Rondo Therapeutics Shares Preclinical Data on New CD28 x Nectin-4 Bispecific Antibody for Advanced Bladder Cancer at ASCO GU

Rondo Therapeutics, a biopharmaceutical company at the forefront of immuno-oncology, is preparing to launch a Phase 1/b clinical trial focused on patients with relapsed or refractory advanced bladder cancer by the end of this year. Located in Hayward, California, this private company is renowned for its pioneering work on next-generation T cell-engaging bispecific antibodies aimed at treating solid tumors.

In a significant development, Rondo has announced that preclinical data regarding its innovative bispecific antibody, RNDO-564, is being showcased at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium. This event is scheduled to take place from February 13th to 15th in San Francisco, California.

The RNDO-564 antibody represents a novel approach, combining CD28 and Nectin-4 costimulatory pathways to target advanced bladder cancer. These CD28 co-stimulatory bispecific antibodies are engineered to enhance the effectiveness of T cell-mediated tumor destruction, helping to counter T cell fatigue often observed in the tumor microenvironment. The preclinical results for RNDO-564 are promising, showing strong anti-tumor activity both in vivo and in vitro, even in models resistant to antibody drug conjugates (ADCs). This capability suggests that RNDO-564 can potentially overcome T cell exhaustion and address challenges associated with ADCs, such as toxicity, resistance, and limitations with sequential ADC administration.

Thomas Manley, the Chief Medical Officer of Rondo Therapeutics, emphasized the potential of RNDO-564 to address important limitations in current cancer therapies. The company plans to advance RNDO-564 through studies necessary for Investigational New Drug (IND) applications, with the intention of commencing clinical trials in patients suffering from advanced bladder cancer by year-end.

Rondo Therapeutics' proprietary platform focuses on CD28-targeting binders, which are designed with a broad spectrum of co-stimulatory strengths. This approach is meant to enhance T cell-mediated tumor eradication and to mitigate T cell exhaustion within solid tumor environments. By developing bispecific antibody therapeutics tailored to specific tumor types and treatment protocols, Rondo offers a personalized alternative to conventional cancer therapies, aiming to bring about sustained responses in patients with solid tumors.

Rondo Therapeutics is committed to revolutionizing cancer treatment through its innovative bispecific antibody therapies, addressing previously unmet needs in solid tumor management. The company is working on a new class of bispecific antibodies that leverage the immune system to effectively target and destroy tumors while enhancing safety profiles. Supported by notable investors such as Canaan Partners, Red Tree Venture Capital, Johnson & Johnson, SV Health Investors, and Novo Holdings, Rondo’s pipeline features immune-engaging bispecifics designed for various solid tumors, including bladder and ovarian cancers.

Through its cutting-edge research and development, Rondo Therapeutics continues to break new ground in the field of cancer therapy, bringing new hope to patients with difficult-to-treat solid tumors.