CytoDyn Inc.

IMPORTANT CORRECTION OF INVESTIGATIONAL DRUG INFORMATION

On February 11, 2022, CytoDyn, Inc. received a Warning Letter from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion in which FDA asserted that statements made in a video created a misleading impression regarding the safety and efficacy of leronlimab.  Leronlimab is an investigational drug that has not been approved (or authorized) by the U.S. FDA for the treatment of COVID-19 or for any indication.  For more information, click here to access a Dear Healthcare Provider (DHCP) Letter: View Here.

Our Science

The Development of Monoclonal Antibodies

Antibodies are soluble proteins that are produced by the body in response to infections from pathogens like bacteria and viruses. Each individual antibody is synthesized by a unique cell. The secreted protein is shaped like a Y and possesses two identical yet unique binding sites that are specific for a short segment of the offending pathogen.

Vaccines capitalize on the ability of the body to produce antibodies to foreign proteins, also known as antigens, by injecting the antigen of interest with an immune stimulating molecule referred to as an adjuvant. This causes the body to react by producing antibody molecules specific for different parts of the antigen.

Once the antigen is gone from the body the antibody-producing cells revert to a dormant state until the antigen is again detected in the body. Then a brisk response ensues, and antibody levels rapidly rise in the bloodstream to neutralize the antigen.

Because of the genetic uniqueness among species, antibodies can also be developed that are specific for normal cell proteins. For example, immunizing a mouse with human proteins allows one to produce mouse antibodies that can recognize virtually any human antigen. This has allowed for the development of a variety of diagnostic reagents and therapeutic antibodies specific for human cells.

About Our Company

How Monoclonal Antibodies Came to Be

CytoDyn’s monoclonal antibody, leronlimab (PRO 140), is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor  metastasis, and immune signaling.

Monoclonal Antibodies Today

Monoclonal antibodies have come to represent one of the fastest expanding opportunities in the biotechnology/pharma sector. The ability to transition from research reagents generated in mice to fully humanized structures suitable for clinical and commercial development has provided some of the most effective and largest selling therapeutics over the last 10 years.  The development of monoclonal antibodies is expanding on a yearly basis and monoclonal antibody sales are expected to reach US$130–$200 billion by 2022.

The Future of Monoclonal Antibodies

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, tumor metastases and immune signaling. Leronlimab (PRO 140) has successfully completed nine Phase 1/2/3 clinical trials with over 800 patients, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

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