FLT3

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

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Giovedì, Novembre 2, 2023
Trae tha Truth, ECOG, Vomiting, CYP3A4, WT, Abstract, NPM1, KMT2A, OBD, PK, DLT, TKD, Cancer, Diabetes, ORR, Clinical study design, Safety, Patient, Cohort, HSCT, SETBP1, CR, DSM-IV codes, NUP214, DOR, Dicarboxylic acid, CRi, ASH, CD135, QT interval, RFS, FLT3, Arm, Cellular, FMS, Transplant, ALL, Toxic leukoencephalopathy, Gene family, Survival, Postcholecystectomy syndrome, DS, Trial of the century, Incidence, CRC, Infrared spectroscopy correlation table, AL, Osteopathic medicine in Canada, MN1, BID, CNS, KRAS, ATD, NUP98, Society, WBC, Pharmacokinetics, CLL, Acute leukemia, Common, ITD, Toxicity, AML, Cardiovascular disease, Pharmaceutical industry, Dentistry, Vaccine, Decitabine, DLBCL

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

Kura Oncology Reports Third Quarter 2023 Financial Results

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Giovedì, Novembre 2, 2023
CR, Research, Mirati Therapeutics, NSCLC, AACR, Kura, Acute myeloid leukemia, FTI, Hematology, Mirati, Conference, KMT2A, CRH, KRAS, Azacitidine, HRAS, HNSCC, Disease, ID, Marketing, Webcast, Cancer, KURA, Oncology, Venetoclax, Mixed-phenotype acute leukemia, FLT3, Safety, European Society of Gynaecological Oncology, Renal cell carcinoma, Investment, Patient, Therapy, AML, Pharmaceutical industry, Bank, Video game, Cryptocurrency

ET –

Key Points: 
  • ET –
    SAN DIEGO, Nov. 02, 2023 (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 third quarter 2023 financial results and provided a corporate update.
  • Research and development expenses for the third quarter of 2023 were $29.3 million, compared to $25.0 million for the third quarter of 2022.
  • General and administrative expenses for the third quarter of 2023 were $13.1 million, compared to $11.6 million for the third quarter of 2022.
  • ET / 1:30 p.m. PT today, November 2, 2023, to discuss the financial results for the third quarter 2023 and to provide a corporate update.

Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights

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Lunedì, Ottobre 30, 2023
Week, DLBCL, FDA, Research, Research and development, NSCLC, Trial of the century, IND, DSM-IV codes, Food, Diabetes, Health Canada, G&A, BID, CRS, KRAS, Investment, R, NUP98, Glycated hemoglobin, CLL, CD135, Disease, Clinical trial, CRC, Cancer, QT interval, Menin, MM, FLT3, Safety, PDAC, Patient, FMS, Administration, AML, Mutation, Pharmaceutical industry, Medical imaging, Cryptocurrency, Osteopathic medicine in Canada

Both studies are now open for enrollment more than a quarter ahead of schedule.

Key Points: 
  • Both studies are now open for enrollment more than a quarter ahead of schedule.
  • Finally in this quarter, we also initiated the clinical study of our second, Biomea-discovered investigational covalent inhibitor, BMF-500, a novel FLT3 inhibitor.
  • Continued to advance development candidates derived from Biomea’s proprietary FUSION™ System platform to discover novel covalently binding small molecules.
  • G&A expenses were $17.1 million for the nine months ended September 30, 2023 compared to $15.2 million for the same period in 2022.

Aptose Presents Highlights from Clinical Update Webcast Featuring Latest Available Data on AML Drug Tuspetinib

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Lunedì, Ottobre 30, 2023
APS, VEN, TUS, KIT, Acute myeloid leukemia, SYK, European School, Treatment, MD, Conference, Doctor of Philosophy, ORR, University, FLT3, Safety, International Conference on Population and Development, MD Anderson Cancer Center, Patient, TSX, AML, Response-rate ratio, SAN, Toxic leukoencephalopathy, Pharmaceutical industry, Airline, Biology

Dr. Daver is the lead investigator on Aptose’s APTIVATE trial of tuspetinib and is recognized for significant achievements in the development of novel acute myeloid leukemia (AML) treatments, including several combination therapies.

