ARIUS Research Inc. has announced it has completed its Pre-IND (Investigational New Drug) meeting with the FDA to discuss the upcoming IND submission for ARH460-16-2, its lead CD44 Cancer Stem Cell Program.
ARH460-16-2 is an anti-cancer antibody targeting a novel epitope of CD44 found in hematological and solid cancers, including breast, colon and prostate. The Pre-IND meeting focused on development plans for the drug, including manufacturing details, preclinical pharmacology and toxicology data, and the proposed plans for the Phase I clinical program.
"The completion of our pre-IND meeting with the FDA is an important milestone for the Company and demonstrates the significant progress we have made with our lead CD44 Cancer Stem Cell Program and our ability to advance drug candidates towards human clinical trials," said Dr. David Young, President and Chief Executive Officer.
"We are pleased with the outcome of this meeting and will continue to prepare for our IND submission with the intention of initiating human clinical trials this year," Young added.
Concurrently, ARIUS announced the promotion of Susan Hahn, PhD, formerly Director of Development, to the position of Vice resident of Development.
"Dr. Hahn has been instrumental in leading the development of our antibody programs that we are taking to the clinic," said Dr. Young. "In her new role, Dr. Hahn will continue to focus on meeting ARIUS' development milestones as we move each of our lead drug candidates towards human clinical trials."
The CD44 Cancer Stem Cell program was generated using ARIUS' proprietary FunctionFIRST™ technology, which selects antibodies based on their ability to kill cancer cells.
Pre-clinical data from a dose-ranging pilot toxicology study in non-human primate models demonstrated no dose-limiting toxic effects at doses up to 95 mg/kg and significant tumor growth inhibitory activity in in vivo animal models of breast, prostate, liver and AML cancers. The Company will now complete manufacturing and advanced toxicology studies toward filing the IND later this year.