CDK9

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

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星期四, 五月 9, 2024
Biotechnology, Pharmaceutical, Health, Oncology, CDK9, Investment, Venetoclax, Research, MEI, Trial of the century, Bevacizumab, AML, Cohort, Oxidative phosphorylation, Wind, Disease, Week, IDH, Patient, Toxicity, Acute myeloid leukemia, FLT3, Clinical trial, Calendar, Pharmaceutical industry

“Over the past several months, MEI has received encouraging clinical data for voruciclib and ME-344 supporting the further development of these programs,” said David Urso, president and chief executive officer of MEI Pharma.

Key Points: 
  • “Over the past several months, MEI has received encouraging clinical data for voruciclib and ME-344 supporting the further development of these programs,” said David Urso, president and chief executive officer of MEI Pharma.
  • As of March 31, 2024, MEI had $56.6 million in cash, cash equivalents, and short-term investments with no outstanding debt.
  • Research and development expenses decreased by $9.9 million to $5.2 million for the quarter ended March 31, 2024, compared to $15.1 million for the quarter ended March 31, 2023.
  • MEI recognized no revenue for the quarter ended March 31, 2024, compared to $5.9 million for the quarter ended March 31, 2023.

Kronos Bio Reports First-Quarter 2024 Financial Results

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星期四, 五月 9, 2024
CDK9, Investment, Research, KRON, Genentech, IND, ASCO, Therapy, Patient, Society, AACR, Adenoid cystic carcinoma, Cancer, SAN, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today reported recent business progress and financial results for the first-quarter of 2024.

Key Points: 
  • SAN MATEO, Calif. and CAMBRIDGE, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today reported recent business progress and financial results for the first-quarter of 2024.
  • R&D Expenses: Research and development expenses were $14.2 million for the first quarter of 2024, which includes non-cash stock-based compensation expense of $1.2 million.
  • Impairment of Long-lived Assets and Restructuring: The Company incurred impairment of long-lived assets expense of $6.6 million for the first quarter of 2024.
  • The Company also incurred restructuring expense of $6.2 million for the first quarter of 2024, which includes non-cash stock-based compensation of $4.4 million.

Prelude Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

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星期二, 五月 7, 2024
Corporation, Patient, Research and development, Mutation, CDK9, SMARCA4, Safety, Pharmacokinetics, Cancer, Research, Bain & Company, AML, SMARCA2, Growth, Docetaxel, Administration, IND, Senior, ViroPharma, Lead, Toxicity, Acute myeloid leukemia, AACR, Prelude, NSCLC, Lymphoid leukemia, Therapy, G&A, Vertex Pharmaceuticals, Head, Pharmaceutical industry

WILMINGTON, Del., May 07, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for the first quarter ended March 31, 2024 and provided an update on recent clinical development pipeline and other corporate developments.  

Key Points: 
  • 2024 AACR Annual Meeting: Prelude participated in the 2024 American Association for Cancer Research Annual Meeting, presenting three preclinical poster presentations.
  • Corporate Updates: In April 2024, Prelude appointed Sean Brusky to the newly created position of Chief Business Officer.
  • Additionally, in April 2024, Prelude appointed Robert Doody to the newly created position of Senior Vice President, Investor Relations.
  • We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

Kronos Bio to Present Clinical Update on Phase 1/2 Trial of KB-0742 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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星期三, 四月 24, 2024
Cancer, CDK9, Safety, KRON, ASCO, Society, AACR, Annual general meeting, SAN, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that it will present a study update of the oral CDK9 inhibitor KB-0742 in relapsed or refractory transcriptionally addicted advanced solid tumors from the ongoing Phase 1/2 trial, KB-0742-1001 ( NCT04718675 ), at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held from May 31 – June 4, 2024 in Chicago, Illinois and online.

Key Points: 
  • SAN MATEO, Calif. and CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that it will present a study update of the oral CDK9 inhibitor KB-0742 in relapsed or refractory transcriptionally addicted advanced solid tumors from the ongoing Phase 1/2 trial, KB-0742-1001 ( NCT04718675 ), at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held from May 31 – June 4, 2024 in Chicago, Illinois and online.
  • “We are looking forward to sharing updated data from KB-0742-1001, our ongoing Phase 1/2 trial of KB-0742, including data from the 80mg three days on/four days off dosing regimen.
  • The trial is designed to assess the safety, tolerability, and preliminary efficacy at increasing dose levels of KB-0742, an orally bioavailable and selective CDK9 inhibitor with a long half-life,” said Norbert Bischofberger, Ph.D., chief executive officer and president of Kronos Bio.
  • “Our last update at the 2023 AACR-NCI-EORTC meeting showed that KB-0742 exhibited anti-tumor activity while maintaining an acceptable safety profile at the 60mg three-days-on, four-days-off dose, which is an important step as we seek to identify the optimal dose of KB-0742.”
    Details for the ASCO 2024 abstract are as follows:

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

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星期四, 四月 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

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星期二, 四月 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

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星期五, 三月 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

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星期四, 三月 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

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星期日, 四月 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

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星期四, 三月 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.