AML


Associated tags: Acute myeloid leukemia, Bone marrow, AML, Acute leukemia, Blood, Pharmaceutical industry, Patient, Gene expression, MDS, Safety, Cancer, Therapy, Foghorn, Chromatin, BRM

Locations: UNITED STATES, TEXAS

Foghorn Therapeutics to Present Preclinical Data from Its Selective CBP and EP300 Protein Degrader Programs and Preclinical Data for FHD-286, a Potent, Selective Inhibitor of BRG1 and BRM, at the 2023 American Association for Cancer Research Annual Meetin

Retrieved on: 
Monday, April 10, 2023
AACR, Selective, CBP, Foghorn, Chromatin, Skin, BRM, Uveal melanoma, Breast, BRG1, Gene expression, NSCLC, Prostate, Lung cancer, EP300, Lung, MDS, Malignancy, AML, Discovery, BAF, Lymphoma, Leukemia, Therapy, MD Anderson Cancer Center, Biology, Pharmaceutical industry, Glass fiber, Management, Science

Also at AACR, the company will provide an overview of its Selective EP300 and Selective CBP degrader programs.

Key Points: 
  • Also at AACR, the company will provide an overview of its Selective EP300 and Selective CBP degrader programs.
  • The EP300 program targets CBP mutant cancers and subsets of EP300 dependent malignancies, which include bladder, NSCLC, and various leukemias and lymphomas.
  • The CBP program is focused on a wide number of EP300 mutant cancers, including prostate, bladder, colorectal, breast, gastric, and lung.
  • If successful, the Selective EP300 and Selective CBP programs have the potential to address significant unmet medical need in large patient populations.

Foghorn Therapeutics Provides 2023 Outlook and Full Year 2022 Corporate Update

Retrieved on: 
Thursday, March 9, 2023
Fred Hutchinson Cancer Research Center, Survival, Mutation, Merck, Research, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Malignancy, Prostate cancer, Food, Senior, ARID1A, Drug discovery, Therapy, Breast, BAF, EP300, Selective, IND, Acute leukemia, Myelodysplastic syndrome, Chromatin, Lung cancer, BRM, CREB, Mum, Gene expression, Lymphoma, CBP, Investment, Development, ARID1B, Ionis Pharmaceuticals, Synovial sarcoma, BRG1, Cancer, NSCLC, AML, Trial of the century, MDS, Uveal melanoma, Collaboration, Patient, State Administrative Expenses, Lilly, BRD9, Lung, Leukemia, Factorization of polynomials, Safety, Pharmaceutical industry, Vaccine, Cryptocurrency, Foghorn

CAMBRIDGE, Mass., March 09, 2023 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, today provided a corporate update including the Company’s 2023 strategic priorities and 2022 key achievements in conjunction with its 10-K filing for the year ending December 31, 2022. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline has the potential to transform the lives of people suffering from a wide spectrum of diseases.

Key Points: 
  • “2022 was a productive year for Foghorn as we made significant progress advancing our robust preclinical and clinical pipeline,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn.
  • In 2023, Foghorn will continue to leverage its Gene Traffic Control platform to discover and develop novel therapeutics based on disruptors of an undisclosed transcription factor target.
  • In 2022, Foghorn announced Steven Bellon, Ph.D., former Senior Vice President of Drug Discovery, was promoted to Chief Scientific Officer.
  • During 2022, Foghorn announced the election of B. Lynne Parshall, Esq., and Thomas J. Lynch Jr., M.D., to its Board of Directors.

First AML Patient Transplanted with Vor Bio’s Trem-cel Demonstrated Durable Engraftment through Multiple Mylotarg™ Cycles at Initial Dose Level

Retrieved on: 
Thursday, February 16, 2023
AML, AUC, CD33, Cmax, Transplant, Aes, Haematopoiesis, Passive treatment system, MRD, Bone marrow, Patient, AE, Vomiting, Memorial Sloan Kettering Cancer Center, Acute promyelocytic leukemia, Acute myeloid leukemia, Learning, IND, MD, Pharmaceutical industry, Gemtuzumab ozogamicin

In the first patient, trem-cel maintained hematopoiesis through three cycles of Mylotarg (gemtuzumab ozogamicin), which was well-tolerated at the initial dose level of 0.5 mg/m2.

