First Advanced Cancer Patients Dosed With VT1021 in Trial’s Expansion Phase

First Advanced Cancer Patients Dosed With VT1021 in Trial’s Expansion Phase

A Phase 1b/2 trial investigating Vigeo TherapeuticsVT1021 as a stand-alone treatment for advanced ovarian cancer and other tumor types has dosed the first patients in its dose expansion stage.

Early results are expected later this year.

Roughly 75 adults will be enrolled in this stage of the trial (NCT03364400). Besides ovarian cancer, the other groups will have patients with either pancreatic cancer, triple negative breast cancer, or glioblastoma — all of which express high levels of CD36, a cell surface protein receptor increasingly suggested as a target in cancer treatment.

There is also a fifth group of patients with high CD36 expression but who are considered tissue agnostic, meaning that they have a different, although not specified, cancer type.

Recruitment is ongoing across the United States. More information on contacts and locations is available here.

“Advancing VT1021 in this study is a key milestone for Vigeo and we are excited to commence investigation of this promising agent in five patient groups in tumors that have a high expression of CD36,” said Jing Watnick, PhD, president and CEO of Vigeo, in a press release. “We look forward to providing updates over the course of the study.”

An initial dose escalation stage that began in late 2017 determined the recommended dose of VT1021 to be used in the current dose expansion phase. No adverse effects related to systemic delivery of VT1021 have been reported to date.

The recommended dose will now be used in a greater number of patients to conduct preliminary assessments of efficacy.

Specifically, researchers will analyze the proportion of patients who show tumor reduction (objective response rate), the length of time without disease progression (progression-free survival), and the proportion of patients who show either cancer shrinkage or stable disease (disease control rate).

VT1021 is a small peptide designed to target both CD36 and CD47, two receptor proteins that can be over-expressed on the surface of tumor cells. The therapy is intended to promote production of thrombospondin-1, a protein that acts via both these receptors to reprogram the local immune system surrounding the tumor and block cancer progression.

According to Vigeo, targeting both CD36 and CD47 may make VT1021 more effective than targeting either receptor alone.

“As opposed to targeting only one receptor, like CD47, VT1021 exploits multiple antitumor mechanisms that contribute to tumor cell death and immune response enhancement,” said Lou Vaickus, MD, the interim chief medical officer of Vigeo.

In preclinical studies, VT1021 led to tumor reduction at the initial tumor and its metastases, according to Vigeo.

Besides this trial of stand-alone treatment, the company is also planning to study combinations of VT1021 with other treatment approaches, including chemotherapies and immune checkpoint inhibitors.