Key Points: 
  • Dr. Daver is the lead investigator on Aptose’s APTIVATE trial of tuspetinib and is recognized for significant achievements in the development of novel acute myeloid leukemia (AML) treatments, including several combination therapies.
  • Tuspetinib (TUS) is a once-daily, oral, precision targeted kinase inhibitor that suppresses select kinases that drive the proliferation of AML.
  • “We are really pleased by our growing safety and efficacy data on tuspetinib in very difficult-to-treat AML patient populations,” said Dr. Bejar.
  • “Data from the TUS/VEN doublet gives us confidence to move tuspetinib forward into a TUS/VEN/HMA triplet for the treatment of frontline newly-diagnosed AML patients.

Aptose to Hold Clinical Update and KOL Data Review of AML Drug Tuspetinib on Monday, October 30th

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Lunedì, Ottobre 23, 2023
VEN, TUS, Acute myeloid leukemia, European School, Treatment, MD, Conference, Abstract, SAN, Venetoclax, University, FLT3, Safety, MD Anderson Cancer Center, Patient, TSX, AML, International Conference on Learning Representations, Pharmaceutical industry, Biology

Dr. Daver is the lead investigator on Aptose’s APTIVATE trial and is recognized for significant achievements in the development of novel AML treatments, including several combination therapies.

Key Points: 
  • Dr. Daver is the lead investigator on Aptose’s APTIVATE trial and is recognized for significant achievements in the development of novel AML treatments, including several combination therapies.
  • Tuspetinib also is being studied in combination with venetoclax (VEN) in the APTIVATE international Phase 1/2 expansion trial in R/R AML patients.
  • Notably, tuspetinib targets venetoclax resistance mechanisms that may re-sensitize Prior-VEN failure patients to venetoclax.
  • Note that the poster presentations will include additional data not found in the abstracts.

Biomea Fusion Announces First Patient Dosed with Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia in Phase I Clinical Trial (COVALENT-103)

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Martedì, Ottobre 17, 2023
Cancer, MD, Acute leukemia, Aplastic anemia, Safety, AML, Gene family, Disease, DSM-IV codes, FLT3, Patient, Pharmaceutical industry

REDWOOD CITY, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that the first patient has been dosed in COVALENT-103, the company’s Phase I trial of BMF-500, an investigational covalent FLT3 inhibitor developed using the proprietary FUSIONTM System, in adult patients with relapsed or refractory acute leukemia.

Key Points: 
  • “Despite several late stage and approved therapies targeting FLT3, the majority of patients with AML harboring FLT3 mutations have not achieved durable remissions.
  • We believe that BMF-500, which is designed to have key attributes of covalency, potency, and selectivity, has the capacity to fully extinguish FLT3-driven disease and the potential to combine with other targeted therapies and standard-of-care agents,” said Steve Morris, MD, Biomea’s Chief Development Officer.
  • “Today, we have taken another important step to bring novel covalent drug candidates into the clinic by exploring the potential of BMF-500, an investigational covalent FLT3 inhibitor, in treating adult patients with relapsed or refractory acute leukemia.
  • BMF-500 is designed to be a potent molecule and is the second covalent inhibitor we have developed in-house, demonstrating the potential of the FUSIONTM platform and our team in bringing novel assets to the clinic.

Aptose Clinical and Preclinical Data to be Presented at European School of Haematology (ESH) 6th International Conference

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Lunedì, Ottobre 16, 2023
TSX, Abstract, TUS, International Conference on Emerging Infectious Diseases, Treatment, Trial of the century, Apoptosis, European School, AML, VEN, RSK, Acute myeloid leukemia, SAN, SYK, KIT, FLT3, Conference, Patient, Pharmaceutical industry, Biology

Aptose is planning to hold a clinical update webcast on October 30, 2023, to provide additional up-to-date data on tuspetinib.

