MCL1

SELLAS Announces Positive Topline Data in Lymphoma Cohort from SLS009 Phase 1 Dose-Escalation Trial, Supporting Advancement to Phase 2 Clinical Study; Primary and Secondary Endpoints Met

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星期四, 九月 21, 2023
Pharmacodynamics, Lymphoma, PTCL, MYC, Index, Peripheral T-cell lymphoma, PD, Relapse, Trae tha Truth, Pharmacokinetics, Cmax, Biomarker, Acute myeloid leukemia, Plasma, QW, AML, Doctor of Science, SLS, MD, Patient, Hypokalemia, Bilirubin, AUC, MCL1, MTD, Bone marrow, Toxic leukoencephalopathy, CDK9, BIW, Safety, Vaccine, Pharmaceutical industry, Generic drug

All primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD), were successfully achieved.

Key Points: 
  • All primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD), were successfully achieved.
  • A dose-limiting toxicity occurred in one out of five patients treated at the 100 mg dose level.
  • No dose-limiting toxicities were observed at any other dose level, and there were no unexpected toxicities across the study.
  • For more information on the Phase 1 study of SLS009 in r/r AML and r/r lymphomas, please visit ClinicalTrials.gov and reference Identifier NCT04588922 .

Prelude Therapeutics Announces Second Quarter 2023 Financial Results and Provides Corporate Update

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星期四, 八月 3, 2023
Neutropenia, KRAS, Hepatotoxicity, Glioblastoma, SMARCA2, EU, Cell death, Sarcoma, HER2, Chromatin, Survival, Cancer, Mutation, Head, G&A, Brain, Deletion, MEK, SMARCA4, Lung cancer, Richter's transformation, HR, Net, Azacitidine, Patient, Security (finance), Administration, Mantle cell lymphoma, MCL1, MCL, Toxicity, Research and development, T-cell lymphoma, Bone marrow, Growth, Research, R, IND, Cardiotoxicity, CDK9, Safety, Breast cancer, Rare-earth element, Pharmaceutical industry, Vaccine, Dietary supplement, Life insurance

WILMINGTON, Del., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.

Key Points: 
  • Recent equity financing extends cash runway into 2026, enabling advancement of Prelude’s pipeline through critical milestones
    WILMINGTON, Del., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
  • The Company intends to provide a program update by year end and present initial results at a future scientific meeting.
  • Research and Development (R&D) Expenses: For the second quarter of 2023, R&D expense increased to $25.0 million from $21.3 million for the prior year period.
  • General and Administrative (G&A) Expenses: For the second quarter of 2023, G&A expenses decreased to $7.4 million from $8.2 million for the prior year period.

SELLAS Announces First Patient Dosed in Phase 2a Clinical Trial of GFH009 in Acute Myeloid Leukemia

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星期四, 六月 22, 2023
CRC, MYC, PD, DOR, Therapeutic index, Bone marrow, Biomarker, Cell, Acute myeloid leukemia, MRD, AML, Azacitidine, BCL2, Doctor of Science, SLS, MD, Patient, Hematology, MCL1, CR, EFS, Toxic leukoencephalopathy, CDK9, NOXA, Venetoclax, Safety, Disease, Pharmaceutical industry, Vaccine

The Phase 2a clinical trial is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of GFH009 (once weekly 45 mg or 60 mg) in combination with aza/ven.

Key Points: 
  • The Phase 2a clinical trial is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of GFH009 (once weekly 45 mg or 60 mg) in combination with aza/ven.
  • Treatment will continue for as long as there are no dose limiting toxicities and no progression of disease.
  • Bone marrow will be assessed after the first two infusions of GFH009: at day 14 and day 28.
  • Full Phase 1 AML data is expected be presented at a major medical conference in the fourth quarter of 2023.

Trueline Therapeutics Announces Completion of IND-Enabling Studies for MCL1 Inhibitor TTX-810

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星期二, 五月 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MCL1, Hematological Cancer Research Investment and Education Act, Cancer, Partnership, Broad Institute, Cell death, Therapy, IND, Doctor of Philosophy, Bayer, Patient, Harvard University, MIT, Pharmaceutical industry

Trueline Therapeutics Inc. , an oncology-focused subsidiary of Anji Pharmaceuticals, today announced the successful completion of IND-enabling studies with MCL1 inhibitor TTX-810, a highly potent and selective macrocyclic compound to treat patients with solid tumor or hematological cancers.

