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Two New Breakthrough Humanized Monoclonal Antibody-Based Drugs

|Includes: CytoDyn Inc. (CYDY)

Humanized monoclonal antibodies are lab-engineered antibodies developed from non-human species that have been used to treat various degenerative diseases for the past few years. From arthritis to cancer therapeutics, humanized monoclonal antibodies have proven effective in improving patients' quality of life. Found below are two innovative drugs based on humanized monoclonal antibodies:

1. ZMapp for Ebola Treatment

ZMapp is an experimental drug that cured U.S. doctor Dr. Kent Brantly and missionary Nancy Writebol, who both contracted Ebola in Liberia. ZMapp had not been tested on humans yet and has only been tested on monkeys before it was given to Brantly and Writebol. According to the Centers for Disease Control and Prevention (NASDAQ:CDC), the drug is being developed by California-based company Mapp Biopharmaceutical, Inc.

Mapp's website revealed that ZMapp was developed from a combination of three monoclonal antibodies that were humanized and recombinantly made in low nicotine tobacco (Nicotiana benthamiana). The tobacco species has been chosen because it could produce foreign or non-tobacco proteins that are gathered and humanized in a lab.

ZMapp works by attaching to the glycoproteins of the virus, explained a CBS report. Since it is composed of three monoclonal antibodies, it can attack the virus on all fronts.

In October, U.S. health officials have requested three other biopharmaceutical labs to submit plans to manufacture ZMapp. The Biomedical Advanced Research and Development Authority (BARDA) released the "task order," CNBC reported.

"You're stapling the viral glycoprotein in three different places with these antibodies," Dr. Kartik Chandran, Albert Einstein College of Medicine microbiology and immunology associate professor, told CBS News.

2. PRO 140 for HIV/AIDS Therapeutics

PRO 140 is a viral entry inhibitor that blocks HIV-1 from entering CCR5, a cell surface molecule that the virus uses as a molecular channel to penetrate healthy cells. It suppresses the virus when a patient has to stop highly active antiretroviral therapy (HAART) due to side-effects, an upcoming surgery, or when shifting to a new treatment plan.

CCR5 is involved in trafficking and attracting leukocytes to areas of inflammation when the body has an infection. It also plays a major role in completely stopping or slowing down the progression of diseases, according to an article published on The Oxford Journal.

What PRO 140 does is that it attaches to CCR5, and guard it against HIV-1 to prevent the virus from harming new cells and replicating. PRO 140's application is especially useful when the patient stops HAART and is at risk for viral rebound. According to a research paper published on Aids Research and Therapy, cessation of HAART leads to viral load breakout within days or weeks, with viral load relapsing to pre-treatment levels within a year.

Based on the results of Phase 2b of its clinical trial, Cytodyn Inc. (OTCQB: CYDY), the biotechnology company behind the drug found that PRO 140 was able to effectively suppress viral load in patients receiving it for four weeks. For the trial, PRO 140 was administered to patients once weekly; the drug was given to patients with their normal antiretroviral regimen during the first week of the trial, after which it was given once weekly as a monotherapy. This means that from the second week of the trial onwards, patients were taken off their antiretroviral meds, and received only PRO 140.

According to Cytodyn's news release, as of mid-October, 21 patients who have received the drug for four weeks exhibited no virologic failures. 36 patients out of 40 have received their first injection of PRO 140 within the same period. Meanwhile, patients who have stopped monotherapy continued to have improved viral load suppression of up to eight weeks. Due to the drug's effectiveness, the FDA has given the drug a "fast-tracked" status.