Rondo Therapeutics Presents Preclinical Data at ASCO GU for its Novel CD28 x Nectin-4 Costimulatory Bispecific Antibody for Advanced Bladder Cancer

- Company plans to initiate a Phase 1/b trial in relapsed/refractory, locally advanced/metastatic bladder cancer by year-end

HAYWARD, Calif.--(BUSINESS WIRE)--Rondo Therapeutics, a privately held biopharmaceutical immuno-oncology company pioneering the development of next-generation T cell-engaging bispecific antibodies for the treatment of solid tumors, today announced that data from preclinical studies of RNDO-564, a novel CD28 x Nectin-4 costimulatory bispecific antibody for advanced bladder cancer, is being presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place February 13-15, 2025, in San Francisco, CA.

“CD28 co-stimulatory bispecific antibodies are designed to boost T cell-mediated tumor killing and overcome T cell exhaustion in the solid tumor microenvironment. In preclinical studies, RNDO-564 demonstrated robust anti-tumor activity in vivo and in vitro, including in an antibody drug conjugate (ADC)-resistant bladder cancer model, suggesting the ability of RNDO-564 to overcome T cell exhaustion and address limitations of ADCs, including toxicity, resistance, and sequential ADC re-challenge,” said Thomas Manley, CMO of Rondo Therapeutics. “Based on these promising preclinical findings, we are advancing RNDO-564 through IND-enabling studies, with the goal of entering the clinic in advanced bladder cancer by year-end.”

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

Poster Session Details

Title:	A novel CD28 x Nectin-4 costimulatory bispecific antibody for advanced bladder cancer
Poster No.:	810
Session:	Poster Session B: Urothelial Carcinoma
Date/Time:	Friday, February 14, 2025 = 11:30am-12:45pm PST

Rondo Therapeutics’ proprietary platform features CD28-targeting binders with a wide range of co-stimulatory potencies designed to boost T cell-mediated tumor killing and overcome T cell exhaustion in the solid tumor microenvironment. Rondo’s platform delivers bispecific antibody therapeutics tailored to specific tumor targets, indications, and treatment regimens, offering a transformative alternative to traditional “one size fits all” strategies, unlocking the potential for durable responses in patients with solid tumors.

About Rondo Therapeutics:

Rondo Therapeutics is a biopharmaceutical company breaking new ground in cancer therapy. The company’s mission is to advance bispecific antibody therapies that address unmet needs in the treatment of solid tumors. Rondo is developing a new class of bispecific antibodies designed to harness the immune system to target and eliminate tumors with enhanced safety. Rondo Therapeutics is supported by Canaan Partners, Red Tree Venture Capital, Johnson & Johnson, SV Health Investors, and Novo Holdings. The company’s pipeline includes immune-engaging bispecifics for a range of solid tumors, including bladder and ovarian cancers. For more information, please visit www.rondotx.com.