runimotamab (RG6194) / Roche - LARVOL DELTA

ABP-102/CT-P72: a novel HER2 x CD3 T cell engager with selective activity for HER2-overexpressing tumors and reduced activity on cells with normal HER2 expression levels (AACR 2025) - "Bispecific antibody T cell engagers (TCEs) have unrealized potential as novel treatments for solid tumors, with notable past successes in hematological malignancies and the encouraging recent FDA approval of tarlatamab for a solid tumor indication...In the HER2-overexpressing models, ABP-102/CT-P72 displayed up to a two-fold increased tumor growth inhibition compared to a biosimilar of runimotamab, a HER2 x CD3 TCE...are co-developing ABP-102, which CELLTRION, INC. has designated under the project code name CT-P72."

Biomarker • Gastric Cancer • Hematological Malignancies • Oncology • Solid Tumor • HER-2

Phase 1a/b study of runimotamab, a HER2 x CD3 T cell-engaging bispecific antibody, administered as a single agent and in combination with trastuzumab in patients with HER2-expressing breast cancer (BC) (AACR 2025) - P1 | "Improved tolerability and higher runimotamab dose levels were achieved in combination with trastuzumab, compared to runimotamab alone. Runimotamab + trastuzumab demonstrated a manageable safety profile and encouraging clinical activity in heavily pretreated HER2-positive BC patients."

Clinical • Combination therapy • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (clinicaltrials.gov) - P1 | N=123 | Active, not recruiting | Sponsor: Genentech, Inc. | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Roche drops HER2 bispecific, Xencor-partnered cytokine from early-phase pipeline (FierceBiotech) - "Roche has given two early-phase bispecifics the heave-ho, ending work on a HER2xCD3 prospect and an IL-15 candidate it picked up from Xencor...The drugmaker removed (PDF) the molecules from its phase 1 pipeline as part of its fourth-quarter clearout. The HER2 asset, known as both RG6194 and runimotamab, was in development in breast cancer....The IL-15 candidate, efbalropendekin alfa, was designed to drive the expansion and activation of T cells and natural killer cells by fusing IL-15 to its alpha receptor and Xencor’s bispecific Fc domain."

Discontinued • Breast Cancer • Multiple Myeloma

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (clinicaltrials.gov) - P1 | N=123 | Active, not recruiting | Sponsor: Genentech, Inc. | N=537 ➔ 123

Combination therapy • Enrollment change • Metastases • Breast Cancer • Esophageal Cancer • Gastric Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Mitigation of liver toxicity effects of bispecific T cell engagers in immune-competent liver-tumor co-culturing high-throughput platform (AACR 2024) - "Additionally, we established a solid tumor model using human cancer cell lines (HCT116-GFP) and primary cancer-associated fibroblasts, effectively mimicking the complex tumor microenvironment We treated 3D spheroid models with runimotamab (HER2xCD3 BiTE), catumaxomab (EPCAMxCD3), nivatrotamab (GD2xCD3) and control bispecific antibodies in the presence of peripheral blood mononuclear cells (PBMCs)...To mitigate potential liver toxicity, we co-treated spheroid co-cultures with adalimumab (anti-TNF), tocilizumab (anti-IL-6R), raleukin (IL-1R antagonist) (each 100ug/ml), desatanib, dexamethasone or ruxolitinib (each 100nM)...In summary, we have developed a relevant, high-throughput platform for the evaluation of novel immunotherapies closely reflecting clinical scenarios. High throughput of the assay represents a powerful screening tool for clinical candidate development."

Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (clinicaltrials.gov) - P1 | N=537 | Active, not recruiting | Sponsor: Genentech, Inc. | Trial completion date: Apr 2024 ➔ May 2025 | Trial primary completion date: Apr 2024 ➔ May 2025 | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (clinicaltrials.gov) - P1 | N=537 | Recruiting | Sponsor: Genentech, Inc. | Phase classification: P1a/1b ➔ P1

Combination therapy • Metastases • Phase classification • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Combined investigation of anti-tumor efficacy and liver safety of bispecific T cell engagers in immune-competent high-throughput co-culturing platform (AACR 2023) - "To evaluate our system, we treated 3D spheroid models with runimotamab (HER2xCD3 BiTE) in the presence of peripheral blood mononuclear cells (PBMCs)...In summary, we have developed a human disease relevant, high-throughput platform for the evaluation of novel immunotherapies closely emulating clinical results. Automation-compatible with up to 192 co-culture conditions per plate it represents a powerful tool for clinical candidate development."

Clinical • IO biomarker • Oncology • Solid Tumor • IL17A • IL2 • IL6 • TNFA

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (clinicaltrials.gov) - P1a/1b | N=521 | Recruiting | Sponsor: Genentech, Inc. | Phase classification: P1 ➔ P1a/1b | Trial completion date: Jun 2023 ➔ Apr 2024 | Trial primary completion date: Jun 2023 ➔ Apr 2024

Combination therapy • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

A Phase I Study of BTRC4017A in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers (clinicaltrials.gov) - P1; N=449; Recruiting; Sponsor: Genentech, Inc.; Trial completion date: May 2024 ➔ Jun 2023; Trial primary completion date: May 2024 ➔ Jun 2023

Clinical • Trial completion date • Trial primary completion date