On June 1, 2024 Sairopα, a clinical-stage developer of innovative cancer therapies, reported updated results from its dose-escalation phase of the ongoing Phase 1 study evaluating safety, pharmacokinetics and clinical efficacy of ADU-1604 (anti-CTLA4 antibody) in advanced PD-1 relapsed/refractory melanoma patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024 in Chicago (Press release, Sairopa, JUN 1, 2024, View Source [SID1234643919]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data from the completed dose-escalation study (n=20) in PD-1 relapsed/refractory melanoma patients shows that ADU-1604 is well tolerated at dosages of 25, 75, 225 and 450 mg Q3W, demonstrating a mild safety profile and no dose-limiting toxicities. Early signs of clinical efficacy were observed in three patients (two patients at 225 mg and one patient at 450 mg). Dose-dependent increase of pharmacodynamic biomarkers was detected, including strong increase of CD8+ T-cell proliferation in patients that showed tumor reduction.

The currently ongoing dose-expansion phase will treat an additional 20 patients (n=20) at the recommended Phase 2 dose (RP2D) of 225mg to support potential future combination therapies.