CytoDyn Enlists Syneos Health as CRO for Phase II Colorectal Cancer Trial of Leronlimab
Key Insights
CytoDyn (search) has engaged Syneos Health as the CRO for its Phase II oncology trial, focusing on relapsed/refractory micro-satellite stable colorectal cancer (search).
The Phase II trial will assess the efficacy of leronlimab, a CCR5 (search) antagonist, in combination with trifluridine, tipiracil (TAS-102), and bevacizumab.
CytoDyn (search) anticipates initiating patient screening for the trial in early 2025, following the submission of the study protocol to the FDA in September 2024.
CytoDyn (search) Inc. has partnered with Syneos Health, a fully integrated biopharmaceutical solutions organization, to act as the contract research organization (CRO) for its upcoming Phase II oncology trial. The study will investigate the effectiveness of leronlimab in treating patients with relapsed/refractory micro-satellite stable colorectal cancer (search) (CRC).
Dr. Jacob Lalezari, CEO of CytoDyn (search), emphasized the company's commitment to exploring leronlimab's potential in oncology. "Investigating leronlimab in the field of oncology remains our top priority, and we are excited to further invest in our promising relationship with Syneos Health," he stated.
The Phase II trial will evaluate leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. CytoDyn (search) submitted the final study protocol to the FDA in September 2024 and expects to begin screening patients in early 2025.
Leronlimab: A CCR5 Antagonist
Leronlimab is an investigational humanized IgG4 monoclonal antibody (mAb) designed to bind to C-C chemokine receptor type 5 (CCR5 (search)). CCR5 is a protein found on the surface of certain immune system cells and is believed to play a role in various disease processes. CytoDyn (search) is exploring leronlimab for potential applications in oncology, inflammation, HIV, and MASH.
Syneos Health's Role
Syneos Health brings to the collaboration its expertise in biopharmaceutical solutions, including advanced data analytics and AI/ML capabilities. According to CytoDyn (search), Syneos Health has contributed to the development or commercialization of 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.