Key Points: 
  • Aptose is planning to hold a clinical update webcast on October 30, 2023, to provide additional up-to-date data on tuspetinib.
  • The posters accepted for presentation are listed below and can be viewed beginning October 29, 2023, on site at the ESH poster exhibit hall and online on the Aptose website here .
  • Notably, TUS targets VEN resistance mechanisms and appears to re-sensitize Prior-VEN failure patients to VEN.
  • We investigated the effects of TUS on key elements of the phosphokinome and apoptotic proteome in both parental and TUS-resistant AML cells.

Aptose to Present at the Cantor Global Healthcare Conference

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Lunedì, Settembre 18, 2023
CRC, Failure, Symantec Endpoint Protection, TUS, CRH, Clinical trial, European School, AML, Patient, SAN, CR, CFO, CRi, TSX, FLT3, CRP, Conference, Venetoclax, Pharmaceutical industry

SAN DIEGO and TORONTO, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced that the Aptose management team will participate in the Cantor Global Healthcare Conference being held September 26-28, 2023, in New York City.

Key Points: 
  • SAN DIEGO and TORONTO, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced that the Aptose management team will participate in the Cantor Global Healthcare Conference being held September 26-28, 2023, in New York City.
  • Dr. William G. Rice, Chairman, President and CEO of Aptose, will participate on a panel, Targeted Therapies for AML, and with Mr. Fletcher Payne, CFO of Aptose, will be hosting one-on-one meetings during the conference.
  • To schedule a one-on-one meeting with the Aptose management team, please contact your conference representative.
  • Aptose expects to update these data and release data on additional evaluable patients next month during the European School of Haematology (ESH) meeting in Estoril, Portugal.

Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML

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Venerdì, Settembre 15, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, Neutropenia, Maintenance, Cardiac arrest, Febrile neutropenia, Civil service commission, QT interval, European Medicines Agency, European Directive on Traditional Herbal Medicinal Products, Quizartinib, ECG, Acute myeloid leukemia, Committee, EMA, AML, Arrhythmia, MD, Patient, Risk, Hypokalemia, Daiichi Sankyo, European, HR, Committee for Medicinal Products for Human Use, FLT3, Ventricular fibrillation, Death, Pneumonia, European Commission, TSE, CHMP, Pharmaceutical industry, EU, Lancet

Daiichi Sankyo (TSE: 4568) announced that quizartinib has been recommended for approval in the European Union (EU) in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

Key Points: 
  • Daiichi Sankyo (TSE: 4568) announced that quizartinib has been recommended for approval in the European Union (EU) in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
  • The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.
  • QTcF > 500 ms occurred in 2.3% of patients receiving quizartinib and 0.8% of patients discontinued quizartinib due to QT prolongation.
  • Two (0.8%) patients receiving quizartinib experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

Aptose Announces Closing of $3 Million Investment by Hanmi Pharmaceutical

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Mercoledì, Settembre 6, 2023
TP53, Toronto Stock Exchange, TUS, Hope, Mutation, Consultant, Acute myeloid leukemia, AML, Hanmi Pharmaceutical, Patient, SAN, FLT3, TSX, Safety, Pharmaceutical industry, Security (finance), Hanmi, Share (finance)

Under the terms of the strategic investment, Hanmi purchased each Share at a price of $4.488, representing a premium over Aptose’s common stock price.

Key Points: 
  • Under the terms of the strategic investment, Hanmi purchased each Share at a price of $4.488, representing a premium over Aptose’s common stock price.
  • Aptose has granted Hanmi certain rights pursuant to an investor rights agreement, including registration rights, pre-emptive rights, information rights and the right to appoint non-executive consultants.
  • The closing of the second tranche for up to $4 million or a maximum of 19.99 percent ownership interest will be triggered upon Aptose achieving, prior to July 1, 2024, certain manufacturing and data milestones related to tuspetinib.
  • “We are grateful to our valued partner Hanmi Pharmaceutical for this investment and their confidence in our strategic direction," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer.