BTK

Abbott's Breakthrough Dissolving Stent Receives FDA Approval for Arteries Below the Knee

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星期一, 四月 29, 2024
Stent, FDA, Leg, Education, Physician, Knee, Esprit, TCT, Everolimus, Food, PAD, Survival rate, Breast, Columbia University, Conference, Foot, Disease, Amputation, Oxygen, Standard of care, Artery, Plaque, Peripheral artery disease, BTK, CLTI, Pharmaceutical industry

The Esprit BTK System is designed to keep arteries open and deliver a drug (Everolimus) to support vessel healing prior to completely dissolving.

Key Points: 
  • The Esprit BTK System is designed to keep arteries open and deliver a drug (Everolimus) to support vessel healing prior to completely dissolving.
  • Until today, there were no stents or drug-coated balloons approved for use below the knee in the U.S.
  • The Esprit BTK System is a first-of-its-kind dissolvable stent and is comprised of material similar to dissolving sutures.
  • That's why we're revolutionizing treatments with resorbable scaffold technology below the knee," said Julie Tyler, senior vice president of Abbott's vascular business.

Press Release: Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia

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星期二, 四月 23, 2024
FDA, DSM-IV codes, Prurigo nodularis, Fast track (FDA), Safety, Risk, ITP, Food, Thrombocytopenia, Orphan, Research and development, Development, Patient, Fatigue, Intracranial hemorrhage, LUNA, Asthma, Sanofi, Hematology, BTK, IgG4-related disease

Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia (ITP).

Key Points: 
  • Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia (ITP).
  • The safety profile of rilzabrutinib was consistent with that reported in previous studies.
  • LUNA 3 study met its primary endpoint demonstrating a significantly higher proportion of patients receiving rilzabrutinib achieved the primary endpoint of durable platelet response versus placebo.
  • This clinically and statistically significant result was achieved in a population of patients with primary ITP that had been refractory to prior therapy.

Nurix Therapeutics Reports First Quarter Fiscal 2024 Financial Results and Provides a Corporate Update

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星期三, 四月 10, 2024
Mantle cell lymphoma, MCL, FDA, Cancer, Inflammation, DLBCL, Paclitaxel, Gilead Sciences, Research, PCNSL, Partnership, B-cell lymphoma, Trial of the century, STAT6, IND, CNS, Lymphoma, Patient, Rheumatoid arthritis, NHL, Chronic lymphocytic leukemia, Central nervous system, AACR, Neoplasm, Clinical trial, Annual general meeting, Therapy, Sanofi, Lymphoid leukemia, Non-Hodgkin lymphoma, Calendar, SAN, BTK, Pharmaceutical industry

SAN FRANCISCO, April 10, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today reported financial results for the first quarter ended February 29, 2024, and provided a corporate update.

Key Points: 
  • SAN FRANCISCO, April 10, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today reported financial results for the first quarter ended February 29, 2024, and provided a corporate update.
  • Nurix and Sanofi extended their ongoing research program for STAT6 (signal transducer and activator of transcription 6).
  • Nurix retains its option to co-develop and co-promote future products in the United States under programs for which Nurix has exercised its option.
  • Nurix presented new clinical data for NX-5948 at the American Association for Cancer Research (AACR) 2024 Annual Meeting.

BeiGene Demonstrates Global Progress in 2023 Responsible Business & Sustainability Report

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星期五, 四月 26, 2024
Environmental, Social and Governance (ESG), Green Technology, Climate Change, Sustainability, Pharmaceutical, Business, Oncology, Professional Services, General Health, Environment, Science, Biotechnology, Other Science, Health, Research, Responsibility, Cancer, Health equity, Woman, BGNE, Entrepreneurship, Patient, Global Health, Chronic lymphocytic leukemia, Tislelizumab, Carbon accounting, BTK

