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IMCLONE IND FOR BEC-2 ANTI-IDIOTYPE ANTIBODY MELANOMA TREATMENT

Executive Summary

IMCLONE IND FOR BEC-2 ANTI-IDIOTYPE ANTIBODY MELANOMA TREATMENT was filed in September and the seven-year-old firm expects to begin its first clinical trials before the end of the year, ImClone said in an Oct. 1 preliminary prospectus for an initial public offering. Phase I trials for the treatment of malignant melanoma will be conducted by the New York City-based company's collaborators at Memorial Sloan-Kettering Cancer Center. , BEC-2 is designed to stimulate the immune system to "prevent or delay the onset of recurrent primary tumors or metastatic disease" after surgical removal of a tumor. ImClone signed up German ImCone Signed up german firm E. Merck as a licensing partner for BEC-2 in December 1990. E. Merck paid an initial fee of $ 3.5 mil. for European rights and agreed to additional research support and milestone payments. ImClone intends to retain U.S. rights to manufacture and market BEC-2. Another start-up firm, IDEC Pharmaceuticals, recently completed Phase I trials on its anti-id for melanoma, I Mel-I IMel-1 ("The Pink Sheet" July july 8, T&G- 6). The three other principal products under development by ImClone are a totipotent stem ceel cell growth factor (T-SCF) as an adjunct to chemotherapy, radiation therapy and bone marrow transplants; a recombinant molecular variant of interleukin-6; and an interleukin-1 inhibitor. ImClone expects Erbamont to initiate clinicl clinical trials on the IL-6 variant by the end of 1992. A May 1989 licensing pact gives Erbamont N.V. exclusive worldwide rights to manufacture and market hematopoietic hematopooietic growt factors developed as part of the agreement. Erbamont has provided $ 2.6 mil. in research fees for IL-6 to date and is responsible for pre-clinical and clinical studies as well as obtaining regulatory and marketing approval. Although Immunex/Hoechst's granulocyte macrophage-colony stimulating factor and Amgen's G-CSF have been approved for the treatment of neutropenia, ImClone notes that it is "not aware of any effective drug therapy for thrombocytopenia [the reduction of platelets resulting in susceptibility to bleeding], a condition which affects a high proportion of patients" undergoing cancer therapy. The 2 mil. share offering for an estimated $ 14 per share should fund operations through 1993, ImClone said. Approximately $ 15 mil. of the anticipated $ 25.5 mil. net proceeds from a successful offering is intended for R&D. About $ 2 mil. will be used to retire debt, with the balance of the proceeds going toward general corporate expenses, including the possible construction of a clinical-scale manufacturing facility. As of June 30, ImClone had an accumulated deficit of around $ 33 mil. The estimated proceeds from the initial public offering would match the $ 25 mil. ImClone previously netted through private placements. The firm has received an additional $ 7.1 mil. in R&D support and licensing fees totaling $ 5.7 mil. American Cyanamid terminated a 1989 licensing agreement for wound healing growth factors in September after providing $ 1 mil. in research support. An earlier Cyanamid/ImClone pact focusing on vaccines has resulted in ImClone identifying vaccine candidates for gonorrhea and herpes simplex. Cyanamid is responsible for conducting preclinical and clinical trials; ImClone believes clinical trials for the gonorrhea vaccine might begin in 1992. ImClone was founded in 1984 by two brothers who were previously in academic posts: President and CEO Samuel Waksal, PhD, and Exec VP and Chief Operating Officer Harlan Waksal, MD. The Waksals will control 31% of ImClone stock post-offering, while Erbamont and American Cyanamid will have beneficial stakes of 8% and 6% stake, respectively.

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