SAN DIEGO, July 6, 2018 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company, announced today that Memorial Sloan Kettering Cancer Center (MSK) was awarded an R01 research project grant by the National Institutes of Health (NIH) to extend the Phase 1 clinical study of the Company's immunoPET imaging agent, MVT-2163, for patients with pancreatic cancer and scheduled for surgical resection.

MabVax Therapeutics discovered the HuMab-5B1 antibody from patients treated at MSK with a vaccine developed by Dr. Philip Livingston. In collaboration with MSK, the Company established the preclinical proof of concept for using the HuMab-5B1 immunoPET imaging agent for improving the visualization of pancreatic cancer. MabVax conducted the initial Phase 1 clinical trial of MVT-2163 and reported positive results last year at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. The clinical trial was conducted at MSK under the direction of Dr. Christian Lohrmann, Dr. Eileen O'Reilly, Dr. Wolfgang Weber and Dr. Jason Lewis. Dr. Lohrmann has been designated as the Contact Principal Investigator on this Multiple PI (Dr. Christian Lohrmann, Dr. Peter Allen, Dr. Wolfgang Weber and Dr. Jason Lewis) R01 grant-funded study.

The R01 grant extends the Phase 1 work already completed by MabVax by evaluating MVT-2163 visual images and biopsies of targeted tissues illuminated with the PET agent. This information will then be used to determine if the new PET imaging agent can improve pre-surgical staging of patients with pancreatic ductal adenocarcinoma. Since surgery is currently the only cure for pancreatic cancer and the success rate of surgical intervention is low, having a new diagnostic tool to more accurately assess the location and extent of the dissemination of the cancer has the potential to improve surgical outcomes. Additionally, these data can be used to support the dose and dose distribution determinations for the Company's HuMab-5B1 antibody based radioimmunotherapy agent, MVT-1075, currently being evaluated in a Phase 1 trial.
The Phase 1 clinical investigation will be conducted under MabVax's Investigational New Drug (IND) application. Additionally, MabVax will provide clinical supplies and manufacturing, regulatory, and clinical support to MSK as needed.

"The NIH R01 grant is a significant boost to the clinical development of our MVT-2163 immunoPET imaging agent. The aims defined by MSK and funded by the NIH will generate clinical data that address fundamental questions including the accuracy of MVT-2163 to detect cancerous lesions and whether our diagnostic agent can improve the assessment of a patient's suitability for curative surgery. We are grateful to the team at MSK, who were motivated by the early clinical data from our Phase 1 study to develop the grant application and secure institutional support for the new clinical work," stated David Hansen, MabVax's President and Chief Executive Officer.

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