NEW YORK – The US Food and Drug Administration has cleared Lamassu Biotech to begin a Phase I/IIa trial of SA53-OS, its MDM2-targeted therapy, in patients with locally advanced, metastatic p53-wildtype tumors, the company announced on Thursday.
SA53-OS is Lamassu's lead pipeline candidate, with which it aims to "trigger the body's natural defense mechanism" by activating p53 in patients with the wildtype or functional version of the tumor suppressor gene. Around half of all tumors have functional p53.
SA53-OS is specifically designed to inhibit the MDM2 protein, which regulates p53, so that it doesn't deactivate the gene's tumor suppressing capabilities. Lamassu is developing this agent and conducting the Phase I/IIa trial with the Cleveland Clinic.
"It is a critical step to move beyond conventional chemotherapy to targeted therapy to bring hope and healing to millions who suffer from stubborn cancers that don't respond to conventional treatments and to reduce the toxicity of cancer treatments," Lamassu CEO Gabi Hanna said in a statement.
In March, the National Institutes of Health and the National Cancer Institute awarded Lamassu a $2.05 million grant to further develop SA53-OS in p53-wildtype sarcomas. Funds from that grant will be also support this clinical trial, the company said.
Lamassu, based in Durham, North Carolina, is also developing RABI-767 as a treatment for pancreatitis.