Key Points: 
  • Trueline Therapeutics Inc. , an oncology-focused subsidiary of Anji Pharmaceuticals, today announced the successful completion of IND-enabling studies with MCL1 inhibitor TTX-810, a highly potent and selective macrocyclic compound to treat patients with solid tumor or hematological cancers.
  • A distinguishing feature of TTX-810 is a rapid clearance profile to minimize the potential risks of sustained MCL1 inhibition in non-cancerous tissues.
  • “The completion of IND-enabling studies marks the culmination of over a decade’s work to truly understand the safest and most effective way to approach MCL1 inhibition,” said Ulla Rauh, Ph.D., CEO/CSO of Trueline Therapeutics.
  • Following candidate selection, Trueline Therapeutics scientists designed and executed the IND-enabling program in preparation for first-in-human testing.

SELLAS Announces Positive Topline Data from GFH009 Phase 1 Dose-Escalation Trial in Acute Myeloid Leukemia Cohort Supporting Advancement to Phase 2 Clinical Study

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星期四, 五月 4, 2023
Pharmacodynamics, Lymphoma, MYC, University, PD, BMB, Leukemia Research, Therapeutic index, Survival, Bone marrow, Associate, Acute myeloid leukemia, MRD, AML, Azacitidine, Hematological Cancer Research Investment and Education Act, Doctor of Science, SLS, MD, Patient, Cure, MCL1, CR, Toxic leukoencephalopathy, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Leukemia, CDK9, BIW, Food, Pharmaceutical industry, Vaccine, Hematology

NEW YORK, May 04, 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 topline data for the cohort of patients with acute myeloid leukemia (AML) from its Phase 1 dose-escalation trial in relapsed/refractory (r/r) myeloid malignancies for GFH009, its CDK9 inhibitor. Dose escalation continues in the lymphoma cohort with the last dose level of 75 mg weekly. Clinical activity observed in the lymphoma group will be announced after completion of the last dose level and is expected by the end of the second quarter or early third quarter of 2023.

Key Points: 
  • Dose escalation continues in the lymphoma cohort with the last dose level of 75 mg weekly.
  • In the cohort of patients with AML, GFH009 treatment showed evidence of anti-tumor activity increasing with higher doses and no significant safety issues, including at the highest dose levels.
  • The recommended Phase 2 dose (RP2D) for AML has been established and submitted to the U.S. Food and Drug Administration (FDA).
  • SELLAS plans to commence a Phase 2a trial with GFH009 in combination with venetoclax and azacitidine (aza/ven) in patients with AML during the second quarter of 2023 with topline data expected by the end of the year.

SELLAS Life Sciences Successfully Completes Phase I Trial Dose Escalation of Novel, Highly Selective CDK9 Inhibitor GFH009 in Acute Myeloid Leukemia

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星期四, 四月 20, 2023
CRC, PK, MYC, Venetoclax, DOR, Malignancy, Survival, Research, Acute myeloid leukemia, Bone marrow, AML, Azacitidine, BCL2, Data analysis, SLS, Patient, MCL1, EFS, Toxic leukoencephalopathy, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CDK9, Food, Safety, Pharmaceutical industry, MD

NEW YORK, April 20, 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 completion of the safety evaluation stage of the highest dose cohort of patients with acute myeloid leukemia (AML) who relapsed after or were refractory to available antileukemic therapies in its Phase 1 dose escalation clinical trial of GFH009. No further dose escalations are planned in the AML group, while dose escalation continues in the lymphoma group with the addition of a 75 mg once-a-week dose cohort, which is planned to be the highest dose level for that group.

Key Points: 
  • “We are very encouraged by the strong efficacy signals and safety profile of our highly selective CDK9 inhibitor, GFH009, observed in this positive Phase 1 trial.
  • The trial will be a single arm open label dose ranging study with one dose level at the RP2D and one dose below RP2D.
  • GFH009 continued to be safe and well tolerated at all dose levels, with no dose limiting toxicities and no significant off target toxicities observed.
  • Based on the available Phase 1 data, the Phase 2a trial design will be submitted to the FDA by the end of the month.

Prelude Therapeutics Announces Third Quarter 2022 Financial Results and Provides Business Update

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星期一, 十一月 14, 2022
BRM, Clinical trial, Brain, T-ALL, MYC, Thrombocytopenia, Monocyte, CLL, Safety, Security (finance), Anemia, Research and development, BTK, Prelude, R, Administration, Constipation, Drug resistance, CDK9, SMARCA4, Biotechnology, G&A, Research, Vomiting, NHL, COVID-19, Public expenditure, Incidence, Uveal melanoma, Large-cell lung carcinoma, FDA, Pharmacology, Sarcoma, BH3, CDK, Mesothelioma, Lymphoid neoplasms with plasmablastic differentiation, Hematological Cancer Research Investment and Education Act, Cancer, Pharmacokinetics, IND, MCL1, Fatigue, CD14, Glioma, Breast cancer, PRMT5, Human, SMARCA2, Risk, Nausea, Head, Patient, Pharmaceutical industry, Medical device

WILMINGTON, Del., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the third quarter ended September 30, 2022 and provided an update on recent clinical and development pipeline progress.

