Agreement covers process development and manufacture of CytoDyn’s PRO 140
Bothell, Washington and Vancouver, Washington, USA– February 15, 2017 – CMC Biologics, a global leader in clinical and commercial manufacturing of monoclonal antibodies, coagulation factors and other therapeutic proteins, and CytoDyn Inc., a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection, announced today they have entered into an agreement for the process development and commercial manufacture of CytoDyn’s PRO 140.
PRO 140 is one of the most advanced experimental monoclonal antibodies for HIV treatment and has been used in more than 200 HIV-infected subjects in placebo controlled and open label FDA-approved clinical trials. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product candidate by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.
“With limited new drugs in development for treatment of HIV, CytoDyn believes that monoclonal antibodies are poised to become the next class of anti-viral agents on the market for the treatment of HIV. We have selected CMC Biologics based on their successful track record, experience and capacity for scale-up of our mAbs,” said Nader Pourhassan, President and CEO of CytoDyn. “Their experience will help us fully develop our downstream processes and enable production of Phase III clinical material, with a keen eye towards process validation and commercial production for PRO 140.”
“As HIV continues to be a significant global health issue today, we are pleased to be working with CytoDyn to help fast track this promising new therapy to market,” said Gustavo Mahler, PhD, Global Chief Executive Officer & President of CMC Biologics. “Our singe-use Bioreactor 6Pack™ facility will allow CytoDyn the flexibility to scale from 2000L up to 12000L in a single production suite. The bioreactors can be run in single unit operations or in groups, simultaneously, sequentially or in staggered fashion to achieve their desired production needs. We very much look forward to working with CytoDyn’s team.”
