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Initial TakeAim Lymphoma combination data shows anti-cancer activity, including 1 complete response and 2 partial responses, in heavily pretreated patients including those with prior ibrutinib use
LEXINGTON, Mass., May 12, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that multiple abstracts have been accepted for presentation at the upcoming European Hematology Association 2022 Hybrid Congress (EHA), which will be held virtually and in-person in Vienna on June 9-12, 2022. The abstracts include data from both the TakeAim Leukemia and TakeAim Lymphoma studies as well as other studies by Curis and independent collaborators. These planned presentations are in addition to the previously announced presentations scheduled for the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago and online June 3-7, 2022.
"We are pleased that research from our lead programs will be shared with the oncology community at ASCO and EHA this year," said James Dentzer, Chief Executive Officer of Curis. "We are excited to share the initial data from the TakeAim Lymphoma study investigating the use of emavusertib in combination with ibrutinib in patients with several types of Non-Hodgkin's Lymphoma. Data in the abstract indicates that the combination has shown signs of early anti-cancer activity, including in patients with prior BTK inhibitor use, and the regimen appears to be well tolerated. The data from the TakeAim Leukemia study are consistent with our findings reported in January of this year, demonstrating emavusertib's encouraging monotherapy activity in patients with R/R AML and MDS including importantly those with spliceosome and FLT3 mutations. Currently the prognosis for patients with R/R AML or MDS is grim, there are no effective therapies and new options are very much needed. In addition to data from Curis, there will be several interesting data sets from Curis's collaborators. We look forward to providing further updates at EHA and ASCO next month."
Both of the TakeAim studies are to be presented at both the ASCO and EHA meetings. In addition, at EHA Curis will present data on the development of potential biomarkers for emavusertib in AML. Finally, Curis's collaborators will present data at EHA on the use of emavusertib in primary CNS lymphoma.
Details of the EHA presentations are as follows:
Abstract Title: TakeAim Lymphoma- An Open-Label, Dose Escalation And Expansion Trial Of Emavusertib (CA-4948) In Combination With Ibrutinib In Patients With Relapsed Or Refractory Hematologic Malignancies
Presenting Author: Grzegorz Nowakowski, MD, Mayo Clinic Rochester
Abstract Code: P1121
Session Type/Title: Poster Session
Date and Time: June 10, 2022, 4:30 – 5:45 pm CEST
Abstract Title: TakeAim Leukemia A Phase 1/2a Study Of The IRAK4 Inhibitor Emavusertib (CA-4948) As Monotherapy Or In Combination With Azacitidine Or Venetoclax In Relapsed/Refractory AML Or MDS
Presenting Author: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center
Abstract Code: S129
Session Type/Title: Novel insights into AML treatment
Session Room: Hall A7
Date and Time: June 11, 2022, 4:30 – 5:45 pm CEST
Abstract Title: Development of Potential Biomarkers for IRAK4 Inhibitor Emavusertib in Human Acute Myeloid Leukemia
Presenting Author: Andrey Ugolkov, PhD
Abstract Code: P473
Session Title: Poster session
Date and Time: Friday, June 10, 2022 - 4:30 - 5:45 pm CEST
Abstract Title: The IRAK-4 Inhibitor Emavusertib (CA-4948) For The Treatment Of Primary CNS Lymphoma
Presenting Author: Christina Von Roemeling, PhD The University of Florida
Abstract Code: P1298
Session Type/Title: Poster Session
Date and Time: June 10, 2022, 4:30 – 5:45 pm CEST
The abstracts are available online at ehaweb.org/.
About Curis, Inc.
Curis is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer. In 2015, Curis entered into a 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 antagonists of immune checkpoints including the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, emavusertib (CA-4948). Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma trial, in patients with hematologic malignancies, such as non-Hodgkins lymphoma and other B cell malignancies, both as a monotherapy and in combination with BTK inhibitor ibrutinib, and the Phase 1/2 TakeAim Leukemia trial in patients with acute myeloid leukemia and myelodysplastic syndrome, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. The FDA has placed a partial clinical hold on the TakeAim Leukemia and TakeAim Lymphoma trials during which no new patients will be enrolled, and current study participants benefiting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody, which is currently undergoing testing in a Phase 1 trial in patients with solid tumors. 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.
Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, any statements with respect to Curis's plans, strategies, objectives or financial results; statements concerning product research, development, clinical trials and studies and commercialization plans, timelines, anticipated results or the therapeutic potential of drug candidates including any statements regarding the initiation, progression, expansion, use, efficacy, dosage and potential benefits of CA-4948 in clinical trials as a monotherapy and/or as a combination therapy, the progression, use and potential benefits of CI-8993, Curis's plans and timelines to provide preliminary, interim and/or additional data from its ongoing or planned clinical trials, any statements concerning Curis's expectations regarding its interactions with the FDA or its ability to resolve the partial clinical hold of the TakeAim Leukemia study or the partial clinical hold of the TakeAim Lymphoma study, and statements with respect to mutations or potential biomarkers; and statements of assumptions underlying any of the foregoing. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission," 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, the FDA may not remove the partial clinical hold on the Phase 1/2 TakeAim Leukemia trial or the partial clinical hold on the Phase 1/2 TakeAim Lymphoma trial, or may take further regulatory action with regard to such trials; 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 agreements with Aurigene and ImmuNext will continue for their full terms, or the CRADA with NCI, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to develop or commercialize Erivedge in BCC. Erivedge may not demonstrate sufficient or any activity to merit its further development in disease indications other than BCC. Competing drugs may be developed that are superior to Erivedge. In connection with its agreement with Oberland Capital, Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, including the risk that, in the event of a default by Curis or its wholly-owned subsidiary, Curis could lose all retained rights to future royalty and royalty-related payments, Curis could be required to repurchase such future royalty and royalty-related payments at a price that is a multiple of the payments it has received, and its ability to enter into future arrangements may be inhibited, all of which could have a material adverse effect on its business, financial condition and stock price. Curis will require substantial additional capital to fund its business. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate some of its research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, any of its product candidates, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. For example, the COVID-19 pandemic may result in closures of third-party facilities, impact enrollment in clinical trials or impact sales of Erivedge by Genentech and/or Roche. The extent to which the COVID-19 pandemic may impact Curis's business or operating results is uncertain. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K and Form 10-Q, and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission ("SEC"). 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.
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