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4C Biomed’s uniquely sensitive immunological-based screening platform is based on patient-derived material. The technology combines autologous cell systems in two formats:
This approach allows precise immune recognition, as compared with using commercially available cell lines and/or engineered T cells, leading to accurate identification of clinically relevant checkpoint proteins. Its efficacy is illustrated by the fact that 20% of targets the platform has identified have subsequently been the subject of clinical trials.
Anti-4CB1, is a novel fully human anti-HVEM monoclonal antibody capable of blocking the HVEM-BTLA interaction, inhibiting downstream BTLA signalling, and so enhancing the cytotoxicity of lymphocytes towards tumor cells. In addition, anti-4CB1 blocks the interaction of HVEM with the T-cell inhibitory receptor CD160.
Anti-4CB1 has demonstrated efficacy as a monotherapy in ex-vivo studies testing clinical samples that did not respond to the current market leading drug, anti-PD-1. In addition, pre-clinical investigations in mouse models, representing a number of human solid tumor indications, have shown HVEM specific anti-tumor activity of anti-4CB1. Importantly, the combination of anti-4CB1 with an anti-PD-1 antibody showed significant improvement in anti-tumor activity compared with anti-PD-1 alone. Anti-4CB1 has completed IND-enabling studies and 4C Biomed projects to enter clinical Phase I trials of anti-4CB1 in 2026.
Anti-4CB1, is a novel fully human anti-HVEM monoclonal antibody capable of blocking the HVEM-BTLA interaction, inhibiting downstream BTLA signalling, and so enhancing the cytotoxicity of lymphocytes towards tumor cells. In addition, anti-4CB1 blocks the interaction of HVEM with the T-cell inhibitory receptor CD160.
Anti-4CB1 has demonstrated efficacy as a monotherapy in ex-vivo studies testing clinical samples that did not respond to the current market leading drug, anti-PD-1. In addition, pre-clinical investigations in mouse models, representing a number of human solid tumor indications, have shown HVEM specific anti-tumor activity of anti-4CB1. Importantly, the combination of anti-4CB1 with an anti-PD-1 antibody showed significant improvement in anti-tumor activity compared with anti-PD-1 alone. Anti-4CB1 has completed IND-enabling studies and 4C Biomed projects to enter clinical Phase I trials of anti-4CB1 in 2025.
In development and pre-clinical testing, anti-4CB1 showed a promising safety profile. Specific binding to HVEM, without any “off-targets” was demonstrated. In addition, in a single dose range finding toxicity study in Non-Human Primates (NHP), all tested doses were well tolerated with no mortality and no test article-related clinical signs. Importantly, in a pivotal repeated dose GLP toxicity study in NHP, anti-4CB1 was well tolerated up to 225 mg/kg with no adverse findings.
4C Biomed’s Intellectual Property, relating to its first target – HVEM – covers the use of its lead drug, Anti-4CB1, to treat cancer as well as a method for predicting response to anti-PD-1/PD-L1 treatment. All patent families are currently under examination in the National Phase. Once approved, these exclusive patents provide robust protection to 4C Biomed and provide it with appropriate freedom to operate in all major target markets where anti-4CB1 will be commercialized. More information can be found under the technology page.
Based on the strong evidence it has developed, 4C Biomed’s business plan is now to move forward rapidly with a well-planned clinical development program, financed by the ongoing Series A round. The Company’s strategy is to seek to license anti-4CB1 as a combination therapy in subsets of patients who did not respond or relapsed on anti-PD-1/PD-L1 treatment, or even as a monotherapy.
Alongside this opportunity, the Company plans to promote further pre-clinical development of additional potential drug candidates previously highlighted through 4C Biomed’s unique discovery platform, so broadening its pipeline.
4C Biomed has recently entered into a manufacturing agreement with a world leader international CDMO for cell line development and CMC activities. Manufacturing process development is completed and Master Cell Bank are ready for the GMP manufacturing of its lead drug anti-4CB1 to be used in the upcoming Phase I clinical trial.
4C Biomed is seeking to secure additional funds in a Series A funding round. The funds will be used to support the company through the completion of Phase I trials and to promote further pre-clinical development of additional potential drug candidates to broaden its pipeline. Out-licensing of our lead during, or at the end of Phase I, or at the end of Phase II will aid in sustaining the company’s financial stability through the development phases.