RNDO-564 / Rondo Therap - LARVOL DELTA

Rondo Therapeutics Doses First Patient in Phase 1 Trial of RNDO-564, a First-in-Class Co-Stimulatory Bispecific Antibody Targeting Nectin-4 in Advanced Solid Tumors (Businesswire) - "The open-label, multicenter, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of RNDO-564 both as a monotherapy and in combination with pembrolizumab in adults with relapsed or refractory locally advanced or mUC."

Trial status • Urothelial Cancer

Comprehensive Characterization of RNDO-564, a First-in-Class CD28 x Nectin-4 Bispecific Antibody for the Treatment of Solid Tumors (SITC 2025) - "Mechanistic data highlights its potential to restore T-cell function and overcome tumor antigen heterogeneity. A Phase 1, first-in-human, dose-escalation study in mUC and other Nectin-4-expressing tumors is ongoing.Ethics Approval Cynomolgus study was approved and designated an IACUC number D16-00594 (A4112-01).Abstract 889 Figure 1Request permissionsCostimulatory bispecific, RNDO-564, for immune primed tumors"

IO biomarker • Hematological Malignancies • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

RNDO-564-001: A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4 (clinicaltrials.gov) - P1 | N=149 | Not yet recruiting | Sponsor: Rondo Therapeutics

Monotherapy • New P1 trial • Bladder Cancer • Breast Cancer • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

RNDO-564-001: A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4 (clinicaltrials.gov) - P1 | N=149 | Recruiting | Sponsor: Rondo Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Bladder Cancer • Breast Cancer • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

Rondo Therapeutics Publishes Preclinical Data on RNDO-564, a Novel CD28 x Nectin-4 Co-Stimulatory Bispecific Antibody for the Treatment of Bladder Cancer (Businesswire) - "Rondo Therapeutics...announced the publication detailing the discovery and preclinical development of RNDO-564, a CD28 x Nectin-4 bispecific antibody in the Journal for ImmunoTherapy of Cancer (JITC)....Key findings for RNDO-564: Elicits robust Nectin-4 and signal-1 dependent T-cell mediated killing of Nectin-4-expressing tumor cells. Enhances T-cell function in settings with mixed Nectin-4 positive and negative target cells. Restores tumor cell killing function of serially stimulated T cells in vitro. Fully eliminates established tumors in in vivo mouse model as monotherapy and in combination with a checkpoint inhibitor. Preliminary tolerability studies in non-human primates demonstrate safety and support clinical evaluation of RNDO-564."

Preclinical • Bladder Cancer

Potency-optimized CD28-activating bispecific antibody for the targeted treatment of Nectin-4 positive cancers. (PubMed, J Immunother Cancer) - "Our study reports the first CD28 bsAb targeting Nectin-4 and highlights the potential of CD28 × Nectin-4 bsAbs as a new immunotherapeutic modality. The findings support the clinical development of RNDO-564 in patients with locally advanced and metastatic UC and other Nectin-4 positive malignancies."

IO biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

OmniAb Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights (Businesswire) - "RNDO-564:...Based on promising preclinical findings, Rondo is advancing RNDO-564 through IND-enabling studies and expects to initiate a Phase 1/b trial in relapsed/refractory, locally advanced/metastatic bladder cancer by year-end 2025."

New P1 trial • Bladder Cancer

A novel CD28 x Nectin-4 costimulatory bispecific antibody for advanced bladder cancer. (ASCO-GU 2025) - "Background: Effective T-cell activation is driven by multiple signals. RNDO-564 has a high affinity Nectin-4 binding arm and an affinity-tuned CD28 arm optimized for activity in metastatic bladder cancer. A phase 1 study is planned to evaluate the safety, tolerability, PK/PD, and clinical activity of RNDO-564 alone and in combination with CPI in mUC."

Metastases • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

Rondo Therapeutics Presents Preclinical Data at ASCO GU for its Novel CD28 x Nectin-4 Costimulatory Bispecific Antibody for Advanced Bladder Cancer (Businesswire) - "Key Findings: RNDO-564 is designed to elicit robust Nectin-4 and signal-1 dependent T-cell mediated killing of Nectin-4-expressing tumor cells; RNDO-564 restored tumor cell killing function of serially stimulated T cells in vitro; RNDO-564 inhibited tumors in vivo as monotherapy and in combination with checkpoint therapy in vivo; Preliminary toxicology studies support clinical evaluation of RNDO-564; RNDO-564 maintained cytotoxicity against antibody drug conjugate-resistant bladder cancer cells....Company plans to initiate a Phase 1/b trial in relapsed/refractory, locally advanced/metastatic bladder cancer by year-end."

New P1 trial • Preclinical • Bladder Cancer

A novel CD28 x Nectin-4 costimulatory bispecific antibody targeting metastatic bladder cancer (SITC 2024) - "As of 2023, standard of care for metastatic urothelial carcinoma(mUC) in the first line setting is Padcev in combination with checkpoint inhibitors (CPI). Conclusions RNDO-564 has favorable functional and developability characteristics and is being developed to enter a Phase I clinical trial in 2025 targeting mUC. Ethics Approval The study was approved and designated an IACUC number ASP #: 980701.Download figure Open in new tab Download powerpoint Abstract 939 Figure 1 Schematic illustrating RNDO-564"

Metastases • Bladder Cancer • Genito-urinary Cancer • Hematological Malignancies • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

Rondo Therapeutics to Showcase Next-Generation CD28 Bispecific Platform at Upcoming Therapeutic Antibody Conferences (Businesswire) - "Rondo Therapeutics...announces oral presentations at both Protein & Antibody Engineering Summit (PEGS) and Antibody Engineering & Therapeutics (AET) EU. Rondo Therapeutics will describe its immune-cell engaging bispecific antibody platforms and how it is building a clinical pipeline with a focus on treating solid tumors. The company will provide an update on its lead program, RNDO-564, a co-stimulatory T-cell engaging bispecific antibody targeting CD28 and Nectin-4 for the treatment of bladder cancer."

Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor