KITE

U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta® Showing Prophylactic Steriod Use Improves Management of Cytokine Release Syndrome

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월요일, 1월 31, 2022
Oncology, Health, FDA, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology

Yescarta is now the first and only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects.

Key Points: 
  • Yescarta is now the first and only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects.
  • Cohort 6 builds on this growing knowledge regarding how to manage and minimize side effects gained over many years of developing Yescarta.
  • The Yescarta label update may help physicians manage potential complications and determine appropriate setting for care of their patients.
  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta.

Kyverna Therapeutics Closes $85 Million Series B Financing led by Northpond Ventures

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수요일, 1월 26, 2022
Argentum, Insight Partners, RTW, Nektar, Genentech, Westlake Village, California, Immune system, Investment, Intellia Therapeutics, Science, National, Gilead Sciences, Therapy, Industry, CAR, Patient, Myopathy, Anti-CD19 immunotoxin, Inflammation, Regulation, Myriad Genetics, Autoimmune disease, Pharming, Degenerative disease, Multimedia, Capital, Autoimmunity, Regulatory T cell, NIH, Scleroderma, CD19, Synthetic biology, Nektar Therapeutics, CEO, Lupus nephritis, Pharmaceutical industry, Vaccine, Management

EMERYVILLE, Calif., Jan. 26, 2022 /PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a cell therapy company engineering a new class of therapies for serious autoimmune diseases, today announced it has closed an oversubscribed $85 million Series B financing round led by Northpond Ventures.

Key Points: 
  • EMERYVILLE, Calif., Jan. 26, 2022 /PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a cell therapy company engineering a new class of therapies for serious autoimmune diseases, today announced it has closed an oversubscribed $85 million Series B financing round led by Northpond Ventures.
  • As part of the financing, Shaan Gandhi, M.D., D.Phil., director at Northpond Ventures and Chris Liu, Ph.D., senior analyst at RTW will join Kyverna's board of directors as board member and board observer, respectively.
  • Kyverna Therapeutics is a cell therapy company engineering a new class of therapies for autoimmune and inflammatory diseases.
  • By offering more than one mechanism for taming autoimmunity, Kyverna is positioned to transform how autoimmune diseases are treated.

AppTek Language Packages to Power Advanced AI-Enabled Live Automatic Transcriptions and Translations for Zoom

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월요일, 1월 24, 2022
Research, Natural language, Apptek, Karlsruhe Institute of Technology, Speech recognition, Translation, ASR, City centre, Materials Research Science and Engineering Centers, TTS, CEO, Machine learning, GLOBE, Solution, Government, Language, Acquisition, Artificial intelligence, Efficiency, Neural machine translation, Carnegie Mellon University, Communication, NMT, Organization, Natural language processing, Customer service, Management, Medical device, Zoom

AppTek will allow Zoom the use of its high-quality acoustic and language packs.

Key Points: 
  • AppTek will allow Zoom the use of its high-quality acoustic and language packs.
  • "We are thrilled at the opportunity to support the impressive and innovative language technology and research group at Zoom," said AppTek CEO Mudar Yaghi.
  • "AppTek and Zoom share the same mission - to connect people around the globe regardless of their language or location.
  • "Zoom is committed to seamlessly connecting people regardless of the language they speak," said Vijay Parthasarathy, Head of AI/ML at Zoom.

Daiichi Sankyo Authorizes the First YESCARTA® (Axicabtagene Ciloleucel) CAR T-cell Therapy Treatment Site in Japan

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목요일, 12월 16, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Hospital, Daiichi Sankyo, Risk, Cardiovascular disease, Axicabtagene ciloleucel, CRS, Cytokine release syndrome, Adult, LinkedIn, Haematopoietic system, Physician, Follicular lymphoma, Social media, ORR, B-cell lymphoma, Thrombocytopenia, Non-Hodgkin lymphoma, Safety, Â, Quality of life, Commercial, Sustainable development, U.S. Securities and Exchange Commission, CAR, Securities and Exchange Commission (Philippines), Primary central nervous system lymphoma, Medication, Leukemia, Cancer, The New England Journal of Medicine, Neutropenia, CD19, Engineering, DLBCL, Investment, Multimedia, Twitter, MHLW, Gilead Sciences, Primary mediastinal B-cell lymphoma, Toxicity, Private Securities Litigation Reform Act, Lymphocytopenia, Patient, Immune system, Technology, Pharmaceutical industry, Wood drying, Lymphoma, Limited

Kite, a Gilead Company, and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that YESCARTA (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, will be available to patients with relapsed or refractory large B-cell lymphomas in Japan through the first treatment center now authorized by Daiichi Sankyo.

Key Points: 
  • Kite, a Gilead Company, and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that YESCARTA (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, will be available to patients with relapsed or refractory large B-cell lymphomas in Japan through the first treatment center now authorized by Daiichi Sankyo.
  • Kite and Daiichi Sankyo will also build on the exclusive licensing deal for commercialization rights for axicabtagene ciloleucel in Japan, formalized in January 2017.
  • We are pleased to be able to deliver axicabtagene ciloleucel, Daiichi Sankyo's first cell therapy product, to patients in Japan, said Akio Sakurai, Daiichi Sankyo Corporate Officer, Head of Sales Division.
  • CAR T-cell therapy is a complex immunotherapy, and all hospitals must complete a rigorous training process before administering axicabtagene ciloleucel to patients.

