Curis announced the presentation of data in two poster presentations at the 22nd EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics,” held in Berlin, Germany, November 16-19
CAMBRIDGE, MA, USA | November 18, 2010 | Curis, Inc. (NASDAQ:CRIS – News), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced the presentation of data in two poster presentations at the 22nd EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics,” held in Berlin, Germany, November 16-19. One presentation is titled “Anti-Tumor Activity of CU-201, an Inhibitor of HDAC, SFK and Abl Kinases” and was presented by Rudi Bao, M.D., Ph.D., Curis’ Senior Director of Oncology on November 17th. The other presentation is titled “The First-in-Human, First-in-Class Study of CUDC-101, a Multi-Targeted Inhibitor of HDAC, EGFR and HER2: A Phase I Study in Patients with Advanced Cancer” and was presented by Toshio Shimizu, M.D., Ph. D., Visiting Clinical Fellow, South Texas Accelerated Research Therapeutics (START) on November 18th.
“CUDC-101 is the first in a series of candidates designed to address some of the challenges associated with kinase inhibitors given in monotherapy, which often either fail to produce clinical benefits or lead to resistance following kinase mutation or activation of compensatory pathways. We are extremely pleased that CUDC-101 has been shown to be well tolerated at pharmacologically meaningful concentrations, and we are encouraged by evidence of its biological activity observed in this first-in-human Phase I study,” stated Dan Passeri, Curis President and Chief Executive Officer.
“We also expect to move additional network-targeted agents from our proprietary portfolio into clinical studies in the near future,” Mr. Passeri continued. “In 2011, we expect to select at least one new development candidate, and are continuing studies in compounds targeting HDAC and PI3 kinase as well as in CU-201 and other molecules from this class. We also are currently exploring potential development collaborations around CU-201 and related compounds.”
Curis’ discovery and development efforts are focused on building a portfolio of small molecule network-targeted inhibitors against a wide range of cancer types. Compounds within each of Curis’ research and development programs are designed to inhibit one or more validated cancer targets, including EGFR, Her2, PI3K, Abl, SRC family kinases and others, as well as the inhibition of histone deacetylase, or HDAC, a validated non-kinase cancer target. Each target combination is chosen for its potential of mechanistic synergy, an approach intended to disrupt cancer resistance networks and provide a more durable response for the cancer patient. This potential breakthrough approach in cancer therapy differentiates Curis from other cancer-focused companies.
About CUDC-101
In March 2007, Curis selected CUDC-101 as the first development candidate from its network-targeted cancer drug development platform. CUDC-101 is designed to simultaneously inhibit HDAC, EGFR and Her2, all validated cancer targets. Curis filed an IND for CUDC-101 in May of 2008 and began treating patients in August of 2008.
This Phase I trial was designed as an open-label, dose escalation study of CUDC-101 in patients with advanced, refractory solid tumors whose primary objectives were to evaluate the safety and tolerability of escalating doses of CUDC-101 and to establish the MTD and dose limiting toxicities. Secondary objectives included the assessment of efficacy. The study was conducted at two clinical sites within the United States and enrolled 25 patients across several dose-escalating cohorts. CUDC-101 demonstrated promising evidence of antitumor activity at doses ranging from 150 milligrams per meter2 and 275 milligrams per meter2, including one confirmed partial response that was achieved in a gastric cancer patient at 275 milligrams per meter2, and a stable disease of greater than three months observed in a refractory breast cancer patient cancer patient at 150 milligrams per meter2. Two head and neck cancer patients, including one patient with salivary gland adenocarcinoma and one patient with tongue squamous cell carcinoma, exhibited anti-tumor activity with a decrease of greater than 20% in their respective target lesions. Curis concluded the Phase I dose escalation study in March 2010 and determined that 275 milligrams per meter2 represented the maximum tolerated dose of CUDC-101.
CUDC-101 also exhibited dose-proportionate increases in pharmacological parameters and what Curis believes to be a favorable safety profile. The most frequent adverse events were mild to moderate and included fatigue, vomiting, dyspnea (shortness of breath), pyrexia (fever), and dry skin.
A Phase Ib expansion study exploring alternative dosing schedules of CUDC-101 in specific tumor types (head and neck, gastric, breast, liver and non-small cell lung cancer) is ongoing.
About CU-201
CU-201 is a network-targeted molecule that is designed to simultaneously inhibit HDAC, Abl and Src family kinases, the combination of which Curis scientists believe have synergistic interaction against cancer cells. Src family kinases are critical components of multiple signaling pathways that regulate cancer cell proliferation, survival, angiogenesis and metastasis. Thus, as a network disrupting agent that directly targets multiple nodes of genetic and epigenetic dysregulation, CU-201 is expected to impact processes as diverse as proliferation, survival, metastasis and angiogenesis in cancer. In vitro studies demonstrate that CU-201 is able to potently inhibit class I and class II HDACs, Src and Bcr-Abl. It has been shown to outperform single target agents in proliferation assays of hematologic and solid tumor lines and to inhibit migration and invasion of cancer cell lines in vitro. In vivo, it displays potent anti-tumor activity in a variety of hematologic and solid tumor models, including subcutaneous, metastatic and orthotopic models.
