CLEVELAND, Ohio. April 11, 2024 — More hope for successfully combating some of the deadliest cancers. Lamassu Biotech is proud to announce 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.
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.
ABOUT LAMASSU:
Accelerating treatment means saving more lives. At Lamassu, our team of dedicated physicians, engineers, and translational scientists, are driven by a passion to treat patients like family. Our goal is to speed up the innovation process by bringing transformational treatments from concept to bedside faster than other companies. Lamassu's patient-centric approach to research focuses on making advancements that address unmet needs with novel and targeted strategies, ensuring greater efficiency and shorter approval timeframes. With decades of experience developing leading medical treatments, we believe that it is not only the transformative power of science, but also hope that leads to healing. Learn more at LamassuBioTech.com.
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