STC-1010 / Brenus Pharma - LARVOL DELTA

Early Safety and clinical activity of Phase I dose-escalation study of STC-1010 in first-line mismatch repair proficient (pMMR)/microsatellite stable (MSS) metastatic colorectal cancer (CRC) (ESMO 2026) - No abstract available

Clinical • Metastases • Mismatch repair • P1 data • pMMR • Colorectal Cancer • Oncology • Solid Tumor

3D tumor spheroids support translational development of STC-1010, an off-the-shelf immunotherapy (EACR 2026) - "Overall, these advances underscore the value of 3D spheroid systems as scalable, reproducible and physiologically relevant testing platforms that bridge in vitro and in vivo responses. Combined with early clinical progress, these data support STC-1010 as a promising immunotherapy designed to overcome immune resistance in checkpoint-refractory cancers."

Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD8 • CD86

Brenus Pharma Announces FDA Acceptance of IND Application for STC-1010 (BreAK-CRC001) in MSS Metastatic Colorectal Cancer (mCRC) (Businesswire) - "The FDA validated Brenus Pharma's advanced regulatory and manufacturing capabilities. This operational readiness will accelerate patient access and data generation across both European and US sites for a Phase II program planned for 2027."

IND • New P2 trial • Colorectal Cancer

From preclinical models to first-in-human evaluation of STC-1010 immunotherapy in unresectable advanced colorectal cancer (AACR 2026) - "BreAK CRC 001 is a first-in-human, open-label phase I/IIa study of STC-1010 combined with low-dose of cyclophosphamide, GM-CSF (STC-1010 regimen), and associated to standard chemotherapy for unresectable locally advanced or metastatic CRC... STC-1010 regimen restores anti-tumor immunity and enhances immune cell activation in CRC models, supporting its continued clinical development. Combined with chemotherapy, it showed a manageable safety profile and early signs of clinical activity, consistent with the antitumor effects observed in preclinical models."

First-in-human • Metastases • P1 data • Preclinical • Colorectal Cancer • Oncology • Solid Tumor • CD8 • CSF2 • MSI

AACR 2026: First‑in‑Human STC‑1010 Data Show Favorable Safety and Early Immune Engagement in Metastatic MSS Colorectal Cancer (Businesswire) - "Clinical findings from BreAK CRC001 (NCT06934538), Phase I/IIa first‑in‑human evaluation of STC‑1010 in unresectable metastatic MSS CRC, first-line setting (n=6; median follow‑up: 6 months) show : Favorable safety with no dose‑limiting toxicities (DLTs) observed. Promising early efficacy, including 100% disease control rate (DCR) in RECIST. Evidence of immune activation, including delayed‑type hypersensitivity (DTH) responses."

First-in-human • P1/2 data • Colorectal Cancer

AACR 2026: First‑in‑Human STC‑1010 Data Show Favorable Safety and Early Immune Engagement in Metastatic MSS Colorectal Cancer (Businesswire) - "Clinical findings from BreAK CRC001 (NCT06934538), Phase I/IIa first‑in‑human evaluation of STC‑1010 in unresectable metastatic MSS CRC, first-line setting (n=6; median follow‑up: 6 months) show: (i) Favorable safety with no dose‑limiting toxicities (DLTs) observed; (ii) Promising early efficacy, including 100% disease control rate (DCR) in RECIST; (iii) Evidence of immune activation, including delayed‑type hypersensitivity (DTH) responses. Exploratory analyses are ongoing to further characterize tumor–immune dynamics and identify predictive biomarkers supporting subsequent stages of clinical development."

First-in-human • P1 data • Colorectal Cancer

Preclinical efficacy of an innovative therapeutic cancer vaccine: A new era for immunotherapy (AACR 2025) - "A phase I/II trial is planned for non resectable metastatic and advanced CRC patients, comprising a dose-escalation phase I and cohort-extension phase IIa. This trial aims to evaluate the safety and preliminary effectiveness of STC-1010 in combination with immunostimulants and mFOLFOX6, with or without bevacizumab, in MSS and MSI-H CRC patients."