Yescarta® ZUMA-12 Study Demonstrates 78% Complete Response Rate as Part of First-Line Treatment in Newly Diagnosed High-Risk Large B-Cell Lymphoma

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월요일, 12월 13, 2021
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology

The impressive response rates in ZUMA-12 support the potential of CAR T-cell therapy earlier in treatment to improve outcomes in these high-risk patients.

Key Points: 
  • The impressive response rates in ZUMA-12 support the potential of CAR T-cell therapy earlier in treatment to improve outcomes in these high-risk patients.
  • The high rate of durable response to a one-time infusion of Yescarta in newly diagnosed patients with high-risk LBCL is exceptional, said Frank Neumann, MD, PhD, Kites Global Head of Clinical Development.
  • Yescarta has not been approved by any regulatory agency for the treatment of patients in the first-line setting.
  • Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

Yescarta® Demonstrates Durable Two-Year Clinical Benefit in Adults With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma Including Follicular Lymphoma

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토요일, 12월 11, 2021
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology

Yescarta is currently under review in the European Union for the treatment of adult patients with relapsed or refractory FL.

Key Points: 
  • Yescarta is currently under review in the European Union for the treatment of adult patients with relapsed or refractory FL.
  • Follicular lymphoma (FL) is a form of indolent non-Hodgkin lymphoma (iNHL) in which malignant tumours slowly grow but can become more aggressive over time.
  • FL is the most common form of indolent non-Hodgkin lymphoma and the second most common type of lymphoma globally.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Yescarta® Is First CAR T-cell Therapy to Report Five-Year Survival Data From Pivotal Study Showing Durable Long-Term Survival in Patients With Refractory Large B-cell Lymphoma

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토요일, 12월 11, 2021
Oncology, Health, Hospitals, Genetics, Clinical Trials, Pharmaceutical, Biotechnology

Among all patients treated with Yescarta, the five-year overall survival (OS) rate was 42.6% (95% CI, 32.8 51.9).

Key Points: 
  • Among all patients treated with Yescarta, the five-year overall survival (OS) rate was 42.6% (95% CI, 32.8 51.9).
  • Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution.

Yescarta® CAR T-Cell Therapy Quadruples Median Event-Free Survival Duration Over Standard of Care in Second-Line Relapsed or Refractory Large B-Cell Lymphoma

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토요일, 12월 11, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Multimedia, ASH, EFS, Axicabtagene ciloleucel, Exposition, Patient, Abstract, CAR, The New England Journal of Medicine, NEJM, SOC, American Society of Hematology, Society, Standard of care, Pharmaceutical industry

Yescarta was evaluated against the current SOC which is a multi-step process intended to culminate in a stem cell transplant.

Key Points: 
  • Yescarta was evaluated against the current SOC which is a multi-step process intended to culminate in a stem cell transplant.
  • Median overall survival (OS), evaluated as a preplanned interim analysis, favored Yescarta compared to SOC (not reached vs. 35.1 months, respectively).
  • Global regulatory filings to expand the indication for Yescarta to include second-line relapsed or refractory LBCL based on the ZUMA-7 data are currently underway.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Agree Realty Names Peter Coughenour Chief Financial Officer

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화요일, 12월 7, 2021
NYSE, Interim, Company, ESG, View, ADC, KRG, REIT, KPMG, Multimedia, Peter, Market for corporate control, New, Acquisition, Management

BLOOMFIELD HILLS, Mich., Dec. 7, 2021 /PRNewswire/ --Agree Realty Corporation (NYSE: ADC) (the "Company") announced that effective immediately, Peter Coughenour has been named its Chief Financial Officer and Secretary.

Key Points: 
  • BLOOMFIELD HILLS, Mich., Dec. 7, 2021 /PRNewswire/ --Agree Realty Corporation (NYSE: ADC) (the "Company") announced that effective immediately, Peter Coughenour has been named its Chief Financial Officer and Secretary.
  • Mr. Coughenour has been with the Company in various finance roles since 2015 and most recently served as Interim Chief Financial Officer of the Company.
  • "After a thoughtful and deliberate process, I am extremely pleased to announce that Peter has been given the permanent responsibility of Chief Financial Officer," said Joey Agree, President and Chief Executive Officer.
  • Mr. Agree commented that "We are excited to welcome Stephen to Agree Realty.

Chimeric Transforms Portfolio With a Clinically Validated, Off the Shelf, Natural Killer (NK) Cell Platform

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수요일, 12월 1, 2021
Patient, Research, CAR, Basic research, Safety, Cell, Technology, Merck, ASX, Partnership, MD, Cancer, Clinical trial, 1101, Doctor of Philosophy, University, NK, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center, City, Glioblastoma, Janssen, CDH17, GLOBE, Phases of clinical research, Case, Associate, Case Western Reserve University, Therapy, CWRU, Lymphatic system, Vaccine, Pharmaceutical industry, Medical imaging, Medical device, Fine chemical

Natural killer (NK) cells have innate safety features and the natural ability to target and destroy cancer cells through both indirect and direct mechanisms.

Key Points: 
  • Natural killer (NK) cells have innate safety features and the natural ability to target and destroy cancer cells through both indirect and direct mechanisms.
  • The challenge with natural killer (NK) cells is that they are not naturally abundant or active enough to overcome cancer.
  • Preclinical data on the CORE-NK platform was published in the prestigious family of Nature publications in 2019.
  • The phase 1 clinical trial of the CORE-NK platform was completed in June 2021 with clinical data expected in 2022.