On November 27, 2023 XENOTHERA, a Nantes-based biotech developing innovative treatments using multispecific polyclonal glyco-humanized antibodies (GH-pAb), reported the enrolment of the first patient in its clinical trial in solid cancers entitled "First In class Polyclonal in Oncology" (FIPO trial, EU Trial Number 2023-505266-29-00) (Press release, Xenothera, NOV 27, 2023, View Source [SID1234638018]). This Phase I/II trial is being carried out in collaboration with four hospitals, three in France and one in Belgium.
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XENOTHERA’s antibody platform enables accelerated development thanks to its in-house biomanufacturing facility, its clinical experience (400 patients exposed to GH-pAb), and its clinical and regulatory expertise. In less than 4 years, the French biotech has developed a new hope for patients with solid tumors. XON7 is a GH-pAb developed in several tumors, in particular lung, breast, prostate, colon and pancreas, for the most common. XON7 is an anti-cancer agent with totally innovative mechanisms of action, combining the effects of tumor destruction (oncolysis), modification of the microenvironment and synergy with immune checkpoint inhibitors. XON7 has demonstrated very significant anti-tumor effects in pre-clinical studies, and its safety in regulatory studies has enabled the European authorities to confirm its potential interest for patients.
The FIPO trial is a Phase I/II trial beginning with an ascending phase, in which increasing doses of XON7 will be administered to volunteer patients, with the aim of analyzing its safety and identifying the therapeutic dose. An expansion phase in 7 tumor indications is planned at the end of the ascending phase. FIPO has been granted a clinical trial authorization by the European Medicines Agency in September 2023. The clinical centers participating in the FIPO trial are Foch (Suresnes, France), Léon Bérard (Lyon, France), Oncopole (Toulouse, France) and Jules Bordet (Brussels, Belgium). The first patient was recruited at Hôpital Foch, in Professor Bennouna’s department, XON7 was administered on November 21st, with no immediate side effects. The next patients should be recruited in the coming weeks.
"We’ve known for four years that our antibodies could be of interest for cancer patients. Being multispecific and similar to natural immunity, our GH-pAb are particularly interesting, at a time when we need to push back the frontiers of anti-cancer treatments. XON7 is one of our candidates, it targets several original tumoral antigens and could be effective in many cancers with high medical needs. I would like to thank the team of the Foch hospital, the patients taking part in the trial and the hospitals involved, and I hope that the treatment will rapidly demonstrate its safety and efficacy," comments Odile Duvaux, President and co-founder of XENOTHERA.