First-in-human • IO biomarker • Late-breaking abstract • Preclinical • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • CD4 • CD8 • CSF2 • CXCL8 • IFNG • IL12A • MSI

Efficacy of the STC-1010 a new allogenic cancer vaccine in different colorectal cancer models (AACR 2024) - "In addition, mSTC-1010 associated with immunostimulant (cyclophosphamide and mGM-CSF), combined or not with chemotherapy (FOLFOX or FOLFIRI) led to a significant decrease of tumor volume, a M1-oriented macrophage response (immunohistochemical, iNOS/CD163 >1), and an increase of T lymphocyte infiltration...The good tolerability and reproducible efficiency of the STC-1010 vaccine in these different clinical models allow to plan a first-in-human phase I/II clinical trial for metastatic CRC(mCRC) patients. A dose-escalation and cohort extension phase I followed by a phase IIa with STC-1010 plus immunostimulant, associated to mFOLFOX6 w/o bevacizumab, will be performed for MSS mCRC patients to evaluate the safety and preliminary effectiveness in human."

Clinical • First-in-human • IO biomarker • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD163 • CD4 • CD8 • IFNG • IL12A • IL2

First-in-human hapten-enhanced stressed-ghost cell immunotherapy (STC-1010) for advanced colorectal cancer: preclinical and early clinical data (AACR-IO 2026) - P1/2 | "As of the current data cutoff, three patients have been treated with first-line SOC mFOLFOX6 combined with STC-1010...In: Proceedings of the AACR Immuno-Oncology Conference (AACR IO): Discovery and Innovation in Cancer Immunology: Revolutionizing Treatment through Immunotherapy; 2026 Feb 18-21; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Immunol Res 2026;14(2 Suppl):Abstract nr A061."

Clinical data • First-in-human • IO biomarker • Metastases • P1 data • Preclinical • Colorectal Cancer • Oncology • Solid Tumor • CD8

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

First-in-human • P1 data • Colorectal Cancer

Investigating the Synergistic Potential of a Promising Vaccine Platform Combined with Checkpoint Inhibitors in Colorectal Cancer (CICON 2025) - "Based on these results, we investigated a combination approach using STC-1010 with anti-CTLA-4 (ipilimumab) and / or anti-PD-1 (nivolumab) in both in vivo and ex vivo models. The study assessed multiple treatment conditions to evaluate the synergistic anti-tumor effects of ICIs following immune activation by STC-1010."

Checkpoint inhibition • IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • CCR7 • CD8 • CD80 • CD86 • CXCL10 • CXCL8 • CXCL9 • HAVCR2 • HLA-DRB1 • LAG3 • PD-L1 • TIGIT

Brenus Pharma Announces First Patients Dosed in its First-in-Human Trial Evaluating STC-1010, a Next-Generation Immunotherapy (Businesswire) - "Three patients have already been enrolled in the study. The first completed eight weeks of treatment with no adverse events attributed to the investigational therapy....Additional centers will open in 2026 in France and Belgium."

Trial status • Colorectal Cancer

CAM Assay: An Alternative, 3Rs-compliant, In Vivo Model for the Development of Anticancer Immunotherapies (EACR 2025) - "A treatment with different immunotherapy reagents is performed between EDD10 and EDD18: monoclonal Abs (bevacizumab, trastuzumab, rituximab) in 4 doses; ADC (trastuzumab emtansine) in 1 dose; ICIs (pembrolizumab, nivolumab, atezolizumab, avelumab) in 5 doses; tumor cell based vaccine (STC1010) in 3 doses; CAR-T cells & CAR-NK cells in 1 dose. Our work demonstrates that the CAM assay is suitable for testing different IO anticancer treatments. The presence of an active immune system allows a suitable characterization of the effects of immunotherapy reagents on tumor cells, the microenvironment, and the entire organism. As one part of New Approach Methodologies (NAMs), the CAM assay provides a relevant alternative, 3Rs-compliant, in vivo model for testing novel immunotherapies on a large spectrum of cancer types, as a monotherapy or as an in combination approach."

