On October 10, 2024 XENOTHERA, a Nantes-based biotech developing innovative treatments using multi-specific polyclonal glyco-humanized antibodies (GH-pAb), reported the recruitment of the first patient in its new clinical trial in onco-hematology. PALT1 is a multicenter phase I/II trial evaluating the safety and efficacy of its antibody directed against tumoral T-cells in patients with relapsed/refractory PTCL (NCT 06495723) (Press release, Xenothera, OCT 10, 2024, View Source [SID1234647145]). The PALT1 trial started at the beginning of July in five French centers.
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Meanwhile, the company received orphan drug designation (ODD) for this antibody in PTCL from the European Medicines Agency (EMA), in addition to the ODD already granted by the Food and Drug Administration (FDA).
Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of non-Hodgkin’s lymphomas for which there is a great medical need. PTCL are aggressive hematological tumors with a poor prognosis. Patients are generally treated with CHOP chemotherapy as first line, which unfortunately has limited efficacy, like other treatments, which response rate is usually less than 30%.
XENOTHERA’s antibody is derived from its platform of multi-specific glyco-humanized antibodies. In preclinical studies, it recognizes most PTCL, is more effective than CHOP on T lymphoma cells, and has a significant anti-tumor effect, reducing tumor size by up to 90% in preclinical in vivo models.
The EMA granted the clinical trial authorization for PALT1 in April 2024 and the orphan drug designation (ODD) in June 2024, confirming its interest in this innovative treatment for a serious disease. ODD provides XENOTHERA with benefits at every stage of development, including assistance with the development process, tax credit, technical assistance in preparing the application, streamlined administrative procedures, intellectual property protection and a marketing exclusivity clause once marketing authorization has been obtained. Orphan designation had already been obtained from the FDA in 2023.
The first centers to take part in the trial are the university hospitals of Caen (Professor Damaj), Clermont-Ferrand (Professor Tournilhac), Bordeaux (Professor Bouabdallah), AP-HP (Hôpital Henri-Mondor, Professor Lemonnier) and the Hospices Civils de Lyon (Hôpital Lyon-Sud, Professor Bachy). The first patient was recruited at Caen University Hospital by Professor Damaj’s teams.
PALT1 is a non-randomized, open-label phase I/II trial conducted in two stages in volunteer patients: a dose escalation phase to assess safety and tolerability and identify the maximum tolerated dose (MTD), followed by an expansion phase to assess the efficacy of PTCL treatment in relapsed/refractory patients.
"The start of this trial strengthens our position in oncology. We currently have another antibody in the clinic in solid tumors, in the FIPO trial. By entering the field of onco-hematology with the PALT1 trial, we maintain our focus on patients for whom medicine currently has no solution. I would like to thank this first patient and Professor Damaj’s teams for their confidence, and I sincerely hope that the expected benefits will be confirmed. PALT1 also supports the quality of the work done by XENOTHERA’s scientific and medical teams. Moreover, the agencies – EMA in 2024 and FDA in 2023 – are supporting our approach to patients’ needs, and reinforcing our credibility", comments Odile Duvaux, Chairman and co-founder of XENOTHERA.