Clinical Trials

Date: 2017-06-27

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: MabVax Therapeutics (USA - CA)

Product: MVT-1075 (177Lu-CHX-A-DTPA-HuMab5B1)

Action mechanism:

• monoclonal antibody/radiopharmaceutical/immunotherapy product. The MVT-1075 RIT agent combines the targeting specificity of the HuMab-5B1 antibody for an antigen overexpressed on pancreatic cancer and other CA19-9 positive cancers with 177Lutetium to target delivery of therapeutic radiation to cancer cells. Preclinical studies have demonstrated marked suppression and in some instances regression in xenograft animal models of pancreatic cancer, potentially making it an important new therapeutic agent in the treatment of pancreatic cancer and other cancers expressing the same antigen, CA19-9.

Disease: recurrent pancreatic cancer and other CA19-9 positive malignancies

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

• This Phase 1 first-in-human clinical trial is an open-label, multi-center study evaluating the safety and efficacy of MVT-1075 in up to 22 patients with CA19-9 positive malignancies in the U.S. The primary objective is to determine the maximum tolerated dose and safety profile in patients with recurring disease who have failed prior therapies. Secondary endpoints are to evaluate tumor response rate and duration of response by RECIST 1.1, and to determine dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design. The investigative sites will include Honor Health in Scottsdale, Arizona and Memorial Sloan Kettering Cancer Center in New York City. (NCT03118349)

Latest news:

• • On June 27, 2017, MabVax Therapeutics announced that the first patient has been dosed in the Phase 1 clinical trial evaluating MVT-1075, the Company's fully human antibody radioimmunotherapy (RIT), for the treatment of CA19-9 positive malignancies including pancreatic, colon and lung cancers. In April, the Company reported preclinical results for MVT-1075 at the American Association of Clinical Research (AACR) Annual Meeting, demonstrating marked suppression, and in some instances, regression of tumor growth in xenograft animal models of pancreatic cancer, potentially making this product an important new therapeutic agent in the treatment of pancreatic, colon and lung cancers.
• • On April 5, 2017, MabVax Therapeutics has presented two posters featuring MVT-1075 (177Lu-CHX-A?-DTPA-HuMab5B1) at the American Association for Cancer Research (AACR) Annual Meeting. Preclinical development of MVT-1075 as radioimmunotherapy for pancreatic cancer and other CA19-9 positive malignancies (Presenting Author: Toni Jun, Ph.D., Director of Pharmacology, MabVax Therapeutics): The poster summarizes the IND supporting preclinical pharmacology, efficacy, and safety studies of MVT-1075 that supported starting dose determination and includes a synopsis of the phase I clinical trial design. These non-clinical studies include xenograft and orthotopic models of human pancreatic cancer and demonstrate tumor growth suppression and regression after a single dose of MVT-1075. These investigations provide supporting evidence that efficacy of MVT-1075 when administered as a single dose or as a fractionated dose is maintained. Fractionated doses may be useful to potentially minimize adverse effects. Biodistribution data comparing normal to tumor bearing mice demonstrate that approximately 70% of the dose administered was bound to tumor tissue within 24 hours of administration.
• IND enabling investigations of MVT-1075, a CA19-9 targeting Radioimmunotherapy (Presenting Author: Paul Maffuid, Ph.D., Executive Vice President, Research and Development, MabVax Therapeutics): The poster summarizes the chemistry, manufacturing, and controls (CMC) IND enabling investigations conducted to support the manufacture of clinical grade MVT-1075 drug product and includes details of the manufacturing process and characterization studies including product stability. MVT-1075 can be reproducibly manufactured as a high-quality product with conditions that maintain antibody affinity and integrity. Stability investigations support product manufacturing, storage and shipment to clinical trial sites. MabVax plans to initiate patient enrollment in during the second quarter of 2017 and evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075.
• • On February 23, 2017, MabVax Therapeutics announced that it has received notice from the FDA authorizing the initiation a Phase I clinical trial with MVT-1075 as a therapeutic treatment for pancreatic cancer. MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies the first half in 2017.
• • On January 9, 2017, MabVax Therapeutics announced the filing an Investigational New Drug (IND) application with the FDA for MVT-1075 (177Lu-CHX-A?-DTPA-HuMab5B1), the Company's novel fully human antibody radioimmunotherapy (RIT). Subject to receiving FDA authorization to proceed, MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies early in 2017. This is the third IND filed by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company's proprietary cancer vaccines.
• In this initial phase I trial the company plans to evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status will be evaluated based on tumor measurements using RECIST 1.1 criteria. The investigative sites will include Memorial Sloan Kettering Cancer Center in New York City.

 

Is general: Yes