CDK9

Cyclacel Pharmaceuticals Reports Third Quarter Financial Results and Provides Business Update

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星期一, 十一月 13, 2023
Webcast, CYCC, Research, Patient, CDK9, PLK1, Research and development, Cyclacel, Neoplasm, CDK2, R, Biomarker, Pharmaceutical industry, Cryptocurrency, Broadcasting

BERKELEY HEIGHTS, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today third quarter financial results and provided a business update.

Key Points: 
  • - Cyclacel Expects to Release Updated Phase 1/2 Clinical and Biomarker Data with Oral Fadraciclib and Provide Safety, Efficacy and Putative Mechanism Update for Oral Plogosertib -
    BERKELEY HEIGHTS, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today third quarter financial results and provided a business update.
  • If confirmed, these findings may be relevant in the upcoming Phase 2 part of our 065-101 study.
  • The operating plan includes discretionary expenditures, which if not incurred could extend cash runway into the second quarter of 2024.
  • Webcast link
    For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com .

SELLAS Provides Business Update and Reports Third Quarter 2023 Financial Results

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星期四, 十一月 9, 2023
Azacitidine, Research, Safety, Doctor of Science, GPS, SLS, Treatment of lung cancer, ODD, Food and Drug Administration, Clinical trial, Administration, Patient, CDK9, FDA, Pembrolizumab, Ovarian cancer, MD, Development, Death, Survival, IDMC, Lymphoma, Financial toxicity, Bone marrow, AML, Fast Track, PTCL, Venetoclax, Pharmaceutical industry

Phase 1/2 Study in combination with pembrolizumab (Keytruda®) in ovarian cancer:

Key Points: 
  • Phase 1/2 Study in combination with pembrolizumab (Keytruda®) in ovarian cancer:
    Final data were presented in November 2023 at the International Gynecologic Cancer Society Annual 2023 Annual Global Meeting.
  • Financial Results for the Third Quarter 2023:
    Research and Development Expenses: Research and development expenses for the third quarter of 2023 were $5.8 million, compared to $4.3 million for the same period in 2022.
  • Acquired In-Process Research and Development: There was no acquired in-process research and development in the third quarter of 2023 or the third quarter of 2022.
  • Cash Position: As of September 30, 2023, cash and cash equivalents totaled approximately $4.0 million.

MEI Pharma Reports Clinical Data on Oral CDK9 Inhibitor Voruciclib at ASH2023

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星期一, 十二月 11, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, Pharmacokinetics, BCL2, Safety, Toxicity, Lymphoid leukemia, Acute myeloid leukemia, ASH, Cohort, Dana–Farber Cancer Institute, Cellular, Clinical research, Fatigue, Patient, CDK9, Division, DLT, Exposition, Index, Bone marrow, MD, Diarrhea, Nausea, MTD, Half-life, Transplant, AML, Biomarker, Anemia, MMSc, Infrared spectroscopy correlation table, Society, Failure, Poster, Venetoclax, Pharmaceutical industry, Vaccine, Lymphoma

The poster can be viewed on the MEI Pharma website here: https://meipharma.com/ash2023.html .

Key Points: 
  • The poster can be viewed on the MEI Pharma website here: https://meipharma.com/ash2023.html .
  • The second stage of the study is ongoing and is evaluating voruciclib in combination with venetoclax in patients with R/R AML.
  • 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.

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

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星期四, 十一月 9, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Bevacizumab, MEI, Glycolysis, Colorectal cancer, Acute myeloid leukemia, Lymphoid leukemia, ASH, Cohort, Investment, Patient, Research, CDK9, Calendar, Wind, VEGF, Exposition, Cancer, AML, Society, Neoplasm, OXPHOS, Venetoclax, Kyowa Kirin, Pharmaceutical industry, Cryptocurrency

The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.

Key Points: 
  • The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.
  • For the quarter ended September 30, 2023, cash used in operations was $18.5 million, compared to $14.8 million during the quarter ended September 30, 2022.
  • Research and development expenses were $3.5 million for the quarter ended September 30, 2023, compared to $19.5 million for the quarter ended September 30, 2022.
  • MEI recognized revenue of $65.3 million for the quarter ended September 30, 2023, compared to $8.7 million for the quarter ended September 30, 2022.

