For-Robin, Inc.

luding triple negative breast cancer which currently has no targeted therapy. In addition, this technology should be applicable to colon, prostate, and bladder carcinoma patient populations. For-Robin plans to bring its core humanized JAA-F11 technology as an adjunct therapy to patient populations as quickly, safely and efficaciously as possible. JAA-F11 antibody targets a disaccharide tumor marker, the Thomsen-Friedenreich glycoantigen (TF-Ag), and shows great promise because JAA-F11:

• is the only patented antibody that is highly specific for TF-Ag alpha, a well-known antigen found on the surface of 80% of all carcinomas and is not expressed on normal cells.

• prolongs survival in a mouse breast cancer model.

• reduces metastasis. TF-Ag is involved in metastasis, so even if targeted treatment with JAA-F11 resulted in a down-regulation of TF-Ag expression in the surviving tumor cells, these cells should be less metastatic. Lower TF-Ag expression on a tumor has been shown to be related to a less metastatic tumor type and to better prognosis.

• is expected to be safe. Humans have small amounts of naturally-occurring antibody to the TF-Ag, indicating likelihood of safety at higher quantities. Patients with higher levels of this naturally-occurring antibody have better prognoses than patients with lower levels.

• is specific for tumor tissue. Immunohistological studies show that JAA-F11 selectively binds to 77% of human breast tumor specimens tested, regardless of receptor status. Selective binding was also shown for ~60% of human colon, prostate, bladder and ovarian cancers tested.

• internalizes in tumor cells. Internalization studies, key to the use of JAA-F11 as an antibody drug conjugate, show that within one hour, 80% of JAA-F11 is internalized in human tumor cells.

• shows imaging specificity. JAA-F11 successfully images human tumors in SCID and nude mice models. Five humanized JAA-F11 human IgG1 constructs have been made and show great promise.

• All humanized constructs exhibit the same unique or improved TF-Ag alpha chemical specificity as the mouse antibody, using glycan array analysis.
• 3 constructs kill tumor cells by antibody directed cellular cytotoxicity (ADCC).
• 2 constructs internalize rapidly in human tumor cells even at concentrations as low as 0.1 μg/ml. JAA-F11 is owned and patented by the University at Buffalo (Patent number US7374755 B2, filing date July 26, 2005, publication date May 20, 2008) and exclusively licensed to F-R (2014) for commercialization. A new patent application was filed in April 2014 for humanized antibody (patent pending). F-R is supported in part through a phase I STTR grant and recently received a $2 M phase II grant from NIH/NCI. Our strategic plan is to bring JAA-F11 to the investigational new drug (IND) phase to treat breast cancers and to seek strategic pharmaceutical partnerships with the intent to license our technology. Potential licensees may come from immunotherapy specifically targeting treatment of breast, colon, bladder, prostate or other cancers and or antibody drug conjugates where partner companies seek a highly targeted solution for the selective delivery of their drugs to tumors.