Novel p53-activiting MDM2 inhibitor oncology platform therapy

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Principal Investigator:

François-Xavier Lacasse / UdeM

Co-Investigators:

John Sampalis, Ramy Saleh / RI-MUHC

Gabi Hanna / Saydi Biotech

Project of $3,342,000 over 3 years

Supported by CQDM through:

Ministère de l’Économie, de l’Innovation et de l’Énergie du Québec (MEIE)

And by co-funding partners:

Saydi Biotech

The project in details:

Challenge:  All human cells have an innate tumor suppressor function that is deactivated during cancer development, leading to a potential potent therapeutic target if the mechanism can be reactivated. The p53 protein, tumor suppressor, is inhibited by the MDM2 protein in a very large number and variety of cancers, including 85% of sarcomas. It is estimated that this type of mutation is involved in 600,000 cases of cancer per year worldwide and is responsible for 200,000 deaths. MDM2 inhibitors are drawing more attention from several major pharmaceutical companies as they recognize the huge benefits for patients.

Solution: The Quebec-based company Saydi Biotech has developed a novel MDM2 inhibitor with a far superior therapeutic activity and bioavailability than the competition, capable of eliminating and preventing osteosarcoma relapse in mouse models. The molecule has also demonstrated efficacy in several other tumor types. This collaborative project proposes the development of a new orally bioavailable treatment approach based on the Saydi’s novel MDM2 inhibitor ‘S53’ that will activate the cell’s own defence mechanism against cancer, leading to improved survival and quality of life for patients. The team will refine the compound’s formulation and carry out a Phase I clinical trial to determine the optimal therapeutic dose, assess its safety and obtain preliminary results on its efficacy in humans.

Expected Achievements /Impacts:  This study has the potential to drastically increase patient survival rate in a wide variety of aggressive cancers, starting with sarcomas, therefore the primary objective is to advance rapidly and efficiently this novel and effective S53 drug product through clinical trials to positively impact patients’ lives. Saydi Biotech will benefit from this project by developing and growing rapidly in the province of Quebec, hence allowing the company to raise the capital necessary to carry out subsequent clinical phases in Quebec and to set up new partnerships.

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