Product Overview

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 (F158) and FcGR-2A (R131) 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.
Highlights
  • MAbs are molecularly targeted therapies used to treat a wide range of cancers and autoimmune diseases.
  • PIKAMAB stratifies patients into a proprietary 3×3 Matrix™ based on the FcGR-3A and FcGR-2A polymorphisms.
  • Through antibody engineering, proprietary MAb therapies are customized to achieve excellent therapeutic response rate in each patient group in the 3x3 Matrix.
  • In the infectious disease space (for example, HIV, HCV, and malaria), the 3x3 Matrix can be integrated to develop vaccines and therapies.

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