subslover
1 year ago
Nobody saw this because it was sent out along with a 2nd of 15 mil direct financing offering. Next update we RUN!
NEWS
FDA Removes Partial Clinical Hold on TakeAim Leukemia Study RP2D Established at 300 mg BID
LEXINGTON, Mass., July 6, 2023 /PRNewswire/ -- Curis, Inc., (Nasdaq: CRIS), a biotechnology company focused on the development of emavusertib, an orally available small molecule triple target inhibitor (IRAK4, FLT3 and CLK) for the treatment of hematologic malignancies, today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. Further, the recommended phase 2 dose (RP2D) for emavusertib as a monotherapy has been established at 300 mg BID in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS).
"We are pleased to announce that FDA has removed the partial clinical hold on the TakeAim Leukemia study and that we are proceeding with 300 mg BID as our RP2D. We are working with our clinical sites to enroll targeted patients with AML (patients with a FLT3 or spliceosome mutation who have received ≤ 2 prior lines of treatment). We also plan to initiate a front-line combination study of emavusertib with azacitidine and venetoclax. We believe emavusertib has the potential to be the cornerstone agent in the treatment of hematological malignancies." said James Dentzer, President and Chief Executive Officer of Curis. "In 2024, we expect to have updated data from the TakeAim Leukemia monotherapy study, clarification of a monotherapy registrational study design, and initial data from an azacitidine and venetoclax combination study."
On April 4, 2022, the Company announced that the FDA placed a partial clinical hold on the TakeAim Leukemia study. On August 30, 2022, the Company announced that the FDA notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase of the TakeAim Leukemia study, so that the Company could enroll at least nine additional patients at the 200 mg BID dose level. On July 6, 2023, the Company announced the FDA had removed the partial clinical hold on the TakeAim Leukemia study and that the RP2D has been established at 300 mg BID.
In the TakeAim Leukemia study, as of the March 17, 2023 data cutoff for patients dosed prior to February 9, 2023, 84 patients received emavusertib monotherapy, ranging from doses of 200 mg to 500 mg BID. Significant blast count reductions have been observed across all patient groups, regardless of dose level, mutation status, or number of prior lines of treatment. Emerging from these data are two genetically-defined subpopulations of relapsed/refractory (R/R) patients who have demonstrated compelling responses in monotherapy: AML patients with FLT3 mutation and AML patients with spliceosome mutation (U2AF1 or SF3B1 mutation) who have received ≤ 2 prior lines of treatment. In these subpopulations of evaluable patients (patients whose disease has been determined to be evaluable for objective response with baseline and post-treatment marrow assessments) treated with 300 mg BID, 2 of 3 patients with a FLT3 mutation achieved a CR (Complete Response), and 2 of 3 patients with spliceosome mutation achieved a CR or CRh (Complete Response with Partial Hematologic Recovery). The duration of response for these patients ranged from 5.6 to 7.0 months.
"A significant unmet need remains for patients with AML and MDS with the majority of front-line patients relapsing with currently available treatment options," said Dr. Reinhard von Roemeling, Senior Vice President of Clinical Development of Curis. "Emavusertib has the potential to be uniquely positioned as an addition to frontline therapy in combination with standard of care and also as a monotherapy in targeted R/R patient populations."
About emavusertib (CA-4948)
Emavusertib is a triple target inhibitor (IRAK4, FLT3 and CLK). IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-?B protein complex. Preclinical studies targeting IRAK1/4 in combination with FLT3 have demonstrated the ability to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax.
About TakeAim Studies
TakeAim Leukemia Study (NCT04278768) – study is open for enrollment.
TakeAim Lymphoma Study (NCT03328078) – study is open for enrollment.
About Curis, Inc.
subslover
2 years ago
FDA Allows Patient Enrollment to Resume in Monotherapy Dose Escalation of Emavusertib in TakeAim Leukemia Study
August 30 2022 - 08:00AM
PR Newswire (US)
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Curis working with clinical sites to resume enrollment
Preliminary clinical data update expected in 2023
LEXINGTON, Mass., Aug. 30, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has notified Curis that it may resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study.
(PRNewsfoto/Curis, Inc.)
Previously, Curis announced that the FDA had placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies in April 2022. On August 18, 2022, Curis reported that the partial clinical hold on the TakeAim Lymphoma study was lifted. After review of the comprehensive data package submitted by Curis, the FDA has notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase (Phase 1a) of the TakeAim Leukemia study, in which the company has agreed to enroll at least nine additional patients at the 200mg dose level. The partial hold remains in place for the combination therapy phase (Phase 1b) and the expansion phase (Phase 2a) of the study until Phase 1a is complete and the FDA approves proceeding to the next phases of the study.