About Curis, Inc.
Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis’ website at www.curis.com.
Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation the Company’s belief that its approach to developing cancer drug candidates may represent a breakthrough in cancer therapy. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates”, “assumes”, "will", "may" 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 the actual results to be materially different from those indicated by such forward-looking statements including, among other things:
* Curis’ collaborators, Genentech and Roche, may experience adverse results, delays and/or failures in their development program under collaboration with Curis. For example, Genentech and Roche may not be able to replicate in later trials any favorable safety and efficacy data from earlier trials of GDC-0449, or may otherwise fail to meet applicable regulatory standards for approval of GDC-0449.
* Curis may experience adverse results, delays and/or failures in its internal drug development programs, including with respect to its ongoing and planned clinical trials of CUDC-101, and with respect to its ongoing preclinical studies of its other targeted cancer programs.
* Curis’ collaborator Debiopharm may experience adverse results, delays and/or failures in its development program under collaboration with Curis. For example, Debiopharm may not be able to successfully advance Debio 0932 through its ongoing Phase I clinical trial as planned.
* Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations.
* Curis may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of drug candidates based on its technologies.
* Curis may not be able to obtain the substantial additional funding required to conduct research and development of its drug candidates.
* Curis may experience unplanned cash requirements, and may not receive additional anticipated payments under its collaborations, any of which could shorten the estimated period in which Curis will have cash to fund its operations and which could also adversely affect Curis’ estimated operating expenses for 2010 and beyond.
* Curis faces risks relating to its ability to enter into and maintain planned collaborations for development candidates under its targeted cancer programs, its ability to maintain its current collaborations with Genentech/Roche and Debiopharm, and the risk that any such collaborators will not perform adequately or may terminate such collaborations on short notice and/or for circumstances outside of our control.
* Curis also faces other risk factors identified in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 and other filings that it periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views only as of today and should not be relied upon as representing Curis’ 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.
SOURCE: Curis, Inc.
Post Views: 44
Curis announced the presentation of data in two poster presentations at the 22nd EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics,” held in Berlin, Germany, November 16-19
CAMBRIDGE, MA, USA | November 18, 2010 | Curis, Inc. (NASDAQ:CRIS – News), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced the presentation of data in two poster presentations at the 22nd EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics,” held in Berlin, Germany, November 16-19. One presentation is titled “Anti-Tumor Activity of CU-201, an Inhibitor of HDAC, SFK and Abl Kinases” and was presented by Rudi Bao, M.D., Ph.D., Curis’ Senior Director of Oncology on November 17th. The other presentation is titled “The First-in-Human, First-in-Class Study of CUDC-101, a Multi-Targeted Inhibitor of HDAC, EGFR and HER2: A Phase I Study in Patients with Advanced Cancer” and was presented by Toshio Shimizu, M.D., Ph. D., Visiting Clinical Fellow, South Texas Accelerated Research Therapeutics (START) on November 18th.
“CUDC-101 is the first in a series of candidates designed to address some of the challenges associated with kinase inhibitors given in monotherapy, which often either fail to produce clinical benefits or lead to resistance following kinase mutation or activation of compensatory pathways. We are extremely pleased that CUDC-101 has been shown to be well tolerated at pharmacologically meaningful concentrations, and we are encouraged by evidence of its biological activity observed in this first-in-human Phase I study,” stated Dan Passeri, Curis President and Chief Executive Officer.
“We also expect to move additional network-targeted agents from our proprietary portfolio into clinical studies in the near future,” Mr. Passeri continued. “In 2011, we expect to select at least one new development candidate, and are continuing studies in compounds targeting HDAC and PI3 kinase as well as in CU-201 and other molecules from this class. We also are currently exploring potential development collaborations around CU-201 and related compounds.”
Curis’ discovery and development efforts are focused on building a portfolio of small molecule network-targeted inhibitors against a wide range of cancer types. Compounds within each of Curis’ research and development programs are designed to inhibit one or more validated cancer targets, including EGFR, Her2, PI3K, Abl, SRC family kinases and others, as well as the inhibition of histone deacetylase, or HDAC, a validated non-kinase cancer target. Each target combination is chosen for its potential of mechanistic synergy, an approach intended to disrupt cancer resistance networks and provide a more durable response for the cancer patient. This potential breakthrough approach in cancer therapy differentiates Curis from other cancer-focused companies.
