On September 14, 2022 Phost’in Therapeutics (Montpellier, France), a clinical stage company focused on the discovery and development of N-glycosylation inhibitors for the treatment of cancer and other serious diseases, reported dosing of the first three patients in the Dose Escalation phase of the PhAST trial, an adaptive Phase I/II study in patients with advanced solid tumors evaluating the First-In-Class selective N-glycosylation inhibitor, PhOx430 (Press release, Phost’in, SEP 14, 2022, View Source [SID1234619532]). The study is operated with the scientific contribution of the Gianni Bonadonna Foundation which collaborated to the conception of the research protocol.

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PhAST trial will evaluate safety and pharmacodynamic effects of PhOx430 in patients. Additional objectives will include a preliminary evaluation of efficacy and the identification of biomarkers. The current dose escalation phase will eventually enroll two dozen of patients with non-selected tumour types. It will be followed by three expansion cohorts gathering patients with selected tumour types, including Glioblastoma multiforme (GBM), Triple-negative breast cancer (TNBC) and a selection of other solid tumour types, for which few therapeutic options exist.

Dr. Alain Herrera, CMO of Phost’in Therapeutics, said: "Dosing of first three patients marks an important milestone in the development of PhOx430. And beyond any scientific achievement, as a selective N-glycosylation inhibitor is administered for the 1st time in patients, it is a step ahead in the fight to overcome cancer and immune resistance with disrupting approaches". Dr. Luca Gianni, President of The Gianni Bonadonna Foundation, added "With the activation of both sites involved in the Dose Escalation Phase, a further step has been taken in this innovative first-in-human clinical trial, that could open new avenues for solid tumors therapy. With this in mind, Fondazione Gianni Bonadonna will continue collaborating with the PhAST Trial Team to achieve the best results for cancer patients’ benefit.".

First patients have been enrolled at the I.R.C.C.S. Ospedale San Raffaele in Milan, Italy, and at the Institute of Cancer of Montpellier (ICM), France. Dr. Diego Tosi, head of the Early Clinical Trial Unit-Medical Oncology Department and Principal Investigator at ICM, has been entrusted with the international direction of the first-in-human clinical trial.

The contract research organization ("CRO") Michelangelo Tech Srl (Milan, Italy) has been appointed by Phost’in to coordinate the PhAST trial. Owned by the Michelangelo Foundation with the aim of contributing to progress in cancer research and improving treatment options for tumors, Michelangelo Tech Srl provides extensive expertise in early phase clinical development, precisely to favor the rapid clinical application of new therapies. In parallel, Phost’in Therapeutics has selected Leads to Development (Paris, France), an agency with a strong reputation across Europe and the United States for regulatory and development expertise, to support product development strategy definition, operations and filings

About PhOx 430 treatment
The aberrant, complex and hypersialylated glycosylation of tumor cells is now recognized as a novel immune checkpoint, affecting key membrane receptors and masking tumor cells to the immune system, via the formation of complex abnormal glycan patterns operating as a shield. PhOx430 targets this aberrant glycosylation directly to the source through selective inhibition of a specific enzyme for a double antitumor effect, inducing simultaneously an anti-cancer immune response and the down regulation of the main receptors implicated in cancer progression. The program has demonstrated a significant antitumoral efficacy in several animal models, associated with a promising safety profile in regulatory preclinical studies. It is the first program from the Phost’ScreenTM platform that combines unique and patented chemical libraries with cutting-edge screening tools to produce selective nglycosylation inhibitors.