Developer of personalized nanoparticle paclitaxel for multiple cancer types using. Our lead drug candidate- IG-001- is manufactured and marketed by Samyang Biopharmaceuticals in Korea.
At IGDRASOL, we are taking advantage of the convergence of three technologies that make personalized paclitaxel therapy possible. These are the three cornerstones of personalized paclitaxel therapy being developed at IGDRASOL:
1) Next Generation Nanoparticle Paclitaxel—The availability of IG-001/Genexol-PM as next generation nanoparticle paclitaxel with clinical activities on par with Abraxane, and possibly a higher MTD and a more gradual toxicity curve. IG-001 is free from issues with Cremophor and albumin; excipients for Taxol and Abraxane, respectively. It combines the manufacturing simplicity of Taxol with the albumin-mediated transport properties of Abraxane. IG-001 will be undegoing phase III clinical trials against multiple cancer types for marketing approval in the US.
2) Point-of-Care Therapeutic Drug Monitoring (TDM)—Point-of- care device allowing for self sampling and self monitoring of blood paclitaxel level is becoming a reality. IGDRASOL is spearheading this activity together with its corporate partners. For paclitaxel, there exists a large inter-individual variation in pharmacokinetics, for AUCinf (area under the plasma concentration time curve from time zero extrapolated to the infinite time), the average coefficient of variation (CV) being in the range of 20-50%. The cause of this large variation is not completely understood and therefore cannot be controlled for. Hepatic impairment and obesity have been identified as contributing factors, however, other unknown factors remain to be defined. Looking at paclitaxel PK, it is apparent that patients administered the approved dose, have a high chance of being either underdosed or overdosed.
3) Point-of-Care Biomarker Testing—Patient self sampling and self monitoring of PD biomarkers. In this case, ovarian cancer CA-125, BNP, FSH, and LH, will personalize patient care so that disease progression, therapeutic effectiveness, and prognosis can be monitored continuously. Our rapid point-of-care tests for detection of these biomarkers using the expanded range platform alleviating the need for complicated dilution and repeats making it truly a point-of-care testing. For example, traditional immunoassay for FSH exhibits at best two logs of dynamic range (1-100 IU/L); whereas, our FSH assay exhibits at least 4 logs of dynamic range (1-10,000 IU/L).