About CUDC-101
In March 2007, Curis selected CUDC-101 as the first development candidate from its network-targeted cancer drug development platform. CUDC-101 is designed to simultaneously inhibit HDAC, EGFR and Her2, all validated cancer targets. Curis filed an IND for CUDC-101 in May of 2008 and began treating patients in August of 2008.
This Phase I trial was designed as an open-label, dose escalation study of CUDC-101 in patients with advanced, refractory solid tumors whose primary objectives were to evaluate the safety and tolerability of escalating doses of CUDC-101 and to establish the MTD and dose limiting toxicities. Secondary objectives included the assessment of efficacy. The study was conducted at two clinical sites within the United States and enrolled 25 patients across several dose-escalating cohorts. CUDC-101 demonstrated promising evidence of antitumor activity at doses ranging from 150 milligrams per meter2 and 275 milligrams per meter2, including one confirmed partial response that was achieved in a gastric cancer patient at 275 milligrams per meter2, and a stable disease of greater than three months observed in a refractory breast cancer patient cancer patient at 150 milligrams per meter2. Two head and neck cancer patients, including one patient with salivary gland adenocarcinoma and one patient with tongue squamous cell carcinoma, exhibited anti-tumor activity with a decrease of greater than 20% in their respective target lesions. Curis concluded the Phase I dose escalation study in March 2010 and determined that 275 milligrams per meter2 represented the maximum tolerated dose of CUDC-101.
CUDC-101 also exhibited dose-proportionate increases in pharmacological parameters and what Curis believes to be a favorable safety profile. The most frequent adverse events were mild to moderate and included fatigue, vomiting, dyspnea (shortness of breath), pyrexia (fever), and dry skin.
A Phase Ib expansion study exploring alternative dosing schedules of CUDC-101 in specific tumor types (head and neck, gastric, breast, liver and non-small cell lung cancer) is ongoing.
About CU-201
CU-201 is a network-targeted molecule that is designed to simultaneously inhibit HDAC, Abl and Src family kinases, the combination of which Curis scientists believe have synergistic interaction against cancer cells. Src family kinases are critical components of multiple signaling pathways that regulate cancer cell proliferation, survival, angiogenesis and metastasis. Thus, as a network disrupting agent that directly targets multiple nodes of genetic and epigenetic dysregulation, CU-201 is expected to impact processes as diverse as proliferation, survival, metastasis and angiogenesis in cancer. In vitro studies demonstrate that CU-201 is able to potently inhibit class I and class II HDACs, Src and Bcr-Abl. It has been shown to outperform single target agents in proliferation assays of hematologic and solid tumor lines and to inhibit migration and invasion of cancer cell lines in vitro. In vivo, it displays potent anti-tumor activity in a variety of hematologic and solid tumor models, including subcutaneous, metastatic and orthotopic models.
About Curis, Inc.
Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis’ website at www.curis.com.
Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation the Company’s belief that its approach to developing cancer drug candidates may represent a breakthrough in cancer therapy. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates”, “assumes”, "will", "may" 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 the actual results to be materially different from those indicated by such forward-looking statements including, among other things:
* Curis’ collaborators, Genentech and Roche, may experience adverse results, delays and/or failures in their development program under collaboration with Curis. For example, Genentech and Roche may not be able to replicate in later trials any favorable safety and efficacy data from earlier trials of GDC-0449, or may otherwise fail to meet applicable regulatory standards for approval of GDC-0449.
* Curis may experience adverse results, delays and/or failures in its internal drug development programs, including with respect to its ongoing and planned clinical trials of CUDC-101, and with respect to its ongoing preclinical studies of its other targeted cancer programs.
* Curis’ collaborator Debiopharm may experience adverse results, delays and/or failures in its development program under collaboration with Curis. For example, Debiopharm may not be able to successfully advance Debio 0932 through its ongoing Phase I clinical trial as planned.
* Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations.
* Curis may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of drug candidates based on its technologies.
* Curis may not be able to obtain the substantial additional funding required to conduct research and development of its drug candidates.
* Curis may experience unplanned cash requirements, and may not receive additional anticipated payments under its collaborations, any of which could shorten the estimated period in which Curis will have cash to fund its operations and which could also adversely affect Curis’ estimated operating expenses for 2010 and beyond.
* Curis faces risks relating to its ability to enter into and maintain planned collaborations for development candidates under its targeted cancer programs, its ability to maintain its current collaborations with Genentech/Roche and Debiopharm, and the risk that any such collaborators will not perform adequately or may terminate such collaborations on short notice and/or for circumstances outside of our control.
* Curis also faces other risk factors identified in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 and other filings that it periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views only as of today and should not be relied upon as representing Curis’ 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.
SOURCE: Curis, Inc.
Post Views: 44
