Curis and Aurigene Extend Exclusivity Period of Immuno-Oncology and Precision Oncology Collaboration
January 09 2017 - 7:00AM
Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the
development and commercialization of innovative and effective drug
candidates for the treatment of cancer, today announced that it has
exercised its option to extend the exclusivity period with Aurigene
under the collaboration, license and option agreement established
in January, 2015. As previously reported, the extension of
exclusivity is associated with a payment of $7.5 million to
Aurigene, payable in two equal installments in the first and third
quarters of 2017.
The collaboration between Curis and Aurigene is focused on the
discovery, development and commercialization of small molecule drug
candidates in the fields of immuno-oncology and selected precision
oncology targets. Licensed programs within the collaboration
include CA-170, a first-in-class oral, small molecule antagonist
targeting programmed death ligand-1 (PD-L1) and V-domain Ig
suppressor of T cell activation (VISTA) immune checkpoints that is
currently being studied in a Phase 1 trial in patients with solid
tumors and lymphomas; and CA-327, an oral, small molecule immune
checkpoint antagonist targeting PD-L1 and T-cell immunoglobulin and
mucin domain containing protein-3 (TIM-3) and CA-4948, an oral
small molecule inhibitor of Interleukin-1 receptor-associated
kinase 4 (IRAK4), both of which are currently completing
IND-enabling studies.
The exclusivity extension comes two months after initial data
from the CA-170 Ph. 1 Clinical Trial were presented at a scientific
meeting – and four months after the companies closed a $24.5M
investment in Curis by Aurigene.
“The Curis-Aurigene partnership has been very productive in
designing and developing oral, small molecule inhibitors of immune
checkpoints for cancer therapy,” said Dr. Ali Fattaey, Curis's CEO,
“With the CA-170 Phase 1 Clinical Trial now well under way, we look
forward to working with our partner, Aurigene, to initiate the
first clinical trial of CA-327 planned for later this year, and the
expected selection of additional collaboration programs in the
years to come.”
“We are delighted that our collaboration has advanced three
small molecule programs in the last two years,” said CSN Murthy,
Aurigene’s CEO. “We continue to work closely with Curis to focus
our collective resources, creating and developing innovative drug
candidates for cancer patients, including multiple first-in-class
oral small molecule checkpoint antagonists within
immuno-oncology.”
About Curis, Inc.Curis is a biotechnology
company focused on the development and commercialization of
innovative and effective drug candidates for the treatment of human
cancers, including its lead development candidate, CUDC-907 that is
being investigated in clinical studies in patients with lymphomas
and solid tumors. Curis is also engaged in a broad
collaboration with Aurigene in the areas of immuno-oncology and
precision oncology. As part of this collaboration, Curis has
exclusive licenses to oral small molecule antagonists of the PD-1
and VISTA pathways, including PD-L1/VISTA antagonist CA-170, and
oral small molecule antagonists of the PD-1 and TIM-3 pathways,
including PD-L1/TIM-3 antagonist CA-327, as well as to molecules
designed to inhibit the IRAK4 kinase, including CA-4948.
CA-170 is currently undergoing testing in a Phase 1 trial in
patients with advanced solid tumors and lymphomas. Curis is also
party to a collaboration with Genentech, a member of the Roche
Group, under which Genentech and Roche are commercializing
Erivedge® for the treatment of advanced basal cell carcinoma, and
are further developing Erivedge in other diseases including
idiopathic pulmonary fibrosis and myelofibrosis. For more
information, visit Curis's website at www.curis.com.
Cautionary Note Regarding Forward-Looking
Statements:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including without limitation statements regarding the
potential advantages and benefits of small molecule checkpoint
inhibitors and Curis’s plans and expectations for the collaboration
with Aurigene, including its plans to discover and develop
multiple first-in-class oral, small molecule checkpoint inhibitors
for the treatment of patients with cancer. Forward-looking
statements may contain the words "believes," "expects,"
"anticipates," "plans," "seeks," "estimates," "assumes," "will,"
"may," “look forward,” "could" or similar expressions. These
forward-looking statements are not guarantees of future performance
and involve risks, uncertainties, assumptions and other important
factors that may cause actual results to be materially different
from those indicated by such forward-looking statements. For
example, Curis may experience adverse results, delays and/or
failures in its drug development programs and may not be able to
successfully advance the development of its drug candidates in the
time frames it projects, if at all. Curis's drug candidates may
cause unexpected toxicities, fail to demonstrate sufficient safety
and efficacy in clinical studies and/or may never achieve the
requisite regulatory approvals needed for commercialization.
Favorable results seen in preclinical studies and early clinical
trials of Curis’s drug candidates may not be replicated in later
trials. There can be no guarantee that the collaboration
agreement with Aurigene will continue for its full term, that Curis
or Aurigene will each maintain the financial and other resources
necessary to continue financing its portion of the research,
development and commercialization costs, that the parties will
successfully discover, develop or commercialize drug candidates
under the collaboration, or that Curis receive full or partial
benefit of payments waived by Aurigene. Curis Royalty may not
receive sufficient levels of royalty revenue from sales of Erivedge
to satisfy its royalty-collateralized debt obligation or may
otherwise lose its rights to Erivedge royalties and royalty-related
payments as a result of a foreclosure of the loan. Curis will
require substantial additional capital to fund its business and
such capital may not be available on reasonable terms, or at all.
Curis also faces risks relating to: potential adverse decisions
made by the FDA and other regulatory authorities, investigational
review boards, and publication review bodies; competition; its
ability to obtain or maintain necessary patent protection; unstable
market and economic conditions; unplanned expenses; and
other important risks relating to its business, operations,
financial condition and future prospects that are discussed in its
most recent Form 10-K and Form 10-Q and other filings that it
periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views
of Curis only as of today and should not be relied upon as
representing Curis's views as of any subsequent date. Curis
disclaims any intention or obligation to update any of the
forward-looking statements after the date of this press release
whether as a result of new information, future events or otherwise,
except as may be required by law.
Company Contact:
James E. Dentzer
Chief Financial Officer & Chief Administrative Officer
617-503-6500
jdentzer@curis.com
Media Contact:
David Schull
Russo Partners
212-845-4271
david.schull@russopartnersllc.com
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