CD135

ORYZON Announces FDA Approval of IND for FRIDA, a Phase Ib Trial With Iadademstat in R/R AML FLT3mut+ Patients

Retrieved on: 
Monday, March 21, 2022
Company, Cancer, Leukemia, Azacitidine, Measure (mathematics), LSD1, CD135, Population, Mission statement, ORY, Sale, Genomics, AML, Investigational New Drug, Forward-looking statement, CNMV, Patient, ORR, Squamous cell carcinoma, Public expenditure, IND, Mercado, FLT3, ALICE, CEO, Food, Communication, Senior, Spanish, ISIN, Prospectus, Medulloblastoma, The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, Safety, Person, Hematological Cancer Research Investment and Education Act, Trial of the century, Dor, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, Duration, ESMO, ASH, Wilms' tumor, FDA, FMS, SCLC, Pharmaceutical industry

FRIDA is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3mutations.

Key Points: 
  • FRIDA is an open-label, multicenter study of iadademstat plus gilteritinib for the treatment of patients with relapsed or refractory AML (R/R AML) with FLT3mutations.
  • Dr. Carlos Buesa, President and CEO of Oryzon, said: FDAs clearance to start FRIDA is a relevant corporate milestone for Oryzon and the patients we hope to serve.
  • Iadademstat, a uniquely potent and selective LSD1 inhibitor, has already shown a safe profile and high and prolonged responses in AML patients in combination with azacitidine.
  • In an ongoing Phase IIa trial in elder 1L-AML patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine (see Salamero et al., ASH 2021 poster).

CTI BioPharma Announces FDA Accelerated Approval of VONJO™ (pacritinib) for the Treatment of Adult Patients with Myelofibrosis and Thrombocytopenia

Retrieved on: 
Tuesday, March 1, 2022
Janus, Hematology, TYK2, Pneumonia, JAK3, Mount Sinai, Population, HIV disease progression rates, Heart, Webcast, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Peripheral edema, BAT, Bleeding, Toxicity, Fever, Haematopoiesis, Diarrhea, Associate professor, ID, CTI, JAK1, Cytokine, CTIC, Nausea, FMS, Vera, Disease, BD, CD135, DRI, Food, CSF1R, Acquisition, FLT3, Ruxolitinib, Caregiver, Cytopenia, Skin, FDA, Primary myelofibrosis, Platelet, Nasdaq, BID, Thrombocytopenia, Patient, Anemia, Pacritinib, Icahn School of Medicine at Mount Sinai, Oncology, JAK2, Pharmaceutical industry, Medicine

The accelerated approval is based on efficacy results from the pivotal Phase 3 PERSIST-2 study of VONJO in patients with myelofibrosis (platelet counts less than or equal to 100 109/L).

Key Points: 
  • The accelerated approval is based on efficacy results from the pivotal Phase 3 PERSIST-2 study of VONJO in patients with myelofibrosis (platelet counts less than or equal to 100 109/L).
  • As part of the accelerated approval, CTI is required to describe a clinical benefit in a confirmatory trial.
  • CTI is conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement.
  • "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions.

FMS-like Tyrosine Kinase 3 Inhibitors Pipeline Market Research Report 2022: Insights on Approx 25+ Companies and 25+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Monday, January 31, 2022
Pharmaceutical, Health, Clinical Trials, MHLW, Acute myeloid leukemia, Toxicity, III, CLL, Patient, FMS, Myelodysplastic syndrome, Ministry, Neoplasm, Clinical trial, Discovery, MDS, NHL, II, Adult, Animal, ITD, FLT3, News, Therapy, CD135, AML, Pharmaceutical industry, Health, Quizartinib

The "FMS-like tyrosine kinase 3 inhibitors - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "FMS-like tyrosine kinase 3 inhibitors - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "FMS-like tyrosine kinase 3 inhibitors - Pipeline Insight, 2022" report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in the FMS-like tyrosine kinase 3 inhibitors pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence FMS-like tyrosine kinase 3 inhibitors R&D.
  • The companies which have their FMS-like tyrosine kinase 3 inhibitors drug candidates in the most advanced stage, i.e.

