Curis Expands Oncology Pipeline with an Oral Small Molecule PD-L1/TIM-3 Immune Checkpoint Antagonist
October 11 2016 - 7:00AM
CA-327, a PD-L1/TIM3 dual antagonist designed and
optimized by Aurigene, licensed as the 2nd oral small molecule
immuno-oncology development candidate under the Curis Aurigene
collaboration
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 the
expansion of its pipeline with CA-327, an oral, small molecule
immune checkpoint antagonist targeting programmed death ligand-1
(PD-L1) and T-cell immunoglobulin and mucin domain containing
protein-3 (TIM-3).
Curis licensed the PD-1/ TIM-3 antagonist program,
and designated CA-327 as the development candidate, by exercising
its option under the collaboration, license and option agreement
established with Aurigene in January 2015. The collaboration is
focused on the discovery, development and commercialization of
small molecule drug candidates in the fields of immuno-oncology and
selected precision oncology targets. The previous licensed
programs within the collaboration include CA-170, a first-in-class
oral, small molecule antagonist targeting 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-4948, an oral small molecule inhibitor
of Interleukin-1 receptor-associated kinase 4 (IRAK4) that is
completing IND-enabling studies.
In addition to targeting PD-L1, a negative
regulator of immune activation, CA-327 also targets TIM-3, an
inhibitory checkpoint molecule that plays an important role in
immune suppression and is co-expressed with programmed cell death-1
(PD-1) receptors on exhausted cytotoxic T cells in tumor tissues as
well as expressed on certain regulatory T cells.
The in-license of CA-327 comes three months after
the collaboration’s first oral immuno-oncology program entered the
clinic and less than a month after a $24.5M investment in Curis by
Aurigene.
“We are pleased with the progress of our
collaboration,” said Dr. Ali Fattaey, Curis's CEO, “and look
forward to working with our partner, Aurigene, to complete
IND-enabling studies for CA-327 in the coming months and expect to
file an IND in 2017.”
“We are delighted that our collaboration is
advancing its third small molecule program in less than 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 in the field of oncology, 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. The company's clinical drug
candidates include CUDC-907, which is being investigated in a Phase
2 trial in patients with Diffuse Large B Cell Lymphoma, or DLBCL,
and in a separate Phase 1 trial in patients with solid tumors. As
part of a broad collaboration with Aurigene, Curis has an exclusive
license to CA-170, an oral small molecule PD-L1/VISTA antagonist
that is currently being investigated in a Phase 1 trial in patients
with solid tumors or lymphoma. Curis also has an exclusive license
to molecules designed to inhibit IRAK4, including CA-4948,
currently in the pre-IND stage of development. 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," "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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