Periodic Reporting for period 1 - NTX1088 (First-in-class anti-PVR mAb NTX1088 - a novel oncology drug that unlocks the power of human immune system and revolutionizes cancer care)
Berichtszeitraum: 2024-08-01 bis 2026-01-31
Nectin Therapeutics is a venture-backed biotechnology company developing innovative immuno-oncology therapies designed to overcome tumor-driven immune suppression. Its lead candidate, NTX1088, is a first-in-class monoclonal antibody targeting the poliovirus receptor (PVR), a membrane protein highly upregulated in many solid tumors and associated with poor prognosis. By blocking PVR, NTX1088 restores DNAM1-mediated activation of T and NK cells while simultaneously neutralizing inhibitory signaling through TIGIT, CD96, and KIR2DL5A, thereby promoting a coordinated antitumor immune response with potential synergy alongside anti-PD1 therapies. Robust preclinical data demonstrated strong in vitro and in vivo antitumor activity. Following IND clearance in April 2022, the ongoing first-in-human, open-label Phase 1 study (NTX-1088-01) is evaluating intravenous NTX1088 as monotherapy and in combination with pembrolizumab in patients with advanced solid malignancies, advancing development toward the €80 billion immuno-oncology market.
Phase 1 NTX-1088-01 study has enrolled patients across six sites in the U.S. Israel and Poland. To date, 85 patients with advanced solid tumors have received NTX1088, either as monotherapy (n=24) or combined with pembrolizumab (n=61). NTX1088 was administered intravenously across eight dose levels (12–1750 mg) during dose escalation (Phase 1a), with 1750 mg selected for expansion (Phase 1b) based on pharmacokinetics and target occupancy. Pembrolizumab was administered at 200 mg IV. Treatment has been well tolerated, with no dose-limiting toxicities observed. Among heavily pretreated patients, including many patients refractory to prior PD1 therapy, remarkable signals of activity were observed. In 38 evaluable combination patients, I complete response, 5 partial responses, and 24 stable disease cases were confirmed, with the longest ongoing response reaching 86 weeks.
Strategic expansion into EU was achieved through regulatory engagement with the European Medicines Agency via CTIS and operational partnerships with specialized clinical research organizations, laboratories, and other service providers in the EU. Following comprehensive site feasibility assessment, Maria Sklodowska Curie National Research Institute of Oncology (Warsaw, Poland) was selected, opened and now actively enrolling patients.
European uptake can broaden access to novel immuno-oncology therapies for hard-to-treat patients, reinforce regional translational research capabilities, and position NTX1088 within Europe’s competitive oncology landscape. Sustained impact will depend on activating additional EU sites in future trials, maintaining close regulatory alignment, deepening KOL engagement, strengthening biomarker-driven evidence generation, and preparing early for strategic partnerships and commercialization pathways.
European uptake can broaden access to novel immuno-oncology therapies for hard-to-treat patients, reinforce regional translational research capabilities, and position NTX1088 within Europe’s competitive oncology landscape. Sustained impact will depend on activating additional EU sites in future trials, maintaining close regulatory alignment, deepening KOL engagement, strengthening biomarker-driven evidence generation, and preparing early for strategic partnerships and commercialization pathways.