Entospletinib

Kronos Bio and Invivoscribe Partner on Companion Diagnostic for Use with Entospletinib, Kronos Bio’s Investigational Compound Being Developed for Patients with AML

Retrieved on: 
Tuesday, August 16, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Acute myeloid leukemia, U.S. Securities and Exchange Commission, SYK, Phase 3, Risk, NDA, Precision medicine, MRD, Forward-looking statement, GLOBE, Drug, Private Securities Litigation Reform Act, SEC, Cancer, Clinical trial, EFS, Research, Security (finance), AML, CDK9, Patient, Cell, SAN, Therapy, NPM1, Safety, PMA, Mutation, Nasdaq, LinkedIn, Cdx, New Drug Application, Food, Global health, Factor X, KRON, Medical imaging, Medical device, Pharmaceutical industry, Management, Entospletinib, Kronos

SAN MATEO, Calif. and SAN DIEGO, Aug. 16, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, and Invivoscribe, a global provider of diagnostic kits and services for oncology, today announced their agreement to develop a companion diagnostic (CDx) for use with Kronos Bio’s investigational therapy, entospletinib.   Entospletinib is Kronos Bio’s lead clinical compound, currently in the ongoing Phase 3 registrational AGILITY study for the treatment of newly diagnosed NPM1-mutated acute myeloid leukemia (AML).

Key Points: 
  • Entospletinib is Kronos Bios lead clinical compound, currently in the ongoing Phase 3 registrational AGILITY study for the treatment of newly diagnosed NPM1-mutated acute myeloid leukemia (AML).
  • The diagnostic will screen for the NPM1 mutation, which is present in approximately one-third of all patients with AML.
  • The FDA requires the validation and approval of companion diagnostics used to select patients for treatment with a specific therapeutic agent.
  • The agreement builds on Invivoscribes experience in developing and obtaining approval for diagnostics used for identification of patients with genetically mutated AML.

Kronos Bio and Invivoscribe Partner on Companion Diagnostic for Use with Entospletinib, Kronos Bio's Investigational Compound Being Developed for Patients with AML

Retrieved on: 
Tuesday, August 16, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, Acute myeloid leukemia, SYK, Risk, NDA, Precision medicine, MRD, Forward-looking statement, Drug, Private Securities Litigation Reform Act, SEC, Cancer, Clinical trial, EFS, Security (finance), Research, AML, CDK9, Patient, Cell, SAN, Therapy, NPM1, Safety, PMA, Mutation, Swiss Precision Diagnostics, Nasdaq, LinkedIn, Cdx, New Drug Application, Food, Global health, Factor X, KRON, Medical imaging, Medical device, Pharmaceutical industry, Entospletinib

SAN MATEO, Calif. and SAN DIEGO, Aug. 16, 2022 /PRNewswire/ -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, and Invivoscribe, a global provider of diagnostic kits and services for oncology, today announced their agreement to develop a companion diagnostic (CDx) for use with Kronos Bio's investigational therapy, entospletinib. Entospletinib is Kronos Bio's lead clinical compound, currently in the ongoing Phase 3 registrational AGILITY study for the treatment of newly diagnosed NPM1-mutated acute myeloid leukemia (AML).

Key Points: 
  • The diagnostic will screen for the NPM1 mutation, which is present in approximately one-third of all patients with AML.
  • The FDA requires the validation and approval of companion diagnostics used to select patients for treatment with a specific therapeutic agent.
  • The agreement builds on Invivoscribe's experience in developing and obtaining approval for diagnostics used for identification of patients with genetically mutated AML.
  • "This companion diagnostic NPM1mutation assay development work with Kronos Bio represents a significant milestone for our company," said Jeffrey Miller, Ph.D., chief scientific officer and chief executive officer of Invivoscribe.

Spleen Tyrosine Kinase Inhibitors Pipeline Market Research Report 2022 - ResearchAndMarkets.com

Retrieved on: 
Monday, January 31, 2022
Health, Pharmaceutical, Hematological Cancer Research Investment and Education Act, III, BCR, Autoimmune hemolytic anemia, Clinical trial, Neutrophil, Factor X, Discovery, Acute myeloid leukemia, Signal transduction, TRN, Tyrosine-protein kinase SYK, Macrophage, MEIS1, BTK, COVID-19, II, PI3K, Fostamatinib, HOXA9, Entospletinib, Phase II, SYK, News, Degenerative disease, B cell, FC, ENTO, Therapy, PTK, AML, Monocyte, TNF, Vaccine, Pharmaceutical industry, Spleen

The "Spleen tyrosine kinase inhibitors - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Spleen tyrosine kinase inhibitors - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "Spleen tyrosine kinase inhibitors - Pipeline Insight, 2022" report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Spleen tyrosine kinase inhibitors pipeline landscape.
  • Spleen tyrosine kinase (Syk) is a cytosolic non-receptor protein tyrosine kinase (PTK) and is mainly expressed in hematopoietic cells.
  • The companies which have their Spleen tyrosine kinase inhibitors drug candidates in the most advanced stage, i.e.

Kronos Bio Announces First Patient Dosed in AGILITY Phase 3 Clinical Trial of Entospletinib in Patients With Newly Diagnosed NPM1-mutated Acute Myeloid Leukemia

Retrieved on: 
Monday, December 6, 2021
MLL, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cell, Haematopoietic system, Disease, Lymphatic system, Gilead Sciences, SYK, Hematology, NPM1, DNA, Mutation, Risk, GLOBE, Infection, CDK9, Bone marrow, LinkedIn, Department, Food, Private Securities Litigation Reform Act, Security (finance), Cytarabine, Cancer, Acute myeloid leukemia, U.S. Securities and Exchange Commission, Research, Polymerase chain reaction, Bleeding, CR, MFC, Allele, Bone marrow failure, Protein, EFS, Forward-looking statement, Therapy, MRD, Survival, Adult, FDA, Minimal residual disease, Patient, Heart failure, Safety, PCR, SEC, SAN, City, COVID-19, KRON, Nasdaq, MEIS1, Antibody, HOXA9, Entospletinib, Factor X, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., Dec. 06, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that the first patient has been dosed in the registrational Phase 3 AGILITY clinical trial of entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK), in combination with standard of care anthracycline and cytarabine (7+3) chemotherapy. This trial is the first in acute myeloid leukemia (AML) to use measurable residual disease (MRD) as the primary endpoint and has the potential to support accelerated approval of entospletinib by the U.S. Food and Drug Administration (FDA) as a treatment for patients newly diagnosed with NPM1-mutated AML who are fit for intensive induction.

Key Points: 
  • Entospletinib is Kronos Bios lead product candidate, and the company expects to share data from the trial in the second half of 2023.
  • This trial will test the hypothesis, based on robust preclinical and Phase 2 clinical data, that NPM1 mutation leads to dependency on SYK signaling.
  • In the trial, patients will be randomized 1:1 to receive either entospletinib or placebo in combination with standard induction and consolidation chemotherapy.
  • Kronos Bio is developing entospletinib for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML).

Kronos Bio Announces FDA Clearance of Investigational New Drug Application for Lanraplenib (LANRA) for Treatment of Patients with Acute Myeloid Leukemia (AML)

Retrieved on: 
Tuesday, July 27, 2021
Acute myeloid leukemia, Leukemia, Cancer, Entospletinib, 7+3, HOXA9, Clinical medicine, Branches of biology, Myeloid sarcoma

SAN MATEO, Calif. and CAMBRIDGE, Mass., July 27, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for lanraplenib (LANRA), allowing the company to proceed with a Phase 1/2 clinical trial of LANRA in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with gilteritinib. Kronos Bio expects to initiate the trial in the fourth quarter of this year. The company is developing LANRA as a next-generation spleen tyrosine kinase (SYK) inhibitor, with improved pharmacokinetic (PK) and pharmacologic properties compared with entospletinib (ENTO), the company’s lead program. ENTO will be evaluated in combination with standard chemotherapy in a planned Phase 3 clinical trial in patients newly diagnosed with NPM1-mutated AML.

Key Points: 
  • Previously, LANRA demonstrated an acceptable safety profile in clinical trials of more than 250 healthy volunteers and patients with autoimmune diseases.
  • Kronos Bio is developing ENTO for the treatment of patients who are newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) and eligible for intensive induction chemotherapy.
  • Results of a Phase 1b/2 study of entospletinib (GS-9973) monotherapy and in combination with induction chemotherapy in newly diagnosed patients with acute myeloid leukemia.
  • Entospletinib in combination with induction chemotherapy in previously untreated acute myeloid leukemia: response and predictive significance of HOXA9 and MEIS1 expression.

