- Grant intended to evaluate the utility of MVT-2163 to improve pre-operative staging of patients with pancreatic cancer
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.
About the MVT-2163 PET Imaging Agent
MVT-2163, 89Zr-HuMab-5B1, combines a well-established PET imaging radiolabel, Zirconium [Zr-89], with the targeting specificity of the Company's HuMab-5B1 antibody. The Company reported positive results from its Phase 1 clinical trial of MVT-2163, for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies in a poster presentation and podium talk at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting held in 2017. At the meeting the Company reported that the uptake of MVT-2163 was observed in primary tumors and metastases as early as day 2 and continuously through day 7. The investigators reported that the high reported SUVs are amongst the highest lesion uptake values 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.
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology 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. Our antibody MVT-5873, is a fully human IgG1 monoclonal antibody (mAb) that targets sialyl Lewis A (sLea), an epitope on CA19-9, and is currently in Phase 1 clinical trials as a therapeutic agent for patients with pancreatic cancer and other CA19-9 positive tumors. CA19-9 is expressed in over 90% of pancreatic cancers and in other diseases including small cell lung and GI cancers. CA19-9 plays an important role in tumor adhesion and metastasis, and is a marker of an aggressive cancer phenotype. CA19-9 serum levels are considered a valuable adjunct in the diagnosis, prognosis and treatment monitoring of pancreatic cancer. With our collaborators including Memorial Sloan Kettering Cancer Center, Sarah Cannon Research Institute, Honor Health and Imaging Endpoints, we have treated more than 56 patients with either our therapeutic antibody designated as MVT-5873 or our PET imaging diagnostic product designated as MVT-2163 in Phase 1 clinical studies, and demonstrated early safety, specificity for the target and a potential efficacy signal. Patient dosing has commenced for our lead development program in Phase 1 clinical study of the Company's radioimmunotherapy product MVT-1075. For additional information, please visit the Company's website, www.mabvax.com.
Forward Looking Statements:
This press release on announcing the R01 research grant contains "forward-looking statements" regarding matters that are not historical facts, including statements relating to the Company's clinical development programs for MVT-5873, MVT-1075 and the immunoPET imaging agent MVT-2163. We have no assurance that the near-term milestones related to our clinical development programs will be fully achieved by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "anticipates," "plans," "expects," "intends," "will," "potential," "hope" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its annual report on Form 10-K for the fiscal year ended December 31, 2017, as amended, and which may be supplemented in other filings that the Company could submit in the future to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
MabVax Investor Contact:
Russo Partners LLC
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SOURCE MabVax Therapeutics Holdings, Inc.
Released July 6, 2018