Stratified MAbs
The term “stratified medicine” is herein defined as the method by which patients are classified into distinct groups based on clinically relevant genetic and/or immunological properties in order to enhance the efficacy of drug development and patient treatment. Such stratification is based on the clinically relevant information generated by a theragnostic test.
Despite the introduction of many targeted MAb (monoclonal antibodies) therapies to treat cancers in recent years, efficacy has been limited when administered as monotherapies. Only a subset of patients (~5-10%) actually achieve excellent therapeutic response, and progression-free survival (PFS) for many of the MAb monotherapies. This variability is due to the fact that patients are genetically and immunologically different. Currently cancer patients are subjected to combination therapies that include chemotherapies and radiation therapies, which are both expensive and have serious side effects and toxicity profiles.
PIKAMAB takes a unique ‘drug portfolio’ approach in developing its proprietary MAb therapies in order to potentially save time and capital while minimizing risks associated with new drug development. The MAb therapies developed through our proprietary antibody engineering platform are expected to have superior efficacy as well as excellent therapeutic outcomes in each patient group in the matrix. Specifically, the antigen binding CDR regions are not altered. To generate these MAb variants, PIKAMAB employs its proprietary antibody engineering platform to modify the Fc portion of the MAb. Although a maximum of nine different Fc constructs are necessary to cover the matrix, a minimum of four Fc constructs could be enough to cover all the patient groups in the matrix, and even one additional construct may be sufficient to significantly expand the number of treatable patients. However, for the purposes of patient selection and treatment, the 3×3 Matrix is particularly useful.
PIKAMAB is developing its proprietary MAb products with the goal of improving the clinical efficacy of currently marketed ADCC-MAbs and plans to develop or co-develop these stratified MAb products with the intent to commercialize these drugs worldwide. Additionally, PIKAMAB will license its product candidates (MAbs+Tx test) to clinical development partners. Through strategic partnerships with biopharma companies, PIKAMAB will co-develop second-generation MAb therapies in the combination drug (MAb+Tx test) format. This stratified medicine approach provides significant competitive advantages to our biopharma partners as part of their product life-cycle management and as a way to effectively compete in an ever-evolving biogeneric landscape in the U.S., Europe, and Japan.
Highlights Improved treatment outcomes with significant advantages for patients, payers, and biopharma partners:
- Customized MAb therapies designed to achieve excellent results in all patient groups in the 3x3 Matrix.
- Excellent ADCC results in each patient group will maximize the efficacy of MAb therapies in treatment of various cancers.
- In autoimmune diseases, excellent clearance of immune complexes can be achieved through phagocytosis and mesangial clearance in the kidneys.
- Higher pricing premium, market refinement, and market exclusivity for biopharma companies.
- Guided drug development process leads to reduced attrition, and reduced drug development cost and time.
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