Kronos Bio Presents Positive Preliminary Data from the Phase 1 Dose Escalation Portion of the Ongoing Phase 1/2 KB-0742 Study at the Connective Tissue Oncology Society Annual Meeting

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星期四, 十一月 2, 2023
Mechanism of action, Trial of the century, AACR, Vomiting, Lung cancer, Drug, Conference, Doctor of Philosophy, Carcinoma, CDK9, Nausea, KRON, Kronos, Learning, Case Western Reserve University, Ewing sarcoma, Washington University School of Medicine, Neoplasm, Sarcoma, Safety, Cancer, Patient, Neutropenia, SAN, Rhabdomyosarcoma, Fatigue, Pharmaceutical industry, Medicine

SAN MATEO, Calif. and CAMBRIDGE, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the presentation of positive preliminary data from the phase 1 dose escalation portion of the ongoing phase 1/2 KB-0742 study at the Connective Tissue Oncology Society annual meeting in Dublin, Ireland. Today’s presentation by Dr. Van Tine of Washington University School of Medicine includes clinical data that was first presented at the AACR-NCI-EORTC International Conference on October 13, 2023, in Boston, Massachusetts in the context of pre-clinical models that provide a better understanding of the observed anti-tumor activity. Preclinical studies led by Berkley Gryder, PhD, of Case Western Reserve University demonstrated KB-0742's on-mechanism activity in transcription factor fusion positive models for rhabdomyosarcoma and Ewing sarcoma.

Key Points: 
  • Preclinical studies led by Berkley Gryder, PhD, of Case Western Reserve University demonstrated KB-0742's on-mechanism activity in transcription factor fusion positive models for rhabdomyosarcoma and Ewing sarcoma.
  • Today, I shared a case study on one of my sarcoma patients who exhausted all standard therapies as well as multiple experimental treatments.
  • The preliminary analysis included 28 patients enrolled in a dose escalation study who received doses from 10 mg up to 60 mg (data cut-off September 1st, 2023).
  • To learn more about the preliminary positive KB-0742 data presented at the AACR-NCI-EORTC International Conference on October 13, 2023, in Boston, Mass.

Vincerx Pharma To Present Three Posters at ASH 2023 in December

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星期四, 十一月 2, 2023
Acute lymphoblastic leukemia, Therapy, University of Calgary, MDS, Drug resistance, Myelodysplastic syndrome, CD123, Activity, Novel, Safety, PALO, Humanized antibody, CDK9, PM, CXCR5, Drug, Society, ASH, Hematology, ADC, Lymphoid neoplasms with plasmablastic differentiation, MCL, University, Pharmacology, Cancer, Lymphoid leukemia, Cellular, Patient, Transplant, Model, Fine chemical, Medicinal plants, Flour

PALO ALTO, Calif., Nov. 02, 2023 (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 that it will present three posters related to VIP943 (NCT06034275), VIP924 (in preclinical studies), and enitociclib (in collaboration with University of Calgary) at the 65th American Society for Hematology Meeting (ASH), taking place in San Diego California from December 9 to 12, 2023.

Key Points: 
  • "The three ASH 2023 posters highlight the strong scientific foundation for Vincerx’s programs.
  • “In addition, we are pleased to share preclinical data related to the activity of VIP924, a first-in-class CXCR5 ADC for the treatment of B-cell malignancies.
  • Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II
    Presentation Time: 6:00 PM - 8:00 PM, Pacific Standard Time
    Title: Targeting CDK9 in KMT2A-Rearranged Infant Leukemia: Evidence for Activity and Drug Synergy with Enitociclib
    Session Name: 616.
  • Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
    Presentation Time: 6:00 PM - 8:00 PM, Pacific Standard Time

Prelude Announces Strategic Pipeline Progress and Updates, including its Partnership with AbCellera, and Reports Third Quarter Financial Results

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星期三, 十一月 1, 2023
Survival, Research, Standard of care, Research and development, Plasma, AACR, IV, Antigen, MCL1, SMARCA4, MD, G&A, SMARCA2, Conference, Hematological Cancer Research Investment and Education Act, Chromatin, CDK9, MYC, Protein, AbCellera, R, Growth, Cell death, Antibody, Partnership, Spacecraft, Cancer, Hepatotoxicity, Security (finance), Brain, Bone marrow, Toxicity, Safety, Lymphoid leukemia, Patient, EU, Administration, Neutropenia, AML, Mutation, Prelude, Pharmaceutical industry, Vaccine, Fine chemical, IND, PRB

WILMINGTON, Del., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today provides strategic pipeline updates and reports third quarter financial results.

