-

French Blood Establishment (EFS) & Brenus Pharma Partner for the GMP Production of STC-1010, an Innovative Therapy Against Colorectal Cancer

LYON, France--(BUSINESS WIRE)--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.

EFS’ Cell Therapy and Engineering Unit (UTICELL), based in Saint-Ismier, France, shows recognized expertise in the cell therapy field since 2003 confirmed by a European GMP Certification issued by the ANSM in 2015 for manufacturing, control and storage sites for MTIs. UTICELL also benefits from EFS’ four other certified sites’ expertise.

Brenus’s proprietary platform passed key regulatory milestones in 2022 (FDA Pre-IND, EMA Scientific-Advice) and the two synergistic entities have been collaborating effectively for several months to produce GMPs batches through a first scale-up.

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.

"This collaboration is the result of a scientific and regulatory technical evaluation conducted with several CDMOs. The competitiveness, flexibility, and expertise of the EFS caught our attention. The UTICELL teams’ knowledge bring added value to the STC-1010 project's development, thanks to their unfailing proactivity and proposal strength," said Benoit Pinteur, Brenus Pharma's CSO.

"This collaboration reflects the importance of having both technical and scientific expertise in France to quickly advance the development of this promising drug and fulfill our public health mission. From the first exchanges with Brenus, we were impressed by the maturity of the STC-1010 project and convinced that through this collaboration, we could give patients a chance to fight their cancer," said Anaick MOISAN, Pharmacist Delegate, UTICEL EFS Rhône-Alpes.

ABOUT BRENUS

Brenus Pharma is developing first-in-class tumor-antigens focused immunotherapies for solid tumors’ treatment. Brenus has developed STC (Stimulated Tumor Cells), a technology platform mimicking relapsing conditions and enabling the education of patients' immune system, to fight the resistance mechanisms of tumor cells. www.brenus-pharma.com

ABOUT THE EFS

EFS is the public blood service in France. We are 10,000 professionals, including doctors, nurses, biologists, technicians, pharmacists, collection teams, researchers, administrative staff… driven by the same vital mission. We are present throughout the care chain and thus give blood the power to heal. efs.sante.fr

Contacts

More News From Brenus Pharma

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

LYON, France--(BUSINESS WIRE)--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 do...

Brenus Pharma Expands Its Global Scientific Advisory Board With Us Immuno-Oncology Expert Prof. Olivera J. Finn

LYON, France & PITTSBURGH--(BUSINESS WIRE)--Brenus Pharma, a clinical-stage biotechnology company developing first-in-class in vivo immunotherapies for solid tumors, announced the appointment of Olivera J. Finn, Distinguished Professor at the University of Pittsburgh School of Medicine, to its Scientific Advisory Board (SAB). This strategic addition strengthens Brenus’ international SAB as the company advances its proprietary Stimulated Ghost Cell (SGC) platform and lead candidate STC-1010 towa...

Brenus Pharma Announces First Patients Dosed in its First-in-Human Trial Evaluating STC-1010, a Next-Generation Immunotherapy

LYON, France--(BUSINESS WIRE)--Brenus Pharma today announced that first patients have been successfully dosed in its first-in-human clinical trial evaluating STC-1010, the company’s lead in vivo immunotherapy candidate developed through its proprietary off-the-shelf platform. 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. This trial targets patients with unresectable, locally...
Back to Newsroom