CDK9

Prelude Therapeutics Announces Clinical Trial Collaboration with BeiGene to Evaluate PRT2527 in Combination with Zanubrutinib in Hematologic Cancers

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Mercoledì, Marzo 15, 2023
BTK, Bone marrow, MD, CDK9, BeiGene, Patient, Pharmaceutical industry

WILMINGTON, Del., March 15, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced a clinical trial collaboration with BeiGene, for future evaluation of its investigational CDK9 inhibitor, PRT2527, in combination with BeiGene’s BTK inhibitor, zanubrutinib, in hematologic malignancies.

Key Points: 
  • WILMINGTON, Del., March 15, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced a clinical trial collaboration with BeiGene, for future evaluation of its investigational CDK9 inhibitor, PRT2527, in combination with BeiGene’s BTK inhibitor, zanubrutinib, in hematologic malignancies.
  • Inhibition of BTK is an active therapeutic approach in several B cell malignancies and the combination of CDK9 inhibition with BTK inhibition has demonstrated, in recent data publications, synergistic clinical efficacy over BTK inhibition alone; hence, there is a strong rationale for studying the combination in patients with certain hematologic malignancies.
  • “The opportunity to combine Prelude’s potent, selective and potentially best-in-class CDK9 inhibitor with BeiGene’s next-generation highly efficacious and tolerable BTK inhibitor, zanubrutinib, reflects our commitment to bringing the most promising options to patients,” said Jane Huang, MD, President and Chief Medical Officer, Prelude Therapeutics.
  • Under terms of the clinical trial collaboration agreement, BeiGene will provide zanubrutinib to Prelude, and Prelude will retain all global operational, development and commercialization rights and responsibilities for PRT2527.

MEI Pharma and Infinity Pharmaceuticals Announce Definitive Merger Agreement to Advance Three Promising Clinical Oncology Candidates

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Giovedì, Febbraio 23, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Pembrolizumab, Cancer, Survival, Venetoclax, PD-1, Organization, Drug development, Colorectal cancer, Patient, Bone marrow, Bevacizumab, Trial of the century, Neoplasm, Therapy, MEI, OXPHOS, PFS, CDK9, HNSCC, Head, General counsel, Eganelisib, Pharmaceutical industry, Infinity

All three clinical-stage development programs have the potential, in combination with current therapies, to overcome known resistance mechanisms and meaningfully improve patient outcomes.

Key Points: 
  • All three clinical-stage development programs have the potential, in combination with current therapies, to overcome known resistance mechanisms and meaningfully improve patient outcomes.
  • “We are very excited to enter into this agreement with Infinity given the strength of a combined organization that builds on each company’s potential.
  • The combined organization will have three differentiated clinical-stage oncology assets, expected funding into mid-2025 to reach clinical data in all three programs, and a team with extensive oncology clinical development expertise.
  • I believe these ingredients place the merged organization in a strong position to create value for all our stakeholders,” said Daniel Gold, Ph.D., President and Chief Executive Officer of MEI Pharma.

SELLAS Announces Positive Phase 1 Data with CDK9 Inhibitor GFH009 Monotherapy in Patients with Relapsed/Refractory Hematologic Malignancies

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Martedì, Dicembre 13, 2022
CDK9, Annual report, Doctor of Science, PD, SD, Lymphoma, Memorial Sloan Kettering Cancer Center, Biomarker, Toxic leukoencephalopathy, Pharmacokinetics, WT1, ASH, CR, AML, MYC, SLS, MD, Acute myeloid leukemia, Drug development, MRD, GPS, Health status of Asian Americans, Society, COVID-19, Tissue, Patient, Therapy, Pharmaceutical industry, Antibiotics, Greater China

NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), today announced positive results from its ongoing dose escalating Phase 1 first-in-human study of its highly selective CDK9 inhibitor, GFH009, in patients with relapsed and/or refractory (r/r) hematologic malignancies. Results include preliminary safety and efficacy data presented this week at the American Society of Hematology (ASH) Annual Meeting, along with updated data since the ASH abstract cutoff date of August 2, 2022.

Key Points: 
  • NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), today announced positive results from its ongoing dose escalating Phase 1 first-in-human study of its highly selective CDK9 inhibitor, GFH009, in patients with relapsed and/or refractory (r/r) hematologic malignancies.
  • Anti-cancer effects were also observed at multiple dose levels in both the r/r AML and r/r lymphoma treatment groups.
  • Neutrophil counts improved in most patients from both groups while on treatment, and drug-related severe neutropenias were observed in less than 10% of enrolled patients.
  • GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications.

