SF3B1

Peak Bio, Inc. Awarded Patent with Broad Coverage for Thailanstatin-ADC platform technology (PH-1) a Payload with Novel Immunomodulatory Effects that Target RNA Splicing

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Thursday, January 4, 2024
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Pleasanton, CA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Peak Bio, Inc. ("Peak Bio" or the "Company") (OTCQB) PK: PKBO), announced that it was awarded US Patent No.

Key Points: 
  • Pleasanton, CA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Peak Bio, Inc. ("Peak Bio" or the "Company") (OTCQB) PK: PKBO), announced that it was awarded US Patent No.
  • The new patent describes properties of potent heteroaryl-substituted Thailanstatin payloads, proprietary non-cleavable and cleavable linkers, and antibody-drug conjugate (ADC) technology derived from it.
  • The patent granted by the USPTO covers claims for the Company’s potent Thailanstatin payload platform specific to the spliceosome protein, SF3B1.
  • This patent application is a divisional patent of the Company’s R&D toxin portfolio on Thailanstatin, termed PH-1, building on the portfolio of previously issued patents (Patent No.

Geron Announces IMerge Phase 3 Presentations at ASH Highlighting Significant Durability of Transfusion Independence and Breadth of Effect Across MDS Subgroups with Imetelstat in Lower Risk MDS

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Monday, December 11, 2023
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The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.

Key Points: 
  • The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.
  • Overall, durable 24-week and 1-year RBC-TI responses were observed with imetelstat in all lower- and higher-risk subgroups.
  • This analysis suggests clinical benefit of imetelstat across different molecularly defined subgroups and independent of the underlying molecular mutation pattern.
  • This analysis indicates that achievement of RBC-TI was associated with improved survival, suggesting that transfusion dependence is a modifiable predictor of clinical outcomes in lower risk MDS.

Geron IMerge Phase 3 Presentations at Upcoming ASH Annual Meeting Reinforce Significant Durability and Breadth of Effect of Imetelstat in Lower Risk MDS

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Thursday, November 2, 2023
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Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.

Key Points: 
  • Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.
  • “Additionally, our abstract showcasing a real-world data population level analysis of over 5,000 lower risk MDS patients adds to the significant literature suggesting a correlation between TI and improvement in survival.
  • This analysis suggests imetelstat has clinical activity in lower risk MDS patients independent of risk categories.
  • Achievement of durable TI was associated with improved survival, supporting the clinical benefit of achieving transfusion independence in lower risk MDS.

Peak Bio, Inc. Announces Filing of Provisional Patent Applications for PH-1, a Novel and Specific Immunomodulatory ADC payload platform targeting RNA splicing

Retrieved on: 
Tuesday, September 19, 2023
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Peak Bio, Inc. today announced that it has filed provisional patent applications with the United States Patent and Trademark Office (USPTO) covering claims for the Company’s potent Thailanstatin payload platform specific to the spliceosome protein, SF3B1.

Key Points: 
  • Peak Bio, Inc. today announced that it has filed provisional patent applications with the United States Patent and Trademark Office (USPTO) covering claims for the Company’s potent Thailanstatin payload platform specific to the spliceosome protein, SF3B1.
  • These patent applications are the second set of applications related to the Company’s R&D toxin portfolio on Thailanstatin, termed PH-1.
  • Previously, the USPTO had issued a patent (Patent No.
  • US 10,815,246 B2) covering potent Thailanstatin drug payloads, non-cleavable and cleavable linkers, and antibody-drug conjugate (ADC) technology derived from it.

FDA Removes Partial Clinical Hold on TakeAim Leukemia Study RP2D Established at 300 mg BID

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Thursday, July 6, 2023
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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).

Key Points: 
  • 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.
  • On April 4, 2022, the Company announced that the FDA placed a partial clinical hold on the TakeAim Leukemia study.
  • 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.

Geron Announces New Data and Analyses from IMerge Phase 3 Presented at EHA Reporting Robust Durability of Transfusion Independence, Evidence of Disease-Modifying Activity and Favorable Fatigue PRO in Imetelstat-Treated Lower Risk MDS Patients

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Monday, June 12, 2023
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This is the first Phase 3 trial we know of to show an improvement in fatigue in lower risk MDS patients,” stated Dr. Platzbecker.

Key Points: 
  • This is the first Phase 3 trial we know of to show an improvement in fatigue in lower risk MDS patients,” stated Dr. Platzbecker.
  • For patients treated with imetelstat, there was a numerically higher percentage of patients reporting any episode of sustained meaningful improvement in fatigue.
  • Further, patients receiving imetelstat experienced a shorter median time to first sustained clinically meaningful improvement in fatigue vs placebo (28.3 vs 65.0 weeks).
  • In addition to these IMerge Phase 3 presentations, Geron collaborators presented a translational analysis from a subset of IMerge Phase 2 patients, as well as imetelstat myelofibrosis (MF) pre-clinical results.

Geron Presentations at Upcoming EHA Annual Meeting to Report Updated Durability, Disease Modification and Favorable Patient Reported Outcomes (PRO) in Imetelstat-Treated Lower Risk MDS Patients in IMerge Phase 3

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Thursday, May 11, 2023
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The continuous TI for more than one year represents substantial relief from transfusion-associated complications for this lower risk MDS patient population.

Key Points: 
  • The continuous TI for more than one year represents substantial relief from transfusion-associated complications for this lower risk MDS patient population.
  • As reported in January, 39.8% (47/118) of imetelstat-treated patients versus 15.0% (9/60) of placebo-treated patients achieved the study primary endpoint of 8-week TI (P
  • As noted in the abstract, a main therapeutic goal in lower risk MDS is to alter disease biology by eradicating malignant clones.
  • Of the 178 patients enrolled in IMerge Phase 3, 22.0% of imetelstat-treated patients and 21.7% of placebo-treated patients had baseline cytogenetic abnormalities.

Curis Announces Additional Encouraging Clinical Data from TakeAim Leukemia Study of emavusertib (CA-4948) in Monotherapy R/R AML and hrMDS

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Monday, December 12, 2022
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LEXINGTON, Mass., Dec. 12, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced positive updated clinical data from the ongoing open label Phase 1a dose escalation study of emavusertib (CA-4948), a novel, small molecule IRAK-4 inhibitor, as a monotherapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high risk myelodysplastic syndromes (hrMDS) in both targeted and non-targeted populations. Patients in a targeted population are those with disease harboring U2AF1, SF3B1 (collectively "spliceosome") or FLT3 mutations. The company also announced positive initial data of emavusertib in combination with venetoclax in patients with AML or hrMDS that enrolled in the combination phase (Phase 1b) of the TakeAim Leukemia study prior to the partial clinical hold placed in April 2022.

Key Points: 
  • This represents 11 additional patients treated in targeted monotherapy populations and 13 additional patients in the non-targeted monotherapy population.
  • In addition to the monotherapy data, there are 4 patients with AML/hrMDS who have been treated with emavusertib in combination with venetoclax.
  • Previous data presented by Curis highlighted preliminary efficacy data of emavusertib in R/R AML/MDS patients whose disease is characterized by spliceosome or FLT3 mutation.
  • TakeAim Leukemia Study (NCT04278768) - This study is only enrolling in the monotherapy dose finding phase (phase 1a) of the study.

Curis to Host Webcast to Discuss Updated Emavusertib Clinical Data in Leukemia

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Tuesday, December 6, 2022
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LEXINGTON, Mass., Dec. 5, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that it will host a webcast on Monday, December 12, 2022, at 10:00 a.m. ET to discuss new data from the TakeAim Leukemia trial of emavusertib, including data presented at the 64th American Society of Hematology Annual Meeting.

Key Points: 
  • ET to discuss new data from the TakeAim Leukemia trial of emavusertib, including data presented at the 64th American Society of Hematology Annual Meeting.
  • This presentation will include data for 28 additional evaluable AML/MDS patients:
    Patients in a targeted population are those with FLT3, U2AF1, or SF3B1 mutations.
  • A live webcast will be available under "Events & Presentations" in the Investors section of the Company's website at www.curis.com .
  • A replay of the webcast will be available on the Curis website shortly after completion of the call.

SOPHiA GENETICS Launches New Solution to Advance Chronic Lymphocytic Leukemia Care, in Collaboration with IDIBAPS

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Thursday, June 9, 2022
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SOPHiA GENETICS has already facilitated the analysis of one million genomic profiles through the SOPHiA DDM Platform, including a significant amount of onco-hematological-related diseases such as acute myeloid leukemia and lymphomas.

Key Points: 
  • SOPHiA GENETICS has already facilitated the analysis of one million genomic profiles through the SOPHiA DDM Platform, including a significant amount of onco-hematological-related diseases such as acute myeloid leukemia and lymphomas.
  • The new CLL solution allows for progress of Chronic Lymphocytic Leukemia research using genomic analysis.
  • "We are proud to work together with some of the most renowned experts in the field of Chronic Lymphocytic Leukemia research around the world.
  • Forward-looking statements are based on SOPHiA GENETICS' management's beliefs and assumptions and on information currently available to its management.