PRL3-Zumab / Intra-ImmuSG - LARVOL DELTA

The PRL3-zumab paradigm: A multicenter, single-dose-level phase 2 basket clinical trial design of an unconventional cancer immunotherapy. (PubMed, Cell Rep Med) - P2 | "PRL3-zumab demonstrates excellent safety and clear clinical benefits in late-stage IV solid cancer patients. This trial is registered at ClinicalTrials.gov as NCT04452955."

Journal • P2 data • Oncology • Solid Tumor

Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=14 | Completed | Sponsor: National Cancer Centre, Singapore | Recruiting ➔ Completed | N=30 ➔ 14

Biomarker • Enrollment change • Trial completion • Gastric Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Phase I/II Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD) (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: Intra-IMMUSG Pte Ltd

New P1/2 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

China Phase II: PRL3-Zumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Intra-IMMUSG Pte Ltd

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Intra-IMMUSG Pte Ltd | Trial completion date: Mar 2026 ➔ Dec 2026 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients (clinicaltrials.gov) - P2/3 | N=52 | Recruiting | Sponsor: Intra-IMMUSG Pte Ltd | Trial completion date: Feb 2026 ➔ Dec 2026 | Trial primary completion date: Feb 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

PRL3-zumab cancer immunotherapy shows promise for treating neovascular eye diseases. (PubMed, Expert Opin Investig Drugs) - No abstract available

Journal • Oncology • Ophthalmology

Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients (clinicaltrials.gov) - P2/3 | N=52 | Recruiting | Sponsor: Intra-IMMUSG Pte Ltd

New P2/3 trial • Oncology • Solid Tumor

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Intra-IMMUSG Pte Ltd | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Nov 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Solid Tumor

A First-in-Human Study of PRL3-ZUMAB (clinicaltrials.gov) - P1 | N=38 | Active, not recruiting | Sponsor: National University Hospital, Singapore | Unknown status ➔ Active, not recruiting | Trial completion date: Feb 2020 ➔ Feb 2027 | Trial primary completion date: Feb 2020 ➔ Feb 2027

Enrollment closed • First-in-human • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

PRL3-zumab as an anti-angiogenic therapy in neovascular eye diseases. (PubMed, Nat Commun) - "PRL3-zumab, an anti-PRL3 humanized monoclonal antibody, has shown a strong safety profile in ongoing multi-national Phase II trials as an intravenous-administered cancer immunotherapeutic. PRL3's involvement in ocular pathological angiogenesis suggests the potential of repurposing PRL3-zumab to treat neovascular eye diseases."

IO biomarker • Journal • Oncology • Ophthalmology • Retinal Disorders • MAPK1 • MAPK3

Novel cancer immunotherapy offers new hope for late-stage cancer patients (PRNewswire) - P2 | N=51 | NCT04452955 | Sponsor: Intra-IMMUSG Pte Ltd | "Published in Cell Reports Medicine, the study shows PRL3-zumab safely slows disease progression in patients with advanced solid cancers unresponsive to existing treatments....The Phase II trial enrolled 51 patients with various advanced-stage solid cancers. PRL3-zumab demonstrated a favorable safety profile, with no serious drug-related side-effects reported.....In comparison, patients receiving existing treatments after standard therapies typically see disease progression in about two months, highlighting PRL3-zumab's potential to significantly improve patient outcomes."

P2 data • Solid Tumor

PRL-3: unveiling a new horizon in cancer therapy. (PubMed, Acta Pharmacol Sin) - "Targeted therapies against PRL-3, encompassing small molecule inhibitors and the monoclonal antibody PRL-3-zumab, have shown promise in clinical and preclinical studies, presenting new avenues for cancer treatment. In addition, innovative approaches such as CAAX motif-targeting agents and PRL-3 degradation strategies hold promise for developing more precise and effective interventions. This review explores PRL-3's multifaceted roles across different tumor types and microenvironments, while discussing current and emerging therapeutic strategies aimed at exploiting its oncogenic potential."

Journal • Review • Oncology • PTP4A3

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients with Solid Tumors (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Intra-IMMUSG Pte Ltd | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Intra-IMMUSG Pte Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Jun 2025 | Trial primary completion date: Sep 2023 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Protein Tyrosine Phosphatase PRL-3: A Key Player in Cancer Signaling. (PubMed, Biomolecules) - "PRL-3-zumab, a humanized antibody, shows promise in preclinical studies and clinical trials. Our review summarizes the current understanding of the cancer-related cellular function of PRL-3, its prognostic value, and the research progress of therapeutic inhibitors."

Journal • Review • Oncology • PTP4A3

Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: National Cancer Centre, Singapore | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Biomarker • Metastases • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Exploiting frequent and specific expression of PRL3 in pediatric solid tumors for first-in-child use of PRL3-zumab humanized antibody. (PubMed, Mol Ther Oncolytics) - "A 28.6% reduction in maximum target lesion diameter was achieved when PRL3-zumab was administered concurrently with hypofractionated radiation. These findings support wider exploration of PRL3 expression in embryonal and mesenchymal tumors and further clinical application of PRL3-zumab in pediatric patients."

Journal • CNS Tumor • Nephrology • Neuroblastoma • Neuroendocrine Tumor • Oncology • Osteosarcoma • Pediatrics • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Wilms Tumor • PTP4A3 • TIMP1 • TIMP2

PRL3 as a therapeutic target for novel cancer immunotherapy in multiple cancer types. (PubMed, Theranostics) - "Much effort has been made in developing PRL3-targeted therapy with small chemical inhibitors against intracellular PRL3, and notably, the development of PRL3-zumab as a novel cancer immunotherapy against PRL3. In this review, we summarize the current understanding of the role of PRL3 in cancer-related cellular functions, its prognostic value, as well as perspectives on PRL3 as a target for unconventional immunotherapy in the clinic with PRL3-zumab."

IO biomarker • Journal • Review • Oncology • PTP4A3

A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies. (PubMed, Target Oncol) - P1 | "PRL3-zumab, a first-in-class humanized antibody, was safe and tolerable in solid tumors and hematological malignancies."

Journal • Metastases • P1 data • Acute Myelogenous Leukemia • Fatigue • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • PTP4A3

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=55 | Recruiting | Sponsor: Intra-IMMUSG Pte Ltd | N=33 ➔ 55 | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Enrollment change • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: National Cancer Centre, Singapore | Trial completion date: Dec 2021 ➔ Jun 2024 | Trial primary completion date: Dec 2021 ➔ Jun 2024

Biomarker • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immune Modulation • Oncology • Solid Tumor

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Intra-IMMUSG Pte Ltd | Trial completion date: Jun 2022 ➔ Dec 2022 | Trial primary completion date: Mar 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors (clinicaltrials.gov) - P2; N=33; Recruiting; Sponsor: Intra-IMMUSG Pte Ltd; Trial completion date: Jan 2022 ➔ Jun 2022; Trial primary completion date: Sep 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

PRL3 induces polypoid giant cancer cells eliminated by PRL3-zumab to reduce tumor relapse. (PubMed, Commun Biol) - "PRL3-zumab has been approved for Phase 2 clinical trials in Singapore, US, and China to block all solid tumors. This study further showed PRL3-zumab could potentially serve an 'Adjuvant Immunotherapy' after tumor removal surgery to eliminate PRL3 PGCC stem-like cells, preventing metastasis and relapse."

IO biomarker • Journal • Oncology • Solid Tumor • POU5F1 • SOX2