On January 15, 2025 XENOTHERA reported the launch of two new dose cohorts in its oncology clinical trials (Press release, Xenothera, JAN 15, 2025, View Source [SID1234649744]). The biotech announces the fifth dose cohort (16mg) in the FIPO trial, which is testing XON7 in patients with solid tumors, and the second dose cohort (4mg) in the PALT trial, which is testing LIS22 in peripheral T-cell lymphoma (PTCL). These results indicate that the biotech’s anti-cancer antibodies are well tolerated, and mark major milestones in its development.
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Since 2019, XENOTHERA has been extending its expertise to the development of antibodies against cancer, in addition to its initial positioning in transplantation. Its innovative glyco-humanized polyclonal antibody (GH-pAb) technology offers promising prospects by killing cancer cells, blocking tumor escape mechanisms, limiting metastasis and combining several actions to fight cancers effectively (see publication by Ciron et al. 2024).
XENOTHERA is currently conducting clinical trials with two antibodies designed to combat cancer. XON7 is a GH-pAb that targets an original combination of tumor markers and induces a modification of the tumor environment. In vivo, XON7 has superior activity to chemotherapy in several types of cancer. The FIPO trial (NCT06154291) is a phase I/II trial testing XON7 in patients with various solid tumors (according to the protocol, sarcoma, triple-negative breast, colorectal, lung, gastro-esophageal, pancreas, ovary). Following the 1.5mg, 3mg, 6mg and 12mg dose cohorts, XENOTHERA has announced the start of the 16mg dose cohort, which has been validated by the trial’s Scientific Advisory Board. Three patients have already received this new dose. A final dose of 20mg is planned in the trial design before moving on to phase II.
LIS22 is a GH-pAb designed to specifically target mature tumour lymphocytes responsible for certain aggressive lymphomas (PTCL). It has been granted orphan drug status by the FDA and the EMA and is in phase I/II (PALT1 trial, NCT06495723) since July 2024 in PTCL patients. Following an initial patient treated at 2mg, the trial’s Scientific Advisory Board approved the switch to a 4mg dose. Three patients are currently being treated at 4mg, and will be followed by 6 patients at 6mg. The PALT trial is being supported in the France 2030 programme, with a 4M€ funding recently announced by the biotech company.
"These important milestones document the safety of our antibodies, which is per se a major asset in the treatment of cancer, where too many drugs induce harmful side-effects for patients. We are now reaching dose levels where we can expect the first signs of efficacy, even if this is not the intention at this stage, when we are focusing on safety. Basically, we are confident because the in vivo scientific data are very convincing, and we hope that patients will be the first to benefit from our advances. More fundamentally, this is a clear sign that our technology represents an avenue of innovation in oncology, and we are very proud of this. I would like to take this opportunity to thank the patients, the medical teams and the entire XENOTHERA team for their involvement in these major clinical trials’, comments Odile Duvaux, Chairman of the company.