XOMA Announces Development and Commercialization Agreement for First-in-Class Anti-TGF-beta Antibody Program in Immuno-Oncolo...
October 01 2015 - 7:30AM
- $37.0 million upfront payment
- $13.5 million loan maturity date extended to September
2020
- Potential milestone payments of up to $480.0 million
- Royalties tiered from mid-single digits to low double
digits
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today it has
exclusively licensed the global development and commercialization
rights to its anti-transforming growth factor-beta (TGFb) antibody
program to Novartis. Under the terms of the agreement, XOMA will
receive $37.0 million in the form of an upfront payment and is
eligible to receive up to $480.0 million if all development,
regulatory, and commercial milestones are met. In addition, XOMA is
eligible to receive royalties on product sales that range from the
mid-single digits to the low double digits. In connection with this
license agreement, Novartis has agreed to extend the maturity date
on the approximately $13.5 million of outstanding debt under the
secured note agreement, which bears interest at the six-month LIBOR
plus 2% (currently 2.53%), to September 30, 2020. XOMA has also
agreed to reduce the royalty rate to XOMA associated with Novartis'
clinical stage anti-CD40 antibodies.
"XOMA and Novartis have worked closely together for several
years to develop new product candidates. When they expressed
interest in our anti-TGFb program, we knew Novartis was the best
company to bring this exciting potential therapy to the patients
whom it may help," stated John Varian, Chief Executive Officer of
XOMA. "Novartis is recognized as a leader in oncology, where an
anti-TGFb molecule has real potential either as monotherapy or in
combination with other therapeutic options.
"We had said we did not plan to raise equity capital at our
recent stock price in order to fund the development of our very
exciting endocrine portfolio. With this non-dilutive liquidity of
essentially $50.5 million, we currently project this capital, in
combination with our planned cost savings measures, will fund
operations into 2017. We remain on track to begin our XOMA 358
Phase 2 clinical program this fall and fully anticipate we will
have the data from these studies during that timeframe," concluded
Mr. Varian.
About TGF-beta
Transforming growth factor-beta (TGFb) is a potent immune
suppressive cytokine that is involved in many cellular processes,
including inhibition of cell growth and immune suppression. While
TGFb is essential for normal tissue homeostasis, elevated levels of
TGFb may drive the progression of numerous diseases, including
advanced metastatic cancer and fibrosis.
Three isoforms of TGFb exist in humans: TGFb1, 2 and 3. TGFb1 is
overexpressed in many cancers and is believed to increase the
likelihood of metastasis. Inhibiting TGFb1 and 2 while sparing
TGFb3 may reduce tumor-protecting regulatory T cells, while
allowing for the development of cytotoxic immune responses enhanced
by TGFb3, improving the therapeutic index of TGFb inhibitors. Given
the role of the TGFb pathway in cancer, it has become an attractive
target for cancer drug development.
About XOMA 089
Discovering the TGFb antibody program was made possible because
of XOMA's proprietary antibody discovery technology platform. XOMA
089 is a fully human, high-affinity, late preclinical monoclonal
antibody that neutralizes TGFb1 and 2 while sparing TGFb3. Data
have shown this compound to be both active against tumor growth in
preclinical models of head and neck cancer as well as breast cancer
and breast cancer metastasis. Preclinical data also suggest that it
may be synergistic with PD1 inhibition and work highlighting these
results was recently presented at the 2015 FASEB meeting on the
TGFb Superfamily: Signaling in Development and Disease. XOMA has
made significant progress regarding this lead compound on both the
understanding of its activity, mechanism of action, as well as
preclinical toxicology and manufacturing. Other antibodies included
in this license agreement inhibit TGFb1, which may be a more
appropriate approach to certain indications. These antibodies have
potential in immuno-oncology either as a monotherapy and may be
particularly amenable to combination therapies, especially with
immune checkpoint inhibitors.
About XOMA Corporation
XOMA Corporation is a leader in the discovery and development of
therapeutic antibodies. The Company's innovative product candidates
result from the Company's expertise in developing ground-breaking
monoclonal antibodies, including allosteric antibodies, which have
created new opportunities to potentially treat a wide range of
human diseases. XOMA's scientific research has produced a portfolio
of six endocrine assets, each of which has the opportunity to
address multiple indications. The Company's lead product candidate,
XOMA 358, is an allosteric monoclonal antibody that reduces both
the binding of insulin to its receptor and down-regulates insulin
signaling, which could have a major effect on the treatment of
hyperinsulinism. For more information, visit www.xoma.com.
Forward-Looking Statements
Certain statements contained in this press release including,
but not limited to, statements related to therapeutic potential of
our product candidates, anticipated timing of clinical trials,
anticipated timing of the release of clinical data, the anticipated
process of clinical data analysis, the anticipated receipt by XOMA
of royalty or milestone payments, cost savings and anticipated cost
savings and capital reserves and cost saving activities or
statements that otherwise relate to future periods are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. These statements are based on assumptions that may not
prove accurate, and actual results could differ materially from
those anticipated due to certain risks inherent in the
biotechnology industry and for companies engaged in the development
of new products in a regulated market. Potential risks to XOMA
meeting these expectations are described in more detail in XOMA's
most recent filing on Form 10-K and in other SEC filings. Consider
such risks carefully when considering XOMA's prospects. Any
forward-looking statement in this press release represents XOMA's
views only as of the date of this press release and should not be
relied upon as representing its views as of any subsequent date.
XOMA disclaims any obligation to update any forward-looking
statement, except as required by applicable law.
CONTACT: Investor Contacts:
Ashleigh Barreto, XOMA Corporation
510-204-7482
barreto@xoma.com
Juliane Snowden, The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Ryan Flinn, W2O Group
415-946-1059
rflinn@w2ogroup.com
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