Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or AML After Failure of Prior Standard Therapies and Voruciclib in Combination With Venetoclax in Subjects With Relapsed/Refractory AML

This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML

开始日期2018-05-31

申办/合作机构

Lite Strategy, Inc.

NCT02117336

/ Suspended临床1期

A Phase I/Ib Study of P1446A-05 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).

This is an open-label, Phase I/Ib trial with a dose escalation phase, followed by a dose extension phase. The objective of the dose escalation phase is to evaluate the pharmacokinetics (PK) and MTD of P1446A-05 in relapsed/refractory CLL and the objective of the dose extension phase is to evaluate the safety, efficacy and pharmacodynamics of P1446A-05 in 14 patients at the MTD level.

开始日期2014-06-01

申办/合作机构

Piramal Enterprises Ltd.

[+1]

NCT01841463

/ Suspended临床1期

An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered With an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients With Advanced or Inoperable Malignant Melanoma With BRAF Mutation

* An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with Advanced or Inoperable Malignant Melanoma with BRAF Mutation
* The primary objective is to determine the safety, maximum tolerated dose (MTD), and dose limiting toxicity (DLT) of the co-administration of P1446A-05 with vemurafenib, in melanoma patients with BRAF mutation

开始日期2013-08-01

申办/合作机构

Piramal Enterprises Ltd.

[+1]

100 项与 Voruciclib Hydrochloride 相关的临床结果

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100 项与 Voruciclib Hydrochloride 相关的转化医学

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100 项与 Voruciclib Hydrochloride 相关的专利（医药）

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项与 Voruciclib Hydrochloride 相关的文献（医药）

2025-08-01·Blood Neoplasia

The oral CDK9 inhibitor voruciclib combined with venetoclax for patients with relapsed/refractory acute myeloid leukemia

Article

作者: Tang, Min ; Abedin, Sameem ; Keng, Michael ; Ghalie, Richard G ; Davids, Matthew S ; Javidi-Sharifi, Nathalie ; Rajagopalan, Prabhu ; Cook, Rachel J ; Wiley, Sandra E ; Dinner, Shira N ; Al Malki, Monzr M ; Begna, Kebede H ; Alvarado-Valero, Yesid ; Bhatt, Vijaya Raj

The antiapoptotic protein myeloid cell leukemia 1 (Mcl-1) promotes cell survival in acute myeloid leukemia (AML), and its overexpression is associated with resistance to venetoclax. Voruciclib, an oral cyclin-dependent kinase 9 inhibitor, indirectly decreases Mcl-1 protein expression and has synergistic activity with venetoclax in AML preclinical models. We hypothesized that voruciclib in combination with venetoclax would induce responses in patients with AML with disease progression after venetoclax therapy. This dose-escalation study evaluated voruciclib administered on days 1 to 14 of 28-day cycles with venetoclax daily. The study enrolled 41 adult patients with AML after failure of previous standard therapies. Patients had a median of 2 (range, 1-7) previous lines of therapy, 19 patients (46%) had ≥3 previous lines of therapy, and 39 (95%) had previous venetoclax. No dose-limiting toxicities were reported in 7 dose levels evaluated. The most common adverse events were nausea (34%), febrile neutropenia (32%), diarrhea (22%), dyspnea (22%), hypokalemia (22%), and thrombocytopenia (22%). Antileukemic activity was observed in 10 (24%) patients, including 3 with complete marrow remission and 7 with stable disease lasting ≥3 months. We observed a rebound of circulating blasts during the 14 days of single-agent venetoclax dosing in 40% of evaluable patients. Mcl-1 protein expression and RNA polymerase II Ser-2 phosphorylation decreased on voruciclib. Overall, the combination of voruciclib with venetoclax was tolerable in patients with relapsed/refractory AML, had antileukemic activity, and showed on-target effects in heavily pretreated patients with disease progression after venetoclax. This trial was registered at www.ClinicalTrials.gov as #NCT03547115.

