BSI-585 / Celldex, Biosion - LARVOL DELTA

A Study of CDX-585 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Celldex Therapeutics | Active, not recruiting ➔ Completed | N=130 ➔ 20 | Trial completion date: Dec 2025 ➔ May 2025 | Trial primary completion date: Dec 2025 ➔ May 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

A Study of CDX-585 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=130 | Active, not recruiting | Sponsor: Celldex Therapeutics | Trial completion date: May 2025 ➔ Dec 2025 | Trial primary completion date: May 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

A Study of CDX-585 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=130 | Active, not recruiting | Sponsor: Celldex Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2026 ➔ May 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Celldex Announces First Patient Dosed in Phase 1 Study of CDX-585 in Patients with Advanced Malignancies (GlobeNewswire) - "Celldex Therapeutics, Inc...announced that the first patient has been dosed in a Phase 1 study of CDX-585. CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. Celldex plans to develop CDX-585 for the treatment of solid tumors either as monotherapy or in combination with other oncologic treatments."

Trial status • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

A Study of CDX-585 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Celldex Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Celldex Reports First Quarter 2023 Financial Results and Provides Corporate Update (Market Screener) - "CDX-585 has successfully completed GMP manufacturing and IND-enabling studies to support clinical development. CDX-585 will initially be developed for the treatment of solid tumors either as monotherapy or in combination with other oncologic treatments and is expected to enter the clinic in mid-2023 in patients with advanced malignancies."

Trial status • Oncology • Solid Tumor

CDX-585, a novel bispecific antibody targeting PD-1 and ILT4 (AACR 2023) - "(2022 Clin Cancer Res 28: 57-70) reported encouraging results of the initial clinical study combining the ILT4 antagonist mAb MK-4830 with pembrolizumab. Doses of CDX-585 up to 60 mg/kg were well tolerated in cynomolgus macaques and displayed a favorable pharmacokinetic profile. Together these data demonstrate that CDX-585 effectively combines PD-1 and ILT4 blockade into one molecule with favorable biophysical and functional characteristics supporting the initiation of a dose-escalation clinical trial in patients with advanced solid tumors."

IO biomarker • Melanoma • Oncology • Solid Tumor • CD40

A Study of CDX-585 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=130 | Not yet recruiting | Sponsor: Celldex Therapeutics

Metastases • New P1 trial • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Celldex Reports Fourth Quarter and Year End 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "CDX-585 has successfully completed GMP manufacturing and IND-enabling studies to support clinical development. CDX-585 will initially be developed for the treatment of solid tumors either as monotherapy or in combination with other oncologic treatments and is expected to enter the clinic in 2023 in patients with advanced malignancies."

New trial • Oncology • Solid Tumor

Celldex Reports Third Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "CDX-585 is currently completing CMC and IND-enabling activities and is expected to enter the clinic in 2023."

New P1 trial • Oncology • Solid Tumor

Bispecific Antibodies Can Drive Synergistic Immune Activation through Simultaneous Engagement of Multiple Immune Targets (PEGS 2022) - "CDX-527 is a clinical-stage bispecific antibody that is designed to simultaneously relieve PD-(L)1 suppression by inhibiting PD-L1 and stimulate CD27 to induce further T-cell activation. CDX-585 is a preclinical bispecific antibody candidate designed to inhibit myeloid suppression through ILT4/LILRB2 and overcome T cell suppression through PD-1 inhibition. Both bsAbs have demonstrated synergistic activity relative to the combination of individual parental mAbs in cultured immune assays and exhibited anti-tumor activity in animal models. The design, development and preclinical characterization of these bispecifics will be presented."

Oncology • CD27

CDX-585, A bispecific antibody with dual targeting of ILT4 and PD-1 checkpoint pathways (SITC 2021) - "Pilot studies in mice and cynomolgus macaques confirmed a favorable pharmacokinetic profile without adverse effects of treatment noted in clinical observations or clinical chemistry. Conclusions CDX-585 effectively combines ILT4 and PD-1 blockade into one molecule with favorable biophysical and functional characteristics supporting the initiation of development activities including manufacturing and IND-enabling studies."

IO biomarker • Oncology

Celldex Presents Positive Preclinical Data from PD-1/ILT4 Bispecific Antibody Program CDX-585 at SITC 2021 (GlobeNewswire) - "In the preclinical data presented at SITC, the simultaneous inhibition of ILT4 and PD-1 checkpoints with CDX-585 led to myeloid and T cell activation which may potentially demonstrate clinical utility, particularly in the T cell checkpoint inhibitor refractory setting. CDX-585 promoted T cell activation as measured by mixed lymphocyte reactions superior to that achieved by the combination of ILT4 and PD-1 monoclonal antibodies. CDX-585 also demonstrated anti-tumor activity in a humanized mouse model of melanoma and had a favorable pharmacokinetic profile in pilot studies, without adverse effects of treatment noted in clinical observations or clinical chemistry."

Preclinical • Oncology

Celldex Presents Promising Data from ILT4/PD-(L)1 Bispecific Antibody Program at AACR 2021 (GlobeNewswire) - "The Company described the discovery and characterization of ILT4 inhibitory monoclonal antibodies (mAbs) for engineering bispecific antibodies (bsAbs) that revert myeloid cell suppression by antagonizing ILT4 and activate T-cell responses through PD-(L)1 inhibition (poster # 1865). Based on the results reported today, Celldex is developing clinical bispecific candidates that co-target ILT4 and PD-(L)1."

Clinical • Oncology