MAbs have emerged as the fastest growing class of pharmaceutical products in recent years and in 2007 achieved worldwide sales of approximately $25 billion.
Despite exquisite specificity to their targets, many antibodies,
particularly when used in a monotherapy setting, exhibit excellent
therapeutic response in some patients but perform poorly in many
others. This variability is due to the fact that patients are
genetically and immunologically different. As a result, there is a
significant market pressure to develop an effective method to stratify
patients into potential responders versus non-responders.
By incorporating the 3×3 Matrix™ into the
antibody engineering platform, PIKAMAB develops
customized MAb therapies for each patient group in the matrix such that ADCC and ADCC-related mechanisms of action are fully enabled by effectively engaging the necessary immune cells such as the NK-cells, macrophages, and neutrophils. This patient and group-specific Fc engineering allows for effective engagement of IgGs to FcGR-3A and FcGR-2A in immune cells (NK-cells, macrophages, and neutrophils). For example, the Group-9 IgG construct in the matrix has the optimized Fc for FcGR-3A (F
158) and FcGR-2A (R
131) receptors. Thus, effective ADCC and phagocytosis-mediated clearance of immune complexes can be achieved in each patient group.
PIKAMAB captures these inventions in its theragnostic and MAb drug development programs. The theragnostic products,
ADCC Therasight™
and Lupus Therasight™, stratify patients into nine distinct groups
through a proprietary 3×3 Matrix™ and provide critical treatment
guidance to biopharma companies, regulatory agencies, payers, and
physicians.
- PIKAMAB’s theragnostic products that include ADCC Therasight™ and Lupus Therasight™ provide therapeutic guidance to marketed MAb therapies.
- ADCC is the major mechanism of action of several marketed MAbs (FcGR-3A and FcGR-2A receptors are directly involved in mediating ADCC).
- In several autoimmune diseases and inflammatory disorders, immune complexes are cleared in kidney, liver, and spleen by macrophage-mediated phagocytosis: FcGR-3A and FcGR-2A receptors play a central role in phagocytosis.
Emerging Market
The blockbuster antibody market, currently led by MAbs such as Rituxan, Remicade, and Herceptin, is projected to exceed $20 billion in sales in 2009. Currently, there are over 200 antibody product candidates in clinical development.
PIKAMAB is planning to initiate an antibody engineering R&D efforts
in India to operationalize the generation of these stratified MAb
products. PIKAMAB is also in the process of establishing a
CLIA-certified testing facility in the U.S. to commercialize
theragnostic products. In the second phase, we plan to expand
theragnostic operations into Europe and Asia.