Therapeutic (MVT-5873)

Targeting Pancreatic Cancer and Other CA19-9 Expressing Tumors

We initiated the MVT-5873 therapeutic antibody Phase 1 clinical trial in February 2016 to evaluate the safety, tolerability and pharmacokinetics of the antibody as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with pancreatic cancer or other CA19-9 expressing tumors. The monotherapy portion of the trial enrolled 32 patients with stage 3 or 4 pancreatic cancer who have failed all other treatments and have progressive disease. The combination therapy trial is enrolling newly diagnosed treatment naïve patients.

Program Collaborators Discovery Pre-IND Phase 1
Therapeutic (MVT-5873) Monotherapy Sialyl Lewisa for 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
Therapeutic (MVT-5873) + Chemo Metastatic Pancreatic Cancer and CA19-9 malignancies including Lung and GI Cancers MSKCC
Discovery Phase complete
Pre-IND Phase complete
Phase 1 Phase in progress
Commercial Rights: WW

Clinical Trials

The objectives of the trial include:

  • Determination of safety and tolerability as a single agent and in combination with chemotherapy as first line therapy
  • Determination of recommended Phase 2 dose for both single agent and combination therapy
  • Determination of pharmacokinetics of MVT-5873
  • Evaluate tumor response rate (RECIST 1.1) and duration of response

Clinical Trials Results

  • Phase 1a results for the single agent were reported in thirty-two patients who have been treated to date. Patients enrolled have stage 3 or 4 pancreatic cancer with progressive disease who have failed all previous therapies and receive only MVT-5873 as monotherapy.
  • Single-agent was generally well tolerated and the maximum tolerated dose (MTD) was established at 1 mg/kg clearing that dose for use in our other clinical programs. Dose-limiting toxicities consisting of transient elevations in ALT, AST and bilirubin that typically resolved within a week. Infusion reactions were mitigated with pre-medication and extended infusion times.
  • Our Phase 1a study identified a “responder subset” with at least 50% reduction in CA19-9 levels after single agent treatment. These patients had at screening CA19-9 levels < 2500 U/mL and stayed on treatment on average 4 months versus 1 month for patients > 2500 U/mL.