Before lifting the restriction on patient enrollment, the FDA reviewed additional data provided by the company related to the risk of rhabdomyolysis, a side effect also associated with statins, as well as with cancer medications such as Odomzo® and Cotellic®. The FDA also reviewed the company's strategy for utilizing objective laboratory measurements, similar to those used with Odomzo and Cotellic, to identify rhabdomyolysis, as well as the company's strategy for managing rhabdomyolysis, if it is detected.
"We are pleased to announce the results of the FDA's review and to have addressed potential concerns about the identification and management of rhabdomyolysis," said James Dentzer, President and Chief Executive Officer of Curis. "We are working with our clinical sites to quickly resume enrollment of additional patients."
Similar to the TakeAim Lymphoma study, the Company is updating its timeline for clinical data release to reflect the availability of updated preliminary data from the TakeAim Leukemia study in 2023. In addition, Curis is proactively discussing the clinical plans for emavusertib in leukemia, including alignment on optimal dose and development path, with the FDA's leukemia division.
About Emavusertib (CA-4948)
Emavusertib is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-?B protein complex. Additionally, third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1. In addition to inhibiting IRAK4, emavusertib was also designed to inhibit FLT3, a known oncologic driver, which may provide additional benefit in patients with AML and MDS.
About TakeAim Leukemia
The TakeAim Leukemia study (NCT04278768) is a Phase 1/2 open-label dose
subslover
2 years ago
FDA Lifts Partial Clinical Hold on the TakeAim Lymphoma Study of Emavusertib
(PRNewsfoto/Curis, Inc.)
NEWS PROVIDED BY
Curis, Inc.
Aug 18, 2022, 08:00 ET
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Curis working with clinical sites to resume enrollment
Preliminary clinical data update expected in 2023
LEXINGTON, Mass., Aug. 18, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the TakeAim Lymphoma Phase 1/2 study of emavusertib after reviewing the comprehensive data package submitted by Curis.
"We are excited to announce that FDA has completed its review of the TakeAim Lymphoma study and has lifted the partial clinical hold. We are working with our clinical sites to quickly resume enrollment of new patients in this study in the third quarter," said James Dentzer, President and Chief Executive Officer of Curis.
Previously, Curis announced that the FDA had placed separate partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies on April 4 and April 11, 2022, respectively. The partial hold on the TakeAim Leukemia study was issued by the FDA Division of Hematologic Malignancies 1 (DHM1), which regulates clinical studies in leukemia. The partial hold on the TakeAim Lymphoma study, and the lifting of that hold, was issued by the FDA Division of Hematologic Malignancies 2 (DHM2), which regulates clinical studies in lymphoma. The partial clinical hold was lifted following agreement with the FDA on Curis's strategy for rhabdomyolysis identification and management, as well as on the enrollment of at least nine additional patients at the 200 mg dose level of emavusertib in combination with ibrutinib.
With the partial clinical hold lifted on the TakeAim Lymphoma study, the Company is updating its timeline for clinical data release to reflect the availability of updated preliminary data from this study in 2023. In addition, Curis is proactively discussing the clinical plans for emavusertib, including alignment on optimal dose and development path, with DHM2 for the TakeAim Lymphoma study.
About Emavusertib (CA-4948)
Emavusertib is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-?B protein complex. Additionally, third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1. In addition to inhibiting IRAK4, emavusertib was also designed to inhibit FLT3, a known oncologic driver, which may provide additional benefit in patients with AML and MDS.
About TakeAim Leukemia
The TakeAim Leukemia study (NCT04278768) is a Phase 1/2 open-label dose escalation, dose expansion clinical trial investigating emavusertib as a monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory (R/R) AML or high risk MDS. After dose escalation in both monotherapy and combination therapy to determine the recommended Phase 2 dose (RP2D), we plan to expand five cohorts: monotherapy in AML patients with spliceosome and FLT3 mutations, monotherapy in patients with MDS and spliceosome mutations and combination therapy with azacitidine or venetoclax in patients without spliceosome or FLT3 mutations. The goals of the study are to determine several parameters including safety, maximum tolerated dose (MTD), RP2D and signals of activity.
About TakeAim Lymphoma
subslover
3 years ago
Under $1,00 is like taking candy from a baby.
As of April 28, 2022, there were 91,645,369 shares of the registrant’s common stock, par value $0.01 per share, outstanding.
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