dodekin (F8-IL12) / Philogen - LARVOL DELTA

DODEKA: Safety and Early Signs of Efficacy of IL12-L19L19. (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Philogen S.p.A. | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

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

Targeted Delivery of IL-12 Shows Preliminary Antitumor Activity in Advanced Solid Tumors (OncLive) - P1 | N=94 | DODEKA (NCT04471987) | Sponsor: Philogen S.p.A. | "Treatment with the antibody-cytokine fusion protein L19-IL12 led to stable disease (n = 10) and partial response (PR; n = 1) lasting 4 months in patients with metastatic solid tumors (n = 22)...Additional findings from the study showed that treatment-related adverse effects (TRAEs) that occurred in at least 1 patient in order of frequency were pyrexia, chills, fatigue, decreased lymphocyte count, increased aspartate...One DLT occurred in cohort 3 (0.5 μg/kg) of grade 3 AST and ALT elevation."

P1 data • Melanoma • Non Small Cell Lung Cancer • Solid Tumor

Phase I dose-escalation trial with tumor-targeted interleukin-12 (IL12-L19L19) in patients with solid tumors (ESMO-TAT 2024) - P1 | "Conclusions Intravenous infusion with IL12-L19L19 has been tolerated up to 8 μg/kg and the RD is still to be defined. Initial signs of activity with limited toxicity have been observed."

Clinical • IO biomarker • P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • IL12A

Phase I dose-escalation trial with tumor-targeted interleukin-12 (IL12-L19L19) in patients with solid tumors (ESMO 2023) - P1 | "The RD of IL12-L19L19 is still to be defined. Initial signs of activity have been observed."

Clinical • P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • IL12A

DODEKA: Safety and Early Signs of Efficacy of IL12-L19L19. (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Philogen S.p.A. | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Immune Modulation • Oncology • Solid Tumor • IL12A

DODEKA: Safety and Early Signs of Efficacy of IL12-L19L19. (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Philogen S.p.A. | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Immune Modulation • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • IL12A • MSI

Inference of molecular structure for characterization and improvement of clinical grade immunocytokines. (PubMed, J Struct Biol) - "Here, we performed structure investigations on clinical grade fusion proteins L19-IL2, IL12-L19L19 and L19L19-IL2 to elucidate their quaternary organization...Comparison with 3D reconstructions obtained from negative-stain electron microscopy revealed marked flexibility associated to the linker regions connecting the cytokine and the antibody components of the chimeric proteins. Collectively, our results indicate that low-resolution molecular structure characterizations provide useful complementary insights for the quality control of immunocytokines, constituting a powerful tool to guide the design and the subsequent optimization steps towards clinical enhancement of these chimeric protein reagents."

Clinical • Journal • Immune Modulation • Inflammation • Oncology

DODEKA: Safety and Early Signs of Efficacy of IL12-L19L19. (clinicaltrials.gov) - P1; N=94; Recruiting; Sponsor: Philogen S.p.A.

Clinical • New P1 trial • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Immune Modulation • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck