BNT315 / BioNTech, Genmab - LARVOL DELTA

The combination of HexaBody®-OX40 with PD-(L)1 blockade potentiates agonistic activity in vitro and antitumor activity in vivo (CIMT 2025) - P1/2 | "HexaBody-OX40 (GEN1055/BNT315) is an investigational OX40 agonist antibody that clusters OX40 independent of FcγR-mediated crosslinking...Enhanced proliferation was also observed in an antigen-specific CD8+ T-cell proliferation assay upon combining HexaBody-OX40 with PD-(L)1 blockers pembrolizumab, nivolumab, cemiplimab, or atezolizumab...Intratumorally, combination treatment enhanced the number of CD3+, CD4+, and granzyme B+ cells, as shown by IHC.In conclusion, HexaBody-OX40 in combination with PD-(L)1 blockade potentiated single-agent effects on T-cell functions in vitro, and antitumor and pharmacodynamic activity in a syngeneic tumor model in vivo. A first-in-human clinical trial has been initiated to evaluate clinical safety and preliminary efficacy of HexaBody-OX40 in patients with advanced solid tumors (NCT06391775)."

Preclinical • Oncology • Solid Tumor • CD4 • CD8 • GZMB

GCT1055-01: Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy (clinicaltrials.gov) - P1/2 | N=21 | Active, not recruiting | Sponsor: Genmab | N=270 ➔ 21

Enrollment change • Monotherapy • Solid Tumor

GCT1055-01: Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy (clinicaltrials.gov) - P1/2 | N=270 | Active, not recruiting | Sponsor: Genmab | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Oncology • Solid Tumor

The combination of HexaBody®-OX40 with PD-(L)1 blockade potentiates agonistic activity in vitro and antitumor activity in vivo (SITC 2024) - P1/2 | "HexaBody-OX40 (GEN1055/BNT315) is an investigational OX40 agonist antibody that clusters OX40 independent of FcγR-mediated crosslinking...Enhanced proliferation was also observed in an antigen-specific CD8+ T-cell proliferation assay upon combining HexaBody-OX40 with PD-(L)1 blockers pembrolizumab, nivolumab, cemiplimab, or atezolizumab...Ethics Approval The animal experiments were performed at Crown Bioscience, Inc. and approved by their Institutional Animal Care and Use Committee (IACUC) prior to execution."

Preclinical • Oncology • Solid Tumor • CD4 • CD8 • GZMB

The combination of HexaBody®-OX40 with PD-(L)1 blockade potentiates agonistic activity in vitro and antitumor activity in vivo (SITC 2024) - P1/2 | "HexaBody-OX40 (GEN1055/BNT315) is an investigational OX40 agonist antibody that clusters OX40 independent of FcγR-mediated crosslinking...Enhanced proliferation was also observed in an antigen-specific CD8+ T-cell proliferation assay upon combining HexaBody-OX40 with PD-(L)1 blockers pembrolizumab, nivolumab, cemiplimab, or atezolizumab...Ethics Approval The animal experiments were performed at Crown Bioscience, Inc. and approved by their Institutional Animal Care and Use Committee (IACUC) prior to execution."

Preclinical • Oncology • Solid Tumor • CD4 • CD8 • GZMB

HexaBody-OX40, a novel Fcγ receptor crosslinking-independent OX40-targeting antibody, exhibits agonistic activity in vitro and antitumor activity in vivo (CIMT 2024) - "We present the preclinical characterization of HexaBody-OX40 (GEN1055/BNT315), a novel OX40 agonist antibody designed to induce OX40 clustering independently of FcγR-mediated crosslinking to enhance antitumor T-cell responses [1]...HexaBody-OX40 enhanced T-cell activation and proliferation in vitro and showed antitumor activity in vivo. The clinical safety and preliminary efficacy of HexaBody-OX40 will be investigated in a first-in-human clinical trial in patients with advanced solid tumors."

Preclinical • Oncology • Solid Tumor • CD4 • CD8 • GZMB • TNFA

Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy (clinicaltrials.gov) - P1/2 | N=270 | Recruiting | Sponsor: Genmab

Combination therapy • Monotherapy • New P1/2 trial • Oncology • Solid Tumor