Data update expands AML dataset from 5 patients to 30 patients
LEXINGTON, Mass., May 14, 2024 /PRNewswire/ — Curis Co., Ltd. (NASDAQ: CRIS), a biotechnology company focused on the development of emausertib (CA-4948), an orally available small molecule IRAK4 inhibitor, today announced that it will continue to support the ongoing TakeAim Leukemia Study (CA-4948-) in patients with relapsed and relapsed leukemia. 102) announced the latest data. Refractory (R/R) AML to be presented at ASCO and EHA meetings.
This update includes data on 25 new patients in the FLT3 mutation (FLT3m) and U2AF1/SF3B1 splicing factor mutation (SFm) cohorts. These patients had less than three lines of prior therapy and were treated with the recommended phase 2 dose of emausertib as monotherapy (RP2D) 300 mg BID.
Before
data
|
new
|
total
|
||||
FLT3m AML
|
3
|
9
|
12
|
|||
SFm AML
|
3
|
17
|
20
|
|||
Adjustments for patients with double mutations**
|
(1)
|
(1)
|
(2)
|
|||
Five
|
twenty five
|
30
|
||||
*Data cutoff as of February 26, 2024.
** Two patients had both FLT3m and SFm (double mutation)
One patient in the first group of five patients.1 patient included in new group of 25 additional patients
FLT3m cohort – 12 relapsed/refractory patients enrolled to date
Twelve R/R AML patients with FLT3m were treated with emausertib. Previous treatments included venetoclax (8/12), hypomethylating agents or HMA (9/12), and FLT3 inhibitors (9/12). Preliminary data indicate 6 objective responses in 11 response-evaluable patients: 3 complete remissions (CR), 1 CR with partial hematologic recovery (CRh), and 2 The name is morphological leukemia-free status (MLFS), and the treatment period is 46 to 324 days. . At data cutoff, her 4 patients are ongoing, including 1 with CRh and 1 with her MLFS.
- 3/3 patients not receiving FLT3i treatment achieved objective response (2 CR, 1 MLFS)
- Three of eight patients who progressed on or after previous FLT3i therapy achieved objective response (1 CR, 1 CRh, 1 MLFS)
- 1 patient cannot assess response
All responders showed complete normalization of the number of blasts in the bone marrow. One of these patients proceeded to an allogeneic stem cell transplant. Responses were achieved rapidly in this population, with 5 of 6 responses occurring within his 1 cycle of treatment.
SFm cohort – 20 relapsed/refractory patients enrolled to date
Twenty R/R AML patients with SFm were treated with emausertib. Previous treatments included venetoclax (18/20) and HMA (17/20). Preliminary data indicate that 4 of 18 response-evaluable patients in this population achieved an objective response (CR/CRh/MLFS). Eight of the 20 patients were in active disease at the time of data cutoff, including 1 with her MLFS and 3 non-responders with increased neutrophil counts.
- All four responders (1 CR, 2 CRh, 1 MLFS) had been previously treated with HMA.Three of them had also received previous treatment with venetoclax.
- Three additional non-responsive patients are ongoing and have shown increased neutrophil counts
- Response was not evaluable in 2 patients
All responders showed complete normalization of the number of blasts in the bone marrow. One of these patients proceeded to an allogeneic stem cell transplant. “In addition to responders, we also see increased neutrophil counts in several further progressing patients, as the main cause of death in AML patients is infection (associated with low neutrophil counts). , the increase in neutrophils indicates meaningful clinical improvement for these patients,'' said Robert Martel, MD, chief scientific officer at Curis.
“We are encouraged by the continued demonstration of emavusertib with clear single-agent activity supporting its potential as both monotherapy and combination therapy in AML,” said Curis President and CEO. ) said James Dentzer.
About Curis Co., Ltd.