Key Points: 
  • I believe these programs offer the best chance to improve patient outcomes and I share our investigators excitement in our highly differentiated molecules.
  • Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of September 30, 2022, were $224.0 million.
  • Prelude anticipates that its existing cash, cash equivalents and marketable securities will be sufficient to fund Preludes operations into the fourth quarter of 2024.
  • We expect our research and development expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

Cyclacel Reports Preliminary Data From Its Phase 1/2 Clinical Trial of Oral Fadraciclib in Patients With Solid Tumors and Lymphoma at ENA 2022

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星期三, 十月 26, 2022
Company, National University Hospital, MYC, Endometrial cancer, City of Hope National Medical Center, Safety, Cyclin E, CTD, Lymphatic system, Hematology, RNAP, HER2, CDK, CR, Cyclin, Risk, BCL2, CLL, Trastuzumab, Breast cancer, Uterine serous carcinoma, Cyclin-dependent kinase, CDK9, RNA, Annual report, Phosphorylation, Patient, Multiple myeloma, NCT, MCL1, CCNE, ALL, News, Adult, Research, COVID-19, Lymphoma, PLK1, FDA, B-cell lymphoma, RNA polymerase II, CDK2, AML, Ovarian cancer, All rights reserved, Cell cycle, Gene, Neuroblastoma, MD Anderson Cancer Center, Cyclacel, Pharmaceutical industry

Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9.

Key Points: 
  • Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9.
  • By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death of cancer cells at sub-micromolar concentrations.
  • Fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; NCT#04983810 ) and a Phase 1/2 trial for the treatment of hematological malignancies (065-102; NCT#05168904 ).
  • In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously administered, single-agent fadraciclib.

Prelude Therapeutics Receives FDA Clearance of IND for PRT3789, a Potent and Selective First-in-Class SMARCA2 Protein Degrader

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星期二, 十月 18, 2022
U.S. Securities and Exchange Commission, Population, PRMT5, PRT, Family, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Biotechnology, BRG1, RNA, Security (finance), Cell, Technology, Private Securities Litigation Reform Act, Food, Goal, NSCLC, Cell death, Large-cell lung carcinoma, Pharmacokinetics, SMARCA2, Safety, CDK9, Survival, GLOBE, Brain, Forward-looking statement, DNA, BRM, FDA, COVID-19, MCL1, Prelude, Cancer, Risk, Pharmaceutical industry, Vaccine, IND, SMARCA4

Preclinical models with SMARCA4 deletions demonstrated that selective degradation of SMARCA2 with our potent and highly selective molecule PRT3789, resulted in significant anti-tumor activity at well tolerated doses, said Dr. Peggy Scherle, Chief Scientific Officer of Prelude.

Key Points: 
  • Preclinical models with SMARCA4 deletions demonstrated that selective degradation of SMARCA2 with our potent and highly selective molecule PRT3789, resulted in significant anti-tumor activity at well tolerated doses, said Dr. Peggy Scherle, Chief Scientific Officer of Prelude.
  • Historically, structural similarities between members of the SMARCA family have made it challenging to selectively inhibit SMARCA2.
  • Clearance of the IND for PRT3789 represents a major milestone for Prelude Therapeutics, as we advance our first-in-class SMARCA2 protein degrader from discovery to the clinic.
  • Preludes pipeline includes five candidates currently in clinical development: PRT811, a highly selective, potent, orally bioavailable PRMT5 inhibitor; PRT1419, a potent, selective inhibitor of MCL1; PRT2527, a potent and highly selective CDK9 inhibitor, PRT3645, a brain penetrant CDK4/6 inhibitor, and PRT3789, a SMARCA2/BRM protein degrader.

Cyclacel Pharmaceuticals To Present Preliminary Data From The Phase 1/2 Clinical Trial Of Oral Fadraciclib At The 34th EORTC-NCI-AACR Symposium

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星期四, 十月 13, 2022
Cyclin E, News, RNAP, PLK1, Risk, CLL, All rights reserved, AML, Lymphoma, Multiple myeloma, Annual report, Patient, Neuroblastoma, Cyclacel, Research, RNA, CDK2, CR, B-cell lymphoma, HER2, Endometrial cancer, RNA polymerase II, Cyclin-dependent kinase, Company, Trastuzumab, Phosphorylation, CCNE, Breast cancer, Uterine serous carcinoma, Adult, Safety, MYC, BCL2, CDK9, Lymphatic system, Hematology, Cell cycle, ALL, FDA, COVID-19, CDK, NCT, MCL1, Gene, Ovarian cancer, CTD, Pharmaceutical industry

Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9.

Key Points: 
  • Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9.
  • Fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; NCT#04983810 ) and a Phase 1/2 trial for the treatment of hematological malignancies (065-102; NCT#05168904 ).
  • In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously administered, single-agent fadraciclib.
  • The Cyclacel logo and Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc.