CDK9

MEI Pharma Board of Directors Aligns on Strategy to Advance Voruciclib and ME-344

Retrieved on: 
Thursday, April 11, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Agreement, Patient, Cancer, Mutation, CDK9, Venetoclax, Colorectal cancer, MEI, Bevacizumab, AML, Research, Cohort, Salvage therapy, Disease, Exercise, Therapy, IDH, Incidence, Neoplasm, Toxicity, Acute myeloid leukemia, FLT3, Standard of care, Death, Clinical trial, VEGF, Calendar, Pharmaceutical industry

With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.

Key Points: 
  • With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.
  • The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported today.
  • Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice.
  • The goal of the formulation effort is to increase biological activity, improve patient convenience of administration and increase commercial opportunity.

Prelude Highlights Continued Strength of Discovery Engine at 2024 AACR Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024
Breast cancer, SMARCA4, MCL, Generation, Prelude, CDK2, CLL, NSCLC, Patient, SMARCA2, Selective estrogen receptor degrader, BCL2, Cancer, AACR, CRC, BTK, CDK9, DLBCL, Pharmaceutical industry

WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.

Key Points: 
  • Highly selective oral SMARCA2 degrader, PRT7732, shows robust anti-tumor activity in vivo as monotherapy and in combination with chemotherapy, at well-tolerated doses
    Next Generation CDK4/6 Inhibitor, PRT3645, is highly effective in combination with other targeted therapies in preclinical models of breast cancer, CRC and NSCLC
    WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.
  • “These presentations demonstrate our core competencies in medicinal chemistry and cancer biology to optimize and deliver compounds to the clinic with the potential to succeed as differentiated first- and/or best-in-class new therapies,” said Andrew Combs, Ph.D., Chief Chemistry Officer at Prelude Therapeutics.
  • Peggy Scherle, Ph.D., Chief Scientific Officer at Prelude, stated, “Advancement of our second highly selective SMARCA2 degrader strengthens Prelude’s leadership position in the emerging use of SMARCA2 protein degradation as a potential treatment option for underserved patients with cancer.
  • With both a first-in-class IV SMARCA2 degrader, PRT3789, in Phase 1 clinical development and now our oral SMARCA2 degrader, PRT7732, expected to enter the clinic later this year, we believe these distinct modalities may offer new therapies for patients with SMARCA4 mutations.”
    Details on the poster presentations are as follows:
    Identified potent, selective, well-tolerated and orally bioavailable SMARCA2 degrader, PRT7732
    PRT7732 exhibits >3000-fold selectivity for SMARCA2 over SMARCA4, with low nanomolar potency in cell based assays
    Title: PRT2527, a Novel Highly Selective Cyclin-Dependent Kinase 9 (CDK9) Inhibitor, Has Potent Antitumor Activity in Combination with BTK and BCL2 Inhibition in Various Lymphoid Malignancies
    PRT2527 is efficacious as monotherapy in preclinical models of DLBCL, CLL and MCL, and combines with both BTK and BCL2 inhibition to improve depth and duration of responses
    Title: The Brain Penetrant CDK4/6 Inhibitor, PRT3645, is Highly Effective in Combination with Other Targeted Therapies in Preclinical Models of Breast Cancer, CRC and NSCLC
    Next generation CDK4/6 inhibitor, PRT3645, demonstrates preclinical synergy with SERDs, as well as MEK1/2 and CDK2 inhibition

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update

Retrieved on: 
Friday, March 29, 2024
Patient, PTCL, G&A, IND, Prednisone, Neoplasm, Therapy, SMDC, Medicinal chemistry, Lymphoma, Research, Frontiers Media, RNA polymerase II, Body modification, Primate, RNA, NIH, CPT, Potential, Safety, CDK9, ADC, MCL1, Solubility, Oncogene, RNA polymerase, Venetoclax, Journal, Manuscript, Cancer, Peripheral T-cell lymphoma, AACR, Antibody, MYC, Downregulation and upregulation, DLBCL, Annual general meeting, HER2, European Hematology Association, EHA, Spacecraft, PDX, Bangladesh Technical Education Board, Journal of Medicinal Chemistry, Blood, Pharmaceutical industry

PALO ALTO, Calif., March 29, 2024 (GLOBE NEWSWIRE) --  Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Vincerx presented preclinical data at the 2023 AACR Annual Meeting demonstrating significant activity in patient-derived xenograft (PDX) lymphoma mouse models.
  • Vincerx shared preclinical data at the 2023 ASH Annual Meeting showing superior activity and safety compared with commercially available B-cell targeted ADCs.
  • For the fourth quarter and full year 2023, Vincerx reported a net loss of $4.9 million, or $0.23 per share, and a net loss of $40.2 million, or $1.89 per share, respectively.
  • For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.8 million, or $0.65 per share, and a net loss of $63.0 million, or $3.00 per share, respectively.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

Edgewood Oncology Announces Positive Efficacy Data From Investigator-Sponsored Study of BTX-A51 in Preclinical Models of Liposarcoma

Retrieved on: 
Sunday, April 7, 2024
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Bone marrow, CDK7, MDM2, Apoptosis, BH3, CDK, AML, Dana–Farber Cancer Institute, Patient, LPS, Neoplasm, DNA, Cancer, Liposarcoma, Clinical trial, Azacitidine, CDK9, MCL1, Vaccine

The presentation (Abstract 604), “Targeting casein kinase 1 alpha (CK1alpha) and transcriptional CDKs (CDK7/9) in human liposarcomas,” highlighted findings for BTX-A51 in preclinical human models of LPS.

