CytoDyn starts candidate HIV MAb production

By Gareth Macdonald

- Last updated on GMT

Related tags Immune system

New Mexico-headquartered drugmaker CytoDyn has begun the good
manufacturing practice (GMP) standard production of the
developmental candidate anti-HIV monoclonal antibody Cytolin
(lymphocyte function-associated antigen-1).

While the agent has yet to be fully humanized, animal studies and anecdotal data from its off-label use in volunteers with advanced disease indicate that it can help maintain the functioning of the immune system in infected individuals. Earlier this year, CytoDyn regained manufacturing rights to Cytolin from licensee Amerimmune Pharmaceuticals following the bankruptcy of the latter firm. Prior to its collapse Ammerimune had, in collaboration with contract research organization (CRO) Symbion Research International (SRI) carried out preclinical work that further indicated the drug's therapeutic potential. In recent years, the advent of highly active antiretroviral therapies (HAART) that combine reverse transcriptase (RT) drugs and non-nucleoside RT inhibitors have changed HIV from a death sentence to a chronic but manageable illness. However, because the virus can become resistant to such treatments, a small but growing population of patients have run out of effective therapeutic options. CytoDyn also suggested that a once-monthly administration of the drug could delay the need for antiretroviral drugs, resulting in considerable benefit to patients both in terms of economics and quality of life. Correcting flaw in human immune response ​Cytolin belongs to a new class of biologics that prevent the destruction of the immune system during human infection. While other non human primates can catch both HIV and analogous agents such as simian immunodeficiency virus (SIV), the viruses only cause disease in humans due to a characteristic flaw in the human immune response that causes the proliferation of CD8 T lymphocytes. ​While Cytolin does not stop this proliferation, it is designed to interact with the LFA-1 protein on the surface of killer CD8 lymphocytes, preventing the molecule from directing the destruction of CD4 helper cells. As a result, CD4 cell levels are maintained at a sufficient threshold to control HIV infection for an extended period, potentially arresting the transition from long-term infection to AIDS. CytoDyn will use the murine version of Cytolin, for which there is already a considerable amount of human experience, to conduct a randomized trial to supplement data from an earlier Phase Ib/IIa study. The firm aims to complete the trial before the end of the year.

Related news

Related product

Understanding the hidden value of quality

Understanding the hidden value of quality

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | White Paper

The raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success.