On April 8, 2025 Rondo Therapeutics, a privately held biopharmaceutical company pioneering the development of next-generation T cell-engaging bispecific antibodies for the treatment of solid tumors, reported 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) (Press release, Rondo Therapeutics, APR 8, 2025, View Source [SID1234651847]).
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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.