2025-02-25·Blood Advances

A phase 1 study of the CDK9 inhibitor voruciclib in relapsed/refractory acute myeloid leukemia and B-cell malignancies

Article

作者: Bhatt, Vijaya Raj ; Al Malki, Monzr M. ; Dominguez, Edward C. ; Danilov, Alexey V. ; Diefenbach, Catherine S. ; Abedin, Sameem ; Ghalie, Richard G. ; Brander, Danielle M. ; Davids, Matthew S. ; Dinner, Shira N. ; Javidi-Sharifi, Nathalie ; Roleder, Carly ; Rajagopalan, Prabhu ; Collins, Mary C. ; Wiley, Sandra E. ; Alvarado-Valero, Yesid ; Begna, Kebede H. ; Cook, Rachel J. ; Egan, Daniel N.

Abstract:

The antiapoptotic protein, myeloid cell leukemia-1 (Mcl-1), contributes to the pathophysiology of acute myeloid leukemia (AML) and certain B-cell malignancies. Tumor dependence on Mcl-1 is associated with resistance to venetoclax. Voruciclib, an oral cyclin-dependent kinase (CDK) inhibitor targeting CDK9, indirectly decreases Mcl-1 protein expression and synergizes with venetoclax in preclinical models. This dose escalation study evaluated voruciclib in patients with previously treated hematologic malignancies. Initially, voruciclib was administered daily, continuously, on a 28-day cycle (group 1). After 2 patients with prior allogeneic stem cell transplantation had a dose-limiting toxicity (DLT) of interstitial pneumonitis at 100 mg, voruciclib administration was changed to days 1 to 14 of a 28-day cycle (group 2). Forty patients, 21 with AML and 19 with B-cell malignancies, were enrolled. Patients had a median of 3 prior lines of therapy (range, 1-8). Dose escalation in group 2 was stopped at 200 mg, a dose that achieved plasma concentrations sufficient for target inhibition, without DLTs observed. The most common adverse events were diarrhea (30%), nausea (25%), anemia (22%), fatigue (22%), constipation (17%), dizziness (15%), and dyspnea (15%). In AML, 1 patient achieved a morphologic leukemia-free state, and 2 had stable disease. Voruciclib treatment led to a decrease in MCL1 messenger RNA expression, downregulation of myelocytomatosis (MYC) and NF-κB transcriptional gene sets, and reduced phosphorylation of RNA polymerase 2. Voruciclib on intermittent dosing was well tolerated, with no DLTs, paving the way for evaluation of the combination of voruciclib with venetoclax for patients with previously treated AML. This trial was registered at www.clinicaltrials.gov as #NCT03547115.

2024-09-01·ChemistrySelect

Computational Analysis of Phase I Metabolism in Clinically Studied Flavoalkaloids: Molecular Docking, MMGBSA Binding Energy Calculations, and Molecular Dynamics Simulations

作者: Kallurkar, Kailas V. ; Bharate, Sandip B. ; Thakur, Shikha ; Jadhav, Hemant R.

Abstract:

Flavoalkaloids, a potent class of cyclin‐dependent kinase inhibitors, have undergone extensive clinical trials across various cancer types. Among them, flavopiridol, riviciclib, and voruciclib are the most advanced candidates. These molecules are lipophilic and possess functional groups conducive to both phase I and phase II metabolism in the liver. This study employs in‐silico methods to identify the potential cytochrome P450‐mediated sites of phase I metabolism (SOM) in these compounds. According to two web‐server‐based predictions, the N‐methyl group was identified as the primary SOM in these compounds, showing the highest probability score for involvement of CYP3A4. Docking studies conducted using both Glide and the induced‐fit method further confirmed N‐demethylation as a significant metabolic pathway predominantly catalyzed by CYP3A4. The distance between the N‐methyl group of the docked ligands and the iron atom of the heme ranged from 3 to 7 Å, with flavopiridol's N‐methyl group positioned closest to the heme iron at 3.16 Å. The 100 ns molecular dynamic simulations additionally validated the stability of the interaction between flavoalkaloids and the heme Fe. Similarly, the docking‐based SOM predictions matched the experimental SOM for other approved drugs. Thus, employing docking‐based SOM predictions holds potential for enhancing lead optimization efforts in future medicinal chemistry research.