Gastrointestinal Stromal Tumor (GIST) Market Spotlight Report 2021: 10-year Disease Incidence and Prevalence Forecasts, Probability of Success, Licensing and Asset Acquisition Deals, Revenue Forecasts - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 27, 2022
Health, General Health, BCR-ABL, GIST, VEGF, Novartis, PPAR, Ripretinib, Incidence, Peroxisome proliferator-activated receptor gamma, Clinical trial, Probability, Gastrointestinal stromal tumor, FMS, CD135, Pharmaceutical industry

The "Market Spotlight: Gastrointestinal Stromal Tumor (GIST)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market Spotlight: Gastrointestinal Stromal Tumor (GIST)" report has been added to ResearchAndMarkets.com's offering.
  • This Market Spotlight report covers the Gastrointestinal Stromal Tumor (GIST) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, regulatory events, probability of success, a 10-year disease incidence forecast, and drug-specific revenue forecasts.
  • The publisher estimates that in 2019, there were 100,200 incident cases of gastrointestinal stromal tumor (GIST) worldwide, and expects that number to increase to 109,000 incident cases by 2028.
  • Novartis leads industry sponsors with by far the highest overall number of clinical trials for GIST.

Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Friday, November 19, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Patient, University, Safety, MD Anderson Cancer Center, DXD, Growth hacking, Technology, Leukemia, EFS, AML, MD, Cancer, Acute myeloid leukemia, Pharmacokinetics, CRC, Oncology, American Cancer Society, Laboratory, Daiichi Sankyo, Prognosis, Sustainable development, Survival, FLT3, CD135, Risk, Mutation, Research, Adult, Thought, Population, R, HSCT, List of Nature Research journals, Hematology, ADC, Lymphatic system, NCCN, Stem cell, Cardiovascular disease, Statistics, Growth, Quality of life, Pharmaceutical industry, Medical imaging, Medicine, Oil, Dietary supplement, QuANTUM-First, Acute Myeloid Leukemia (AML), Quizartinib, Daiichi Sankyo, QUANTUM-FIRST, ACUTE MYELOID LEUKEMIA (AML), QUIZARTINIB, DAIICHI SANKYO

QuANTUM-First is a randomized, double-blind, placebo-controlled, multi-center global phase 3 study evaluating quizartinib in combination with standard induction and consolidation chemotherapy and then as continued single agent therapy in adult patients (age 18 75) with newly diagnosed FLT3-ITD positive AML.

Key Points: 
  • QuANTUM-First is a randomized, double-blind, placebo-controlled, multi-center global phase 3 study evaluating quizartinib in combination with standard induction and consolidation chemotherapy and then as continued single agent therapy in adult patients (age 18 75) with newly diagnosed FLT3-ITD positive AML.
  • Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo in combination with standard anthracycline and cytarabine-based induction and consolidation regimens.
  • Eligible patients, including those who underwent allogenic hematopoietic stem cell transplant (HSCT), continued with single agent quizartinib or placebo for up to 36 cycles.
  • QuANTUM-First enrolled 539 patients at approximately 200 study sites worldwide including in Asia, Europe, North America, Oceania and South America.

GenScript ProBio Enters into Agreement with SYNIMMUNE for Manufacturing of their Innovative Antibody Drug

Retrieved on: 
Monday, September 6, 2021
Life sciences, Medical specialties, Biology, Immunology, Biotechnology, Pharmaceutical industry, Immune system, Antibody, Glycoproteins, Monoclonal antibody, CD135, Biopharmaceutical

NANJING, China, Sept. 6, 2021 /PRNewswire/ --GenScript ProBio is delighted to announce the signing of a manufacturing service agreement for Synimmune's innovative FLYSYN antibody project for clinical Phase II production.

Key Points: 
  • NANJING, China, Sept. 6, 2021 /PRNewswire/ --GenScript ProBio is delighted to announce the signing of a manufacturing service agreement for Synimmune's innovative FLYSYN antibody project for clinical Phase II production.
  • "GenScript ProBio and SYNIMMUNE GmbH entered into collaboration on FLYSYN antibody project for technology transfer and manufacturing of drug substance and drug product for Clinical Phase II trials, it is our pleasure to support this innovative antibody project," said Dr. Brian Min, CEO of GenScript ProBio, "GenScript ProBio's GMP manufacturing center meets global regulatory requirements.
  • We are confident that GenScript ProBio will produce SYNIMMUNE's lead antibody drug product FLYSYN to all global quality GMP standards within the agreed upon timeline.
  • GenScript ProBio's innovative solutions for antibody drug development include antibody drug discovery, antibody engineering and antibody characterization.

