Comment from CEO of Daewoong9 Jan 2024 09:18
Sorry if this is a repeat :
AffyXell is a clinical ready stage biotechnology company with a proprietary platform engine to develop novel cell and gene therapy (CGT). This platform is a powerhouse not only for internal pipelines but also for external collaboration. We recently signed a research collaboration agreement with one of the pioneering big pharmas in CGT, which is a testimonial of the potential strength and expandability of AffyXell’s platform technologies.
We are dedicated to developing off-the-shelf allogenic cell therapies for the treatment of transplantation rejection and immune disorders. Our technology enables the merge of two different platform technologies from our parent companies: Daewoong's Mesenchymal Stem Cell technology (DW-MSC) and Avacta's Affimer technology.
Our strategic approach is to genetically modify MSCs to express Affimers, with the aim of achieving three key objectives:
1) Significantly enhanced efficacy compared to conventional MSC therapeutics.
2) A clear understanding of the mechanism of action.
3) Consistent, reproducible, and cost-effective manufacturing.
Affimer proteins, based on Stefin A, serve as non-IgG scaffold proteins capable of acting as antagonists or agonists by binding to specific antigens, much like antibodies. We have established cell banks for both DW-MSC and AffyXell, enabling consistent, reproducible, and scalable batch production from a single cell bank.
Our lead pipeline candidate, AFX001, is designed to inhibit CD40-CD40L signaling by binding to CD40L and blocking the interaction through the secretion of an anti-CD40L antagonistic Affimer. CD40-CD40L signaling plays a pivotal role in T cell activation, T cell-mediated B cell activation/differentiation, and immune responses involving antigen-presenting cells (APCs). Inhibition of T cell and B cell activation through CD40-CD40L signaling suppression offers therapeutic potential for conditions like GvHD and various autoimmune diseases, including systemic lupus erythematosus, type 1 diabetes mellitus, multiple sclerosis, and rheumatoid arthritis.
Excitingly, we have demonstrated AFX001's outstanding efficacy compared to un-transduced MSCs using a humanized Graft versus Host Disease (GvHD) mouse model. Furthermore, AFX001 exhibits comparable efficacy to a pre-clinically verified anti-CD40L antibody.
We recently concluded a smooth pre-IND meeting with the US FDA, and we are on track to initiate patient-targeted clinical trials in the second half of this year. We are ready to manufacture GMP batch for the clinical trials with the established GMP-grade Master Cell Bank (MCB) and Working Cell Bank (WCB).
The second program, AFX002 is uniquely positioned to activate patients’ regulatory T cells to induce immune tolerance, which is a critical lacking mechanism in many autoimmune disease patients. We are in the final stage of lead cell selection, and we are excited to have the in vivo efficacy data this
Sign In
Follow the stocks
