Dr. Katherine Harris is Chief Development Officer at Rondo Therapeutics, where she leads all IND-enabling activities and is responsible for the design and execution of preclinical drug development from candidate nomination through IND submission. Previously, she was Vice President of Discovery at Amgen where she was instrumental in providing strategic and scientific direction for antibody therapeutics in Amgen’s Oncology portfolio. While at Amgen, she led integration of the acquired TeneoBio preclinical portfolio and sequence-based antibody discovery platform while serving as site head of the Amgen Newark Research Facility. As Vice President of Discovery at TeneoBio, Katherine built and led a highly successfully Oncology Research team, making key scientific and strategic contributions to clinical candidates that resulted in 4 IND approvals in less than 6 years of company operations. Prior to her work at TeneoBio and Amgen, she was a Research Scientist at Active Motif and SwitchGear Genomics where she focused her efforts on the development of a functional genomics platform for small molecule screening. Katherine holds a Ph.D. in Molecular and Cell Biology from the University of California, Berkeley. She has presented in numerous national and international forums and has multiple peer-reviewed publications and issued patents.

T-cell engaging bispecific antibodies have had tremendous success in treating hematologic tumors but have shown limited efficacy in solid tumors. Alternative strategies for engaging the immune system employing safe and tunable bispecific antibodies are needed to overcome the challenges of solid tumors. In this presentation, we describe the bispecific platforms developed at Rondo Therapeutics and highlight progress on our lead program, RNDO-564, a CD28 x Nectin-4 bispecific antibody for treatment of metastatic bladder cancer.

• RNDO-564 is an optimized CD28 x Nectin-4 bispecific antibody (bsAb) that delivers T-cell costimulation to Nectin-4-expressing tumors and is designed to elicit robust Nectin-4 and signal 1-dependent T-cell mediated killing of Nectin-4-expressing tumor cells while limiting excessive immune activation
• Anti-tumor activity in vivo and in vitro, including EV-resistant bladder cancer, and preliminary tolerability studies in NHPs, support clinical testing of RNDO-564
• RNDO-564 may provide a novel mechanism with an optimized therapeutic window to treat patients who are resistant to standard therapies