PTX-912 / Proviva Therap - LARVOL DELTA

Trial in progress: A first-in-human (FIH) phase I study of PTX-912 in patients with locally advanced or metastatic solid tumors. (ASCO 2025) - P1 | "Moreover, combining IL-2 with pembrolizumab in mRCC demonstrated a durable response rate of 70%, compared to objective response rates (ORR) of 20% and 33% with IL-2 and pembrolizumab monotherapy, respectively (Chatzkel et al., Clin Genitourin Cancer(2022)). Cohorts 1 to 4 (6 patients) have been completed without DLT. Enrollment to cohort 5 is currently ongoing."

Clinical • Metastases • P1 data • CNS Disorders • Genito-urinary Cancer • Immunology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Renal Cell Carcinoma • Respiratory Diseases • Solid Tumor • IL2RA

A First-in-human (FIH), Multicenter, Open-Label, Phase Ia (Dose Escalation)/Phase Ib (Dose Expansion) Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors (ChiCTR) - P1 | N=48 | Recruiting | Sponsor: Proviva Therapeutics (Shanghai) Limited; Shanghai East Hospital

New P1 trial • Oncology • Solid Tumor

PTX912, a first-in-class PD-1/proIL-2 fusion protein, exhibits PD-1 blockade and tumor activated IL-2R agonism for effective cancer immunotherapy with enhanced therapeutic window (SITC 2024) - "PTX-912 also demonstrated a favorable safety profile in a monkey GLP study. A Phase 1 clinical trial of PTX-912 is currently ongoing to study the safety, pharmacokinetics, and anti-tumor activity in patients with advanced solid tumors."

IO biomarker • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • IL2RA • STAT5

A First-in-human (FIH), Phase I Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Proviva Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Effect of a novel anti-PD-1-proIL-2 bifunctional fusion protein on potent anti-tumor activity via PD-1 checkpoint inhibition and conditional IL-2R agonism. (ASCO 2024) - "Furthermore, combination therapy of IL-2 and pembrolizumab in mRCC has shown durable 70% response rate, while the ORR of monotherapy is 20% and 33% for IL-2 and pembrolizumab, respectively. Our preclinical data demonstrated that PTX-912 effectively stimulated the expansion and reinvigoration of antigen specific T cells in the tumor tissue resulting in strong anti-tumor efficacy while it did not cause significant peripheral toxicity. Phase 1 clinical trial of PD-1-proIL-2v is planned to start in early 2024 to evaluate the safety, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors."

Checkpoint inhibition • IO biomarker • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD4 • CD8 • HAVCR2 • IFNG • IL2RA • STAT5

A First-in-human (FIH), Multicenter, Open-Label, Phase I Study of PTX-912 in Patients With Locally Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: Proviva Therapeutics, Inc.

Metastases • New P1 trial • Oncology • Solid Tumor