Our ProgressXLock Biosciences has concentrated on developing our lead molecule, CCL20 Locked Dimer (CCL20LD), to treat CCR6/CCL20 mediated Th-17 autoimmune diseases.
Our current focus is on meeting the known hurdles for commercial drug development. Understanding that CMC and safety are often the stumbling blocks for new molecular entities, we have focused our efforts in these areas. |
CMC
XLock is able to produce CCL20LD in large quantities in 250L E. coli fermentation and deliver purity and complete biological activity.
CCL20LD production is scalable with verified yield increases from pilot to production scale (mg → g)
Consistent QC – API analyzed via analytical HPLC, MS, and NMR
SAFETY AND PHARMACOLOGY
We have done a 2-week safety/toxicology study in mice with Charles River Lab (Mattawan, MI). This study was performed at approximately 30x the anticipated allometric human dose of CCL20LD given daily for 2 weeks. There were no adverse histopathology, clinical chemistry or hematologic findings, even at the significant dose overages.
EXTENDED HALF-LIFE OF CCL20 LOCKED DIMER
The Hwang lab at UC-Davis, using a modified ELISA assay developed by our scientists, has found that CCL20LD in mice has a half-life of 6 ± 2 hours. (Wu X et al (2023) Journal of Immunological Methods)
CCL20LD Half-life determination by collecting mouse serum at multiple time points (0, 1, 8, 24 h) after SC delivery (n = 3 mice per time point). Blood was collected through cardiac puncture at time indicated.
CCL20LD Half-life determination by collecting mouse serum at multiple time points (0, 1, 8, 24 h) after SC delivery (n = 3 mice per time point). Blood was collected through cardiac puncture at time indicated.
XLock is aware that a biologic needs a much longer
half-life to be an acceptable therapeutic.
Therefore, to extend the half-life of our lead molecule, we have formulated an FC fusion version of CCL20LD and as of June 2023, we have demonstrated the ability to express not only, CCL20LD, but also the FC fusion version in CHO cells.
We anticipate scale up of production to test the half-life of this FC molecule during the first half of 2024.
We anticipate scale up of production to test the half-life of this FC molecule during the first half of 2024.