MabVax Therapuetics Holdings, a clinical-stage oncology drug development company, has begun the initiation of patient enrollment at Memorial Sloan Kettering Cancer Center (MSK) in a Phase I clinical trial evaluating its new generation diagnostic PET imaging agent, MVT-2163 for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. This study follows another investigational Phase I trial recently initiated at MSK utilizing the Company’s HuMab-5B1 antibody MVT-5873 as a therapeutic product for the treatment of Pancreatic cancer.
The diagnostic imaging study will administer MVT-2163 as a PET imaging agent for patients with pancreatic cancer. 89Zr-HuMab-5B1 combines a well-established PET imaging radiolabel, Zirconium [Zr-89], with the targeting specificity of the Company’s HuMab-5B1 antibody. This clinical trial will evaluate the safety, pharmacokinetics and biodistribution of MVT-2163 in patients with pancreatic cancer.
The trial will also determine the ideal dose and timing for an optimal PET scan image. Preclinical xenograft animal models demonstrated high image resolution of tumors, making MVT-2163 attractive as a potential companion diagnostic agent for use with the MVT-5873 therapeutic product.
Some of the preclinical data supporting the development of this new agent was funded by the National Cancer Institute contract (HHSN261201300060C) and previously published in the Journal of Nuclear Medicine, Bioconjugate Chemistry, and the Proceedings of the National Academy of Sciences. This study is under the direction of Dr. Christian Lohrmann as lead investigator who has received a grant from a non-profit foundation to help support this clinical trial.
“We are very excited to begin patient enrollment for this Phase I trial at MSK,” said MabVax President and CEO David Hansen, “We expect to see in the next few weeks the first PET images from this study establishing the level of targeting specificity of the HuMab-5B1 antibody. The results of our study are intended to provide investigators with a better understanding of the cancers afflicting these patients. If the product produces the desired images, it could help improve diagnosis and physician decision making on treatment options for pancreatic cancer and other CA19-9 positive malignancies. We look forward to announcing interim results from this trial during the third quarter of 2016.”