Postcholecystectomy syndrome

Kura Oncology Reports Fourth Quarter and Full Year 2023 Financial Results

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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 Reports Positive Preliminary Ziftomenib Combination Data in Acute Myeloid Leukemia

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Tuesday, January 30, 2024
KURA, Failure, Acute myeloid leukemia, Venetoclax, Research, Division, MHS, Patient, Safety, QT interval, AML, Bone marrow, MBBS, QD, Yale Cancer Center, Disease, Therapy, Postcholecystectomy syndrome, Risk, ID, Cancer, Kura, Pharmaceutical industry

Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.

Key Points: 
  • Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.
  • The overall response rate (ORR) among R/R patients treated with ziftomenib and ven/aza was 53% (8/15).
  • As of the data cutoff, 80% (16/20) of patients remain on trial, including 100% (11/11) of all NPM1-m patients.
  • “We are highly encouraged by these preliminary combination data for ziftomenib and believe they support advancement into the frontline AML population,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology.

e-con Systems Launches Robotics Computing Platform During CES; Partners With Ambarella for Industrial AMR and Outdoor Robots

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Friday, January 12, 2024
Time of flight, Heart, SOC, RGB, IP69K, Partnership, Memory, Rover, Exhibition, IMU, HDR, DDR, Consumer Electronics Show, Original equipment manufacturer, Spondias dulcis, CES, Robotics, Marketing, IP67, Postcholecystectomy syndrome, AMR, System, LFM, Som, FPD, Growth, 3D printing

“We are pleased to be partnering with e-con Systems, a leader in vision-based systems and robotics," said Jerome Gigot, Sr. Director of Marketing at Ambarella.

Key Points: 
  • “We are pleased to be partnering with e-con Systems, a leader in vision-based systems and robotics," said Jerome Gigot, Sr. Director of Marketing at Ambarella.
  • e-con Systems also offers support and design services to help OEMs get to market quickly based on this new platform.
  • This partnership provides customers with state-of-the-art technology across diverse markets, including AMR, warehouse robots, pick-and-place robots and industrial automation.
  • For more detailed information about the partnership and a comprehensive overview of the ROAM Robotics Computing Platforms, visit e-con Systems website.

Biomea Fusion Presents Achievement of Minimal Residual Disease Negativity (MRD-neg) in First Complete Responder from Ongoing Phase I Study (COVALENT-101) of BMF-219 in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) at the 2023 ASH

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Monday, December 11, 2023
CRS, CYP, NPM1, Hematopoietic stem cell transplantation, Level 4, Arm, MEN1, ITGAM, Plasma, MEIS1, Society, DS, Hydroxycarbamide, ASH, Postcholecystectomy syndrome, Mutation, Steroid, DSM-IV codes, ANPEP, Gene expression, CD14, Cancer, Poster, Toxicity, HSCT, Patient, AUC, AML, Osteopathic medicine in Canada, Pharmaceutical industry

Pharmacodynamic data from a case study of an AML patient containing NUP98-NSD1 mutation showed suppression of key leukemogenic genes (e.g.

Key Points: 
  • Pharmacodynamic data from a case study of an AML patient containing NUP98-NSD1 mutation showed suppression of key leukemogenic genes (e.g.
  • Initially, patients were enrolled agnostic to mutational status; subsequently, the study protocol was amended to enrich for patients with AML harboring menin-dependent mutations.
  • Biomea is planning to amend the dosing protocol to explore higher dosing levels in Arm B.
  • Dose escalation is to be followed by a dose optimization/expansion to determine the recommended phase 2 dose.

City of Hope presents pivotal clinical trial data at American Society of Hematology (ASH) conference on revumenib, a potential new targeted therapy for high-risk subtypes of acute leukemias

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Tuesday, December 12, 2023
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Eye, Food, City, Volleyball, Postcholecystectomy syndrome, ASH, Disease, Haematopoietic system, Clinical trial, Patient, Multimedia, Bakersfield College, Viral, Division, FDA, CRH, KMT2A, Hematology, Blood, ORR, Nausea, Cancer, Survival, Chronic pain, AML, Family, ALL, Bone marrow, Travel, Acute leukemia, Pharmaceutical industry, Leukemia, Hope

The data was presented as a late-breaking abstrac t at ASH and in a press briefing.

Key Points: 
  • The data was presented as a late-breaking abstrac t at ASH and in a press briefing.
  • View the full release here: https://www.businesswire.com/news/home/20231212429407/en/
    City of Hope's Ibrahim Aldoss, M.D., presented the research at ASH conference.
  • Tatum Demontmorency , 19, participated in the clinical trial at City of Hope after she was diagnosed with leukemia in 2021.
  • If approved for use by the FDA, the product would be the first therapy to target what’s known as the menin-KMT2A interaction.

Syndax Presents Positive Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at Late-Breaking Oral Presentation During 65th ASH Annual Meeting

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Tuesday, December 12, 2023
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The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."