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, released its 2023 Responsible Business & Sustainability Report highlighting the Company’s strategy, the progress it has made towards existing goals, and how it intends to achieve its bold new targets.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, released its 2023 Responsible Business & Sustainability Report highlighting the Company’s strategy, the progress it has made towards existing goals, and how it intends to achieve its bold new targets.
  • BeiGene’s Responsible Business & Sustainability Report highlights key achievements from 2023, including:
    Improved the percentage of women holding positions of Vice President and higher from 33% to 38% year over year.
  • “We are proud of the progress we’ve made on our priority areas in just a few short years,” said Christine Riley Miller, Global Head of Responsible Business & Sustainability at BeiGene.
  • We look forward to continuing our journey.”
    For more information about BeiGene’s Responsible Business & Sustainability strategy, achievements, and goals, please download a copy of the report here .

Prelude Highlights Continued Strength of Discovery Engine at 2024 AACR Annual Meeting

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星期二, 四月 9, 2024
Breast cancer, SMARCA4, MCL, Generation, Prelude, CDK2, CLL, NSCLC, Patient, SMARCA2, Selective estrogen receptor degrader, BCL2, Cancer, AACR, CRC, BTK, CDK9, DLBCL, Pharmaceutical industry

WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.

Key Points: 
  • Highly selective oral SMARCA2 degrader, PRT7732, shows robust anti-tumor activity in vivo as monotherapy and in combination with chemotherapy, at well-tolerated doses
    Next Generation CDK4/6 Inhibitor, PRT3645, is highly effective in combination with other targeted therapies in preclinical models of breast cancer, CRC and NSCLC
    WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.
  • “These presentations demonstrate our core competencies in medicinal chemistry and cancer biology to optimize and deliver compounds to the clinic with the potential to succeed as differentiated first- and/or best-in-class new therapies,” said Andrew Combs, Ph.D., Chief Chemistry Officer at Prelude Therapeutics.
  • Peggy Scherle, Ph.D., Chief Scientific Officer at Prelude, stated, “Advancement of our second highly selective SMARCA2 degrader strengthens Prelude’s leadership position in the emerging use of SMARCA2 protein degradation as a potential treatment option for underserved patients with cancer.
  • With both a first-in-class IV SMARCA2 degrader, PRT3789, in Phase 1 clinical development and now our oral SMARCA2 degrader, PRT7732, expected to enter the clinic later this year, we believe these distinct modalities may offer new therapies for patients with SMARCA4 mutations.”
    Details on the poster presentations are as follows:
    Identified potent, selective, well-tolerated and orally bioavailable SMARCA2 degrader, PRT7732
    PRT7732 exhibits >3000-fold selectivity for SMARCA2 over SMARCA4, with low nanomolar potency in cell based assays
    Title: PRT2527, a Novel Highly Selective Cyclin-Dependent Kinase 9 (CDK9) Inhibitor, Has Potent Antitumor Activity in Combination with BTK and BCL2 Inhibition in Various Lymphoid Malignancies
    PRT2527 is efficacious as monotherapy in preclinical models of DLBCL, CLL and MCL, and combines with both BTK and BCL2 inhibition to improve depth and duration of responses
    Title: The Brain Penetrant CDK4/6 Inhibitor, PRT3645, is Highly Effective in Combination with Other Targeted Therapies in Preclinical Models of Breast Cancer, CRC and NSCLC
    Next generation CDK4/6 inhibitor, PRT3645, demonstrates preclinical synergy with SERDs, as well as MEK1/2 and CDK2 inhibition

Nurix Therapeutics Reports First Clinical Evidence of CNS Activity of NX-5948, a Brain-Penetrant, Orally Available, BTK Degrader in Development for B Cell Malignancies

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星期二, 四月 9, 2024
Histology, Brain, Rituximab, Chronic lymphocytic leukemia, CLL, Lymphoma, Disease, CSF, Central nervous system, SAN, CNS, Patient, PCNSL, BCL2, Cancer, Leukemia, Inflammation, Cerebrospinal fluid, NHL, Lymph, AACR, Proteolysis targeting chimera, Neoplasm, Therapy, MYC, BTK, Myenteric plexus, Lymphoid leukemia, Spleen, Medical imaging

SAN FRANCISCO, April 09, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of the first findings of clinical responses in the brain for NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses. The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement. These data were presented by Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, as part of the Major Symposium session Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances at the AACR 2024 Annual Meeting, which is being held from April 5-10, 2024, in San Diego, CA.

