Clinical Trials

Date: 2017-06-14

Type of information: Presentation of results at a congress

phase: 1

Announcement: presentation of results at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting

Company: MabVax Therapeutics (USA - CA)

Product: [Zr-89]-HuMab-5B1 - MVT-2163

Action mechanism:

• monoclonal antibody. MabVax's HuMab 5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

Disease: locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies

Therapeutic area: Cancer - Oncology - Diagnostic

Country: USA

Trial details: (NCT02687230)

Latest news:

• • On June 14, 2017, MabVax Therapeutics 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. 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. The poster was presented by Joseph O'Donoghue, Associate Attending Physicist, Department of Medical Physics at Memorial Sloan Kettering Cancer Center and the podium talk was presented by Lars Guenter Christian Lohrmann, 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..
• • On November 14, 2016, MabVax Therapeutics reported on progress from its HuMab-5B1 antibody phase I program evaluating the use of  MVT-2163 as an immuno-PET imaging agent in patients with locally advanced and metastatic pancreatic cancer or other CA19-9 positive malignancies. The MVT-2163 phase I trial was initiated in June to evaluate thisPET imaging agent in patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. MVT-2163 (89Zr-HuMab-5B1) combines the well-established PET imaging radiolabel Zirconium [89Zr] with the targeting specificity of MVT-5873. This trial is designed to establish safety, pharmacokinetics, biodistribution, and the amount of MVT-5873 to be used in co-administration to obtain optimized PET scan images. The company has demonstrated interim safety, pharmacokinetics, and biodistribution by completing the initial two cohorts of patients: the first cohort administered MVT-2163 alone and the second cohort administered MVT-2163 following a blocking dose of MVT-5873. The company reports that the initial PET images demonstrated target specificity by correlation with lesions identified by conventional computerized tomography (CT) scans. The biodistribution data obtained in the first two cohorts demonstrates improvement in PET images by pre-administration of MVT-5873, as has been observed with other antibody based PET agents. The company is actively recruiting patients and expects to establish the optimal co-administration dose of MVT-5873 early in 2017.
• • On July 18, 2016, MabVax Therapeutics announced 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. 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.
• • On January 28, 2016, MabVax received authorization from FDA to proceed with a second phase I clinical trial with [Zr-89]-HuMab-5B1 as a new generation PET imaging agent in patients with pancreatic cancer. [Zr-89]-HuMab-5B1 combines a well-established PET imaging radiolabel [Zr-89] with the targeting specificity of the HuMab-5B1 antibody. Preclinical xenograft animal models demonstrated high image resolution of tumors, making [Zr-89]-HuMab-5B1 attractive as a potential diagnostic agent for use with the HuMab-5B1 therapeutic product. Some of the data was previously published in the Journal of Nuclear Medicine, Bioconjugate Chemistry, and the Proceedings of the National Academy of Sciences.

Is general: Yes