Kronos Bio Presents Preclinical Data Supporting Anti-Leukemic Activity of Lanraplenib in Combination with Multiple Targeted Agents in Acute Myeloid Leukemia (AML) Preclinical Models at American Society of Hematology Meeting

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Domenica, Dicembre 11, 2022
SYK, BCL2, CDK9, Bio, PDX, SAN, Lymphatic system, Security (finance), MLL, Cancer, Bone marrow, ASH, FLT3, CR, Acute leukemia, MYC, Survival, MRD, RT, KRON, Research, Chronic lymphocytic leukemia, Society, Apoptosis, Drug, Patient, Pharmaceutical industry, AML

SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 11, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, is presenting preclinical data that demonstrate anti-leukemic activity of the investigational spleen tyrosine kinase (SYK) inhibitor, lanraplenib, in combination with multiple targeted agents in patient-derived cell isolates and cell lines at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition in New Orleans. The data are being shared as part of a poster presentation.

Key Points: 
  • Lanraplenib is a next-generation SYK inhibitor that is currently being evaluated in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML) in a Phase 1b/2 study.
  • The combination triggered differentiation and apoptosis, suggesting a more complete blockade of the HOXA9/MEIS1 transcriptional program through synergistic inhibition by orthogonal mechanisms.
  • Additionally, the researchers evaluated synergistic activity of lanraplenib with the FLT3 inhibitor, gilteritinib, and BCL2 inhibitor, venetoclax, in patient-derived AML isolates.
  • In a follow-up PDX study with an optimized regimen, the combination significantly extended overall survival compared to either single agent.

SELLAS Life Sciences’ Independent Data Monitoring Committee Recommends Galinpepimut-S REGAL Trial to Continue as Planned

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Giovedì, Dicembre 8, 2022
CDK9, Annual report, Doctor of Science, Safety, Patient safety, News, Memorial Sloan Kettering Cancer Center, WT1, IDMC, AML, SLS, MD, Acute myeloid leukemia, Drug development, GPS, CR2, SAP, COVID-19, Patient, Therapy, Pharmaceutical industry, Greater China

The REGAL study is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients).

Key Points: 
  • The REGAL study is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients).
  • “Following a prespecified review of unblinded data by the IDMC in accordance with its charter, its recommendation to continue the REGAL study as is, and with trial conduct and integrity intact, is outstanding news.
  • About SELLAS Life Sciences Group, Inc.
    SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications.
  • These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties.

Kronos Bio Announces Selection of Recommended Phase 2 Dose for its Oral CDK9 Inhibitor, KB-0742, After Reaching Target Engagement Goal with Acceptable Safety Profile in Ongoing Phase 1/2 Clinical Trial

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Mercoledì, Dicembre 7, 2022
SYK, Squamous cell carcinoma, Cohort study, CDK9, Enzyme, Bio, Chordoma, Sarcoma, SAN, Security (finance), Ovarian cancer, RNA polymerase II, RNA polymerase, Cancer, Cmax, Large-cell lung carcinoma, MYC, KRON, Research, Plasma, PK, Kronos, Drug, COVID-19, CDK, Patient, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that data from the ongoing dose-escalation stage of its Phase 1/2 clinical trial of KB-0742, the company’s cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified and transcriptionally addicted solid tumors, support a recommended Phase 2 dose (RP2D) of 60 mg.

Key Points: 
  • This level of target engagement is consistent with demonstrating anti-tumor activity based on preclinical models.
  • A total of 26 patients have been enrolled and treated in the dose escalation phase of the study.
  • The long plasma half-life enables KB-0742 to achieve sustained pharmacologically active concentrations while avoiding potentially toxic peak (Cmax) concentrations.
  • Kronos Bio is a biopharmaceutical company that is advancing two investigational compounds in clinical trials for patients with cancer.

SELLAS Life Sciences’ CDK9 Inhibitor GFH009 Selected for Pediatric Preclinical in Vivo Testing (PIVOT) Program in Pediatric Cancers by the National Cancer Institute

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Martedì, Dicembre 6, 2022
CDK9, Neoplasm, Annual report, Doctor of Science, Kidney, Therapy, Cancer, Memorial Sloan Kettering Cancer Center, Pharmacokinetics, WT1, Mouse, Human, National Cancer Institute, SLS, MD, Drug development, Liver cancer, GPS, Research, NCI, Disease, University, COVID-19, University of Texas System, Pharmaceutical industry, Medicine, Greater China

NEW YORK, Dec. 06, 2022 (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 SELLAS’ highly selective CDK9 inhibitor, GFH009, will be evaluated in pediatric solid tumors and leukemia models through the National Cancer Institute (NCI) Pediatric Preclinical in Vivo Testing (PIVOT) Program.

