Calando Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) have approved its investigational new drug application (IND) for lead anti-cancer compound, CALAA-01. The drug candidate is a targeted nanoparticle, comprised of a proprietary, non-chemically-modified siRNA against the M2 subunit of ribonucleotide reductase—a clinically-validated cancer target—formulated with Calando’s proprietary RONDEL™ (RNAi/Oligonucleotide Nanoparticle Delivery) polymer delivery system.
The FDA approval allows the initiation of a Phase I trial that will be conducted at the UCLA Jonsson Cancer Center (UCLA) in Los Angeles, California, and the South Texas Accelerated Research Therapeutics (START) clinic in San Antonio, Texas. It will be led by Drs. Antoni Ribas (UCLA) and Anthony Tolcher (START).
“We are pleased to have received FDA approval of our IND application for CALAA-01,” said Jeremy Heidel, CSO of Calando. “We look forward to initiating a Phase I clinical trial with CALAA-01 that we believe will be the first clinical study using targeted, systemic delivery of siRNA in an oncology setting. The entire Calando team is excited to be at the forefront of this new area for therapeutic development.”