Brenus Pharma Reports Favorable Tolerability and Clinical Signals in Early Preliminary Results of First-In-Human Study for STC-1010 in Unresectable Metastatic Stage Colorectal Cancer (MSS CRC) Patients

Brenus Pharma, a clinical stage biotechnology company unlocking the immune system in vivo to fight solid tumors, announced the successful completion of the first dose levels in its ongoing first-in-human study.

The multi-center, open-label trial (NCT06934538) is a phase Ia/Ib study designed to evaluate safety, tolerability and preliminary clinical activity of STC-1010¹ in a first line setting. It will include in vivo analysis of immune and tumor dynamics during dose escalation of treatment and cohort extension to patients with unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) MSS² colorectal cancer (CRC).

Early findings indicate that the first dose levels have been successfully completed with good overall tolerance and no-dose-limiting toxicities observed to date.

“We are pleased to report that the safety profile observed to date is good and consistent with our expectations with no DLT,” said Paul Bravetti, CEO of Brenus Pharma. “Moreover, preliminary clinical signals are very promising and support further evaluation of subsequent cohorts – we are observing trends in efficacy that are stronger than anything that has been previously reported in hard-to-treat solid tumors.”

The trial is continuing to enroll patients at higher dose levels, and additional data on exploratory analyses (cytokine profiles, immunophenotyping, PBMC markers, ctDNA, HLA expression, tumor necrosis, immune infiltration, and TLS evolution) and efficacy will be communicated as the trial progresses.

Brenus’ next report is expected to be released in Q1 2026, as a key milestone in advancing STC-1010 for patients with advanced MSS “cold” colorectal cancer.

About Brenus Pharma
Brenus Pharma develops an off-the-shelf platform advancing novel modalities in immuno-oncology. This cutting-edge precision technology mimics tumor protein expression and makes it visible to the immune system, enabling a multi-specific in vivo immune response against evolving tumor cells in solid tumors.
www.brenus-pharma.com

About SGC Platform
SGC platform is a next-generation in vivo immunotherapy platform based on Stimulated Ghost Cells (SGC), generated by controlled physical or chemical stress and hapten-induced immune flare, to target and destroy tumor cells while anticipating their evolution.

1STC-1010 is a first-in-class, allogeneic in vivo immunotherapy derived from the company’s proprietary platform. It is based on Stimulated Ghost Cells generated through controlled physical or chemical stress and hapten-induced activation on colorectal cancer (CRC) cell lines rendered non-proliferative.
2Micro-Satellite Stable

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