ImmunoPET Imaging (MVT-2163)
Optimizing PET Scan Imaging
MVT-2163, the Company's immunoPET imaging diagnostic product which utilizes the HuMab-5B1 antibody coupled with a positron emission tomography (PET) imaging agent, is in Phase 1 development for the diagnosis and treatment assessment of pancreatic cancer and CA19-9 malignancies including lung and GI cancers. MVT-2163 is based on the MVT-5873 antibody with the radiolabel Zirconium 89 attached to the antibody. This PET agent can potentially be an important tool to aid in the diagnosis, monitoring and assessment of pancreatic cancer patients and an attractive companion diagnostic for the MVT-5873 therapeutic product.
|ImmunoPET Imaging (MVT-2163) Targeting Pancreatic Cancer and CA19-9 malignancies including Lung and GI Cancers||NIH, MSKCC, SCRI, Patheon||
Discovery Phase complete
Pre-IND Phase complete
Phase 1 Phase in progress
|Commercial Rights: WW|
The Phase 1a clinical trial for MVT-2163 determined the ideal dose and conditions for an optimal PET scan imaging. The trial was initiated in July of 2016 in subjects with stage 3 and 4 metastatic pancreatic cancer. The objectives of the trial include:
- Determination of safety as a single agent and in combination with MVT-5873 as a blocking dose
- Determination of the recommended dose of MVT-5873 required for optimal tumor visualization
- Determination of the optimal time interval between dose administration and tumor PET imaging
- Determination of the pharmacokinetics and distribution of MVT-2163
- Evaluation of the ability of MVT-2163 to detect sites of disease (localized and metastatic)
Clinical Trials Results
- The Company has completed the Phase 1a portion of the clinical trial in the first half of 2017 where three dosing cohorts totaling 12 patients were treated and results reported at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) in June of 2017.
- Toxicities were limited to infusion reactions that resolved on the day of the injection, with some requiring routine medication.
- A dosing strategy using increasing levels of “cold” MVT-5873 prior to “hot” MVT-2163 to improve image quality and reduce accumulation in liver and spleen was established and is being used in our MVT-1075 Radioimmunotherapy.
- MVT-2163 was shown to accumulate continuously on tumor lesions at very high levels not typically observed for a radiolabeled antibody through the 7 days monitored for each patient
- MVT-2163 PET images correlate very well with diagnostic CT scans.
For additional information about the Phase 1a MVT-2163 clinical trial, please visit clinicaltrials.gov, and reference Identifier NCT02687230.