curis inc (CRIS) Key Developments
Curis, Inc. Presents Preclinical Data on CUDC-427 at AACR Annual Meeting
Apr 22 15
Curis, Inc. announced data presented from in vitro and in vivo studies for CUDC-427, an antagonist of inhibitor of apoptosis (IAP) proteins, at the American Association for Cancer Research (AACR) 2015 Annual Meeting. CUDC-427 is being studied in a Phase 1 trial in patients with advanced solid tumors or lymphoma. Curis' collaborator, Aurigene Discovery Technologies Limited, also reported preclinical data on its interleukin-1 receptor association kinase-4 (IRAK-4) inhibitor program at AACR. CUDC-427 presentations: Curis scientists presented two CUDC-427 posters at AACR. The first poster, "Predictive biomarker signatures for IAP inhibitor CUDC-427," discussed data from in vitro and in vivo studies that were conducted to identify predictive gene signatures that may be associated with drug response in ovarian and breast cancers. The drug response and genomic/expression profiles of 29 breast and ovarian patient-derived xenografts (PDX) were used to generate a set of gene signatures that will be further validated in additional PDX models and patient samples derived from ongoing clinical testing of CUDC-427. The second poster, "IAP inhibitor CUDC-427 induces tumor regression or stasis in preclinical models of B-cell lymphoma," reported data from in vitro and in vivo studies showing CUDC-427 anti-tumor activity in multiple hematologic cancer models, including diffuse large B-cell lymphoma (DLBCL). Data from a panel of human hematologic cell lines showed that the DLBCL cell lines were most sensitive to CUDC-427 treatment in growth inhibition assays. The anti-tumor effect of CUDC-427 was further confirmed in vivo studies where daily dosing of CUDC-427 induced tumor regression or stasis in certain DLBCL xenograft and B-cell lymphoma syngeneic mouse models. IRAK-4 program presentation: Curis' collaborator Aurigene presented a poster entitled "Novel IRAK-4 inhibitors exhibit highly potent anti-proliferative activity in DLBCL cell lines with activating MYD88 L265P mutation" that included data from multiple chemically distinct series of potent oral IRAK-4 inhibitors. These compounds were shown to potently inhibit IRAK-4 kinase activity in biochemical assays as well as proliferation of MYD88 mutant DLBCL cell lines. Anti-tumor activity in DLBCL was further confirmed in a MYD88 mutant xenograft model. Some of these compounds also significantly reduced disease burden in a rat collagen-induced arthritis model, an in vivo model for inflammation.
Curis, Inc. Presents at 40th Annual Deutsche Bank Health Care Conference, May-06-2015
Apr 10 15
Curis, Inc. Presents at 40th Annual Deutsche Bank Health Care Conference, May-06-2015 . Venue: The InterContinental Hotel, 510 Atlantic Ave, Boston, MA 02210, United States.
Curis, Inc. Announces Orphan Drug Designation for CUDC-907 in Diffuse Large B-Cell Lymphoma
Apr 6 15
Curis, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead proprietary drug candidate, CUDC-907 for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). CUDC-907 is an oral, dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) enzymes
that is currently under investigation in Phase 1 clinical studies in patients with relapsed or refractory lymphomas or multiple myeloma as well as in patients with advanced/relapsed solid tumors, including hormone receptor positive (HR+)/HER2-negative breast cancer or midline carcinoma with certain NUT gene rearrangements. The FDA's Orphan Drug Designation program grants orphan status to drugs and biologics that are intended for use in rare diseases/or disorders, defined as those that affect fewer than 200,000 people in the U.S. or that affect more than 200,000 people in the U.S. where there is no reasonable expectation that the cost of
developing and making the drug or biological product for the specific disease or condition will be recovered from sales in the U.S. Orphan drug designation may qualify the sponsor for financial incentives such as tax credits for qualified trials, the ability to apply for annual grant funding, clinical trial research design assistance and waiver of application fees associated with the approval of new drug under the Prescription Drug User Fee Act. In addition, if a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug or biological product for the same indication for a period of 7 years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or if the product with orphan exclusivity experiences a shortage. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
Curis Seeks Acquisitions
Feb 25 15
Curis, Inc. (NasdaqGM:CRIS) priced its common stock offering resulting in aggregate proceeds of $60 million. Curis will use the proceeds to fund potential acquisitions of new business, technologies or products that it believes complement or expand its business, and for general working capital and capital expenditures.
Curis, Inc. Announces Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014
Feb 24 15
Curis, Inc. announced unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter, revenues were $1,992,699 against $1,524,137 for the same period a year ago. Net loss from operations was $4,811,088 against $4,483,217 for the same period a year ago. Net loss was $5,688,870 or $0.07 basic and diluted per share against net loss of $4,198,032 or $0.05 basic and diluted per share for the same period a year ago.
For the year, revenues were $9,843,481 against $15,002,032 for the same period a year ago. Net loss from operations was $15,862,249 against $9,416,409 for the same period a year ago. Net loss was $18,728,734 or $0.22 basic and diluted per share against $12,322,012 or $0.15 basic and diluted per share for the same period a year ago. The decrease in revenues for the year ended December 31, 2014 was primarily due to a decrease in license fee revenues from Genentech of $7 million when compared to the year ending 2013.