Mum

Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

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火曜日, 8月 15, 2023
Neutropenia, Exercise, REMS, Genotype, US Foods, Radiation, EAP, Private investment in public equity, Liver disease, HLA, Mitigation, PIPE, DCR, RECIST, Delcath Systems, Uveal melanoma, National Comprehensive Cancer Network, Toxicity, Mum, Aplastic anemia, Vaccine, Lung, NCCN, HDS, PHP, Incidence, Overseas Private Investment Corporation, Bleeding, Dor, Patient, Lymph, Microsoft Access, Anemia, Liver, FDA, Melphalan, Liver failure, Death, Thrombocytopenia, ORR, Food, Medical imaging, Dietary supplement, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Key Points: 
  • mUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year.
  • National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases.
  • HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is already included in the NCCN guidelines.
  • "FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company's commitment to bring this treatment option to patients suffering from metastatic uveal melanoma," said Gerard Michel, Delcath's Chief Executive Officer.

Foghorn Therapeutics Provides Second Quarter 2023 Financial and Corporate Update

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金曜日, 8月 4, 2023
ARID1B, Therapy, CBP, Selective, CDX, Chromatin, Clinical trial, BRM, Uveal melanoma, BRG1, Mum, Gene expression, NSCLC, EP300, Preclinical development, PDX, Science, MDS, State Administrative Expenses, AML, Merck & Co., BAF, Lilly, Patient, Investment, LDAC, Biology, Research, IND, Factorization of polynomials, Safety, Prostate cancer, Pharmaceutical industry, Vaccine, Decitabine, Foghorn

CAMBRIDGE, Mass., Aug. 04, 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 financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended June 30, 2023. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

Key Points: 
  • “Foghorn made important progress across both our clinical and preclinical pipeline in the second quarter.
  • We are on track to initiate dosing in a combination study of FHD-286 in AML in the third quarter.
  • On June 28, 2023, Foghorn announced data from the Phase 1 dose escalation safety study of FHD-286 in metastatic uveal melanoma (mUM).
  • As of June 30, 2023, the Company had $284.3 million in cash, cash equivalents and marketable securities, which provides a cash runway into the second half of 2025.

Foghorn Therapeutics Announces Clinical Data from Phase 1 Study of FHD-286 in Metastatic Uveal Melanoma

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水曜日, 6月 28, 2023
DNA, Circulating tumor DNA, CBP, Xerostomia, Foghorn, ALP, Uveal melanoma, Mum, Gene expression, EP300, Rash, AML, Weakness, Patient, Hypokalemia, Anemia, Neoplasm, AST, Tumor microenvironment, Clinical, Safety, Fatigue, Pharmaceutical industry, Decitabine, Dysgeusia

At this time, the company does not plan to advance FHD-286 in uveal melanoma.

Key Points: 
  • At this time, the company does not plan to advance FHD-286 in uveal melanoma.
  • “The clinical data further support the safety and tolerability of FHD-286 and build on the previously disclosed AML/MDS data.
  • In the study, nine patients had stable disease and one patient had a durable partial response,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn.
  • Clinical data seen in the Phase 1 dose escalation study reinforced the safety and tolerability profile of FHD-286.

Immunocore Reports First Quarter 2023 Financial Results and Provides Business Update

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水曜日, 5月 10, 2023
Gastrointestinal cancer, PRAME, Patient, Ipilimumab, Commercial, IMC, Uveal melanoma, Infection, Research, MAD, Conference, Book, Safety, Abstract, DNA, AACR, HLA, Cancer, Record, BRAF, Medicine, Immunotherapy, TCR, CROI, James A. Schlipmann Melanoma Cancer Foundation, PIWIL1, Neoplasm, ImmTAC, Arm, HIV, OS, CTA, Fungal infection, Mum, Sale, ASCO, CTAS, American Society of Clinical Oncology, Melanoma, Annual general meeting, IND Queens Boulevard Line, Viral load, Society, Pharmaceutical industry, Cryptocurrency, Communications satellite, Immunocore, IL6

During the first quarter of 2023, KIMMTRAK became the most prescribed medicine for HLA*02:01 positive patients with mUM with over half of patients in first line (1L) receiving KIMMTRAK.

Key Points: 
  • During the first quarter of 2023, KIMMTRAK became the most prescribed medicine for HLA*02:01 positive patients with mUM with over half of patients in first line (1L) receiving KIMMTRAK.
  • In France and Germany, an estimated 80% and 70%, respectively, of first line HLA-A*02:01 positive patients with mUM treated in the first quarter received KIMMTRAK.
  • The Company launched KIMMTRAK in Austria and Israel in the first quarter and expects the commercial transition in Italy in the second quarter of this year.
  • The Company believes IMC-R117C is the first PIWIL1 targeted immunotherapy and plans to submit an IND / CTA in the fourth quarter of 2023.