IO biomarker • Preclinical • Oncology

First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Brenus Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Bridging the Gap Between In Vitro and In Vivo: STC-1010 Cancer Vaccine Efficacy in 3D Tumor Spheroids (EACR 2025) - "This innovation overcomes ethical, financial, and time limitations of in vivo models while preserving key tumor resistance mechanisms. Our results support STC-1010 as a promising immunotherapy and demonstrate the value of 3D spheroids as reliable preclinical tools for evaluating new treatments. Overall, this work enhances strategies to overcome immunotherapy resistance and accelerates translational research with scalable, physiologically relevant models."

Preclinical • Colorectal Cancer • Oncology • Solid Tumor • CD8 • CXCL8 • IL6

Brenus Pharma and InSphero Have Developed 3D Tumor Spheroids Mimicking in vivo Human Colorectal Cancer Conditions and Confirming STC-1010’s Efficacy (Businesswire) - "Funded through the EUROSTARS program, the collaboration led to vitrified 3D colorectal cancer spheroids using tumor cell lines co-cultured with fibroblasts. The vitrification method preserves morphology, stromal integrity, and viability after thawing, enabling realistic evaluation of STC-1010’s therapeutic potential under conditions mimicking in vivo human tumors."

Preclinical • Colorectal Cancer

Stimulated Ghost Cells (SGC) vaccines: advancing next-generation cancer immunotherapeutics (CIMT 2025) - "The study includes a Phase I dose escalation followed by a Phase IIa cohort extension, evaluating STC-1010's safety and efficacy with immunostimulants and mFOLFOX6 chemotherapy. The trial will enroll microsatellite stable (MSS) and microsatellite instability (MSI-H) CRC patients, providing insights into treating heterogeneous CRC populations"

IO biomarker • MSI-H • Tumor mutational burden • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • CD8 • CXCL8 • IL6 • MSI • TMB

AACR 2025: Brenus Pharma Presents Late-breaking Preclinical Data on its 'off-the-shelf' Next-generation Vaccine-based Immunotherapy Candidate, STC-1010, Now Moving to Clinic (Businesswire) - "Key findings demonstrate the reproducibility of STC-1010’s anti-tumor profile across multiple manufacturing batches and preclinical models (in vivo, in ovo, ex vivo) including those modified to be resistant to current immunotherapies. Dendritic cells showed increased antigen presentation and activation of CD8⁺ T cells with STC-1010, resulting in significant tumor cell apoptosis (tumor killing) and reduced metastasis."

Preclinical • Solid Tumor

Stimulated tumor cells (STC) vaccines: pioneering the future of cancer immunotherapy (SITC 2024) - "Conclusions Multi-omics characterization and efficacy assays demonstrated high similarity across four independent STC-1010 batches, highlighting the standardization of the STC-1010 manufacturing process. Preclinical efficacy and safety results prompted the launch of a clinical trial evaluating the STC-1010 for patients with unresectable advanced/metastatic CRC in 1st (MSS patients) or second line settings (MSI-H patients)."

IO biomarker • Tumor cell • Tumor mutational burden • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • CD8 • CXCL8 • IFNG • IL10 • IL12A • MSI • TMB

Brenus Pharma Raises $25 Million to Accelerate Clinical Trials of Its Precision Cancer Vaccines. (Businesswire) - "Brenus Pharma...announces the completion of a $25 million Series A financing round...The Series A round, led by a group of French investors in association with Belgian investment funds, will be used to finance the first Phase I/IIA clinical trial of Brenus’ first candidate, STC-1010, in metastatic colorectal cancer, as well as the development of a second candidate in another solid tumor indication (STC-1020)...Brenus Pharma will meet this high unmet need thanks to its innovation from end of 2024 with its first clinical trial in France, Belgium and the USA."