Key Points: 
  • Given the overlap with the CDK9 program, Prelude does not plan to advance PRT1419 further at this time.
  • Given the focus of the Company on SMARCA2 and CDK9, Prelude will not advance the program further and is actively pursuing further clinical development with external partners.
  • “We made significant progress in the third quarter with our four clinical stage molecules and, as planned, conducted a rigorous assessment of each program.
  • We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

SELLAS Life Sciences Receives Fast Track Designation from FDA for SLS009 for Treatment of Relapsed/Refractory Peripheral T-cell Lymphomas

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星期一, 十月 30, 2023
SLS, FDA, Food, Non-Hodgkin lymphoma, Fast Track, PTCL, Treatment, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CDK9, Marketing, Doctor of Science, Peripheral T-cell lymphoma not otherwise specified, Breakthrough therapy, Bone marrow, Safety, Therapy, Patient, Lymphoma, Pharmaceutical industry

NEW YORK, Oct. 30, 2023 (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, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL). 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.
  • The Company is also actively pursuing potential Breakthrough Therapy designation from the FDA for SLS009 for the treatment of r/r PTCL and has a scheduled meeting in the fourth quarter of 2023 to discuss with the FDA.
  • Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the candidate’s development plan in addition to a rolling submission of the marketing application.
  • Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

MEI Pharma Announces Acceptance of Abstract for Presentation at ASH 2023

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星期四, 十一月 2, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ASH, AML, Exposition, Society, Cancer, Lymphoid leukemia, Acute myeloid leukemia, Cellular, Patient, Transplant, CDK9, Venetoclax, Pharmaceutical industry, Medical device

MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that an abstract highlighting clinical data from the monotherapy dose escalation stage of the ongoing Phase 1 study evaluating voruciclib, a selective oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta®), a B-cell lymphoma 2 ("BCL2") inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies, will be presented during a poster session at the upcoming 65th American Society of Hematology (ASH) Annual Meeting and Exposition to be held December 9 – 12, 2023.

Key Points: 
  • MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that an abstract highlighting clinical data from the monotherapy dose escalation stage of the ongoing Phase 1 study evaluating voruciclib, a selective oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta®), a B-cell lymphoma 2 ("BCL2") inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies, will be presented during a poster session at the upcoming 65th American Society of Hematology (ASH) Annual Meeting and Exposition to be held December 9 – 12, 2023.
  • Session Title: Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III (616)

SELLAS Announces Positive Initial Topline Phase 2a Data of SLS009 in Acute Myeloid Leukemia

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星期一, 十月 16, 2023
UAB, Survival, Food, CRC, Azacitidine, MD, Venetoclax, CDK9, Safety, University, AML, EFS, MOS, Acute myeloid leukemia, DOR, Associate, Assistant, Patient, Doctor of Science, Hematopoietic stem cell transplantation, PD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Quality of life, SLS, Nursing, Pharmaceutical industry, Treatment, Medicine

NEW YORK, Oct. 16, 2023 (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 positive initial topline data at the 45 mg (safety) dose level from its ongoing Phase 2a clinical trial of its novel and highly selective CDK9 inhibitor, SLS009, in combination with venetoclax and azacitidine (aza/ven) in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) who did not respond or stopped responding to venetoclax-based therapies. Topline data for the recommended Phase 2 dose (60 mg) is expected later this quarter.

Key Points: 
  • Topline data for the recommended Phase 2 dose (60 mg) is expected later this quarter.
  • A total of five patients with r/r AML who failed venetoclax-based therapies have been enrolled to date at the 45 mg dose level.
  • All patients enrolled were alive at the time of their last follow-up and four continue treatment.
  • Among the 31 Phase 1 AML patients, 29 out of 31 (94%) patients were alive as of their May 2023 follow-up.