FLT3

Novotech Publishes Research Report on Acute Myeloid Leukaemia Clinical Trial Landscape for Clinical Stage Biotechs

Retrieved on: 
Thursday, April 11, 2024
Contract research organization, IDH2, FDA, Mutation, Acute myeloid leukemia, SWOT, Risk, Research, Prognosis, AML, USFDA, Leukemia, Pharmacotherapy, Therapy, Smoking, Incidence, Azacitidine, Protein, ROW, FLT3, Standard of care, Acute promyelocytic leukemia, Drug development, Biomarker, Clinical trial, IDH1, Growth, Pharmaceutical industry

BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released an expert report, Acute Myeloid Leukaemia - Global Clinical Trial Landscape , offering critical data-backed analysis of the latest developments in Acute Myeloid Leukemia (AML) research.

Key Points: 
  • BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, has released an expert report, Acute Myeloid Leukaemia - Global Clinical Trial Landscape , offering critical data-backed analysis of the latest developments in Acute Myeloid Leukemia (AML) research.
  • Importantly it also includes an in-depth SWOT analysis to guide strategic decision-making, prioritize research areas, and identify challenges for clinical stage biotechs.
  • The Acute Myeloid Leukaemia (AML) - Global Clinical Trial Landscape report notes that since 2019, the global biotech and biopharmaceutical industry initiated over 1,000 clinical trials for AML.
  • These reports offer current insights into global clinical trial activity, revealing which regions experience the highest trial volumes and the unique factors behind these trends.

MEI Pharma Board of Directors Aligns on Strategy to Advance Voruciclib and ME-344

Retrieved on: 
Thursday, April 11, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Agreement, Patient, Cancer, Mutation, CDK9, Venetoclax, Colorectal cancer, MEI, Bevacizumab, AML, Research, Cohort, Salvage therapy, Disease, Exercise, Therapy, IDH, Incidence, Neoplasm, Toxicity, Acute myeloid leukemia, FLT3, Standard of care, Death, Clinical trial, VEGF, Calendar, Pharmaceutical industry

With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.

Key Points: 
  • With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.
  • The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported today.
  • Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice.
  • The goal of the formulation effort is to increase biological activity, improve patient convenience of administration and increase commercial opportunity.

HanxBio announces the publication of a research paper in Scientific Reports on preclinical evaluation of Narazaciclib for the treatment of acute myeloid leukemia (AML)

Retrieved on: 
Tuesday, April 23, 2024
CDK6, Probability, Pharmacokinetics, Trial of the century, AML, Scientific Reports, Moa, CSF1R, FLT3, Pharmacology, SAN, Nature Portfolio, Pharmaceutical industry

Narazaciclib (HX301 or ON123300) is a clinical stage small molecule investigational new drug jointly developed by HanxBio and its business partner OncoNova Therapeutics, Inc. (now Traws Pharma, Inc.).

Key Points: 
  • Narazaciclib (HX301 or ON123300) is a clinical stage small molecule investigational new drug jointly developed by HanxBio and its business partner OncoNova Therapeutics, Inc. (now Traws Pharma, Inc.).
  • In this peer-reviewed article, the researchers from HanxBio described comprehensive pharmacology characterization of HX301 using a series of preclinical experimental AML models, including in vitro cell lines, and in vivo cell line-derived xenografts (CDXs) and patient-derived xenografts (PDXs).
  • This report also studied the pharmacodynamics and pharmacokinetics of HX301, including the relationship between drug exposure and efficacy, which can be used to assist clinical dosage selection.
  • The results of this study will guide our clinical development strategies for HX301 for the treatment of AML."

Biomea Fusion Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, April 1, 2024
Diagnosis, Research, Week, CD135, Administration, FMS, Growth, Menin, CLL, NSCLC, C-peptide, AML, BID, Diabetes, Insulin, Patient, Hypoglycemia, FLT3, G&A, Acute myeloid leukemia, Food, PDAC, Health Canada, Trial of the century, IND, Cancer, CRC, Safety, Research and development, Investment, FDA, DLBCL, DSM-IV codes, Pharmaceutical industry

In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.

Key Points: 
  • In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.
  • Cash position of $177.2 million at the end of the fourth quarter of 2023.
  • REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported fourth quarter and full year 2023 financial results and corporate highlights.
  • “2023 was a pivotal year for Biomea as we reported first positive data in type 2 diabetes and initiated our first clinical study in type 1 diabetes.

Aptose Reports Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, March 26, 2024
Indian stock exchange, Absorption, Plasma, Exercise, Hanmi Pharmaceutical, AML, BID, Patient, APS, SAN, Venetoclax, G1, VEN, FLT3, EHA, LUX, Acute myeloid leukemia, Trial of the century, TUS, TSX, Hanmi, Azacitidine, G3, Pharmaceutical industry

This included 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option.

Key Points: 
  • This included 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option.
  • Total gross proceeds from the public offering were approximately $9.7 million before deducting underwriting costs, placement agent commissions and other offering-related expenses.
  • Private Placement – On January 31, 2024, Aptose closed a US $4 million private placement of common shares with strategic partner Hanmi Pharmaceutical.
  • Luxeptinib G3 Evaluation Completed – During 2023 and early 2024, clinical evaluation of the new generation 3 (G3) formulation of luxeptinib (LUX) was completed.

