XON7 immunotherapy could represent a new therapeutic approach against solid tumors.
During its participation in ASCO (American Society of Clinical Oncology), the world congress of clinical oncology held in Chicago from May 30th to June 4th, 2024, XENOTHERA, a Nantes-based biotech developing innovative treatments using multi-specific polyclonal glyco-humanized antibodies (GH-pAb), presented first data from its clinical trial in solid cancers entitled FIPO – ‘First In class Polyclonal in Oncology’ – (NCT06154291). FIPO is a phase I/II trial exploring the safety and efficacy of XON7 in patients with advanced metastatic solid tumors.
The publication at ASCO, a recognized event where the world’s cancer experts gather each year to share the latest clinical trial data and innovations in cancer research and education, presents the phase I of the non-randomized multicenter phase I/II FIPO trial. FIPO, which was granted a clinical trial authorization by the European Medicines Agency in September 2023.
Voluntary patients are receiving escalating doses of XON7 intravenously every fortnight for 12 cycles of 28 days, in a BOIN design, with the aim of characterizing safety, MTD (Maximum Tolerated Dose) and the recommended dose for the expansion phase. PK, PD, ADA data and signs of efficacy are also analyzed in the trial.
To date, 3 dose levels have been tested and initiated. Recruitment of the third dose (6 mg/kg) is underway. The data available as of April 30th, 2024, show that XON7 appears to be well tolerated at doses of 1.5 and 3 mg/kg, with no product-related side-effects or LTD (limiting toxicity dose) observed at this stage.
The clinical centers participating in the FIPO trial are located in Lyon (Léon Bérard Centre, Prof. Blay), Suresnes (Foch Hospital, Prof. Bennouna), and Toulouse (Oncopole, Prof. Delord) for France and Anderlecht for Belgium (Jules Bordet Institute, Prof. Awada).
« My first comment goes to the patients and the medical teams who are committed in this important clinical trial, I want to thank them warmly for their implication. At XENOTHERA, we have already demonstrated the safety and detected the clinical efficacy of several other products from our antibody platform, in particular LIS1 in transplantation and XAV19 in Covid. We are focusing on serious pathologies where our technology can rapidly bring hope to patients; in this respect, cancer is obviously a major concern. These initial results from FIPO, hailed in a publication at ASCO, show that we are on the right track to offer a major therapeutic innovation to cancer patients. We strongly wish that the future will confirm this hope. », says Odile Duvaux, Chairman and co-founder of XENOTHERA.
XENOTHERA has also signed a €750,000 financing agreement with BPI France to grant the FIPO clinical trial. XON7 is an anti-cancer agent with a totally innovative mechanism of action, developed in less than 4 years. This first round of funding will support the ascending phase of the trial, which began in November 2023 (first patient admitted) and should be completed by the end of 2024.
XENOTHERA, which celebrates its 10th anniversary this year, has been developing innovative medicines based on its polyclonal glyco-humanized antibody (GH-pAb) technology since its creation. XENOTHERA’s antibodies address major therapeutic needs in a number of areas, including oncology, immunosuppression, and severe viral and bacterial infections. XENOTHERA’s antibody platform enables accelerated development thanks to its in-house biomanufacturing facilities, its clinical experience (400 patients exposed to GH-pAb), and its clinical and regulatory expertise.
To date, four XENOTHERA’s GH-pAbs have been introduced in humans, in transplantation, Covid, infectious diseases and cancer. In the clinical trials already conducted (phase I, phase II, phase III), GH-pAbs have demonstrated their safety and their potential therapeutic value.
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About XON7:
XON7, a glyco-humanized polyclonal oncolytic antibody (GH-pAb), is an anti-cancer agent produced by immunizing double KO pigs (inactivated for the two xenoantigens Neu5Gc and alpha-1-3 galactose) with human tumor antigens. It targets multiple epitopes that modulate cancer metabolism. The antibody induces cell apoptosis, and tumor elimination mainly by CDC (complement-related cytotoxicity). The anti-tumor and anti-metastatic effect of XON7 has been demonstrated in colon, sarcoma, prostate, lung and triple-negative breast xenograft models.
XON7’s ability to recognize multiple solid tumors and act synergistically with immune checkpoint inhibitors (ICIs) confirms its status as promising candidate for a new line of treatments for a number of cancers affecting millions of patients.
Based on fundamentally innovative and different mechanisms of action, XON7 is presented as ‘first in class’, and limits the risk of tumor escape unfortunately observed with other treatments.
The FIPO trial testing XON7 in humans has been approved in September 2023.
About XENOTHERA:
Founded in 2014 by a team of renowned scientists and under the presidency of Odile Duvaux, medical doctor and graduate of the École Normale Supérieure, XENOTHERA is a biotechnology company based in Nantes (France) that develops new therapeutic approaches in a wide range of fields, with a focus on oncology and immunology. The company is developing treatments based on a unique multi-specific glyco-humanized antibody technology. Its technology platform is based on dual expertise in genetics and immunology.
The biotech has a comprehensive portfolio of products, four of which have already been introduced in the clinic. Its main assets are LIS22, in onco-haematology, LIS1 in transplantation, and XON7, in solid tumors.
XENOTHERA is part of the scientific and medical environment of the Pays de la Loire region (France). Since its creation, the company has raised €43 million, its main financiers being the Pays de la Loire Region, BPI France and the European fund EIC Fund, as well as private investors.
More information: www.xenothera.com
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Ingrid Zémor
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