FLT3

Aptose Reports Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Martedì, Marzo 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

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Martedì, Marzo 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

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Martedì, Febbraio 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

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Lunedì, Febbraio 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

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Martedì, Gennaio 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: 
Martedì, Gennaio 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.

Senti Bio Announces FDA Clearance of IND Application for SENTI-202 for the Treatment of Relapsed or Refractory Hematologic Malignancies Including Acute Myeloid Leukemia

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Venerdì, Dicembre 22, 2023
Gene, Research and development, SNTI, Food, IND, NOT, FDA, SAN, Doctor of Philosophy, Clinical trial, Cancer, FLT3, Patient, Acute myeloid leukemia, Safety, CD33, Development, AML, Synthetic biology, IL15

SOUTH SAN FRANCISCO, Calif., Dec. 22, 2023 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies while sparing healthy bone marrow cells.

Key Points: 
  • The dose finding trial will evaluate two dose levels, either 1 or 1.5 billion SENTI-202 cells, administered after lymphodepleting conditioning in adult patients with relapsed or refractory (r/r) CD33 and/or FLT3 expressing hematologic malignancies, including acute myeloid leukemia (AML).
  • “Clearance of our IND application for SENTI-202 is a tremendous milestone and marks an important achievement for Senti as we transition to a clinical-stage therapeutics company,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio.
  • Senti Bio believes this approach can lead to more effective and durable responses in patients.
  • Through Senti Bio’s previously announced agreement with GeneFab, the Company has prepaid the majority of manufacturing-related expenses through the completion of the Phase 1 trial.

Aptose Reports Results for the Third Quarter 2023

Retrieved on: 
Giovedì, Novembre 9, 2023
Apoptosis, ASH, University, Acute myeloid leukemia, APS, Patient, Poster, VEN, SYK, TUS, FLT3, ORR, KIT, CMML, Toxic leukoencephalopathy, AML, MD Anderson Cancer Center, Society, TSX, Cell, European School, Pharmaceutical industry, Airline, Venetoclax

“Investigator enthusiasm for our tuspetinib/venetoclax (TUS/VEN) doublet has led to brisk enrollment in the APTIVATE trial.

Key Points: 
  • “Investigator enthusiasm for our tuspetinib/venetoclax (TUS/VEN) doublet has led to brisk enrollment in the APTIVATE trial.
  • In the most recent data cut (October 23, 2023), the favorable safety profile remained consistent for TUS and TUS/VEN treated R/R AML patients.
  • Aptose researchers investigated the effects of TUS on key elements of the phospho-kinome and apoptotic proteome in both parental and TUS-resistant AML cells.
  • APTIVATE oral presentation at ASH 2023 by Dr.

ChemDiv Presented Non-Clinical Summary Data for The Best-in-Class Selective FLT3 Clinical Candidate at the 65th ASH Annual Meeting and Exposition with Its Partners and Sponsors

Retrieved on: 
Martedì, Dicembre 12, 2023
Immunocompetence, Safety, SAN, Expert system, Chemical Diversity, Eilean Donan, Pharmacology, FLT3, University, Survival, AML, University of Cincinnati, Pharmaceutical industry

SAN DIEGO, Dec. 12, 2023 /PRNewswire/ -- ChemDiv Inc., dedicated to partnering in discovery and development of breakthrough therapies based on its unique chem-bio platforms, announces the presentation of non-clinical summary data for the best-in-class selective FLT3 clinical candidate at the 65th ASH Annual Meeting and Exposition in San Diego, CA.

Key Points: 
  • SAN DIEGO, Dec. 12, 2023 /PRNewswire/ -- ChemDiv Inc., dedicated to partnering in discovery and development of breakthrough therapies based on its unique chem-bio platforms, announces the presentation of non-clinical summary data for the best-in-class selective FLT3 clinical candidate at the 65th ASH Annual Meeting and Exposition in San Diego, CA.
  • "Therapeutic Targeting of FLT3 gatekeeper mutation with E2082-0047 in traditional and a novel Immunocompetent murine adoptive transfer model of AML" was presented by collaborators from University of Cincinnati, Ohio, Molsoft LLC and Expert Systems Inc of San Diego, California, and Eilean Therapeutics LLC from Dover, Delaware.
  • The presentation highlighted best-in-class potency and selectivity against gatekeeper resistant FLT-mutant AML and compelling survival benefit superior to gilteritinib in a fully immunocompetent Nmp1CAFLT3ITD-F692L AML adoptive transfer model, supporting the clinical candidate's ongoing clinical development.
  • In collaboration with rational design groups of Molsoft and Expert Systems, John Byrd's lab at University of Cincinnati, ChemDiv deployed a muti-targeting/multi-property optimization approach to achieve a 400-1000x selectivity of the resulting clinical candidate, which translated in best-in-class efficacy, safety, tolerability and developable pharmacology advantages delivered to partners at Eilean Therapeutics LLC.

VANFLYTA® Approved in the EU as the First FLT3 Inhibitor Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

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Giovedì, Novembre 9, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, QT interval, Cardiac arrest, National Center for Health Research, Acute myeloid leukemia, ECG, European Commission, Hypokalemia, Committee, European Directive on Traditional Herbal Medicinal Products, Febrile neutropenia, MD, Professor, News, University Hospital Heidelberg, EC, Maintenance, Pneumonia, Arrhythmia, Ventricular fibrillation, ALAN, Civil service commission, Daiichi Sankyo, Risk, TSE, HR, Leukemia, FLT3, Committee for Medicinal Products for Human Use, Safety, German Cancer Research Center, European, Patient, Death, Neutropenia, AML, Nursing, Pharmaceutical industry, EU, Lancet

VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2

Key Points: 
  • VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2
    The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet .
  • The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%).
  • QTcF > 500 ms occurred in 2.3% of patients receiving VANFLYTA and 0.8% of patients discontinued VANFLYTA due to QT prolongation.
  • Two (0.8%) patients receiving VANFLYTA experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.