iconic therapeutics
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EXECTUIVE SUMMARY

Iconic Therapeutics, Inc., an Atlanta, Georgia based biopharmaceutical company, has an exclusive license on a Yale University composition of matter patent for a novel recombinant protein called hI-con1™. hI-con1 is a protein designed to specifically attack and destroy pathologic cells which express tissue factor (TF). Such cells include choroidal neovascularization (CNV) associated with wet age-related macular degeneration (wet AMD), TF-expressing cancer cells and tumor-associated pathologic blood vessels (PBV).

In wet AMD, the leakage of fluid and blood from CNV causes rapid vision loss. Current treatments like Lucentis® and Avastin® temporarily stop CNV leakage but leave CNV intact, necessitating lifetime intraocular injections every 4-6 weeks. Animal studies demonstrate that one injection of hI-con1 triggers >60% CNV destruction. CNV destruction will lead to improved vision, reduced treatment frequency and lower lifetime treatment costs. In 4Q10, Iconic expects to begin a 60 patient phase 1/2a study designed to evaluate safety and tolerability of hI-con1 administered to wet AMD patients.

Uterine serous papillary adenocarcinoma (USPC) and ovarian cancer are highly aggressive gynecologic cancers. Recent in vitro experiments conducted at Yale demonstrated that hI-con1 triggers immune cell-mediated killing of TF-expressing USPC and ovarian cancer cells. In 4Q10, Iconic will conduct studies to test the potency of hI-con1 against the same gynecological cancers growing in SCID mice.

The company has developed production and purification procedures for hI-con1 and has completed preparing GMP material in amounts adequate for phase 1/2a clinical trials. Definitive safety studies (intravenous and intraocular administration) are completed. The company expects to file its IND with the FDA in 4Q10. Iconic anticipates initiation of clinical trials 4Q10.

The continued development of hI-con1, an agent which triggers destruction of pathologic, TF-expressing cells, could lead to important new treatments for wet AMD, gynecological cancers other PBV-related diseases (e.g. other cancers and endometriosis).


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