Financing • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Multi-omics characterization of a novel allogeneic colorectal cancer vaccine (CRI-ENCI-AACR ICIC 2024) - "Here we report a multi-omics characterization of STC-1010, a therapeutic CRC allogeneic vaccine comprising of three stressed and haptenized human CRC cell lines...This confirms its promise as a potent allogeneic therapeutic vaccine advancing it to clinical trial. Additionally, the STC platform demonstrated robust vaccine production across different batches, and the technology can be adapted to produce vaccines for other indications."

Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

BreAK CRC, a first-in-human phase I/II trial of STC-1010, a new allogenic cancer vaccine for advanced or metastatic unresectable colorectal cancer. (ASCO 2024) - "Preclinical efficacy and safety results of STC-1010 murine surrogate underline the capacity of the vaccine combined with immunostimulant in low dose (cyclophosphamide and GM-CSF) associated or not with the standard of care (SoC) chemotherapy (FOLFOX or FOLFIRI) to decrease tumor volume, improve mice survival and enhance tumor T cell infiltration in different syngeneic models of mice... The dose-escalation phase I will evaluate on 9 to 18 patients the tolerability of two STC-1010's dose levels (3x10 6 and 6x10 6 vaccine cells) administered intra-dermally on a weekly basis for 8 weeks, followed by 4 boosts, combined with immunostimulants in low dose (oral cyclophosphamide: 50 mg/day, 3 days before vaccine and GM-CSF: 125or 250 µg, co-injected with vaccine), associated to SoC chemotherapy (mFOLFOX6 ± Bevacizumab)...If no safety issue, a single-arm phase IIA- expansion cohort on 52 MSS patients and a separate cohort of 20 MSI-H patients who have progressed on..."

IO biomarker • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Immunology • Microsatellite Instability • Oncology • Solid Tumor • CD8 • CSF2 • IFNG • IL12A • IL2 • MSI

ASCO 2024: Brenus Pharma Presented “BreAK-CRC” First-in-human (FIH) Phase I/IIA Trial of STC-1010: a Next-generation Cancer Vaccine Targeting mCRC (Businesswire) - "Brenus Pharma...has presented the study design of 'BreAK-CRC' First-in-human of STC-1010, Brenus’ lead candidate, during ASCO annual meeting (31st May – 4th June 2024) - Trials in Progress poster session....The Phase I/IIA clinical trial, aims to evaluate the safety and efficacy of STC-1010 in patients with unresectable advanced or metastatic colorectal cancer, 2nd cause of cancer mortality worldwide. The Phase I will assess the tolerability of two dose levels of STC-1010, combined with low-dose immunostimulants and standard of care chemotherapy (SoC). The Phase IIA will enroll patients to further evaluate the treatment's efficacy, particularly focusing on 12-month non-progression rate."

Clinical protocol • Colorectal Cancer

AACR 2024: Brenus Pharma Unveils Promising and Robust Pre-clinical Efficacy Extrapolating Human Conditions with STC-1010 (Businesswire) - "Brenus Pharma unveils groundbreaking results during the American Association Cancer Research (AACR) Annual meeting 2024....This communication confirms the ability of Brenus’ next gen immunotherapy, STC-1010, to fight against resistant colorectal tumors with excellent tolerability....STC-1010 was tested in several models extrapolating human conditions (ex-vivo; in-ovo,) using PBMCs from different donors. Results showed a significant immune response activation coupled with a massive and robust tumor killing that has been consistent with our 3 latest STC1010 batches manufactured. Metastasis reduction has also been shown with in-ovo model."

Preclinical • Colorectal Cancer

Stimulated tumor cells (STC) vaccine induce response in colorectal cancer (SITC 2023) - "On the other hand, proteomic characterization approach showed that around 200 proteins involved in resistances, tumor progression and escape are expressed in the vaccine allowing considerable coverage of patients’ tumor heterogeneity. Conclusions These studies on ex vivo and in ovo models confirm the efficacy of the STC technology to generate human cancer therapeutic vaccine and give more insight about STC-1010 mechanism of action with the activation and maturation of DCs, induction of CD8+ T cells against tumor cells as the main driver of the response, all without toxicity."

IO biomarker • Tumor cell • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD40LG • CD8 • CXCL8 • IFNG • IL10 • IL12A • TNFA