CytoDyn Inc. (CYDY) to Acquire Biotech Developing Therapies to Stop Cancer from Spreading

• CytoDyn signs definitive agreement to acquire privately held ProstaGene
• Gets access to CCR5 technologies related to cancer
• Lead candidate PRO 140 set for Investigational New Drug (IND) application in first cancer indication, expanding CytoDyn’s focus beyond HIV

With its planned acquisition of ProstaGene, LLC, CytoDyn Inc. (OTCQB: CYDY) is expanding its focus beyond HIV and graft-versus-host disease to open up a new front in the fight against cancer. ProstaGene is developing metastasis control technology that targets the chemokine receptor type 5 (CCR5), a protein on the surface of white blood cells. Metastasis is the spread of cancer beyond the original tumor, a phenomenon that contributes to the disease’s deadliness. Studies have suggested that the use of CCR5 antagonists as adjuvants may bolster anti-tumor immune responses.

CytoDyn recently announced signing a definitive agreement to acquire privately held ProstaGene, expected to be finalized in November. CytoDyn also confirmed that Richard G. Pestell, M.D., Ph.D., M.B.A., F.A.C.P., F.R.A.C.P., founder and CEO of ProstaGene, will join CytoDyn as its future chief medical officer (http://nnw.fm/7e5XX). The deal transfers or assigns certain intellectual property rights held by ProstaGene and Pestell to CytoDyn. Of particular interest to CytoDyn is the metastasis control technology and the work done in this area by ProstaGene aimed at developing a therapy that prevents metastasis in prostate, breast and other cancers. ProstaGene is also developing a companion test to identify those patients who will respond to the therapy, estimated at around 50 percent of prostate and breast cancer cases, resulting in the potential for an extensive market. Both the metastasis technology and IP are based on blocking the CCR5 receptor from antigens.

CCR5 is also thought to act as a portal for many forms of the human immunodeficiency virus (HIV) that causes acquired immunodeficiency syndrome, or AIDS, which is why it has been of interest as a drug target to CytoDyn. The normal function of CCR5 is to bind chemokines, molecules that regulate inflammation. However, the receptor can also provide a gateway to HIV; the GP120 protein of HIV first attaches to the CD4 receptor on the cell membrane and then is able to bind to the co-receptor CCR5. Fusing of the membranes of the virus and the immune cell then occurs and genetic material from HIV enters the cell, infecting the cell.

CytoDyn’s lead product candidate, PRO 140 (leronlimab), targets CCR5. PRO 140 is a viral-entry inhibitor, a new class of HIV/AIDS therapies that works by blocking the entry of the virus to healthy cells. PRO 140 works by attaching to the same portion of the CCR5 co-receptor to which HIV normally binds. The PRO 140 antibody physically blocks HIV from attaching to the CCR5 co-receptor and arrests the completion of the second step in the entry process. The HIV is, consequently, rendered ineffective.

CytoDyn has completed a Phase 3 study of PRO 140 in combination with current highly active anti-retroviral therapy (HAART) regimens, and it plans to file a Biological License Application for that usage. The company is also conducting a Phase 3 study of PRO 140 as a potential single-agent treatment for HIV.

The company recently received approval to increase the dosage in its Phase 3 monotherapy trials of PRO 140. Due for completion by year-end (http://nnw.fm/qN1Js), “patients who finish the study will move into a FDA-cleared rollover study.”

The approach taken by PRO 140 has a distinct advantage over other therapies. Other HIV drugs that target CCR5 interact with the pocket of the receptor and thereby inhibit binding of not only the HIV, but chemokines, which may have a number of adverse consequences because of the disruption of the chemokine inflammatory response. However, PRO140 blocks entry of the HIV and yet permits normal chemokine binding, leading to potentially fewer side effects.

CytoDyn is now preparing to move PRO 140 into clinical trials in cancer. In August, CytoDyn announced that PRO140 had been shown effective at inhibiting the growth of a human colon carcinoma cell line (SW480) in a prominent mouse model. The results were statistically significant and provide the basis for filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial in colon carcinoma patients (http://nnw.fm/Ax8yO).

For more information, visit the company’s website at www.CytoDyn.com

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