Key Points: 
  • The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses.
  • The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement.
  • “These data are the first demonstration of clinical activity in the brain of a targeted protein degrader, opening the door for new therapeutic strategies to treat leukemias and lymphomas with CNS involvement,” said Dr. Hansen.
  • “The CLL patient with CNS involvement showed an impressive durable response with NX-5948 as single agent therapy in this setting.

Nurix Therapeutics Announces Extension of Strategic Collaboration with Sanofi to Develop Novel Targeted Protein Degraders of STAT6

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星期二, 四月 9, 2024
Autoimmunity, Inflammation, Patient, SAN, STAT6, Cancer, Therapy, IRAK4, BTK

SAN FRANCISCO, April 09, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, announced today an extension of the ongoing research program with Sanofi for STAT6 (signal transducer and activator of transcription 6). STAT6 is a key drug target in type 2 inflammation.

Key Points: 
  • “STAT6 is a key transcription factor within the IL-4/IL-13 signaling pathways which act as drivers of inflammation in allergic conditions.
  • “Preclinical data from our STAT6 degraders show that targeted degradation of this key transcription factor provides a rapidly acting and potent blockade of signaling.
  • “We are very excited to pursue our collaboration with Sanofi, as it further demonstrates the productivity of our long-standing research program to develop a pipeline of breakthrough degraders to treat inflammation and autoimmunity.
  • Nurix’s disclosed pipeline in inflammation and autoimmunity now includes the STAT6 degrader with Sanofi, the IRAK4 degrader with Gilead, and Nurix’s proprietary BTK degrader, NX-5948.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

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星期四, 三月 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

InnoCare Releases 2023 Results and Business Highlights

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星期四, 三月 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, QD, Tafasitamab, Patient, B-cell lymphoma, NDA, SLE, POC, IND, Clinical trial, Bone marrow, IKZF1, Phase, Therapy, IGA, MCD, Dexamethasone, MCL, Neuromyelitis optica spectrum disorder, IKZF3, AML, NMOSD, Outline of health sciences, DLT, Cancer, Autoimmune disease, Safety, TYK2, HSA, NRDL, BLA, Follicular lymphoma, Food, GC, Development, Multiple sclerosis, PD, CRBN, Public, Gordon Ramsay's Bank Balance, Multiple myeloma, ITP, BCL2, Leukemia, Cmax, Gadolinium, HKEX, SRI, AAD, Proteinuria, DLBCL, Glucocorticoid, IVIG, Loss, European Hematology Association, American Academy, EHA, Lenalidomide, NHL, Non-Hodgkin lymphoma, CCR8, US FDA, BTK, NRS, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease

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星期四, 三月 21, 2024
Medical Devices, Hospitals, Clinical Trials, Cardiology, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Elixir, Peripheral artery disease, CLTI, Medicine, Risk, Patient, PAD, Mortality, Motion, Life, BTK, Amputation, Marketing, FDA, Circulant matrix, Food, Pharmaceutical industry

The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions.

Key Points: 
  • The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions.
  • "The Bioadaptor platform was developed to transform treatment of coronary and peripheral artery disease,” said Motasim Sirhan, CEO at Elixir Medical.
  • “We appreciate the FDA recognition of our innovation for treating the CLTI population with BTK disease and its potential impact on the patients suffering from vascular disease.”
    The FDA Breakthrough Device Designation accelerates the review process for novel technologies designed to address an unmet medical need.
  • Devices that receive breakthrough designation must meet rigorous standards for device safety and effectiveness in order to be authorized for marketing.