MEN1

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.

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

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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

Kura Oncology Presents Late-Breaking Clinical Data for Menin Inhibitor Ziftomenib at 2023 European Hematology Association (EHA) Congress

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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 To Present Two Preclinical Posters at the 114th AACR Annual Meeting

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Thursday, April 13, 2023
CLL, NRAS, KRAS, MYC, AACR, Molecule, TP53, Chronic lymphocytic leukemia, Menin, ITD, Acute leukemia, American Association for Cancer Research, MEK, Doctor of Philosophy, BTK, Gene expression profiling, MEN1, NOTCH1, AML, BCL2, Patient, DSM-IV codes, Proteasome inhibitor, Cancer, Acute myeloid leukemia, Growth, Leukemia, Therapy, Gene, Disease, Pharmaceutical industry, Vaccine, Biology, FLT3

Biomea’s preclinical posters will be made available at https://biomeafusion.com/publications/ following presentation at the meeting.

Key Points: 
  • Biomea’s preclinical posters will be made available at https://biomeafusion.com/publications/ following presentation at the meeting.
  • Menin is an epigenetic protein that drives oncogenic function through transcriptional regulation directed by its interactions with various protein partners.
  • Additionally, we show benefit of combinatorial approaches of menin and FLT3 covalent inhibitors with MEK and BCL2 blockade.
  • These data provide initial pre-clinical evidence for combining pathway specific inhibitors as a promising therapeutic strategy for further investigation in acute leukemia.

Biomea Fusion Releases Pre-Clinical Data with BMF-219 in Diabetes

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Thursday, January 6, 2022
Type 2 diabetes, Harvard Medical School, STZ, Degenerative disease, Securities Act of 1933, Doctor of Philosophy, Hyperglycemia, Natural history, Patient, Cancer, Research, IND, Insulin, Securities Exchange Act of 1934, Pancreas, Diabetes, Microdeletion syndrome, Lists of diseases, ZDF, CEO, SEC, GLOBE, Literature, Regeneration, Risk, Nasdaq, Animal, MEN1, Pharmaceutical industry, Osteopathic medicine in Canada

Loss of functional Beta-cell mass is a core component of the natural history in both types of diabetes type 1 diabetes (mediated by autoimmune dysfunction) and type 2 diabetes (mediated by metabolic dysfunction).

Key Points: 
  • Loss of functional Beta-cell mass is a core component of the natural history in both types of diabetes type 1 diabetes (mediated by autoimmune dysfunction) and type 2 diabetes (mediated by metabolic dysfunction).
  • In patients with diabetes, Beta-cell mass and function are diminished, leading to insufficient insulin secretion and hyperglycemia.
  • Together, Biomea believes these results indicate the clinical potential for a novel menin inhibitor as a ground-breaking treatment for type 2 diabetes.
  • Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Biomea Fusion to Participate in Two Upcoming Investor Conferences

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Wednesday, November 10, 2021
Cancer, Acute leukemia, News, NPM1, Mutation, Leukemia, Board, Preclinical development, GLOBE, MEN1, Jefferies, Nasdaq, Patient, Mixed-phenotype acute leukemia, Lymphoma, Pharmaceutical industry

Biomea Fusion will participate in 1x1 investor meetings during the conferences hosted by Jefferies and Piper Sandler, respectively.

Key Points: 
  • Biomea Fusion will participate in 1x1 investor meetings during the conferences hosted by Jefferies and Piper Sandler, respectively.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers.
  • The company is utilizing its proprietary FUSION discovery platform to advance a pipeline of irreversible treatments against key oncogenic drivers of cancer.
  • Biomea Fusions goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the clinical benefit when treating various cancers.

Biomea Fusion Publishes Abstract on BMF-219 at ASH Annual Meeting

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Thursday, November 4, 2021
Molecule, Society, Safety, AML, TFS, Data, Cancer, Private Securities Litigation Reform Act, Acute leukemia, JUND, Lymph, Immortalised cell line, Factor X, TF, Gene, KMT2A, American Society of Hematology, DHL, Diffusion, DEL, GEO, NPM1, Mutation, BCL2, COVID-19, Leukemia, Menin, Forward-looking statement, Gene expression, Program, Protein, Preclinical development, IC50, Company, GLOBE, U.S. Securities and Exchange Commission, Non-Hodgkin lymphoma, MEN1, MYC, Lymphocyte, Survival, Nasdaq, Patient, MAX, Mixed-phenotype acute leukemia, IND, Vaccine, Pharmaceutical industry, Fine chemical

These results strongly point toward altered MYC-activity mediated by BMF-219 in leukemia cells, prompting additional exploration in MYC-dependent lymphoid malignancies.

Key Points: 
  • These results strongly point toward altered MYC-activity mediated by BMF-219 in leukemia cells, prompting additional exploration in MYC-dependent lymphoid malignancies.
  • TFs with more than one bar represent multiple study sets in GEO that overlap with BMF-219 mediated differentially expressed genes.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers.
  • The company is utilizing its proprietary FUSION discovery platform to advance a pipeline of irreversible treatments against key oncogenic drivers of cancer.

Biomea Fusion Reports Third Quarter 2021 Financial Results and Business Highlights

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Wednesday, November 3, 2021
Safety, MLL, Cancer, DLBCL, Mutation, Chemistry, Mixed-phenotype acute leukemia, IPO, Acute leukemia, Blood, Leukemia, Patient, Private Securities Litigation Reform Act, FDA, Preclinical development, Menin, Lymph, U.S. Securities and Exchange Commission, Adult, Forward-looking statement, Company, Investment, Spleen, Yissum Research Development Company of the Hebrew University, Board, MM, COVID-19, MEN1, IND, Diabetes, Bone marrow, Program, Nasdaq, AML, Research, Death, Multiple myeloma, R, Therapy, GLOBE, Central nervous system, NPM1, Osteopathic medicine in Canada, Pharmaceutical industry, Vaccine, Fine chemical

The Third Quarter was a historic one for the company as it advanced its first investigational drug into a clinical stage program.

Key Points: 
  • The Third Quarter was a historic one for the company as it advanced its first investigational drug into a clinical stage program.
  • We now have our first molecule ready for the clinic, and a number of exciting programs advancing through pre-clinical development.
  • Biomea is conducting preclinical studies to demonstrate the potential for BMF-219 in genetically defined patient subsets of DLBCL and MM.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers.

Biomea Fusion Announces FDA Clearance of Investigational New Drug Application for Irreversible Menin Inhibitor BMF-219

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Thursday, September 16, 2021
Form, FIH, U.S. Securities and Exchange Commission, Preclinical development, Cancer, Phase 1, Food, Lymph, Security (finance), Spleen, Menin, Mutation, Osteopathic medicine in Canada, Central nervous system, Board, FDA, Institutional review board, PD, AML, Forward-looking statement, Leukemia, Consultant, TEAM, Mixed-phenotype acute leukemia, Patient, Contract research organization, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Company, Private Securities Litigation Reform Act, Blood, Nasdaq, Clinical trial, Acute leukemia, Disease, Adult, Safety, MEN1, Growth, Investigational New Drug, NPM1, COVID-19, Contract, MLL, Death, GLOBE, Time, Bone marrow, Pharmaceutical industry, Fine chemical

Food and Drug Administration(FDA) has cleared the company's Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.

Key Points: 
  • Food and Drug Administration(FDA) has cleared the company's Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.
  • This is just the beginning for BMF-219 as we are planning to pursue multiple indications with our novel molecule.
  • This is also just the beginning for the company, as we continue to make significant progress with our pipeline programs.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically defined cancers.