CYDY– Promising Antibody Technology for the Treatment of HIV/FIV

Grant Zeng, CFA

CytoDyn (CYDY) is a development stage biotech company focused on the discovery and development of novel anti-HIV and anti-FIV agents. The Company holds two proprietary platform technologies: Cytolin, a monoclonal antibody targeting HIV and CytoFeline, a monoclonal antibody targeting FIV.

We are optimistic about the potential of the Company’s lead candidate Cytolin, which is a monoclonal antibody targeting CD11a, a subunit of adhesion molecule LFA-1, which is involved in the process of HIV infection. But more data are needed to confirm Cytolin’s clinical benefits.

Unlike all other CD11a antibodies, Cytolin targets a different site of CD11a, without affecting CD11a’s normal functions. Although CD11a exists in the surface of T-lymphocytes and dendritic cells, its presence on the HIV virion makes it a unique and potentially valuable target to interrupt HIV infection. This unique mechanism of action reduces resistance and makes Cytolin an ideal candidate for early treatment of HIV infection.

Previous uncontrolled clinical work has shown that mouse Cytolin is safe and well tolerated. Favorable observations were made regarding global immunity and CD4 counts. Anecdotal data suggested an effect on viral burden.

Based on the observations from mouse Cytolin, the Company plans to focus on humanized Cytolin for future clinical trials. A fully humanized Cytolin has been constructed and an ex-vivo study is under way to determine the in-vitro immunologic and virology activity of Cytolin. CytoDyn plans to initiate a Phase I clinical trial for humanized Cytolin in 2012.

Based on the Cytolin concept, CytoDyn plans to develop CytoFeline monoclonal antibody to specifically treat feline immunodeficiency virus (FIV), which will be complementary to Cytolin and diversify the Company’s pipeline.

The Cytolin difference

o Safety: Cytolin is safe and well tolerated. It also does not block the normal function of LFA-1 on CTLs and other cells.

o Clinical Administration: Cytolin is delivered by infusion. This brings the patient to a clinical setting; greatly increase the opportunity for interaction between the patient and their care giver to provide counseling and other auxiliary care.

o Reduced chance of resistance: Because Cytolin’s target is not made by the virus it cannot be mutated by the virus to escape the action of the antibody.

o Novel activity: Cytolin’s target (LFA-1) is a cellular antigen that is also expressed on the surface of the virus. This allows for a direct action against the virus in the bloodstream.

Risk/return profile of CytoDyn is balanced at this point. Although Cytolin/CytoFeline has potential to become a new class of agents to combat HIV/FIV, risk is high considering the early stage of development. Cash burn is also a major concern.

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