PBF-1129 / Palobiofarma, Xoma - LARVOL DELTA

Phase 1 dose escalation trial of the selective adenosine A2B antagonist PBF-1129 in patients with metastatic non-small cell lung cancer. (PubMed, Invest New Drugs) - P1 | "The reduction of PD-1 expression on CD4⁺ T cells and decreased myeloid-derived suppressor cells were also associated with better outcomes. These findings suggest PBF-1129 is safe and modulates the systemic immune parameters, warranting further evaluation in combination with immune checkpoint blockade."

IO biomarker • Journal • P1 data • Anorexia • Fatigue • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • PD-1

Targeting adenosine A2B receptor using PBF-1129 in treating patients with metastatic non-small cell lung cancer (AACR 2025) - P1 | "PBF-1129 was safe and tolerable in patients with heavily pretreated mNSCLC, although limited single-agent activity was observed. The treatment improved immune cell function by alleviating PD-1 levels in cytotoxic T cells."

Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD73 • CD8 • ENTPD1 • NT5E • PD-1

PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Dwight Owen | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1

PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Dwight Owen | Suspended ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1 • STK11

Palobiofarma Secures €7 Million Investment: Paving the Way for Transformative Treatments (BNN Breaking) - "Adenosine receptor modulation specialist Palobiofarma secures €7 million investment, fuels hope for transformative treatments...This significant financial boost will enable Palobiofarma to complete three Phase II clinical trials for...PBF-1129. These innovative therapies target...non-small cell lung cancer....The funds will also support the company's mission to ink new licensing agreements for its advanced-stage assets."

Financing • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Suspended | Sponsor: Dwight Owen | Recruiting ➔ Suspended

Metastases • Trial suspension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1 • STK11

PBF-1129 in Patients With NSCLC (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Palobiofarma SL | Trial completion date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: Oct 2023 ➔ May 2024

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Improving combination therapies: Targeting A2B adenosine receptor to modulate metabolic tumor microenvironment and immunosuppression. (PubMed, J Natl Cancer Inst) - "Data identify A2BAR as a valuable therapeutic target to modify metabolic and immune TME to reduce immunosuppression, enhance the efficacy of immunotherapies, and support clinical application of PBF-1129 in combination therapies."

Biomarker • Combination therapy • IO biomarker • Journal • Tumor microenvironment • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • IFNG

PBF-1129 in Patients With NSCLC (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Palobiofarma SL | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Oct 2023

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Phase 1 dose escalation trial of the selective A2B adenosine receptor antagonist PBF-1129 in patients with metastatic non-small cell lung cancer (mNSCLC). (SITC 2022) - P1 | "Trial Registration NCT03274479 Ethics Approval The study was approved by the OSU institution's Ethics Board (#2018C0019) Consent All study participants granted a written informed consent prior to treatment initiation. Download figure Open in new tab Download powerpoint Abstract 585 Figure 1 PBF11-29 pharmacokineticsMean Concentrations of PBF-1129 Following Once Daily Oral Administration of PBF-1129"

Clinical • IO biomarker • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Dwight Owen | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1

PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Dwight Owen | Initiation date: Apr 2022 ➔ Nov 2022

Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1

PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Dwight Owen

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1

PBF-1129 in Patients With NSCLC (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Palobiofarma SL; Trial completion date: Dec 2019 ➔ Jun 2023; Trial primary completion date: Nov 2019 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

PBF 1129 (IASLC-LCTT 2020) - No abstract available