Foghorn Therapeutics Provides First Quarter 2023 Financial and Corporate Update

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月曜日, 5月 8, 2023
Synovial sarcoma, ARID1B, Therapy, CBP, Selective, Chromatin, BRM, Uveal melanoma, BRG1, Mum, Gene expression, NSCLC, Lung cancer, EP300, Science, MDS, State Administrative Expenses, AML, Merck & Co., BAF, Lilly, Patient, Investment, Data, Biology, Research, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Conference, Factorization of polynomials, Food, Prostate cancer, Pharmaceutical industry, Cryptocurrency, Foghorn

Top-line Phase 1 safety and efficacy data is expected in the second quarter of 2023.

Key Points: 
  • Top-line Phase 1 safety and efficacy data is expected in the second quarter of 2023.
  • The Company anticipates providing a regulatory update for FHD-286 in AML/MDS in the second quarter of 2023.
  • On April 24, 2023, Foghorn provided an update on the FHD-609 Phase 1 program in synovial sarcoma and SMARCB1-deleted tumors.
  • In 2023, Foghorn will continue to utilize its Gene Traffic Control platform to discover and develop novel therapeutics under the collaboration based on disruptors of a specified transcription factor target.

Immunocore presents new KIMMTRAK data confirming association between early ctDNA reduction and longer overall survival

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火曜日, 4月 18, 2023
DNA, AACR, PD, Neoplasm, Orbit, Survival, RECIST, OS, Cancer, Uveal melanoma, Infection, Mum, TCR, Development, Patient, Circulating tumor DNA, Safety, Pharmaceutical industry, Mobile phone, Research

“KIMMTRAK is now approved in over 30 countries and delivering benefit to hundreds of patients.

Key Points: 
  • “KIMMTRAK is now approved in over 30 countries and delivering benefit to hundreds of patients.
  • The Phase 3 trial data presented at AACR confirms that ctDNA reduction from tebentafusp is strongly associated with survival benefit,” said David Berman, Head of Research and Development of Immunocore.
  • ctDNA clearance in the Phase 3 trial was associated with 84% 1-year OS.
  • The fourth poster shares in vitro data potentially explaining how tebentafusp may lead to OS benefit even in tumors with heterogenous gp100 expression.

Foghorn Therapeutics Provides 2023 Outlook and Full Year 2022 Corporate Update

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木曜日, 3月 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.

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

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月曜日, 1月 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.

Immunocore presents ovarian cancer expansion data for ImmTAC® candidate IMC-C103C targeting MAGE-A4

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木曜日, 12月 8, 2022
ESMO, Platinum, Immunohistochemistry, Annual report, Security (finance), SD, Ovarian cancer, Neoplasm, Autoimmune disease, Poster, AE, Safety, Congress, Cancer, Death, RECIST, OS, PARP, Genentech, Infection, Partial-response maximum-likelihood, Hoffmann-La Roche, Risk, Survival, TCR, Autoimmunity, IHC, United Kingdom, COVID-19, Patient, Development, Pharmaceutical industry, Vaccine, Research, Immunocore, Mum

The Phase 1 data, presented in a poster at the ESMO Immuno-Oncology 2022 Congress, include 33 heavily pre-treated patients with ovarian cancer, who received doses of ≥ 90 mcg intravenously.

Key Points: 
  • The Phase 1 data, presented in a poster at the ESMO Immuno-Oncology 2022 Congress, include 33 heavily pre-treated patients with ovarian cancer, who received doses of ≥ 90 mcg intravenously.
  • This includes 16 new patients, and 17 patients previously reported at the ESMO Immuno-Oncology 2021 Congress, now with longer follow-up.
  • All patients had platinum relapsed/refractory ovarian cancer (70% PARP inhibitors experienced) and were enrolled regardless of MAGE-A4 protein expression, which was analyzed retrospectively.
  • Of the 33 patients, 39% (13/33) were MAGE-A4 negative as measured by immunohistochemistry (IHC), and 2 patients had an unknown H score.

Immunocore to present at the 5th Annual Evercore ISI HealthCONx Conference

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水曜日, 11月 23, 2022
Autoimmune disease, Autoimmunity, Infection, United Kingdom, Conference, Patient, Cancer, TCR, Survival, Vaccine, Mum, Immunocore

& ROCKVILLE, Md., US, 23 November 2022) Immunocore Holdings Plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announced that management will participate in a fireside chat at the 5th Annual Evercore ISI HealthCONx Conference.

Key Points: 
  • & ROCKVILLE, Md., US, 23 November 2022) Immunocore Holdings Plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announced that management will participate in a fireside chat at the 5th Annual Evercore ISI HealthCONx Conference.
  • The presentation is scheduled for Wednesday, November 30, 2022, at 8:25 a.m. Eastern Time (ET).
  • The presentation will be webcast live during the conference and will be available in the Investors section of Immunocores website at www.immunocore.com.
  • A replay of the presentation will be made available for a limited time.