On October 26, 2023 CatalYm reported that the first patient has been dosed in the Phase 2 clinical trial, GDFather-NEO (NCT06059547), evaluating its lead anti-GDF-15 antibody candidate, visugromab, in combination with neoadjuvant immunotherapy (nivolumab, aPD-1 inhibitor) in muscle invasive bladder cancer (MIBC) (Press release, Catalym, OCT 26, 2023, View Source [SID1234636367]). The exploratory study expands visugromab’s clinical Phase 2 evaluation to a therapeutic front-line setting, building on the positive results from the ongoing GDFather-2 (NCT04725474) trial in last-line metastatic patients with a range of advanced, treatment-resistant solid tumors.
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"Visugromab offers a very distinct mechanism of action that has the potential to break key immunotherapy resistance mechanisms preventing aPD-1 therapy to fully deliver," commented Prof. Dr. Andrea Necchi, Director of Genitourinary Medical Oncology at IRCCS San Raffaele Hospital and Principal Investigator of the study. "Based on the encouraging efficacy signs achieved with the visugromab-nivolumab combination in the last-line setting, we are looking forward to exploring this new approach in the front-line setting to open new avenues for the treatment of early-stage bladder cancer."
"This study provides us with the first opportunity to evaluate visugromab in an earlier clinical setting and allows us to gain a deeper understanding of its immunosupportive activity. It will also offer us expanded reference data on response-predictive biomarkers and provide further insights into visugromab’s extensive therapeutic potential for patients with hard-to-treat cancers that have built immune-resistance mechanisms," added Dr. Phil L’Huillier, Chief Executive Officer at CatalYm.
The exploratory, controlled GDFATHER-NEO Phase 2 study is assessing the safety and initial signs of clinical efficacy of a combination treatment of nivolumab plus visugromab compared to nivolumab plus placebo in patients with MIBC who are set to undergo radical cystectomy and cannot or refuse to receive cisplatin-based chemotherapy. In addition, the study will provide data on potential response-predictive biomarkers for patient stratification. The trial will be led from Milan, Italy, and will enroll 30 patients in a 1:1 setting at four sites in Italy.