Key Points: 
  • The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."
  • Minimal residual disease (MRD) status was assessed in 10 of the 13 patients who achieved a CR/CRh, 70% (7/10) of whom were MRD negative.
  • In adults with AML (n=51), the CR/CRh rate was 37.3% and ORR was 68.6%, with 40% of responders proceeding to HSCT.
  • Copies of the ASH presentations are available in the Publications and Meeting Presentations section of Syndax's website.

Sumitomo Pharma Presents Encouraging New Data on DSP-5336 Clinical Activity at the American Society of Hematology Annual Meeting

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Monday, December 11, 2023
Additive effect, Postcholecystectomy syndrome, CRi, JAK, University, ASH, Disease, MLL, Patient, QT, Division, SMPA, Cancer, Acute leukemia, Growth, MD Anderson Cancer Center, Society, Relapse, Blood, Pharmaceutical industry, Leukemia

CAMBRIDGE, Mass., Dec. 11, 2023 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) today announced new data from the ongoing Phase 1/2 first-in-human study of DSP-5336, in patients with relapsed or refractory acute leukemia, presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition. DSP-5336 is an investigational small molecule inhibitor of the menin and mixed-lineage leukemia (MLL) protein interaction, which plays key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.1,2,3 

Key Points: 
  • In the ongoing study, patients are continuing to dose escalate and are now at therapeutic levels.
  • Preliminary results presented at ASH 2023 included four evaluable patients treated with DSP-5336 200 mg twice-daily, three of whom showed objective responses.
  • Inhibition of the menin-MLL protein interaction may be able to reverse the leukemogenic activity of MLL fusion proteins and may be a future therapeutic option for acute leukemia."
  • We look forward to continuing the study of DSP-5336 as a monotherapy and to exploring additional combination studies."

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

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Thursday, November 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 Presents Late-Breaking Clinical Data for Menin Inhibitor Ziftomenib at 2023 European Hematology Association (EHA) Congress

Retrieved on: 
Sunday, June 11, 2023
Postcholecystectomy syndrome, Menin, Continuity, Venetoclax, Crystal structure, Cancer, Mutation, Massachusetts General Hospital, Kura, MEN1, Acute myeloid leukemia, Congress, Mixed-phenotype acute leukemia, AML, Dor, Patient, KURA, EHA, IDH, FLT3, SCT, CRi, Hospital, Poster, Safety, Disease, Pharmaceutical industry

The updated clinical data are being featured during a late-breaking oral session today at the 2023 European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.

Key Points: 
  • The updated clinical data are being featured during a late-breaking oral session today at the 2023 European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.
  • Notably, 33% (2/6) of patients with FLT3 co-mutations and 50% (4/8) of patients with IDH co-mutations achieved a CR on ziftomenib.
  • Two patients underwent a stem cell transplant (SCT) and remain in remission as of the data cutoff, including one on post-SCT ziftomenib maintenance therapy.
  • “The clinical data presented today continue to demonstrate the ability of ziftomenib to drive durable responses as a monotherapy in heavily pretreated patients with NPM1-mutant AML.

Foghorn Therapeutics Announces FDA Has Lifted Clinical Hold on Phase 1 Study of FHD-286 in Relapsed and/or Refractory AML/MDS Patients

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Monday, June 5, 2023
Myelodysplastic syndrome, ANC, Acute leukemia, Therapy, Postcholecystectomy syndrome, Hypocalcemia, CDX, Xerostomia, Alanine transaminase, Foghorn, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Bone marrow, Gene expression, Biomarker, Rash, PDX, MDS, AML, Retinoic acid syndrome, Patient, Patient safety, Stomatitis, Risk, Memorial Sloan Kettering Cancer Center, Cytarabine, Drug development, LDAC, ALT, FDA, Northwestern Memorial Hospital, Food, Safety, Pharmaceutical industry, Decitabine, Leukemia

CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious disease by correcting abnormal gene expression, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Foghorn plans to commence a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory AML patients in the third quarter of 2023.“With a focus on patient safety, we have worked with the FDA to resolve the clinical hold on FHD-286 in AML and MDS,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “Clinical data suggest FHD-286 is a potent, broad-based differentiation therapeutic, and we believe it has significant combination potential as a treatment in AML. We anticipate commencing a Phase 1 combination study focusing on first-line relapsed and/or refractory AML patients in the third quarter of 2023.”

Key Points: 
  • Foghorn plans to commence a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory AML patients in the third quarter of 2023.
  • Foghorn has amended the protocol and plans to commence a Phase 1 study of FHD-286 in combination with decitabine or low-dose cytarabine (LDAC) in relapsed and/or refractory AML patients.
  • Foghorn plans to commence the Phase 1 combination study of FHD-286 in relapsed and/or refractory AML patients in the third quarter of 2023.
  • The study will enroll relapsed and/or refractory AML patients and the protocol allows for first-line relapsed and/or refractory AML patients.