Key Points: 
  • In the first patient, trem-cel maintained hematopoiesis through three cycles of Mylotarg (gemtuzumab ozogamicin), which was well-tolerated at the initial dose level of 0.5 mg/m2.
  • A second patient has successfully received a trem-cel transplant and engrafted normally.
  • “We are also encouraged that a second patient successfully received a trem-cel transplant and look forward to learning more as we treat additional patients and dose escalate Mylotarg.
  • The company is moving forward with dose escalation of Mylotarg per the 3+3 dose escalation schema in the protocol.

Foghorn Therapeutics Highlights Recent Clinical and Research Progress and Provides Strategic Objectives for 2023

Retrieved on: 
Monday, January 9, 2023
Synovial sarcoma, MDS, Gene expression, Myelodysplastic syndrome, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lilly, Cancer, Merck, AML, Trial of the century, Safety, Precision medicine, FDA, CBP, BRM, Postcholecystectomy syndrome, Biology, Factor X, Food, ARID1B, Therapy, Mum, Patient, Observation, BRD9, Retinoic acid syndrome, Chromatin, Pharmaceutical industry, Vaccine, Cryptocurrency, Foghorn, Grand Street station (IND Sixth Avenue Line)

Mr. Gottschalk continued, “Foghorn is a leader in targeting chromatin biology, which has unique potential to address underlying dependencies of many genetically defined cancers.

Key Points: 
  • Mr. Gottschalk continued, “Foghorn is a leader in targeting chromatin biology, which has unique potential to address underlying dependencies of many genetically defined cancers.
  • Over the next four years, we anticipate the filing of at least six new INDs, reflecting the productivity of our precision medicine platform.
  • Initial Phase 1 clinical data is expected in the first half of 2023.
  • The Company anticipates providing clarity on the development path for FHD-286 in AML/MDS in the first half of 2023.

Rigel Announces Availability of REZLIDHIA™ (olutasidenib) in the U.S. for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation

Retrieved on: 
Thursday, December 22, 2022

REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Key Points: 
  • REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
  • If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.
  • Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA.
  • Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity.

First AML Patient Successfully Transplanted with Vor Bio’s Investigational Trem-cel (VOR33) and Tolerated Mylotarg™

Retrieved on: 
Wednesday, December 7, 2022
Gemtuzumab ozogamicin, Cell, HCT, Clinical trial, Leukemia, MTD, Incidence, HLA, Security (finance), Lymphatic system, Webcast, Safety, Stem cell, Engineering, Cancer, CD33, AML1, Acute leukemia, Blood, Cytopenia, AML, Neutropenia, Acute myeloid leukemia, HSPC, Transplant, Toxicity, University Hospitals Cleveland Medical Center, CRISPR, Index (publishing), ANC, Standard of care, Conference call, Patient, Pharmaceutical industry, Conference, Medicine

“These encouraging data represent the first clinical validation of our platform to potentially enable next-generation transplants for patients with blood cancers.

Key Points: 
  • “These encouraging data represent the first clinical validation of our platform to potentially enable next-generation transplants for patients with blood cancers.
  • The patient achieved neutrophil engraftment 10 days post-transplant which was within expectations for CD34-enriched transplants.
  • Transplant with trem-cel is designed to replace standard of care transplants for patients suffering from AML and potentially other blood cancers.
  • The interim data presented in this press release is based on one patient and future results for this patient or additional patients may not produce the same or consistent results.

