AffyXell Platform

Convergence of DW-MSC & Affimer Platform

AffyXell Platform

Novel Cell & Gene Therapy Platform for Immune-mediated Diseases

“AffyXell” developed by AffyXell Therapeutics is a next generation cell & gene therapeutics that has adopted Affimer® gene to DW-MSC with advantage
of consistency of stem cell features for long term cultivation. “AffyXell” maintains the fundamental immune-modulatory function of mesenchymal stem
cell, and that functions are improved further through Affimer®,which is expected to feature more excellent efficacy than any precedented stem cells.
Also, Affimer® has its advantage in being able to clearly explain its mechanism of action property of AffyXell as it affects more specific proteins. AffyXellis
is based on DW-MSC, which means that it can be used for diverse patients (Allogenic therapy) and can be developed into a cryopreservation product
that can be administered to the patient without additional preparation at the hospital, which is expected to be a cell & gene therapeutic in a whole
different concept from the conventional stem cell therapy.

Based on 900 clinical trials, MSC’s immune-modulatory properties are well known,
but it’s in vivo mechanism is hardly explained

Therapeutics for immunologic/inflammatory diseases with clear mechanism

  1. A Paracrine effects : Effect from cytokine or growth factor secreted by MSCs
  2. B Cell to cell contact : Takes on effect by being in interaction with immune cells or damaged cells
  1. 1 AFX-001 : Regulation of T cell-mediated B cell activation
  2. 2 AFX-002 : Treg-mediated suppression of T cell activation and proliferation
  3. 3 AFX-003 : Control of general Immune environment
  • Allogenic MSC therapeutics, high versatility as off-the-shelf product
  • Maximize immunomodulation effects
    (MSC’s effects + Affimer-mediated specific effects)
  • Overcome current challenges and limitations of stem cell therapies (Clear MoA & mass production with consistent quality control)
Mode of Actions
  • Designed to improve immunomodulation function of MSC with Affimer®
  • Specific agonist or antagonist to signal regulator(s) to control abnormal immune responses
  • Designed to recover the balance of immune system by controlling both innate and adaptive immune system
Therapeutic Area
  • Autoimmune disease,Transplantation rejection (SOT, GVHD), and Inflammatory diseases
  • Indication expansion to intractable diseases: sub-acute strokes, severe acute pancreatitis, acute respiratory distress syndrome (ARDS)
Cost Effective
  • Cell banking system, which enables mass production
    (leading to affordable care for patients)
  • Controlled manufacturing process for robust and consistent MSC products
  • Consistent quality management from batch-to-batch and unit-to-unit

AffyXell Development Process

“AffyXell“, by AffyXell Therapeutics, is being developed in the following stages to ensure mass production in highly consistent quality. A parental cell
bank was manufactured with DW-MSC differentiated from PSC, and the AffyXell bank into which the Affimer gene was introduced through a viral
vector are separately manufactured. AffyXell cell bank is stored at cryogenic temperature, and each of 1 vial of cell bank is thawed for batch production.
The fill-finish engineered products are cryopreserved and packaged. The final products are distributed globally using cryogenic temperature logistics
system, and each dose is thawed at each hospital and administered to patients immediately.

DW-MSC platform Affimer® platform

DW-MSC platform

Advanced Mesenchymal Stem Cell Platform

The Most suitable MSC platform for cell & gene therapies

Stem cell therapeutics platform (DW-MSC) of Daewoong Pharmaceuticals is advanced stem cell platform technology that has overcome current
limitations of tissue-derived mesenchymal stem cell. For therapeutic functional improvement through the introduce gene of stem cell, a stem cell must
possible to long-term cultivation. DW-MSC is an advanced platform technology capable of long-term cultivation compared to conventional tissue-
derived mesenchymal stem cell and mass production of cell & gene therapeutic with highly consistent quality after introduction of therapeutic gene.

Next-generation stem cell platform

Human pluripotent stem cell (PSC)-derived MSC, the innovative platform which enables long-term and multiple passages in cell culture

Higher productivity
Cell bank system
  • cGMP manufactured MSC
Mass production
  • Mass production based on single donor
Off-the-Shelf Product
Allogenic product
  • Allogeneic PSC-derived MSC
  • Ready-to-Use formulation
Cell & Gene Platform
Genetic modification
  • Long-term stemness
  • High consistency and quality

Affimer® platform

Novel Class of Biotherapeutic
Based on a Naturally Occurring Human Protein

Affimer® technology of Avacta, U.K is a novel protein therapeutics platform based on the natural substances in the human body called ‘Stefin A’
Affimer® platform allows to develop protein therapeutic with similar function as antibody, and its size is about a tenth of an antibody, with small, simple structure and high stability.
When Affimer® gene is introduced to stem cell, its expression is more convenient, it a great advantage in developing cell & gene therapeutic.

Novel Class of Biotherapeutic Scaffold

Biotherapeutic platform designed and engineered to have similar properties as antibody based on substance that exists in human body

Avacta Affimer® Platform

The Advanced Platform of Non-lgG Scaffold

Small & Stable
  • 1/10th size compared to monoclonal antibody : Differentiated tissue penetration
  • Good drug-like properties : Good safety and strong efficacy
Mix & Match
  • Flexible formatting and structure design : Flexible formatting options for multimeric and membrane-anchored forms
  • Tunable pharmacokinetics: Readily tailored half-life and biodistribution properties
High Expression
  • No disulfide bond nor PTMs : Well behaved, highly soluble therapeutic scaffolds
  • Ideal for cell & gene therapies : High-level expression in stably transfected cells without physiological disturbance
  • Secretion or membrane anchored type