Key Points: 
  • The presentation (Abstract 604), “Targeting casein kinase 1 alpha (CK1alpha) and transcriptional CDKs (CDK7/9) in human liposarcomas,” highlighted findings for BTX-A51 in preclinical human models of LPS.
  • The data demonstrate that BTX-A51 has preclinical efficacy in treating patient-derived LPS in cell lines and human xenograft models and provides insight into the synergy gained by inhibiting both CK1α and CDK9.
  • “Dedifferentiated liposarcomas (DDLPS) are rare tumors derived from precursors of fat cells which can occur anywhere in the body.
  • Importantly, preliminary in vivo data in an LPS patient-derived xenograft model reveal that BTX-A51 is well-tolerated under conditions that inhibit tumor growth.

Kronos Bio Reports Recent Business Progress and Fourth-Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
Research, Ovarian cancer, Conference, Survival, AML, Carcinoma, RECIST, Patient, SAN, Multiple myeloma, KRON, Cancer, IRF4, Lung cancer, IND, AACR, Investment, KAT, CDK9, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and fourth-quarter and full-year 2023 financial results.

Key Points: 
  • “In 2023, we made great progress across our portfolio and business.
  • Kronos Bio extended its expected cash runway by a year, into the second half of 2026, through restructurings and resource optimization.
  • Net Loss: Net loss for the fourth quarter of 2023 was $25.3 million, or $0.43 per share, including non-cash stock-based compensation expense of $5.2 million.
  • Net loss for the full-year 2023 was $112.7 million, or $1.95 per share, including non-cash stock-based compensation expense of $25.0 million.

MEI Pharma Reports Update from Clinical Study Evaluating Oral CDK9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia

Retrieved on: 
Tuesday, March 26, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Toxicity, Aplastic anemia, Salvage therapy, CLL, AML, CRi, Patient, Venetoclax, Biomarker, Diarrhea, BCL2, University, Acute myeloid leukemia, ELN, Safety, Pharmacokinetics, CDK9, Phase 1, Associate professor, Pharmaceutical industry

The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.

Key Points: 
  • The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax.
  • A total of 29 patients with R/R AML, median age 67 years (range 34-89), enrolled in the dose escalation stage of the study evaluating voruciclib in combination with venetoclax.
  • The primary objectives of the study are to determine the safety and biologic effective dose of voruciclib monotherapy or voruciclib in combination with venetoclax.
  • Secondary objectives of the study include assessing the preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers of voruciclib monotherapy or voruciclib in combination with venetoclax.

Edgewood Oncology Emerges From Stealth with $20 Million in Series A Financing to Advance BTX-A51 in Patients with Hematologic Malignancies and Genetically-Defined Solid Tumors

Retrieved on: 
Monday, March 25, 2024
Science, Biotechnology, Research, Oncology, General Health, Health, Genetics, Clinical Trials, Toxicity, CDK7, Apoptosis, Hebrew University of Jerusalem, CRH, CRi, AML, Patient, Immunology, Acute myeloid leukemia, Cancer, Medicine, Alta Partners, Therapy, Drug development, Breast cancer, Safety, Azacitidine, Pharmacokinetics, CDK9, Bone marrow, Pharmaceutical industry

Edgewood acquired the rights to BTX-A51 from Yissum, the technology transfer company of The Hebrew University of Jerusalem, in 2023 and will use the Series A funding to advance efficacy studies in AML and breast cancer.

Key Points: 
  • Edgewood acquired the rights to BTX-A51 from Yissum, the technology transfer company of The Hebrew University of Jerusalem, in 2023 and will use the Series A funding to advance efficacy studies in AML and breast cancer.
  • “We formed Edgewood Oncology because of the synergistic mechanism of action and promising safety and anti-tumor data that was observed with BTX-A51 in Phase 1 in AML and solid tumor patients.
  • In a Phase 1 study in heavily pre-treated R/R AML patients, monotherapy BTX-A51 demonstrated a favorable safety profile and encouraging antileukemic activity.
  • As a next step, Edgewood initiated a study of BTX-A51 in combination with azacitidine in R/R AML patients in December 2023.

GenFleet and BeiGene Enter into Trial Collaboration for a Potentially First-in-class Combination Therapy to Initiate Phase Ib/II Study of GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib) Treating Diffuse Large B Cell Lymphoma

Retrieved on: 
Thursday, March 28, 2024
B-cell lymphoma, Plasma, Shanghai Cancer Center, Rituximab, Apoptosis, Leukemia, International Journal of Hematology, Patient, Hospital, Doxorubicin, Vincristine, Fudan University, CC3, Standard of care, Acute myeloid leukemia, Epidemiology, Biomedical Chromatography, Prednisone, Peripheral T-cell lymphoma, PARP, National Cancer Center, Therapy, MYC, BTK, Safety, BeiGene, CDK9, Cyclophosphamide, DLBCL, Canadian International Council, MCL1, Follicular lymphoma, Pharmaceutical industry

The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.

Key Points: 
  • The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.
  • This study will be the first combination trial conducted by a Chinese biotech to combine CDK9 inhibitor and BTK inhibitor targeting DLBCL.
  • The trials of GFH009 treating peripheral T-cell lymphoma and acute myeloid leukemia have entered into phase II stage in China and the U.S. respectively.
  • Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020–2025, Leukemia & Lymphoma, 2021
    3.

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

Retrieved on: 
Thursday, March 7, 2024
SAN, KRON, AACR, Lung cancer, Safety, Genentech, Ovarian cancer, Patient, Multiple myeloma, CDK9, IND, KAT, Cancer, Pharmaceutical industry

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.