Aphton Announces Closing of Commercialization and Manufacturing Agreements for IGN311 With Celltrion
November 17 2005 - 8:37AM
Business Wire
Aphton Corporation (NASDAQ:APHT) announced the formal completion of
two agreements with Celltrion, Inc., South Korea for the licensing
and commercialization and the product development and manufacturing
of Aphton's clinical product candidate IGN311. IGN311, a humanized
monoclonal antibody targeting the Lewis Y antigen, is being
developed by Aphton's wholly-owned subsidiary, Igeneon AG, as a
potential new therapy for the treatment of cancer. Lewis Y is a
tumor-related antigen that is expressed in up to 90% of all
epithelial cancers, including breast, colon, gastric, and
pancreatic cancers. Under the agreements, Igeneon granted Celltrion
a license to commercialize IGN311 in certain Asian countries,
including Japan. In return, Igeneon will receive milestone payments
and royalties from Celltrion. In addition, Celltrion will provide
development and manufacturing services related to the optimization
and upscaling of IGN311 and will produce material for further
clinical development. Celltrion will have the option to manufacture
IGN311 for global commercialization. "We are excited about the
close cooperation of both companies and about the progress made in
the comprehensive work program laid out in these agreements to
advance the development of IGN311," commented Patrick Mooney, MD,
Chairman and Chief Executive Officer of Aphton. "This deal
validates the concept of our IGN311 anti-Lewis Y antibody, and it
allows us to advance the development of this product candidate with
a limited impact to our cash flow." About IGN311 IGN311 is a
humanized monoclonal antibody against the Lewis Y carbohydrate
antigen, a blood-group-related oligosaccharide. Lewis Y is
overexpressed in up to 90% of all epithelial cancers and its
expression on adult normal tissues is very restricted; hence IGN311
has the potential to target a broad range of carcinomas. IGN311 is
designed to exert clinical effects by destruction of tumor cells by
activation of effector functions and by selective growth inhibition
via functional receptors. About Aphton Aphton Corporation,
headquartered in Philadelphia, Pennsylvania, is a clinical stage
biopharmaceutical company focused on developing targeted
immunotherapies for cancer. Aphton's products seek to empower the
body's own immune system to fight disease. Through the acquisition
of Igeneon AG in March 2005, Aphton acquired late-stage products,
IGN101, a cancer vaccine designed to induce an immune response
against EpCAM-positive tumor cells, as well as IGN311. Aphton has
strategic alliances with Xoma for treating gastrointestinal and
other gastrin-sensitive cancers using anti-gastrin monoclonal and
other antibodies; and Daiichi Pure Chemicals for the development,
manufacturing and commercialization of gastrin-related diagnostic
kits. Aphton's most advanced product, Insegia(TM), targets the
hormone, gastrin 17, in an attempt to treat gastrointestinal
cancers. Aphton is currently seeking partners to support the
further development of Insegia. For more information about Aphton
or its programs please visit Aphton's website at
http://www.aphton.com. Safe Harbor This press release includes
forward-looking statements within the meaning of the federal
securities laws, including statements about Aphton's expectations
regarding: (1) the potential benefits to Aphton resulting from the
licensing and commercialization agreements, including Aphton's
belief that the agreements advance the development of IGN311 and
that such advancement will have very little impact on Aphton's cash
flow; (2) the potential of IGN311 to target a broad range of
carcinomas, destroy tumor cells, and exert clinical effects by
destruction of tumor cells; (3) the Company's belief in gastrin as
a viable target in treating cancer; (4) the Company's expectation
regarding the purpose and effectiveness of fully-humanized
monoclonal antibodies, IGN101 and IGN311, and its cancer
immunotherapy, Insegia; and (5) Aphton's intent to seek partners to
further support the development of Insegia. These forward-looking
statements may be affected by risks and uncertainties that could
cause the actual results to differ materially from those expressed
in such forward-looking statements. Aphton undertakes no obligation
to update forward-looking statements to reflect events or
circumstances after the date hereof. This information is qualified
in its entirety by cautionary statements and risk factor disclosure
contained in Aphton's Securities and Exchange Commission filings,
including Aphton's report on Form 10-K filed with the Commission on
March 16, 2005. These risk factors include, but are not limited to:
(1) the risks and uncertainties inherent in the drug development
process and in Aphton's and Igeneon's business; (2) the ability of
Aphton and Celltrion to successfully collaborate in the development
of IGN311; (3) the timing or results of ongoing and future clinical
trials for IGN311; (4) the ability of Aphton and Celltrion to
obtain regulatory approval for IGN311; (5) the ability of Celltrion
and any approved third parties to manufacture and supply IGN311 in
commercial quantities; (6) the ability of Aphton and Celltrion to
gain commercial acceptance for IGN311; (7) the ability of Aphton
and Celltrion to fund the development, manufacturing and
commercialization of IGN311; (8) Aphton's ability to find a partner
who will support the further development of Insegia; (9)
intellectual property risks; (10) the impact of competitive
products and pricing; and (11) changing economic conditions.
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