LEXINGTON, Mass., Jan. 17, 2018 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
and commercialization of innovative and effective therapeutics for
the treatment of cancer, today announced initiation of
patient dosing in a Phase 1 trial of CA-4948, an orally
available small molecule inhibitor of the IRAK4 kinase, for
treatment of patients with lymphoma. CA-4948 was discovered at
Aurigene and is the second licensed program from the Curis-Aurigene
collaboration to enter the clinic.
The Phase 1 study is designed to evaluate the safety,
tolerability, and pharmacokinetic profile of CA-4948; identify any
dose-limiting toxicities; and establish the recommended Phase 2
dose for the treatment of patients with lymphomas. The dose
escalation stage of the trial will enroll patients with
relapsed/refractory non-Hodgkin's lymphoma, and the expansion stage
will focus on specific populations of patients with lymphomas
harboring alterations in the MYD88 gene or Toll-like receptor (TLR)
signaling pathway.
"We are pleased to announce the advancement of our clinical
pipeline with the initiation of the Phase 1 trial for this
selective IRAK kinase inhibitor in patients with lymphomas,"
commented Ali Fattaey, Ph.D.,
Curis's president and CEO. "Given the prevalence of activating
mutations in the MYD88 gene and the TLR pathway, IRAK4 represents a
significant target for the precision treatment of patients with
different hematologic malignancies. In addition to its
preclinical anti-tumor activity in MYD88-mutated lymphomas, we
have observed encouraging effects of CA-4948 in animal models
of acute myeloid leukemia (AML), myelodysplastic syndromes (MDS) as
well as non-oncology inflammatory disease models. We look forward
to working with our partner Aurigene to develop CA-4948 and
explore clinical opportunities for these conditions in the
near future."
"We are excited to have enrolled the first patient in this
lymphoma clinical trial and look forward to further investigating
CA-4948 as a potential new treatment option for patients with
hematologic malignancies," said Mathew
Lunning, DO, University of Nebraska
Medical Center, an investigator for the study.
"We are delighted with our collaboration that has led to the
advancement of the second program into the clinic, an IRAK4
targeting molecule that came out of Aurigene's discovery efforts
over many years," said CSN Murthy, Aurigene's CEO. "Our investment
into Curis exhibits our belief and commitment for this program and
beyond as we work with Curis to focus our collective resources to
advance exciting drug candidates."
About CA-4948, a Small-Molecule Inhibitor of IRAK4
Kinase
Innate immune responses orchestrated through Toll-like receptors
are important mediators of the body's initial defense against
infections, while their dysregulation is associated with certain
inflammatory conditions. Toll-like receptor signaling through the
adaptor protein MYD88 results in the activation of IRAK4,
initiating a signaling cascade that induces cytokine and survival
factor expression. MYD88 gene mutations occur in approximately 30
percent of activated B-cell subtype of diffuse large B-cell
lymphomas (DLBCL)1,2 and in over 90 percent of cases of
the B-cell malignancy Waldenstrom's macroglobulinemia
(WM).3 IRAK4 has been validated as a target in DLBCL and
WM disease setting, and its inhibition by CA-4948 has been shown to
provide potent in vivo anti-tumor activity in animal
models.4,5 IRAK4 inhibitors are also in clinical testing
for treatment of patients with rheumatoid arthritis.
1Nature. 2011; 470(7332):115–119
2Immunology and Cell Biology. 2011; 89(6):659–660
3N Engl J Med. 2012; 367(9):826–833
4Cancer Res. 2017; 77(13 Suppl): Abstract 1168
5Blood. 2015;126(23):4004–4004
About Curis
Curis is a biotechnology company focused on the development and
commercialization of innovative and effective drug candidates for
the treatment of human cancers, including CUDC-907, which 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 dual antagonists of PD1 and VISTA, including
PDL1/VISTA antagonist CA-170, and oral small molecule
dual antagonists of PD1 and TIM3, including PDL1/TIM3
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. For more information, visit Curis's website
at www.curis.com.
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SOURCE Curis, Inc.