项与 Voruciclib Hydrochloride 相关的新闻（医药）

2024-11-28

·PRNewswire

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法引进/卖出临床3期疫苗细胞疗法

2024-11-12

·investor.meipharma.com

MEI Pharma Reports First Quarter Fiscal Year 2025 Cash Position

Reaffirms Continuation of Evaluation of Strategic Alternatives SAN DIEGO--(BUSINESS WIRE)--Nov. 12, 2024-- MEI Pharma, Inc. (Nasdaq: MEIP) (the “Company”) today reported results for its quarter ended September 30, 2024. As previously announced in July 2024, the Company is continuing its review and evaluation of potential strategic alternatives. In the review, the Company continues to consider options such as out-licensing opportunities for existing programs and merger and acquisition opportunities, with the goal of maximizing the value of its assets for its stockholders. Oppenheimer & Co., Inc. is serving as the Company’s exclusive financial advisor in this process. During the first quarter of fiscal year 2025, the Company commenced cash preservation efforts that include a reduction-in-force, which will continue in stages as the Company’s operational and strategic direction evolves. There can be no assurance the exploration of strategic alternatives will result in any agreements or transactions, or, if completed, any agreements or transactions will be successful or on attractive terms. The Company does not expect to disclose developments with respect to this process unless or until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded disclosure is appropriate or legally required. As of September 30, 2024, MEI had $26.9 million in cash, cash equivalents, and short-term investments with no outstanding debt. About MEI Pharma MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical-stage pharmaceutical company with a portfolio of several drug candidates that may offer novel and differentiated cancer therapies. The drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 inhibitor. For more information, please visit www.meipharma.com. Follow us on X (formerly Twitter) @MEI_Pharma and on LinkedIn. Forward-Looking Statements Certain information contained in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the Company’s ability to identify, assess and execute a strategic transaction or realize value from its existing assets, the Company’s ability to preserve cash in order to adequately fund an orderly wind down of its operations if no transaction is consummated, the ability of stockholders and other stakeholders to realize any value or recovery as part of a transaction or a wind down process, the Company’s workforce reduction and future charges expected to be incurred in connection therewith, the adequacy or sufficiency of the Company’s existing cash resources and other statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to the Company’s ability to identify attractive strategic alternatives; the Company’s ability to retain key personnel; the adequacy of the Company’s capital resources in light of changing circumstances; the actions of various stakeholders of the Company; uncertainty regarding the impact of rising inflation and the increase in interest rates as a result; potential economic downturn; activist investors; government regulation; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. MEI PHARMA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except par value amounts) September 30, June 30, 2024 2024 (Unaudited) (Audited) ASSETS Current assets: Cash and cash equivalents $ 6,952 $ 3,705 Short-term investments 19,953 34,640 Prepaid expenses and other current assets 840 2,424 Total current assets 27,745 40,769 Operating lease right-of-use asset — 214 Property and equipment, net 5 392 Total assets $ 27,750 $ 41,375 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 976 $ 3,168 Accrued liabilities 1,896 5,187 Total current liabilities 2,872 8,355 Total liabilities 2,872 8,355 Stockholders' equity: Preferred stock, $0.01 par value; 100 shares authorized; none outstanding — — Common stock, $0.00000002 par value; 226,000 shares authorized; 6,663 shares issued and outstanding at September 30, 2024 and June 30, 2024, respectively — — Additional paid-in-capital 421,104 421,239 Accumulated deficit (396,226 ) (388,219 ) Total stockholders' equity 24,878 33,020 Total liabilities and stockholders' equity $ 27,750 $ 41,375 MEI PHARMA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) For the Three Months Ended September 30, 2024 2023 (Unaudited) Revenues $ — $ 65,297 Operating expenses: Research and development 3,163 3,485 General and administrative 5,189 6,531 Total operating expenses 8,352 10,016 (Loss) income from operations (8,352 ) 55,281 Other income (expense): Interest and dividend income 355 1,094 Other expense, net (10 ) (1 ) Net (loss) income $ (8,007 ) $ 56,374 Net (loss) income per share - basic and diluted $ (1.20 ) $ 8.46 Weighted-average shares used in computing net (loss) income per share - basic and diluted 6,663 6,663 View source version on businesswire.com: https://www.businesswire.com/news/home/20241112133837/en/ Justin J. File 858-898-0976 investor@meipharma.com Source: MEI Pharma, Inc.

