CDK9

Kronos Bio Announces Restructuring to Focus Resources on Clinical Development with Extended Cash Runway

Retrieved on: 
Thursday, March 7, 2024

SAN MATEO, Calif., and CAMBRIDGE, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced a plan to optimize its resource allocation, restructure, and extend runway to focus resources on key programs in the Company’s pipeline, including the ongoing phase 1/2 study of KB-0742 following the review of additional positive preliminary safety and efficacy data. This plan positions the Company to maximize the potential of KB-0742, an inhibitor of CDK9, by exploring an extended dosing schedule while also continuing to progress KB-9558, a p300 KAT inhibitor, through ongoing IND-enabling studies and into the clinic, and its discovery efforts and collaborations. The Company expects these efforts, which include a 21% reduction in force, will extend cash runway into the second half of 2026.

Key Points: 
  • The Company expects these efforts, which include a 21% reduction in force, will extend cash runway into the second half of 2026.
  • The Company has reported target engagement, tumor regressions, and an acceptable safety profile at 60mg dosed three-days-on, four-days-off.
  • KB-0742 cleared 80mg three-days-on, four-days-off and the Company expects to publish this data in addition to the 60mg expansion mid-year.
  • Pending the completion of IND-enabling studies in 2024, the Company expects to commence a first-in-human study in multiple myeloma in 2025.

Kronos Bio To Present Three Posters at AACR 2024 Annual Meeting

Retrieved on: 
Tuesday, March 5, 2024

SAN MATEO, Calif. and CAMBRIDGE, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that three abstracts have been selected for presentation at the American Association for Cancer Research (AACR) annual meeting, being held from April 5-10, 2024 in San Diego, California.

Key Points: 
  • SAN MATEO, Calif. and CAMBRIDGE, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that three abstracts have been selected for presentation at the American Association for Cancer Research (AACR) annual meeting, being held from April 5-10, 2024 in San Diego, California.
  • “We are excited to present our data at AACR showing that targeting p300’s enzymatic KAT domain can selectively downregulate IRF4, a long sought after transcription factor dependency in multiple myeloma.
  • Although p300 is an essential gene, our data show that through its relationship as a critical IRF4 cofactor, we can achieve selective antiproliferative effects against myeloma cells,” said Charles Lin, Ph.D., Senior Vice President, Research and Development of Kronos Bio.
  • Details for the AACR 2024 abstracts are as follows:
    Title: A dose escalation and cohort expansion study of the CDK9 inhibitor KB-0742 in relapsed, refractory and transcriptionally addicted solid tumors
    Title: KB-0742, an oral highly selective CDK9 inhibitor, demonstrates preclinical activity in transcription factor fusion driven adenoid cystic carcinoma patient-derived models
    Poster Session: Molecular Biology in Clinical Oncology: Characterizing and Modulating Epigenetics and Gene Expression

Prelude Announces Acceptance of Multiple Preclinical Abstracts at the 2024 AACR Annual Meeting

Retrieved on: 
Tuesday, March 5, 2024

WILMINGTON, Del., March 05, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced that three posters with preclinical data on the Company’s highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation CDK4/6 inhibitor, have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place from April 5 to 10, 2024.

Key Points: 
  • WILMINGTON, Del., March 05, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced that three posters with preclinical data on the Company’s highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation CDK4/6 inhibitor, have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place from April 5 to 10, 2024.
  • Peggy Scherle, Ph.D., Chief Scientific Officer of Prelude, stated, “We look forward to sharing data on the preclinical characterization of our lead oral SMARCA2 degrader, PRT7732, which is on track to advance into Phase 1 clinical development in the second half of this year, and to presenting additional preclinical data for our highly selective and potent CDK9 inhibitor, PRT2527, that supports its potential therapeutic value in combination with BTK and BCL2 inhibitors in lymphoid malignancies.
  • To attend in person or via webcast, visit: https://edge.media-server.com/mmc/p/5dwkjbcy .
  • A replay of the webcast will be available on the Prelude website for 90 days.

SELLAS Life Sciences Delivers Oral Presentation of SLS009 Phase 1 Data for Acute Myeloid Leukemia Patients at 2024 European School of Haematology (ESH) Conference

Retrieved on: 
Friday, March 1, 2024

NEW YORK, March 01, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the delivery of an oral presentation of data for the cohort of patients with acute myeloid leukemia (AML) from the Phase 1 dose-escalation study of SLS009 (formerly GFH009) by Dr. Tapan Kadia, Professor at MD Anderson Cancer Center and the study’s primary investigator, at the 2024 European School of Haematology Acute Leukaemias (ESH) Conference: How to Diagnose and Treat Acute Leukaemias, taking place March 1-3, 2024, in Stockholm, Sweden.

Key Points: 
  • Positive topline data for the heavily pretreated AML patients showed evidence of anti-tumor activity increasing with higher dose levels and no significant safety issues.
  • The CR lasted eight months with the patient achieving one year survival at the latest assessment.
  • Strong inhibitory activity against key biomarkers with a dose-proportional response and universal decrease of MYC and MCL-1 in evaluable patients.
  • “Its potential strong synergy with the standard regimen of venetoclax and hypomethylating agents could open up new avenues in the treatment of acute myeloid leukemia.

Prelude Therapeutics Reports Full Year 2023 Financial Results and Outlines Key Objectives for 2024

Retrieved on: 
Thursday, February 15, 2024

WILMINGTON, Del., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for the fiscal year ended December 31, 2023, and outlined key objectives for 2024.   

Key Points: 
  • “Our partnership with AbCellera represents a strategic step to expand our pipeline, based on our core competencies in medicinal chemistry, cancer biology and clinical development.
  • A second cohort of patients with AML is expected to initiate in the first half of 2024.
  • Under the terms of the agreement, Prelude and AbCellera will jointly discover, develop, and commercialize products emerging from the collaboration.
  • The decrease in general and administrative expenses was primarily due to our continued management of general and administrative expenses.

MEI Pharma Reports Second Quarter Fiscal Year 2024 Results and Operational Highlights

Retrieved on: 
Tuesday, February 13, 2024

As of December 31, 2023, MEI had $59.5 million in cash, cash equivalents, and short-term investments with no outstanding debt.

Key Points: 
  • As of December 31, 2023, MEI had $59.5 million in cash, cash equivalents, and short-term investments with no outstanding debt.
  • Research and development expenses decreased by $11.4 million to $3.9 million for the quarter ended December 31, 2023, compared to $15.3 million for the quarter ended December 31, 2022.
  • General and administrative expenses decreased by $0.5 million to $8.0 million for the quarter ended December 31, 2023, compared to $8.5 million for the quarter ended December 31, 2022.
  • MEI recognized no revenue for the quarter ended December 31, 2023, compared to $32.7 million for the quarter ended December 31, 2022.

SELLAS Announces Publication of Preclinical Data on its Highly Selective CDK9 Inhibitor, SLS009, in Oncotarget

Retrieved on: 
Tuesday, February 6, 2024

The publication, entitled, “The pharmacodynamic and mechanistic foundation for the antineoplastic effects of GFH009, a potent and highly selective CDK9 inhibitor for the treatment of hematologic malignancies”, is available online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10732257/ .

Key Points: 
  • The publication, entitled, “The pharmacodynamic and mechanistic foundation for the antineoplastic effects of GFH009, a potent and highly selective CDK9 inhibitor for the treatment of hematologic malignancies”, is available online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10732257/ .
  • The research provides a robust pharmacodynamic and mechanistic foundation for the antiproliferative effects of SLS009 in hematologic cancers.
  • The research shows that through rapid CKD9 inhibition, SLS009 depletes the protective anti-apoptotic proteins produced downstream of CKD9.
  • The Company believes that this induced cancerous cell apoptosis is a key mechanism behind SLS009's robust anti-cancer activity.

SELLAS Life Sciences Receives FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Provides Updated Data for Phase 2a Study of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia Patients

Retrieved on: 
Tuesday, January 9, 2024

NEW YORK, Jan. 09, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009 (formerly GFH009), its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.

Key Points: 
  • The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.
  • Importantly, as of the last follow-up, eight of the nine patients enrolled in the 45 mg cohort were alive.
  • The first patient enrolled in the study achieved a complete response (CR) and continues on study in the seventh month with full peripheral blood recovery.
  • Eight patients (89%) remain alive (one patient succumbed to sepsis having previously contracted COVID 19) and six continue treatment.

GenFleet Therapeutics Announces GFH009 Granted with FDA Fast Track, Orphan Drug Designations for Treating R/R Peripheral T-cell Lymphomas and Acute Myeloid Leukemia

Retrieved on: 
Thursday, January 11, 2024

GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the FDA for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML).

Key Points: 
  • GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the FDA for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML).
  • Numerous subjects in GFH009 studies achieved complete or partial responses, and superior safety profile & efficacy of GFH009 was observed in previous studies.
  • GenFleet is conducting a multi-center, open-label, single-arm study of GFH009 for the treatment of r/r PTCL in close to 40 sites in China.
  • GFH925 was granted with NDA acceptance, priority review and two breakthrough therapy designations in China; GFH009 received FDA fast track and orphan drug designations for two indications.

Vincerx Pharma Announces Compelling Clinical Efficacy of Enitociclib in Combination with Venetoclax and Prednisone in Lymphoma

Retrieved on: 
Sunday, January 7, 2024

PALO ALTO, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC) (“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced promising clinical results from a Phase 1 NIH-sponsored study of enitociclib in combination with venetoclax and prednisone for the treatment of relapsed/refractory lymphoma.

Key Points: 
  • “Enitociclib continues to differentiate itself in the CDK9 inhibitor field,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx.
  • “Enitociclib is well tolerated, making it ‘the partner of choice’ for novel combinations.
  • We are pleased to see the high response rate and tolerability of enitociclib in combination with venetoclax and prednisone in patients with hard-to-treat types of non-Hodgkin’s lymphoma such as peripheral T-cell lymphoma (PTCL) and double-hit diffuse large B-cell lymphoma (DH-DLBCL).
  • ADCs and bi-specifics have been limited by numerous safety and efficacy challenges, so the profile we are observing in these initial dose levels is exciting.”