The study includes a Phase I monotherapy dose escalation portion and a Phase II cohort expansion portion. Credit: National Cancer Institute / Unsplash.

US-based biotechnology company Sensei Biotherapeutics has dosed the first patient in a Phase I/II clinical trial of SNS-101 to treat advanced solid tumours.

The conditionally active, human monoclonal IgG1 antibody SNS-101 selectively blocks the immune checkpoint, V-domain Ig suppressor of T cell activation (VISTA), in the tumour microenvironment.

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The multi-centre study intends to assess SNS-101’s tolerability, safety, pharmacodynamics, pharmacokinetics and efficacy.

It includes a Phase I monotherapy dose escalation portion and a Phase II cohort expansion portion.

SNS-101 will be assessed both as a monotherapy and in combination with Regeneron’s PD-1 inhibitor, Libtayo (cemiplimab), in patients with advanced solid tumours.

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Based on preclinical data that demonstrated SNS-101’s safety profile, tolerability profile and linear elimination kinetics, a starting dose of 0.3mg/kg has been determined for use in the monotherapy dose escalation portion.

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The trial’s Phase I combination dose-escalation portion will begin later based on the clinical data of the monotherapy dose escalation.

Topline Phase I data from both the monotherapy and initial combination therapy are expected next year.

The US Food and Drug Administration (FDA) approved the trial in April 2023.

Sensei Biotherapeutics president and CEO John Celebi said: “We’re excited to bring the promise of Sensei’s approach to VISTA inhibition into the clinical setting, where we believe SNS-101 will be the first drug candidate to effectively test the VISTA axis.

“We believe clinical validation of SNS-101 and the underlying approach would represent a tremendous advancement for the field and provide a potentially transformative treatment option for patients.”

National Cancer Institute Center for Immuno-Oncology co-director James Gulley said: “Studying this novel, a conditionally active antibody for treating patients with a variety of VISTA-positive solid tumours aligns with our research goals.

“The goal is developing novel therapies for a spectrum of cancers with high unmet medical needs.”