财报

2024-09-19

·BioSpace

MEI Pharma Reports Fiscal Year End 2024 Cash Position

Confirms Continuation of Evaluation of Strategic Alternatives SAN DIEGO--(BUSINESS WIRE)--MEI Pharma, Inc. (Nasdaq: MEIP) (the “Company”) today reported results for its fiscal year ended June 30, 2024. Previously on July 22, 2024, the Company announced the commencement of an evaluation of strategic alternatives with the goal of maximizing the value of its assets for its stockholders. Subsequent to that date, the Company announced the engagement of Oppenheimer & Co., Inc. to serve as the Company’s exclusive financial adviser to assist in the review and evaluation of that process. As part of the review of strategic alternatives, the Company will consider options such as out-licensing opportunities for existing programs and merger and acquisition opportunities. To best preserve the Company’s existing cash, the Company commenced a reduction-in-force on August 1, 2024, which will continue in stages as the Company’s operational and strategic direction evolves. Additionally, while the Company has discontinued the clinical development of voruciclib, certain non-clinical activities related to the Company’s drug candidates continue to be conducted. There can be no assurance the exploration of strategic alternatives will result in any agreements or transactions, or, if completed, any agreements or transactions will be successful or on attractive terms. The Company does not expect to disclose developments with respect to this process unless or until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded disclosure is appropriate or legally required. As of June 30, 2024, MEI had $38.3 million in cash, cash equivalents, and short-term investments with no outstanding debt. About MEI Pharma MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical-stage pharmaceutical company with a portfolio of several drug candidates that may offer novel and differentiated cancer therapies. The drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 (“CDK9”) inhibitor, and ME-344, an intravenous small molecule mitochondrial inhibitor targeting the oxidative phosphorylation pathway. For more information, please visit . Follow us on X (formerly Twitter) @MEI_Pharma and on LinkedIn. Forward-Looking Statements Certain information contained in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the Company’s ability to identify, assess and execute a strategic transaction or realize value from its existing assets, the Company’s ability to preserve cash in order to adequately fund an orderly wind down of its operations if no transaction is consummated, the ability of stockholders and other stakeholders to realize any value or recovery as part of a transaction or a wind down process, the Company’s workforce reduction and future charges expected to be incurred in connection therewith, the adequacy or sufficiency of the Company’s existing cash resources and other statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to the Company’s ability to identify attractive strategic alternatives; the Company’s ability to retain key personnel; the adequacy of the Company’s capital resources in light of changing circumstances; the actions of various stakeholders of the Company; uncertainty regarding the impact of rising inflation and the increase in interest rates as a result; potential economic downturn; activist investors; government regulation; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. MEI PHARMA, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except par value amounts) June 30, 2024 2023 ASSETS Current assets: Cash and cash equivalents $ 3,705 $ 16,906 Short-term investments 34,640 83,787 Unbilled receivables - 85 Prepaid expenses and other current assets 2,424 6,750 Total current assets 40,769 107,528 Operating lease right-of-use asset 214 11,972 Property and equipment, net 392 1,309 Total assets $ 41,375 $ 120,809 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 3,168 $ 6,134 Accrued liabilities 5,187 12,461 Deferred revenue - 317 Operating lease liability - 1,428 Total current liabilities 8,355 20,340 Deferred revenue, long-term - 64,545 Operating lease liability, long-term - 11,300 Total liabilities 8,355 96,185 Stockholders’ equity: Preferred stock, $0.01 par value; 100 shares authorized; none outstanding - - Common stock, $0.00000002 par value; 226,000 shares authorized; 6,663 shares issued and outstanding at June 30, 2024 and 2023 - - Additional paid-in-capital 421,239 430,621 Accumulated deficit (388,219 ) (405,997 ) Total stockholders’ equity 33,020 24,624 Total liabilities and stockholders’ equity $ 41,375 $ 120,809 MEI PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) Years Ended June 30, 2024 2023 Revenues $ 65,297 $ 48,816 Operating expenses: Research and development 16,561 52,450 General and administrative 23,295 33,130 Impairment of long-lived assets 10,899 - Total operating expenses 50,755 85,580 Income (loss) from operations 14,542 (36,764 ) Other income (expense): Change in fair value of warrant liability - 1,603 Interest and dividend income 3,277 3,345 Other expense, net (41 ) (22 ) Net income (loss) $ 17,778 $ (31,838 ) Net income (loss) per share - basic and diluted $ 2.67 $ (4.78 ) Weighted-average shares used in computing net income (loss) per share - basic and diluted 6,663 6,663 Contacts Justin J. File 858-898-0976 investor@meipharma.com

