Menin

Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219

Retrieved on: 
Monday, April 1, 2024
Diagnosis, Health, Regeneration, Learning, Glycated hemoglobin, Menin, C-peptide, Insulin, Diabetes, AUC, Patient, Fasting, MD, Metformin, Person, Cancer, Safety, A1C, DSM-IV codes, Pharmaceutical industry

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (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, today announced initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112).

Key Points: 
  • “We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study.
  • Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219.
  • The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis.
  • It has been exciting to participate in this study and explore this new pathway for the benefit of our patients.

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.

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.

Biomea Fusion Announces Near Doubling the Percentage of Patients with Durable HbA1c Reduction in the 200 mg Dose Cohorts

Retrieved on: 
Saturday, December 9, 2023
Phase, Flexner Report, Diabetes, Conference, BID, QD, Menin, ATTD, Animal, Week, DSM-IV codes, Cancer, Food, SAD, Gene, Patient, Diagnosis, Safety, Harvard Medical School, Joslin Diabetes Center, Osteopathic medicine in Canada, Kinetics, Pharmaceutical industry

At Week 26, 22 weeks after the last dose of BMF-219, the 200 mg cohorts increased the percentage of patients to approximately 40% with durable HbA1c reduction of 1% or more as compared to the 100 mg cohorts which reported earlier as 20%.

Key Points: 
  • At Week 26, 22 weeks after the last dose of BMF-219, the 200 mg cohorts increased the percentage of patients to approximately 40% with durable HbA1c reduction of 1% or more as compared to the 100 mg cohorts which reported earlier as 20%.
  • As presented at the conference, we have shown for the first time the long-term follow-up data of our 100 mg patient cohorts.
  • By increasing the dose from 100 mg to 200 mg, we are excited about nearly doubling the percentage of patients treated with BMF-219 having a robust HbA1c reduction of 1% or more, 22 weeks after the last dose.
  • Phase II consists of multiple ascending dose (MAD) cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies.

Biomea Fusion to Present Long-Term Follow-Up Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes and Results from Ex-Vivo Human Islet Experiments at the World Congress Insulin Resistance, Diabetes & Cardiovascular Dis

Retrieved on: 
Thursday, December 7, 2023
Phase, C-peptide, Insulin resistance, Poster session, Insulin, Diabetes, Disease, QD, Menin, Glycated hemoglobin, Week, DSM-IV codes, CCNA2, Cancer, Food, PBK, Poster, A1C, Patient, Safety, Gene expression, Pharmaceutical industry

REDWOOD CITY, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (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 the full abstract, titled “BMF-219: A novel therapeutic agent to reestablish functional beta cells and provide long-term glycemic control”, will be presented during the Abstract Oral Presentation Session as well as the Poster Session of the 21st World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) taking place in Los Angeles, California on December 7-9, 2023.

Key Points: 
  • BMF-219 is the first investigational agent to show durable glycemic control during off-treatment period after four weeks of dosing.
  • These data also further support the potential for BMF-219 as a disease modifying agent in type 2 diabetes.
  • Phase II consists of multiple ascending dose cohorts and dose durations and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

Global Menin Inhibitor Drugs Clinical Trials & Future Opportunity Insight 2023: A New Generation of Proteins that have Found Application as a Therapeutic Target in Several Prevalent Diseases - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 21, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, MLL, Marketing, NPM1, Lung cancer, Protein, Indication, Acute lymphoblastic leukemia, MEN1, KMT2A, Research, FDA, EMA, Colorectal cancer, Leukemia, MYC, Diabetes, Menin, Clinical trial, Cancer, Mutation, Pancreatic cancer, Bone marrow, Patient, Acute myeloid leukemia, ALL, Acute leukemia, AML, Osteopathic medicine in Canada, Fast Track, Pharmaceutical industry

The "Global Menin Inhibitor Drugs Clinical Trials & Future Opportunity Insight 2023" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Menin Inhibitor Drugs Clinical Trials & Future Opportunity Insight 2023" report has been added to ResearchAndMarkets.com's offering.
  • Menin represents a new generation of proteins that have found application as a therapeutic target in several prevalent diseases, especially cancer.
  • This has generated the need for development of menin inhibitors that can be used to treat these diseases.
  • Global Menin Inhibitor Drugs Clinical Trials & Future Opportunity Insight 2023 Report Highlights:
    Menin Inhibitors Drugs In Clinical Trials: > 10 Drugs
    Global Menin Inhibitors Drugs Clinical Trials By Company, Indication & Phase
    Menin Inhibitors Clinical Research Innovation Trends By Region: US, Europe & Canada

Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, October 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.

Biomea Fusion Reports Second Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Monday, July 31, 2023
Momentum, CLL, PDAC, KRAS, Insulin, Food, American Diabetes Association, CRC, Diabetes, Investment, Chronic lymphocytic leukemia, ALL, Week, Menin, DLBCL, Multiple myeloma, NPM1, CD135, Bone marrow, OGTT, Type 2 diabetes, Mutation, G&A, NSCLC, B-cell lymphoma, QT interval, NUP98, AML, Hypoglycemia, HIV disease progression rates, Patient, DSM-IV codes, C-peptide, Administration, Cancer, MM, FLT3, CRS, Research and development, Commonwealth Fusion Systems, Research, R, ADA, IND, Disease, Pharmaceutical industry, Silviculture, Fine chemical, Vaccine, Medical imaging, Cryptocurrency, Glycated hemoglobin, Osteopathic medicine in Canada

Our goal at Biomea is to develop a treatment that can halt or reverse disease progression in patients with type 1 and type 2 diabetes.

Key Points: 
  • Our goal at Biomea is to develop a treatment that can halt or reverse disease progression in patients with type 1 and type 2 diabetes.
  • We look forward to continuing to evaluate BMF-219’s proposed mechanism of action and its potential therapeutic impact as this study progresses.
  • BMF-500 is an investigational oral covalent inhibitor of FLT3, designed and developed in-house, and the second investigational compound discovered by Biomea’s FUSION™ System.
  • G&A expenses were $11.4 million for the six months ended June 30, 2023 compared to $9.9 million for the same period in 2022.

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.

Biomea Fusion Reports First Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Tuesday, May 2, 2023
CLL, PDAC, KRAS, Insulin, Food, CRC, Diabetes, Investment, Chronic lymphocytic leukemia, Menin, DLBCL, Multiple myeloma, NPM1, Acute leukemia, CD135, Type 2 diabetes, Mutation, Cancer, NSCLC, Lung cancer, B-cell lymphoma, Acute myeloid leukemia, AML, MLL, Patient, DSM-IV codes, Colorectal cancer, Administration, Education minister, MM, FLT3, Research and development, R, Commonwealth Fusion Systems, Research, Phase, American Diabetes Association, ADA, IND, Safety, Pharmaceutical industry, Medical imaging, Osteopathic medicine in Canada, Glycated hemoglobin

We believe that none of the currently approved therapies for diabetes adequately addresses the beta cell mass and function loss.

Key Points: 
  • We believe that none of the currently approved therapies for diabetes adequately addresses the beta cell mass and function loss.
  • With its intended disease-modifying mechanism of action, BMF-219 could potentially represent a monumental shift for the treatment of patients with diabetes.
  • Reported initial clinical data in March 2023 from the first two cohorts of the Phase II portion of COVALENT-111.
  • Report initial clinical data of AML/ALL patients (including those with MLLr rearrangement and NPM1 mutations) dosed in the COVALENT-101 study in the second quarter of 2023.