HAYWARD, Calif.– Rondo Therapeutics, a private biopharmaceutical company pioneering next-generation bispecific antibody platforms, has named Thomas Manley, M.D., as Chief Medical Officer (CMO). Dr. Manley will lead the clinical development of Rondo’s innovative T-cell engaging immunotherapies designed to treat solid tumors, including metastatic bladder and ovarian cancers. With more than 25 years in oncology research and development, Dr. Manley brings expertise from both leading biotech and major pharmaceutical companies.
Prior to joining Rondo, Dr. Manley was Vice President of Clinical Development at IGM Biosciences where he advanced several T-cell engager programs targeting hematologic and solid tumors. His previous roles include Vice President of Clinical Development and Medical Affairs at Adaptive Biotechnologies. Earlier in his career at Seagen, he spearheaded multiple antibody-drug conjugate (ADC) initiatives in hematologic cancers, notably leading the successful sBLA for Adcetris in peripheral T-cell lymphomas. He completed his clinical and research fellowship at the Fred Hutchinson Cancer Center and Seattle Children’s Hospital.
As CMO, Dr. Manley will lead the clinical strategy, regulatory engagement, and clinical trial execution for Rondo’s lead candidate, RNDO-564, a CD28 x Nectin-4 bispecific antibody developed for metastatic bladder cancer that will be starting a phase 1 trial at the end of 2025.
“We are thrilled to have Dr. Manley join Rondo Therapeutics,” said Shelley Force Aldred, CEO and co-founder of Rondo Therapeutics. “His depth of experience and strategic insight will be instrumental as we bring RNDO-564 to the clinic. Adding Dr. Manley to our leadership team represents and important step towards our goal of transforming oncology care with next-generation bispecific therapies.”
RNDO-564 represents a first-in-class CD28 x Nectin-4, co-stimulatory bispecific antibody designed to selectively engage and activate immune cells in the tumor microenvironment. Currently in late pre-clinical development, RNDO-564 is slated for IND filing in Q3 2025, with a first-in-human (FIH) trial planned for late 2025. Preclinical data demonstrate promising antitumor activity and specificity, supporting its potential for a robust safety profile.
With Dr. Manley’s leadership, Rondo remains focused on achieving its 2024 and 2025 milestones, including advancing RNDO-564 to IND filing and developing strategic partnerships with top pharmaceutical companies to further the company’s mission.