Global Mantle Cell Lymphoma Clinical Landscape Market Report 2021: Marketed and Pipeline Drugs, Trials, Key Events, Success Probability, 10-Year Disease Prevalence Forecast, Deals, Revenue Forecasts - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 17, 2021
Pharmaceutical, Health, Oncology, Non-Hodgkin lymphoma, Hematology, Mantle cell lymphoma, Medical specialties, Lymphoma, MCL, Branches of biology, Clinical medicine, Tyrosine kinase inhibitors, Entospletinib

The "Market Spotlight: Mantle Cell Lymphoma" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market Spotlight: Mantle Cell Lymphoma" report has been added to ResearchAndMarkets.com's offering.
  • This Market Spotlight report covers the Mantle Cell Lymphoma (MCL) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
  • The publisher estimates that in 2017, there were approximately 14,030 incident cases of mantle cell lymphoma (MCL) worldwide, and forecasts that number to increase to 18,010 incident cases by 2026.
  • Johnson & Johnson leads industry sponsors with the highest overall number of clinical trials for MCL, followed by Bristol Myers Squibb.

Worldwide Mantle Cell Lymphoma Treatment Industry to 2029 - by Mechanism of Action and Geography - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 16, 2021
Health, Oncology, Lymphoma, Clinical medicine, Non-Hodgkin lymphoma, Medicine, Cancer, Mantle cell lymphoma, Chemotherapy, Primary testicular diffuse large B-cell lymphoma, Entospletinib

The "Mantle Cell Lymphoma Treatment Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2021 to 2029" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Mantle Cell Lymphoma Treatment Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2021 to 2029" report has been added to ResearchAndMarkets.com's offering.
  • The World Health Organization has reported the incidence rate of mantle cell lymphoma globally as 0.5 cases per 100,000 people.
  • Mantle cell lymphoma is resistant to chemotherapy drug treatment and so a targeted treatment approach has been adopted with promising drugs in the product pipeline with better drug efficacy and safety e.g.
  • To understand the performance of drugs employed for the treatment of mantle cell lymphoma in the regional segments their respective major countries has been considered in the segment.

Kronos Bio Announces Participation in Upcoming Investor Conferences

Retrieved on: 
Wednesday, May 26, 2021
Enzymes, Tyrosine kinase inhibitors, Chemical compounds, Entospletinib, Indazoles, Morpholines, Tyrosine kinase receptors, Tyrosine kinases, Branches of biology, CD135, Tyrosine-protein kinase SYK, Acute myeloid leukemia

The fireside chats will be webcast live from the Investors & Media section of the companys website at www.kronosbio.com .

Key Points: 
  • The fireside chats will be webcast live from the Investors & Media section of the companys website at www.kronosbio.com .
  • Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering and developing therapies that seek to transform the lives of those affected by cancer.
  • Kronos Bio is developing a portfolio of spleen tyrosine kinase (SYK) inhibitors, entospletinib (ENTO) and lanraplenib (LANRA), for the treatment of NPM1-mutated and FLT3-mutated acute myeloid leukemia (AML).
  • Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass.

Kronos Bio Reports Recent Business Progress and First Quarter Financial Results and Announces Virtual R&D Day

Retrieved on: 
Tuesday, May 11, 2021
Branches of biology, Entospletinib, Indazoles, Morpholines, Tyrosine-protein kinase SYK, Acute myeloid leukemia, NPM1, Myc, Tyrosine kinase

\xe2\x80\x9cWe recently showcased progress with our CDK9 program at the AACR annual meeting in April, where we presented preclinical data indicating that KB-0742 could have utility in the treatment of MYC-amplified cancers.

Key Points: 
  • \xe2\x80\x9cWe recently showcased progress with our CDK9 program at the AACR annual meeting in April, where we presented preclinical data indicating that KB-0742 could have utility in the treatment of MYC-amplified cancers.
  • We look forward to sharing more about our development plans for this compound at our research and development day.\xe2\x80\x9d\nDr.
  • The company focuses on targeting dysregulated transcription factors and the regulatory networks within cells that drive cancerous growth.
  • Kronos Bio\xe2\x80\x99s lead investigational therapy is entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK) in development for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML).

Kronos Bio Announces Participation in Bank of America Securities 2021 Health Care Conference

Retrieved on: 
Thursday, May 6, 2021
Entospletinib, Indazoles, Morpholines, Tyrosine-protein kinase SYK, Enzymes, Acute myeloid leukemia, Tyrosine kinase, NPM1, Protein kinase inhibitors

A replay of the webcast will be archived and available for one month following the event.\nKronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering and developing therapies that seek to transform the lives of those affected by cancer.

Key Points: 
  • A replay of the webcast will be archived and available for one month following the event.\nKronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering and developing therapies that seek to transform the lives of those affected by cancer.
  • The company focuses on targeting dysregulated transcription factors and the regulatory networks within cells that drive cancerous growth.
  • Kronos Bio\xe2\x80\x99s lead investigational therapy is entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK) in development for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML).
  • For more information, visit www.kronosbio.com or follow the company on LinkedIn .\n'