Rondo Therapeutics Publishes Preclinical Data on RNDO-564, a Novel CD28 x Nectin-4 Co-Stimulatory Bispecific Antibody for the Treatment of Bladder Cancer

-RNDO-564 is designed to deliver safe and robust tumor killing activity in Nectin-4 positive tumors.

-RNDO-564 utilizes a novel mechanism of action for the treatment of bladder cancer and addresses the toxicity challenges and resistance mechanisms associated with antibody drug conjugates (ADC).

-Preclinical results serve as proof-of-concept for Rondo Therapeutics’ immune engager platform that is broadly applicable for solid tumors.

HAYWARD, Calif.--(BUSINESS WIRE)--Rondo Therapeutics, a privately held biopharmaceutical company pioneering the development of next-generation T cell-engaging bispecific antibodies for the treatment of solid tumors, today 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).

CD28 co-stimulatory bispecific antibodies are designed to boost T cell-mediated tumor killing and overcome T cell exhaustion in the solid tumor microenvironment. The publication describes the identification of a diverse panel of CD28-targeting binders with a range of potencies. Utilizing this panel, RNDO-564 was designed with optimal potency to elicit robust, safe, and durable tumor killing activity both in vitro and in vivo.

The full article, titled “A Potency-optimized CD28-activating Bispecific Antibody for the Targeted Treatment of Nectin-4 Positive Cancers,” is available online at 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.
• Demonstrates robust cytotoxic activity against bladder cancer cells that are resistant to antibody drug conjugates.

“The data serve as proof-of-concept for Rondo’s immune engager platform for solid tumors,” said Starlynn Clarke, Senior Director of Preclinical Biology of Rondo Therapeutics. “We are excited about the clinical potential of CD28 T-cell engagers as a new modality for solid tumors, as they address the limitations of CD3 T-cell engagers, ADCs, and checkpoint inhibitors.”

Rondo’s immune-engager 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.