Workshop 2 – Clinical Trials for Advanced Therapies
Date: 24 July (Friday) 12:20 – 13:50 (GMT+8)
Venue: www.bioasiataiwan.com / Online event platform
Scott A. Kelly, M.D. Dr. Kelly was named Chairman of the Board of CytoDyn in December 2018 and he has served as a director since April 2017. Dr. Kelly was named to the non-executive position of Chief Science Officer of the Company in July 2019. He was appointed Chief Medical Officer and Head of Business Development in April 2020. Prior to leaving clinical medicine to focus on CytoDyn, he served at Atlanta-based Resurgens Orthopaedics since 2002, including as Director of the Safety Council since 2013 and as Medical Director of the Resurgens Orthopaedics' Spine Center since 2007. He is a fellow of the American Board of Physical Medicine and Rehabilitation and a diplomate of the American Academy of Physical Medicine and Rehabilitation. He also is a member of the Spine Intervention Society, Georgia Society of Interventional Spine Physicians, and the American Academy of Physical Medicine and Rehabilitation. He has received numerous honors including being named as America's Best Physicians in 2018 by the National Consumer Advisory Board, Leading Physicians of the World in 2018 by the International Association of Healthcare Professionals (IAHCP), America's Most Honored Professionals in 2018 and 2019 by The American Registry, America's Best Physicians in 2016, 2017, 2018, and 2019 by The National Consumer Advisory Board, "Top Doctor" in 2015, 2016, 2017, and 2019 by Castle Connolly, and "Top Doctor" by Atlanta Magazine in 2016, 2017 2018, 2019, and 2020. He is the author of What I've Learned from You: The Lessons of Life Taught to a Doctor by His Patients. He received his BA in Psychology from Emory University, his medical doctorate from Medical College of Georgia and completed his medical residency at Emory University.
Speech title & Synopsis
CytoDyn’s monoclonal antibody, Leronlimab (PRO 140), is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, COVID-19, immuno-oncology, and immune trafficking.
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. CytoDyn submitted the final BLA for approval in combination with HAART on May 11, 2020. The FDA granted Cytodyn “Fast Track” designation and Rolling Review for HIV.
The “cytokine storm” is believed to play an integral role in the development of acute respiratory distress syndrome (ARDS) in those affected by COVID-19. Chemokines and chemokine receptors play a critical role in the recruitment, activation, and coordination of leukocytes in the pathophysiology of lung inflammation. The acute respiratory distress syndrome (ARDS) of COVID-19 results from the accumulation of neutrophils within the pulmonary circulation and alveolar spaces. Leronlimab (PRO 140) inhibits the migration of T regs into areas of inflammation, which can inhibit the innate immune response against pathogens and, most importantly, the migration of macrophages and release of pro-inflammatory cytokines in lungs. Leronlimab can potentially mitigate the cytokine storm.
In immuno-oncology, we believe leronlimab can help control the tumor microenvironment by blocking T regs to turn on the anti-tumor response to leverage the immune systems’ natural ability to fight cancer, convert the M2 macrophage into an M1 macrophage (anti-tumor macrophage), control the upregulation of the CCR5 receptor in malignant cell transformation, and decrease angiogenesis at the tumor interface. CytoDyn received “Fast Track” designation from the FDA for triple-negative breast cancer.