In a notable advancement in cancer treatment, Lamassu Biotech has achieved a major milestone with the approval of its investigational new drug application (IND) by the Food and Drug Administration (FDA).
This approval paves the way for the initiation of Phase 1/2a clinical trials for SA53-OS, a therapy designed to combat locally advanced metastatic p53 wild-type tumors.
SA53-OS represents a novel approach to cancer therapy, targeting the MDM2 protein, a critical regulator of the tumor suppressor p53 gene. Through selective activation of p53, Lamassu aims to trigger tumor cell death and inhibit growth, offering a breakthrough in targeted cancer treatment.
The collaborative efforts of Lamassu Biotech and the Cleveland Clinic, led by Peter Anderson, MD, have been instrumental in the development of this innovative treatment. With functional p53 present in approximately half of all cancers, the potential impact of SA53-OS on cancer treatment could be transformative for patients facing limited therapeutic options.
The FDA's approval of the IND follows Lamassu's receipt of a substantial grant from the National Institutes of Health, highlighting the recognition and support for the company's pioneering approach to cancer therapy.
"This approval is the culmination of the dedication and perseverance of our entire Lamassu team and our collaborators," stated Dr. Gabi Hanna, CEO of Lamassu. "It represents a critical step towards transitioning from traditional chemotherapy to targeted therapy, offering hope and relief to millions of individuals suffering from resistant cancers that do not respond to conventional treatments. With patents secured in 69 countries, the success of our trials could have a profound impact on the global fight against cancer," added Dr. Hanna.
Dr. Hanna further emphasized Lamassu's commitment to expediting drug development and delivering innovative therapies with enhanced efficacy and reduced toxicity.