MabVax Therapeutics Holdings Inc. (fka MBVXQ)

[Rogerthat1]

From 10Q

Clinical Product Development – Recent Updates

Phase I Clinical Trial of MVT-5873 (HuMab-5B1) – In March 2016, we announced the initiation of a phase I clinical trial of MVT-5873 for patients with locally advanced or metastatic adenocarcinoma of the pancreas (“PDAC”) or other CA19-9 positive malignancies. The CA19-9 target is expressed on more than 90% of pancreatic cancers and is a validated biomarker for the disease. The Company filed an Investigational New Drug (“IND”) application for this product on November 30, 2015, and received U.S. Food and Drug Administration (“FDA”) authorization to proceed with the study on December 24, 2015. The study is a phase I, open-label, multi-center, dose-escalation clinical trial. The primary objectives are to determine the safety, maximum tolerated dose (“MTD”), and the pharmacokinetics (“PK”) of MVT-5873. The phase I trial will also evaluate the tumor response rate based on RECIST 1.1 guidelines for standard tumor measurement and the duration of response of MVT-5873 as a single agent or in combination with a standard of care chemotherapy regimen. The study will enroll up to approximately 60 patients at multiple centers in the United States. In the dose escalation portion of the trial, patients enrolled have locally advanced or metastatic pancreatic cancer who have failed other therapies. Nine patients treated to date have been observed as tolerating initial dosages of the drug reasonably well. Infusion reactions, which are not uncommon with protein drugs, have been the most frequent adverse events related to drug exposure and have been addressed by slowing the infusion rate. Of the nine patients who have been dosed to date, five have been treated for three or more months and investigator observations have noted stable disease for a subset of those patients. We are continuing to escalate the drug dose to assess safety and reach an MTD and anticipate initiating the second portion of the trial where our drug is dosed in combination with chemotherapy in the fourth quarter of this year. We expect to have the preliminary results of this clinical trial later in the third quarter in 2016, with full results expected in 2017.

Phase I Clinical Trial of MVT-2163 ([89Zr]-HuMab-5B1) – In July 2016, we announced the initiation of a phase I clinical trial of MVT-2163 as a new generation PET imaging agent in patients with pancreatic cancer. MVT-2163 combines a well-established PET imaging radio-label [Zr-89] with the targeting specificity of the HuMab-5B1 antibody. Preclinical xenograft animal models demonstrated high image resolution of tumors, making MVT-2163 attractive as a potential diagnostic agent for use with the MVT-5873 therapeutic product. This second Phase I trial will evaluate the safety, pharmacokinetics and biodistribution of MVT-2163 in cancer patients. The trial results are also intended to determine the ideal dose and conditions for an optimal PET scan image using the new imaging agent. The first patient in the trial was dosed with MVT-2163 in early July and received PET scans on days 1, 2, 4, and 7. Investigator observations showed scans potentially highlighting smaller metastatic sites not seen on standard CT scans. These results are preliminary and require more patients to confirm. We expect to have the preliminary results of this clinical trial later in the third quarter 2016, with full results expected in 2017 .