trial. Both presentations summarized the Company’s Phase 1 clinical findings.

To date, twelve patients have been treated in this first-in-human trial evaluating the safety and feasibility of MVT-2163 to image pancreatic tumors and other CA19-9 positive malignancies. MVT-2163 was administered alone and in combination with MVT-5873, and was well tolerated in all cohorts. The only toxicities were infusion reactions that resolved on the day of the injection, with some requiring supportive medication.

Uptake of MVT-2163 was observed in primary tumors and metastases as early as day 2 and continuously through day 7. Standard Uptake Values (SUV), a measurement of activity in PET imaging, reached as high as 101 in the study. The investigators reported that the high SUV is amongst the highest lesion uptake they have ever seen for a radiolabeled antibody. Bone and soft tissue disease were readily visualized and lesion uptake of the radiotracer was higher than typically seen with PET imaging agents. The correlation with Computerized Tomography (CT) scans was high.

Results showed that MVT-5873 cold antibody pre-dose reduces liver SUV facilitating detection of liver metastases. In addition, the MVT-5873 cold antibody pre-dose does not interfere with the uptake of MVT-2163 on cancer lesions.

"We are delighted with the safety and quality of the PET images obtained with MVT-2163. The promising correlation with diagnostic CT warrants further studies correlating these findings with histopathology to assess the accuracy. The continual increase in high SUV values on cancer lesions in this study supports the use of the Company’s MVT-1075 Radioimmunotherapy product which utilizes the same antibody to deliver a radiation dose for the treatment of patients with pancreatic, lung and colon cancers. We anticipate initiating patient dosing of our MVT-1075 radioimmunotherapy trial later this month," commented David Hansen, President and CEO of MabVax Therapeutics.