Foghorn Therapeutics Announces New Preclinical Data for FHD-286 in AML to Be Presented at the American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 5, 2022
Foghorn, BRG1, Cell, ClinicalTrials.gov, Protein, Leukemia, SMARCA4, ATPase, Security (finance), MDS, Poster, Cancer, Bone marrow, Choroid, Gene expression, Acute leukemia, ASH, Pharmacology, BAF, BRM, Iris, AML, Ciliary body, SMARCA2, Acute myeloid leukemia, Drug resistance, Research, Society, Chromatin, Therapy, Blood, Patient, MD Anderson Cancer Center, Pharmaceutical industry, Dietary supplement, Science

Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III

Key Points: 
  • Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III
    The poster will be accessible following the presentation under the Science section of the Company’s website.
  • In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors.
  • Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system.
  • Any forward-looking statement made in this press release speaks only as of the date on which it is made.

Rigel Announces U.S. FDA Approval of REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation

Retrieved on: 
Thursday, December 1, 2022

SOUTH SAN FRANCISCO, Calif., Dec. 1, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the U.S. Food and Drug Administration (FDA) has approved REZLIDHIA™ (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. REZLIDHIA is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.

Key Points: 
  • Differentiation syndrome was observed in 16% of patients and was manageable in most cases with dose interruption and corticosteroids.
  • Hepatotoxicity, presenting as increases in liver function parameters, occurred in 23% of patients and most cases were manageable with dose modifications.
  • "REZLIDHIA provides a new and important, oral therapy option for patients who typically have a poor clinical outcome.
  • REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Foghorn Therapeutics to Present New Preclinical Data for BRG1/BRM Inhibitor FHD-286 in Combination with Anti-PD-1 Antibody at Society for Immunotherapy of Cancer 37th Annual Meeting

Retrieved on: 
Wednesday, November 9, 2022
GLOBE, Choroid, Forward-looking statement, Protein, Convention center, Foghorn, Ciliary body, U.S. Securities and Exchange Commission, Annual general meeting, Nasdaq, Immunotherapy, Research, Myelodysplastic syndrome, Cancer, Acute leukemia, Acute myeloid leukemia, Boston Convention and Exhibition Center, Bone marrow, SMARCA4, Therapy, Gene expression, ClinicalTrials.gov, Survival, Chromatin, Blood, BRG1, BAF, AML, Poster, Cell, Patient, MDS, BRM, Iris, SMARCA2, Security (finance), ATPase, Society, Adult, SITC, Pharmaceutical industry, Dietary supplement, Science

The meeting will be held November 812, 2022, at the Boston Convention and Exhibition Center and virtually.

Key Points: 
  • The meeting will be held November 812, 2022, at the Boston Convention and Exhibition Center and virtually.
  • The poster will highlight new data demonstrating the potential of FHD-286, in combination with an anti-PD-1 antibody, to provide synergistic efficacy and survival benefit compared to anti-PD-1 alone in preclinical models.
  • In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors.
  • Any forward-looking statement made in this press release speaks only as of the date on which it is made.

Foghorn Therapeutics Provides Third Quarter 2022 Financial and Corporate Update

Retrieved on: 
Tuesday, November 8, 2022

CAMBRIDGE, Mass., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, today provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended September 30, 2022. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline has the potential to transform the lives of people with a wide spectrum of diseases.

Key Points: 
  • In July 2022, a research milestone was achieved under the Merck collaboration triggering a $5 million milestone payment to Foghorn, which was reflected in the financial statements for the quarter endedSeptember 30, 2022.
  • Collaboration Revenues.Collaboration revenues were $6.6 million for the third quarter of 2022 compared to $0.1 million for the third quarter of 2021.
  • Research and Development Expenses.Research and development expenses were $26.9 million for the third quarter of 2022 compared to $20.5 million for the third quarter of 2021.
  • General and Administrative Expenses.General and administrative expenses were $8.0 million for the third quarter of 2022, compared to $5.8 million for the third quarter of 2021.