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.