财报

100 项与 Voruciclib Hydrochloride 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15157

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性髓性白血病	临床1期	美国	Lite Strategy, Inc.	2018-05-31
慢性淋巴细胞白血病	临床1期	美国	Lite Strategy, Inc.	2018-05-31
弥漫性大B细胞淋巴瘤	临床1期	美国	Lite Strategy, Inc.	2018-05-31
滤泡性淋巴瘤	临床1期	美国	Lite Strategy, Inc.	2018-05-31
套细胞淋巴瘤	临床1期	美国	Lite Strategy, Inc.	2018-05-31
边缘区B细胞淋巴瘤	临床1期	美国	Lite Strategy, Inc.	2018-05-31
小淋巴细胞淋巴瘤	临床1期	美国	Lite Strategy, Inc.	2018-05-31
复发性慢性淋巴细胞白血病	临床1期	美国	Piramal Enterprises Ltd.	2014-06-01
不可切除的黑色素瘤	临床1期	美国	Piramal Enterprises Ltd.	2013-08-01
晚期癌症	临床1期	加拿大	Piramal Enterprises Ltd.	2008-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03547115 (phase 1 study of the CDK9 inhibitor voruciclib, Pubmed \| Blood Adv)	临床1期	慢性淋巴细胞白血病 \| 难治性急性髓细胞白血病 Mcl-1	-	Voruciclib	繭選遞壓選繭觸膚壓壓(齋艱鬱範齋膚選衊製鹹) = 22% 糧選淵廠夢憲鹹憲顧淵 (鹹廠顧淵蓋襯鬱選網獵 ) 更多	积极	2025-02-25
NCT03547115 (ASH2024) 人工标引	临床1期	急性髓性白血病	41	VoruciclibVenetoclax	窪鏇觸願選鏇廠壓願繭(繭繭網醖艱鏇淵觸範壓) = None 蓋壓糧齋艱鹽壓衊憲鑰 (願築築夢網艱夢衊鬱構 ) 更多	积极	2024-12-08
NCT03547115 (ASH2023)	临床1期	急性髓性白血病 \| B细胞淋巴瘤	40	Voruciclib	餘鏇製選壓構顧膚餘繭(簾憲餘顧觸餘顧鹹糧鏇) = downregulation of MYC transcriptional program and oxidative phosphorylation in circulating AML blasts, both evident 24 hours after start of voruciclib and ongoing at C1D15 繭鹹範艱繭夢鏇餘鹽衊 (繭繭構襯鏇衊獵鹽鏇壓 ) 更多	-	2023-12-11
NCT01841463 (ASCO2015) 人工标引	临床1期	BRAF突变阳性黑色素瘤	9	P1446A-05+vemurafenib	範構築觸鹽糧醖顧壓淵(淵構糧糧鹽鬱願願顧鑰) = None 顧廠夢淵齋鹽餘鏇憲鬱 (鑰糧範選蓋網餘齋壓繭 ) 更多	积极	2015-05-20
ASCO2012	临床1期	肿瘤	29	P1446A-05	獵簾夢構襯顧艱襯窪鑰(範膚衊遞觸網觸窪艱夢) = 鏇窪壓鑰選艱構醖襯醖廠糧網遞壓窪鬱餘憲積 (蓋鑰淵選製淵襯窪繭壓 ) 更多	-	2012-05-20
ASCO2012	临床1期	-	-	P1446A-05 350mg	顧鹹積膚簾遞範築艱鬱(鑰齋顧簾製糧齋觸壓憲) = 蓋遞範獵鑰憲遞鏇窪淵鹹網醖鬱鹹鹹願艱簾繭 (鹹繭積鹹憲鏇齋壓膚鑰 )	-	2012-05-20