MabVax Therapeutics said Monday it is on track to submit an investigational new drug application to the U.S. Food and Drug Administration for radioimmunotherapy product MVT-1075 later this year.
If approved, if will start the phase 1 trial of MVT-1075 in H1 of 2017.
The company also reported on the progress of its two antibody phase 1 programs evaluating the use of MVT-5873 as a therapeutic antibody and MVT-2163 as an immuno-PET imaging agent in patients with locally advanced and metastatic pancreatic cancer or other CA19-9 positive malignancies.
The company said MVT-5873 interim phase 1 data show its safety has been established and that part 2 of the clinical trial is now open and will include patients with previously untreated pancreatic cancer receiving a standard of care chemotherapy as defined in the protocol.
The MVT-2163 phase 1 trial was initiates in June this year to evaluate the company’s next generation diagnostic PET imaging agent in patients with locally advanced or metastatic adenocarcinoma of the pancreas or other CA19-9 positive malignancies. The study has demonstrated interim safety, pharmacokinetics, and biodistribution by completing the initial two cohorts of patients.
“We are moving ahead with the planned combination of MVT-5873 with a standard of care chemotherapy in a chemotherapy-naive pancreatic cancer patient population and are looking forward to presenting these results next year,” CEO David Hansen said. “We are continuing to accrue patients in order to establish the RP2D for MVT-5873 as a monotherapy.”