STC-1010 / Brenus Pharma - LARVOL DELTA

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

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."

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

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

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 • IO biomarker • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD163 • CD4 • CD8 • IFNG • IL12A • IL2

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

Brenus Pharma unveils promising pre-clinical results extrapolating human conditions in major international congresses. (Businesswire) - "Brenus Pharma announces that pre-clinical advancements of its inaugural research program were presented at the 7th CICON (International Cancer Immunotherapy) Conference in Milan, Italy (September 20-23) and will be showcased at the 38th Annual SITC (Society for Immunotherapy of Cancer) Congress in San Diego, CA, USA (November 1-5). These communications focus on pre-clinical validation of new developments of the first product generated by the STC Platform, STC-1010, which targets colorectal cancer in a first line of treatment."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Efficacy of STC-1010, a new allogenic cancer vaccine in colorectal cancer models. (ASCO 2023) - "mSTC-1010 associated with immunostimulant (cyclophosphamide and GM-CSF at low doses), 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 of the STC-1010 vaccine in different models allows to plan a first-in-human phase I/II clinical trial with MSS and MSI-H metastatic CRC (mCRC) patients. A dose-escalation phase Ia (STC-1010 plus immunostimulant, associated to mFOLFOX6 w/o bevacizumab) will be performed with MSS mCRC patients to evaluate the safety and the recommended phase 2 trial dose (RP2D). A subsequent expansion phase IIa part will assess STC-1010 efficiency, associated with SoC in first-line setting for MSS patients, and in second-line setting after immunotherapy for MSI-H, dMMR or Lynch syndrome mCRC patients."

Clinical • IO biomarker • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Hepatology • Microsatellite Instability • Oncology • Pancreatic Cancer • Solid Tumor • CD163 • CD4 • CD8 • CSF2 • IFNG • IL12A • IL2 • MSI

Brenus Pharma Unveils Groundbreaking Preclinical Results For STC-1010, a Promising New Drug Candidate Targeting Colorectal Cancer & Solid Tumors (Businesswire) - "Brenus Pharma Announces two groundbreaking presentations on STC-1010, the company's first drug candidate for colorectal cancer (CRC), produced by Brenus Pharma's STC (Stimulated Tumor-Cells) Technology Platform....Session Title: Late-Breaking Research: Immunology 2...Antoine ITALIANO..."

Brenus Pharma Unveils Groundbreaking Preclinical Results For STC-1010, a Promising New Drug Candidate Targeting Colorectal Cancer & Solid Tumors (Businesswire) - "Brenus Pharma Announces two groundbreaking presentations on STC-1010, the company's first drug candidate for colorectal cancer (CRC), produced by Brenus Pharma's STC (Stimulated Tumor-Cells) Technology Platform....Results obtained in-ovo confirmed the anti-tumor efficacy -mediated by cytokine secretion and T cells expansion- of the vaccine previously observed in CRC syngeneic mouse models....The second study...showed that STC-1010 is an efficient strategy to educate the immune system by cross-priming DCs and increasing the activity of specific CD8+ T cells (TCR sequencing) all of which promotes the significant tumor killing observed ex-vivo."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Inovative in vivo (in ovo) CAM model to predict efficacy and mode of action of a new antitumor vaccine stc-1010 on human colorectal adenocarcinoma (AACR 2023) - "This in ovo study confirms efficacy of the STC-1010 observed in previous CRC syngeneic models and gives more insight about STC mechanism of action with the activation and maturation of dendritic cells, induction of CD8+ and LTh1 against tumor as the main driver of the response, all without toxicity. Inovotion’s CAM model could be used for indication screening and as a pre-proof-of-concept before syngeneic model study."

IO biomarker • Preclinical • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4 • CD8 • IFNG • IL12A • TNFA

STC-1010 a new therapeutic vaccine promotes tumor cell death (AACR 2023) - "CD8+ T cells primed with STC-1010-treated DCs promote massive apoptosis of HCT116 and HT29 cells compared to the condition without STC-1010 (p<0,001 for all donors). The benefit of STC-1010 was not detectable with LS174T cells characterized by a low expression of HLA-ABC and used as negative control in this study.CONCLUSION Taken together, our results showed that Brenus STC-1010 human vaccine is an efficient strategy to educate immune system and promote the CRC cells death in vitro lending further support in favor of STC technology based on physical or chemical stimulation and haptenization to generate human cancer therapeutic vaccine."

IO biomarker • Late-breaking abstract • Tumor cell • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD40LG • CD8 • CXCL8 • HLA-C • IFNG • IL10 • IL12A

French Blood Establishment (EFS) & Brenus Pharma Partner for the GMP Production of STC-1010, an Innovative Therapy Against Colorectal Cancer (Businesswire) - "The French Blood Establishment (EFS) and Brenus Pharma announce their strategic partnership in the bioproduction of innovative therapy drugs (ITD), highlighting French expertise. This collaboration is part of a shared vision: developing the French bioproduction sector nationally and internationally....This public-private partnership aims for a long-term perspective and will lead in 2023 to the production of clinical batches for the Fist-In-Human study of STC-1010, Brenus Pharma's lead candidate, targeting colorectal cancer."

Licensing / partnership • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

EFFICACY STUDY OF STC-1010 ANTITUMOR VACCINE ASSOCIATED WITH STANDARD CHEMOTHERAPIES ON MC 38 SYNGENEIC COLON CANCER TUMOR MODEL (SITC 2022) - "We report efficacy results of three (3 CL-S) cell lines S=stimulated by irradiation and heat shock versus three cell lines (6 CL-S) physically and chemically stimulated (irradiation, heat shock and chemotherapies), both haptenized (H) and administrated with immunostimulant (IS=cyclophosphamide and mGM-CSF) associated w/o to standard chemotherapy FOLFOX or FOLFIRI...Conclusions This third preclinical study confirms efficacy and safety of Brenus STC vaccine stimulated and haptenized alone or with standard chemotherapies associated to immunostimulant. This significant anticancer effect in mice could be explained by mobilization of CD3, CD8, CD4 T cells within the tumors and oriented M1 macrophage immune responses."

IO biomarker • Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4 • CD8 • FOXP3 • MSI