On April 11, 2024 Lamassu Biotech reported its pioneering effort to combat locally advanced metastatic p53 wild-type tumors has earned investigational new drug application (IND) approval from the Food and Drug Administration (FDA) to proceed in initiate Phase 1/2a clinical trials (Press release, Lamassu Pharma, APR 11, 2024, https://www.prnewswire.com/news-releases/possible-new-hope-for-metastatic-cancer-patients-food-and-drug-administration-grants-approval-for-clinical-trials-for-lamassus-groundbreaking-cancer-treatment-protocol-302114390.html [SID1234646266]).
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The trial will investigate novel therapy SA53-OS, a genetically targeted therapy that targets the MDM2 protein, a key regulator of the tumor suppressor p53 gene. By selectively activating p53, Lamassu aims to induce tumor cell death and inhibit growth, potentially providing a much-needed breakthrough in targeted cancer therapy.
Lamassu has been working in collaboration with the Cleveland Clinic on this trial, led by Peter Anderson, MD, which seeks to develop a new cancer treatment for patients with limited therapeutic options. With functional p53 present in about half of all cancers, the potential impact of this treatment could be transformative in the fight against cancer.
The IND approval by the FDA comes on the heels of Lamassu receiving one of the National Institutes of Health’s largest available SBIR grant awards to help launch the clinical trial study for its innovative approach to cancer treatment.
"This approval is the result of the vision and tenacity of our entire Lamassu team and our partners," said Dr. Gabi Hanna, CEO of Lamassu. "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. With SA53-OS patented in 69 countries, successful trials could make a significant impact on the global fight against cancer."
"The initiation of this trial adds to Lamassu’s record of accelerating drug development, delivering innovative therapies that can go from the laboratory to the bedside faster and with improved outcomes," said Dr. Hanna.