Rigel Pharmaceuticals Announces Appointment of Lisa Rojkjaer, M.D. as Chief Medical Officer

Retrieved on: 
Tuesday, March 12, 2024
CONNECT, Internal medicine, University, Growth, Biotechnology, Novo Nordisk, Hematology, Science, AML, Monroe Dunaway Anderson, Executive, Patient, SAN, Novartis, FLT3, Head, Drug, Therapy, Drug development, Sangamo Therapeutics, Molecular Partners, MorphoSys, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 12, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the appointment of Lisa Rojkjaer, M.D.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 12, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the appointment of Lisa Rojkjaer, M.D.
  • as Executive Vice President and Chief Medical Officer.
  • Dr. Rojkjaer is an industry veteran with over 20 years of clinical development, regulatory, and medical affairs experience with a focus on hematology and oncology.
  • Prior to joining Rigel, Dr. Rojkjaer held several leadership positions in clinical development and medical affairs at biotechnology and global pharmaceutical companies, having most recently served as Chief Medical Officer of Sangamo Therapeutics.

Kura Oncology Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
NSCLC, Leukemia, Research, AML, Pedal, QT interval, FTI, Mirati Therapeutics, Investment, Postcholecystectomy syndrome, Physician, Clinical trial, ID, HRAS, Mirati, Prognosis, Renal cell carcinoma, FLT3, Webcast, Patient, KURA, Disease, G&A, LDAC, HNSCC, Cancer, Pharmaceutical industry

ET –

Key Points: 
  • ET –
    SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported fourth quarter and full year 2023 financial results and provided a corporate update.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $32.5 million, compared to $22.7 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $14.2 million, compared to $12.5 million for the fourth quarter of 2022.
  • ET / 1:30 p.m. PT today, February 27, 2024, to discuss the financial results for the fourth quarter and full year 2023 and to provide a corporate update.

Kura Oncology Doses First Patient in KOMET-008 Trial of Ziftomenib in Combination with Standards of Care, Including FLT3 Inhibitor, in Acute Myeloid Leukemia

Retrieved on: 
Monday, February 26, 2024
AML, Azacitidine, Menin, KMT2A, Safety, Prognosis, FLT3, Pharmacokinetics, Venetoclax, Patient, KURA, Kura, Acute myeloid leukemia, LDAC, Cancer, Pharmaceutical industry

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in KOMET-008, the Company’s Phase 1 trial of its menin inhibitor ziftomenib, in combination with gilteritinib, FLAG-IDA or LDAC for the treatment of NPM1-mutant or KMT2A-rearranged acute myeloid leukemia (AML).

Key Points: 
  • “Roughly half of patients with relapsed or refractory NPM1-mutant AML have co-occurring FLT3 mutations, and the prognosis for these patients is particularly poor,” said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology.
  • Trial participants will be enrolled in one of five dose escalation cohorts, including a cohort of NPM1-mutant AML patients with a documented FLT3 co-mutation, who will be treated in combination with the FLT3 inhibitor gilteritinib.
  • Kura is conducting a series of studies to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations.
  • Preclinical data for menin inhibitors in combination with multiple FLT3 inhibitors demonstrate strong synergistic effects compared to either single agent alone.

Harmonic Discovery Announces Licensing Agreement with BioVentures and UCSF for FLT3 Mutated AML Development Program

Retrieved on: 
Tuesday, January 30, 2024
Medicine, UCSF, Acute myeloid leukemia, MD, Pharmacology, University of Arkansas, IND, Patient, AML, FLT3, Laboratory, Patent, Doctor of Philosophy, University, Aplastic anemia, Pharmaceutical industry

The compound, named HD-10019, is currently in pre-clinical development and is expected to commence IND-enabling studies in late 2024.

Key Points: 
  • The compound, named HD-10019, is currently in pre-clinical development and is expected to commence IND-enabling studies in late 2024.
  • HD-10019 is a type II kinase inhibitor that was rationally designed to overcome tyrosine kinase domain resistance mutations in the FLT3 kinase and improve myelosuppression versus standard of care agents for FLT3 mutated AML.
  • "We are excited to work with BioVentures and UCSF and take a step forward in delivering a novel treatment to FLT3 mutated AML patients," said Rayees Rahman, PhD, CEO of Harmonic Discovery.
  • Wilson Sonsini Goodrich & Rosati served as legal advisor to Harmonic Discovery on matters relating to the Licensing Agreement and related corporate and patent strategy matters.

Biomea Fusion Highlights Recent Updates and Anticipated 2024 Corporate Milestones at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Tuesday, January 9, 2024
Diabetes, DSM-IV codes, Patient, Leukemia, CTA, PST, Research, CLL, Osteopathic medicine in Canada, Diagnosis, FLT3, NSCLC, Insulin, Cancer, IND, Conference, Safety, DLBCL, FDA, Glycated hemoglobin, PDAC, AML, CRC, Phase, Health Canada, Week, Pharmaceutical industry

Open label portion of Phase II COVALENT-112 study readout in 40 patients with type 1 diabetes expected in 2024.

Key Points: 
  • Open label portion of Phase II COVALENT-112 study readout in 40 patients with type 1 diabetes expected in 2024.
  • A live webcast of the presentation will be available on the Investors & Media page of Biomea’s website at: https://investors.biomeafusion.com/news-events/events .
  • “2023 was a truly remarkable year for Biomea as we had several positive data readouts in both type 2 diabetes and AML.
  • “We believe BMF-219 has the potential to address the root cause of diabetes and modify its progression in patients.