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news.Calando Pharmaceuticals, a majority owned subsidiary of Arrowhead Research, has received FDA approval for its investigational new drug application for lead anti-cancer compound, CALAA-01.
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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 polymer delivery system.
The FDA approval allows the initiation of a Phase I trial that will be conducted at the UCLA Jonsson Cancer Center in Los Angeles, California, and the South Texas Accelerated Research Therapeutics clinic in San Antonio, Texas.
Jeremy Heidel, CSO of Calando, said: “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.”