PRODUCT CANDIDATES

Humanized monoclonal antibody (mAb) to Hepatocyte Growth Factor (HGF).  The Company’s lead program is the development of a monoclonal antibody against Hepatocyte Growth Factor (HGF), a growth factor believed to play an important role in the growth of many tumors and in angiogenesis.  This mAb potently inhibits the ability of HGF to stimulate growth of cells in vitro and to induce the first steps of angiogenesis.  No anti-HGF mAb with these properties had previously been described in the scientific literature.  Treatment with this mAb strongly inhibits the growth of cells from human glioma tumors, the most common type of brain cancer, as well as other tumor types, as subcutaneous or orthotopic xenografts in mice.  Based on these exciting results, in 2006 Galaxy licensed a humanized form of the mAb, designated HuL2G7, to Takeda Pharmaceutical Company.  Takeda performed all preclinical and manufacturing activities needed to file an IND for the humanized mAb, and in 2009-2010 conducted a Phase I clinical trial in advanced non-hematologic malignancies,

in which the mAb displayed an excellent preliminary safety profile and indication of activity. However, due to its strategic prioritization, Takeda returned all rights to HuL2G7 to Galaxy in July, 2012. Galaxy is therefore currently seeking a new, committed corporate partner/licensee for development of HuL2G7, worldwide or in specific geographic areas.

Humanized mAb to Fibroblast Growth Factor 2 (FGF2; basic FGF).  FGF2 both directly stimulates growth of tumor cells derived from certain cancers and is a powerful inducer of angiogenesis.  Overexpression of FGF2 and/or correlation of FGF2 level with clinical features or outcome has been reported for glioma, melanoma, prostate cancer, pancreatic cancer, liver cancer (hepatocellular carcinoma; HCC) and other types of cancer.  Galaxy has generated a mAb, GAL‑F2, that has a novel epitope relative to previous anti-FGF2 mAbs.  GAL-F2 binds to FGF2 with high affinity, blocks binding of FGF2 to its receptors, and neutralizes FGF2 biological function.  GAL-F2 strongly inhibited the growth of tumor xenografts from three different HCC cell lines: SK-Hep-1, Hep‑G2, and SMCC-7221.  Importantly, in some of these xenograft models, GAL-F2 acted additively with Nexavar®, which has been approved to treat HCC, and Avastin®, which is being tested in HCC.  The GAL-F2 mAb has already been humanized: the humanized GAL-F2 mAb retains full binding affinity and biological activity.  HCC is not effectively treated with current chemotherapeutic drugs, and drugs that target FGF2 have not previously been tested in clinical trials, so FGF2 is a promising molecular target for newer, more effective agents. In September 2012, Galaxy exclusively licensed humanized GAL-F2 to Hoffmann-La Roche for clinical development and marketing.

Humanized mAb to Fibroblast Growth Factor Receptor 2 (FGFR2).  The FGF family of growth factors is believed to play a role in the growth of many tumors by stimulating cell proliferation and angiogenesis.  FGFR2 is a major cellular receptor for FGF2, FGF7 (Keratinocyte Growth Factor) and other FGFs.  FGFR2 is abnormally expressed in several types of tumors including pancreatic, endometrial, ovarian and breast and may contribute to the malignancy of these tumors.  Overexpression of FGFR2 is associated especially strongly with the poorly differentiated type of gastric cancer.  Galaxy has generated a mAb, GAL‑FR21, that binds to FGFR2 with high affinity and blocks binding of FGF2 and FGF7 to FGFR2.  This mAb strongly or completely inhibited the growth of tumor xenografts from two different gastric cancer cell lines, SNU-16 and OCUM-2M.  GAL-FR21 has already been humanized: the humanized GAL-FR21 mAb retains full binding affinity and biological activity.  Gastric cancer is not effectively treated with current chemotherapeutic drugs, and drugs that specifically target FGFR2 have not previously been tested in clinical trials, so FGFR2 is a new and promising molecular target for more effective agents.