Key Points: 
  • GFH009 testing through the program involves a two-phase research plan for pharmacokinetics (PK) and efficacy in pediatric tumors.
  • In the first phase, PIVOT principal investigators will conduct PK experiments to confirm the appropriate dose and route administration for GFH009.
  • In the second phase, monotherapy in vivo efficacy testing for GFH009 will be performed by PIVOT investigators.
  • “Participation in the NCI PIVOT Program provides an extensive and invaluable level of expertise in preclinical pediatric cancer testing and we are excited that we were granted this program after a diligent review process.

MEI Pharma Initiates Strategic Realignment

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Lunedì, Dicembre 5, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, ATP, PI3K, Cyclin, Lymphoid leukemia, Myc, Cell proliferation, Adenosine triphosphate, Calendar, Bevacizumab, Patient, CDK9, Neoplasm, Cancer, Mitochondrion, Wind, Cyclin-dependent kinase 9, ASCO, Kyowa Hakko Kirin, FDA, Woman, MYC, Investment, COVID-19, Colorectal cancer, Growth, AML, KRAS, Lymphatic system, Nature, Safety, Clinical trial, Failure, Workforce, OXPHOS, Acute myeloid leukemia, Doctor of Philosophy, Marketing, VEGF, Regulation, MEI, Pharmaceutical industry, Medical imaging

As part of the realignment, the company plans to streamline its organization towards the development of two earlier clinical-stage assets, voruciclib and ME-344.

Key Points: 
  • As part of the realignment, the company plans to streamline its organization towards the development of two earlier clinical-stage assets, voruciclib and ME-344.
  • The company further announced that it has engaged Torreya Partners as financial advisor to help explore additional strategic opportunities.
  • We intend to continue development of our earlier-stage clinical assets, streamline MEIs operations towards these efforts, and consider additional strategic opportunities, said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma.
  • MEI Pharma, Inc. (Nasdaq: MEIP) is a pharmaceutical company focused on developing potential new therapies for cancer.

SELLAS Life Sciences’ CDK9 Inhibitor GFH009 Demonstrates Tumor Growth Inhibition in Small Cell Lung Cancer Murine Model

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Giovedì, Dicembre 1, 2022
NCI, COVID-19, BRCA, PARP, Drug, ATR, DNA repair, DNA, Cancer, Squamous cell carcinoma, SCLC, Patient, Toxicity, Annual report, SCL, CDK9, MD, Drug development, Olaparib, Senior, SLS, Memorial Sloan Kettering Cancer Center, Mouse, WT1, Therapy, GPS, DDR, Pharmaceutical industry, Greater China

NEW YORK, Dec. 01, 2022 (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 results from a preclinical in vivo study for its highly selective CDK9 inhibitor, GFH009, that demonstrate robust inhibition of tumor growth in a mouse xenograft model of small cell lung cancer (SCLC).

Key Points: 
  • GFH009 treated mice exhibited a 40.4% decrease in mean tumor growth compared to the control group in this very aggressive cancer model which had a tenfold increase in average tumor volume over 20 days.
  • Strongest effects were observed with GFH009 in combination with olaparib, with mean tumor growth decreased by 72.3%.
  • Treatment with olaparib alone resulted in a 30.2% mean decrease in tumor growth.
  • About SELLAS Life Sciences Group, Inc.
    SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications.

SELLAS Life Sciences to Participate in the JMP Securities Hematology and Oncology Summit

Retrieved on: 
Mercoledì, Novembre 30, 2022
COVID-19, Hematology, Annual report, JMP, CDK9, MD, SLS, Memorial Sloan Kettering Cancer Center, WT1, Doctor of Science, Therapy, GPS, Pharmaceutical industry, Greater China

h.c, President and Chief Executive Officer of SELLAS, will participate in a virtual fireside chat on Wednesday, December 7, 2022, at 3:20 p.m.

Key Points: 
  • h.c, President and Chief Executive Officer of SELLAS, will participate in a virtual fireside chat on Wednesday, December 7, 2022, at 3:20 p.m.
  • For more information about the conference, please refer to the conference website or contact your JMP Securities representative directly.
  • About SELLAS Life Sciences Group, Inc.
    SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications.
  • Any such forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties.