Curis and Debiopharm Group(TM) Announce Initiation of Phase I Dose Finding Clinical Study with a Combination of HSP90 Inhibitor Debio 0932 and Everolimus (Afinitor®)
Designed to target advanced metastatic renal cell carcinoma, the study will determine the maximum tolerated dose of Debio 0932 in combination with everolimus
LAUSANNE, Switzerland and LEXINGTON, Massachusetts, October 22, 2013 /PRNewswire/ –
Curis, Inc. (NASDAQ: CRIS), an oncology focused company developing novel, targeted
drug candidates for the treatment of human cancers, and Debiopharm Group(TM) (Debiopharm),
a Swiss-based global biopharmaceutical group of companies with a focus on the development
of prescription drugs that target unmet medical needs, including oncology as well as
companion diagnostics, today announced the start of an open-label, multicenter Phase I
dose-finding study of Debio 0932, a heat shock protein 90 (HSP90) inhibitor in combination
with everolimus (Afinitor(R)), an inhibitor of mammalian target of rapamycin (mTOR) in
patients with advanced or metastatic renal cell carcinoma (RCC), who have been previously
treated with a VEGF-directed tyrosine kinase inhibitor.
This dose escalation study is designed to determine the safety and maximum tolerated
dose of Debio 0932 in combination with everolimus, in previously treated patients with
advanced/metastatic RCC. The pharmacokinetic profiles and any potential drug-drug
interactions between the two agents will also be assessed. The trial also includes an
expansion cohort of 25 patients with metastatic clear cell RCC. While approved monotherapy
treatments for RCC, including mTOR inhibitors are active, improved therapies are needed to
enhance the depth and duration of response. Several mTOR signaling pathway components such
as mTOR, AKT and LKB1 are HSP90 client proteins. Mechanistic data suggest the potential
for improved efficacy through dual mTOR and HSP90 inhibition, which may also prevent the
development of acquired resistant to this cancer therapy.
“We are very pleased that this phase I study has kicked off and believe that the
combination of our compound with everolimus can potentially further improve the outcome
for patients suffering from RCC,” said Rolland-Yves Mauvernay, President and founder of
“We continue to be impressed with Debiopharm’s systematic approach in developing Debio
0932 for the treatment of cancers where it is shown to have a strong scientific rationale
and supportive preclinical data. We believe that potent inhibition of HSP90 by Debio 0932
with its promising safety profile and convenient oral dosing, in combination with
everolimus has the potential to provide improved benefit for patients with kidney
cancers,” said Ali Fattaey, Ph.D., President and Chief Operating Officer of Curis.
RCC represents approximately 2-3% of all adult malignancies, and is the seventh most
common cancer in men and the ninth most common cancer in women. The European Society of
Medical Oncology (ESMO) estimates approximately 209,000 new cases and 102,000 deaths due
to renal cell carcinoma per annum worldwide. In the United States, according to the
National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) database,
approximately 65,000 new cases and more than 13,500 deaths from kidney and renal pelvic
cancers are expected in 2013.
About Debio 0932
Debio 0932 is a synthetic small molecule that belongs to the HSP90 family inhibitors.
It competes with ATP in binding to the N-terminal portion of HSP90 and inactivates the
ATPase activity of the chaperone. Inhibition of HSP90 results in an increased degradation
of oncogenic proteins resulting in tumor growth inhibition.
In several pre-clinical tumor models, Debio 0932 exhibited potent antitumor activity
against a broad range of cancers. In renal cell carcinoma (RCC) in vitro tumor models,
Debio 0932 combined with sorafenib, sunitinib or everolimus showed significant additive to
synergistic activity in different cell lines. These findings were confirmed in vivo. In a
patient-derived in vivo RCC xenograft model, Debio 0932 combined with everolimus
demonstrated additive to synergistic antitumor activity.
About Debiopharm Group(TM)
Debiopharm Group(TM) (Debiopharm) is a Swiss-based global biopharmaceutical group of
companies with a focus on the development of prescription drugs that target unmet medical
needs. The group in-licenses, develops and/or co-develops promising biological and small
molecule drug candidates having reached clinical development phases I, II or III, as well
as earlier stage candidates. It develops its products for global registration and access
to the largest number of patients worldwide. The products are out-licensed to
pharmaceutical partners for sales and marketing. Debiopharm is also active in the field of
companion diagnostics with a view to progressing in the area of personalized medicine.
Debiopharm independently funds the worldwide development of all of its products while
providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and
formulation, and regulatory affairs.
For more information about Debiopharm Group(TM), please visit:
About Curis, Inc.
Curis is an oncology focused company seeking to develop, targeted drug candidates for
the treatment of human cancers. Erivedge(R) is the first and only FDA-approved medicine
for the treatment of advanced basal cell carcinoma and is being commercialized and
developed by Roche and Genentech, a member of the Roche Group, under a collaboration
agreement between Curis and Genentech. Debio 0932, an oral HSP90 inhibitor is being
developed by Curis’ collaborator, Debiopharm, for multiple oncology indications. Curis is
leveraging its experience in targeting signaling pathways to develop proprietary targeted
cancer programs including CUDC-427, a small molecule antagonist of IAP proteins, and
CUDC-907, a dual PI3K and HDAC inhibitor.
For more information, visit Curis’ website at http://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 Debio 0932′s potential
benefit to patients with renal cell carcinoma. Forward-looking statements used in this
press release 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,
Debiopharm may not be able to successfully enroll patients in this Phase I study,
Debiopharm may experience delays, setbacks and failures in its clinical development of
Debio 0932, and Debio 0932 may cause unexpected toxicities. Moreover, positive results in
preclinical studies of Debio 0932 may not be predictive of similar results in human
clinical trials, and promising results from early clinical trials of Debio 0932 may not be
replicated in later clinical trials. Debiopharm may not achieve projected research,
development and commercialization goals in its expected time frames.
Curis also faces other important risks relating to, among other things, the successful
development and commercialization of its and its collaborators’ product candidates and its
business, operations, financial condition and future prospects generally, that are
discussed in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 and
other filings that it periodically makes with the Securities and Exchange Commission.
Any forward-looking statements in this press release speak only as of the date hereof.
Curis disclaims obligation to update any forward-looking statements except to the extent
required by law.
Debiopharm International SA Contact Beatrice Hirt Communication Coordinator Tel.: +41(0)21-321-01-11 email@example.com Additional Media Contacts In London Maitland Brian Hudspith Tel: +44(0)20-7379-5151 firstname.lastname@example.org In New York Russo Partners, LLC Martina Schwarzkopf, Ph.D. Account Executive Tel: +1-212-845-4292 Fax: +1-212-845-4260 email@example.com Curis, Inc. Contacts Mani Mohindru, Ph.D. Vice President, Corporate Strategy and Investor Relations Tel.: +1-617-503-6605 firstname.lastname@example.org Michael P. Gray Chief Financial and Chief Operating Officer Tel.: +1-617-503-6632 Fax: +1-617-503-6500 email@example.com
SOURCE The Debiopharm Group and Curis, Inc