Curis is a biotechnology company focused on the development of emavusertib, an orally available small molecule IRAK4 inhibitor. Emausertib is currently being tested in the Phase 1/2 TakeAim lymphoma study in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in combination with the BTK inhibitor ibrutinib. It is being tested as monotherapy in the phased TakeAim leukemia trial. Azacitidine and venetoclax combination therapy for relapsed/refractory acute myeloid leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndromes (hrMDS) with FLT3 mutations or splicing factor mutations (U2AF1 or SF3B2) We have obtained a patent as the forefront of this technology. AML. Emausertib has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of AML and MDS. Curis has an exclusive license for emavusertib (CA-4948) through his 2015 partnership with Aurigene. Curis has licensed the rights to Erivedge® to his Genentech, a member of the Roche Group, under which he is commercializing his Erivedge® for the treatment of advanced basal cell carcinoma. For more information, please visit Curis' 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 forward-looking statements regarding Curis' plans, strategies and strategies regarding emavusertib, its clinical trials and research, and commercialization plans. This includes, but is not limited to, statements regarding goals. Descriptions regarding the timeline, expected results or therapeutic potential, initiation, progression, expansion, use, safety, efficacy, dosage and potential benefits of emausertib in clinical trials as monotherapy and/or combination therapy , Curis' plans and timelines to further advance patient enrollment in the TakeAim Lymphoma, TakeAim Leukemia and AML Triplet Trials, preliminary, interim, and/or additional data from ongoing or planned clinical trials capabilities, a statement of Curis' expectations regarding interactions with the FDA, mutations or potential biomarkers, and a description of the assumptions underlying any of the foregoing. Forward-looking statements include the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “seek,” “estimate,” “assume,” and “predict.” , “plan” and “aim” may be included. , “would”, “may”, “would”, “could”, “should”, “continue”, “possibility”, “focus”, “strategy”, “mission” ', or similar expressions. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, assumptions and other risks that may cause actual results to differ materially from those indicated by such forward-looking statements. contains important elements of. Curis may experience adverse outcomes, delays and/or failures in its drug development programs and may be unable to successfully advance the development of its drug candidates within the expected timeframes. Curis' drug candidates may develop unexpected toxicities, may fail to demonstrate sufficient safety and efficacy in clinical studies, or may never receive the necessary regulatory approvals for commercialization. The positive results seen in preclinical studies and early clinical trials of Curis' drug candidates may not be replicated in subsequent trials. Curis is highly dependent on the success of his emavusertib, and any delay in the development of emavusertib could have a material adverse effect on the company's business. Guarantees that the collaboration agreement with Origene will continue for the full term, or that the CRADA with NCI will continue, or that Curis or its collaborators, respectively, may be required to continue funding any portion of their research, development and commercialization. There is no guarantee that we will maintain funding and other resources. or whether the parties will be successful in working together to discover, develop and commercialize drug candidates. Regulatory authorities may make decisions that delay or limit the ability of Genentech and/or Roche to continue commercializing his Erivedge in basal cell carcinoma. Competitive drugs may be developed that are better than Eliedge. In connection with the agreement with Oberland Capital, Curis faces risks related to the transfer and incurrence of certain royalties and royalty-related payments on commercial sales of Erivedge. This includes the risk that Curis or its wholly-owned companies should default on their obligations, such as: As a subsidiary, Curis may lose all rights it had to future royalties and royalty-related payments, and Curis may be entitled to receive future royalties and royalties at a multiple of the payments received. may have to repurchase tea-related payments and has the ability to participate. Future arrangements may be precluded, all of which could have a material adverse effect on the Company's business, financial condition and stock price. Curis will require significant additional capital to fund its operations. Based on our available cash resources, we do not have sufficient cash on hand to support our current operations within the next 12 months from the date of this press release. If we are unable to obtain sufficient funding, we may be forced to delay, reduce the scope of, or discontinue the development of Emausertiv, including related clinical trials and operating costs, which could delay Emausertiv's time to market; Market launch may be hindered. This could adversely affect our business prospects and ability to continue our business, and could adversely affect our financial condition and ability to pursue our business strategy. Curis faces significant competition. Curis and its collaborators face the risk of potential adverse decisions by the FDA and other regulatory authorities, institutional review boards, and publication review bodies. Curis may be unable to obtain or maintain necessary patent protection and may become involved in costly and time-consuming patent litigation or interference proceedings. Volatile market and economic conditions, natural disasters, public health crises, political crises, and other events beyond Curis' control could cause material disruption to Curis' business or the businesses of third parties on which Curis relies. Curis' results of operations and ability to raise capital could be adversely affected. . Other important factors that could cause or contribute to actual results differing materially from those expressed in the forward-looking statements include the Company's most recent Form 10-K and Risk Factors Overview” and the factors described under the captions “Risk Factors.” 10-Q and the factors discussed in the Company's other periodic filings with the Securities and Exchange Commission. Further, forward-looking statements represent Curis' 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 forward-looking statements after the date of this press release, whether as a result of new information, future events or otherwise, except as required by law.
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Company code: NASDAQ-NMS:CRIS