PIKAMAB is an emerging industry leader in the field of stratified medicine. We are advancing the development and commercialization of customized therapeutic monoclonal antibodies (MAbs). One-size-fits-all drug development and treatment approaches have resulted in only limited efficacy for several approved therapeutics despite having undergone extensive clinical trials in humans. Most of the patients in such trials are poor (or moderate) responders, or the drugs themselves work well only in subsets of those treated. This is because the drug approval decisions are based on overall results of randomized clinical trials, and that the therapeutic outcomes and clinical utility of a drug are averaged for entire populations. Evidence-based utility in a single patient is ignored.
Healthcare providers are moving toward pay-for-performance and outcome-based models, and the regulatory agencies are embracing the progressive licensing model (allowing them to revise, when necessary, product labels for already-approved drugs). Developed countries are keen on evaluating the comparative effectiveness of marketed drugs in regards to healthcare quality, costs, outcomes, and patient safety. Under such scenarios, companies can no longer afford to take the standard one-size-fits-all drug development approach which addresses all patients as a single group (see side panel for recent examples).
By understanding the mechanisms of action (MOA) by which many of the MAb therapies induce clinical response in patients, and by understanding the pathophysiology of disease progression, PIKAMAB (pronounced Pick-a-MAb) has developed theragnostic platforms to stratify patients into distinct groups to allow for optimal drug development and patient treatment protocols.
Stratified medicine is a unique method of classifying patients based on clinically relevant genetic and/or immunological properties. Such stratification is performed by the evaluation of clinical information generated by theragnostic products, which can guide in determining precisely which patients will best respond to a given treatment regimen.
- Better treatment with marketed MAbs through the development of theragnostic products, ADCC Therasight and Lupus Therasight;
- Co-development of MAb theragnostic products for new or follow-on therapeutic MAbs;
- More efficient development of MAb therapies through patient stratification in clinical trials to guide the drug development process, resulting in reduced attrition;
- More effective discovery and development of novel MAbs.
- Erbitux®: Even though this drug was originally approved for all advanced, chemotherapy-refractory colorectal patients in Europe, EMEA guidance now limits this therapy only to the patients who do not have mutations in the K-RAS gene as measured by the K-RAS test.
- Vectibix®: EMEA initially turned down the approval but later approved it only for the ‘responders’ group as judged by the K-RAS test.
- Canadian regulatory body, Health Canada, has recently approved K-RAS test as a diagnostic for anti-EGFR therapies, and as the companion diagnostic for Vectibix®.
Click to enlarge