Acute Myeloid Leukemia (AML) Research Report 2021: Market Insight, Epidemiology and Market Forecast to 2030 - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 5, 2021
Biotechnology, Pharmaceutical, Health, Table, RTK, Clinical trial, CD135, Technology, Devimistat, Lymphatic system, AML, Crenolanib, Gist, Limited liability company, Gastrointestinal stromal tumor, Patient, Cancer, News, Mitochondrion, Acute myeloid leukemia, Comprehension, Epidemiology, III, II, Safety, Enzyme, FMS-like tyrosine kinase 3 ligand, Glioma, Dietary supplement, Pharmaceutical industry

The "Acute Myeloid Leukemia (AML)- Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Acute Myeloid Leukemia (AML)- Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The Acute Myeloid Leukemia (AML) market report provides current treatment practices, emerging drugs, and their market share of the individual therapies, current and forecasted Acute Myeloid Leukemia (AML) symptoms market size from 2018 to 2030 segmented by seven major markets.
  • The report also covers current Acute Myeloid Leukemia (AML) symptoms treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities.
  • The Acute Myeloid Leukemia (AML) report's drug chapter segment encloses the detailed analysis of Acute Myeloid Leukemia (AML) early-stage (Phase- I, II, and III) pipeline drugs.

FDA lifts Partial Clinical Hold on Phase Ib Clinical Trial of RVU120 (SEL120) in Acute Myeloid Leukemia and Myelodysplastic Syndrome

Retrieved on: 
Wednesday, July 14, 2021
Enzymes, Chemical compounds, Branches of biology, Tyrosine kinase receptors, Leukemia, Protein kinase inhibitors, CD135, Cyclin-dependent kinase 8, Tumors of the hematopoietic and lymphoid tissues, Acute myeloid leukemia, Myeloid leukemia, Clonal hypereosinophilia

Following the completion ofthe75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established.

Key Points: 
  • Following the completion ofthe75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established.
  • The partial clinical hold was issued following Ryvu's recent report to the FDA of a Serious Adverse Event (SAE) involving a patient death that may possibly be related to RVU120.
  • RVU120 is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase 1b clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome.
  • SEL24 (MEN1703) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

Ryvu Therapeutics Presents Positive Phase I Data for RVU120 at the Virtual 26th Annual Congress of the European Hematology Association. Phase I/II Data for SEL24 (MEN1703) presented by development partner Menarini

Retrieved on: 
Friday, June 11, 2021
Tyrosine kinase receptors, CD135, FLT3LG

The data presented at EHA 2021 covers the first four dose cohorts, in which RVU120 demonstrated favorable safety and PK profile.

Key Points: 
  • The data presented at EHA 2021 covers the first four dose cohorts, in which RVU120 demonstrated favorable safety and PK profile.
  • In vitro data demonstrate that RVU120 can induce erythroid cells to differentiate and therefore rescue anemia inpreclinical models.
  • SEL24 (MEN1703), a first-in-class, orally available, dual PIM/FLT3 kinase inhibitor discovered and initially developed by Ryvu Therapeutics and licensed to the Menarini Group.
  • Ryvu is listed on the main market of the Warsaw Stock Exchange, and is a component of sWIG80 index.

Bergenbio Presents Encouraging Updated Preliminary Data From Phase Ii Study In Relapsed Aml Patients At Eha Virtual Meeting

Retrieved on: 
Friday, June 11, 2021
Chemical compounds, Tyrosine kinase receptors, Protein kinase inhibitors, Organic compounds, AXL receptor tyrosine kinase, Heterocyclic compounds, Bemcentinib, Orphan drugs, CD135, Midostaurin

An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.

Key Points: 
  • An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.
  • The data indicate that the combination of bemcentinib, a once-daily oral AXL-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit relapsed AML population.
  • Ongoing dialogue continues with the FDA and EMA regulatory agenciesto align on a pathway for apivotalregistration trial for the combination ofbemcentinibandLDAC in relapsed elderly AML patients unfit for intensive chemotherapy.
  • Data from a Phase II in human clinical trial has shown that treatment with AXL inhibitor bemcentinib increased the rate ventilator free survival in hospitalised COVID-19 patients.