Canadian Aviation Regulations

Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates

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星期四, 三月 14, 2024
Nucleus, Bone marrow, BCMA, BioNTech, B-ALL, Patient, ALL, SLE, Engineering, Minocycline, European Medicines Agency, Therapy, Research, Canadian Aviation Regulations, Flow cytometry, ASH, General counsel, Immunotherapy, SVP, EMA, Legal Affairs, Trial of the century, GMP, SME, BLA, Nature Communications, Development, UCL, Biologics license application, Multiple myeloma, MIA, University College London, Senior, TRBC, GD2, ASCO, FDA, CD19, Conference call, Conference, MAA, EHA, ADS, MHRA, T cell, ACS Chemical Biology, PDUFA, Autoimmune disease, Pharmaceutical industry

“For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.

Key Points: 
  • “For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.
  • In February 2024, Autolus promoted Dr. Chris Williams to Chief Business Officer and Alex Driggs to Senior Vice President, Legal Affairs and General Counsel.
  • Dr. Leiderman brings extensive transactional and financial expertise, and Mr. Azelby brings more than 30 years of biopharmaceutical leadership and commercial experience to Autolus’ Board.
  • Financial Results for the Year Ended December 31, 2023

Eureka Therapeutics Advances ARYA-3 Clinical Trial to Phase II for Treatment of Liver Cancer Using GPC3-Targeting ARTEMIS® T-cell Therapy

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星期一, 三月 18, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, HCC, Canadian Aviation Regulations, Patient, GPC3, City, Cancer, Glypican 3, ARTEMIS, Clinical trial, Therapy, Safety, Liver cancer, Pharmaceutical industry

Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat cancer, today announced the advancement of its ARYA-3 clinical trial to Phase II ( NCT04864054 ).

Key Points: 
  • Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat cancer, today announced the advancement of its ARYA-3 clinical trial to Phase II ( NCT04864054 ).
  • The ARYA-3 trial is evaluating Eureka’s investigational ARTEMIS® ECT204 T-cell therapy in adult patients with GPC3-positive advanced hepatocellular carcinoma (HCC), the predominant type of liver cancer.
  • The ARYA-3 trial has successfully completed Phase I and is now enrolling patients in Phase II.
  • Moving to Phase II marks a significant milestone in our mission to advance cutting-edge therapies for cancer treatment,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics.

Myeloid Therapeutics to Showcase In Vivo CAR Data and its Diverse mRNA Platform at AACR

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星期四, 四月 4, 2024
Vivo, Canadian Aviation Regulations, Patient, Primate, RNA, Fragment crystallizable region, Cancer, Messenger, AACR, Chemokine, Cytokine, Drug development, Safety, Myeloid tissue, NK, LNP, Antigen, Annual general meeting, Vaccine

This advancing study represents the first human trial of any in vivo chimeric antigen receptor (CAR) therapy.

Key Points: 
  • This advancing study represents the first human trial of any in vivo chimeric antigen receptor (CAR) therapy.
  • Myeloid will also share information on its portfolio of immune cell programming CARs.
  • "We are thrilled to continue driving this first in vivo mRNA CAR program forward," said Chief Executive Officer Daniel Getts, Ph.D. "Myeloid is at the forefront of in vivo immune cell programming.
  • To date, Myeloid has demonstrated CAR activity in human cells, and following systemic mRNA/LNP delivery in mouse and non-human primates.

Advances in Digitalization Presented at the 10th Annual Genedata Biopharma Partner Symposium

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星期四, 三月 21, 2024
AbbVie, Peptide, ChromeOS, Automation, Sanofi, Organization, Canadian Aviation Regulations, AstraZeneca, Novo Nordisk, MAM, Novartis, GSK, Boehringer Ingelheim, UCB, Vivisection, Roche, NGS, RNA, Knowledge, Merck, Hyphen, Spacecraft, Janssen, Daiichi Sankyo, Digitization, Novozymes, Fine chemical

BASEL, Switzerland, March 21, 2024 /PRNewswire-PRWeb/ -- Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the successful conclusion of the 10th Annual Genedata Biopharma Partner Symposium, held over 2 days from March 6–7, 2024 in Basel, Switzerland. This year's event marked the tenth year of bringing together Genedata customers to share best practices and demonstrate how they increase efficiency and productivity across entire organizations by leveraging the Genedata Biopharma Platform.

Key Points: 
  • BASEL, Switzerland, March 21, 2024 /PRNewswire-PRWeb/ -- Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the successful conclusion of the 10th Annual Genedata Biopharma Partner Symposium, held over 2 days from March 6–7, 2024 in Basel, Switzerland.
  • The Genedata Biopharma Partner Symposium has firmly established itself as a community platform to exchange pioneering work in digitalizing biopharma R&D and establishing best practices based on the Genedata software platform.
  • "The Genedata Biopharma Partner Symposium has firmly established itself as a community platform to exchange pioneering work in digitalizing biopharma R&D and establishing best practices based on the Genedata software platform.
  • The record participation this year underscores the leading position of the Genedata Biopharma Platform within the biopharma industry," said Othmar Pfannes, Ph.D., CEO of Genedata.

Nu Holdings Ltd. Reports Fourth Quarter and Full Year 2023 Financial Results

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星期四, 二月 22, 2024
Professional Services, Payments, Technology, Finance, Fintech, Banking, Analysis, Investment, Holding, ROE, Net income, Yoy, Appendix, Webcast, Acceleration, FX, CSA, Ratio, Result, Security (finance), NU, International Financial Reporting Standards, International, Asset quality, Canadian Aviation Regulations, INSS, Conference, Central Bank of Brazil, IEP, NPL, Insurance, Prospectus, Annual report, Brazilian real, FXN, Bank

Nu Holdings Ltd. (NYSE: NU), (“Nu” or the “Company”), one of the world’s largest digital financial services platforms, released today its Fourth Quarter and Full Year 2023 financial results.

Key Points: 
  • Nu Holdings Ltd. (NYSE: NU), (“Nu” or the “Company”), one of the world’s largest digital financial services platforms, released today its Fourth Quarter and Full Year 2023 financial results.
  • Financial results are expressed in U.S. dollars and are presented in accordance with International Financial Reporting Standards (IFRS).
  • In Brazil, the customer base reached 87.8 million by December 31, 2023, representing 53% of the country’s adult population.
  • Nu is the fourth-largest financial institution by number of customers in the country, according to Brazilian Central Bank data.

St. Baldrick's Foundation Allocates $1.1 Million for Fellowships to Empower Emerging Childhood Cancer Researchers

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星期五, 三月 8, 2024
Neoplasm, Cancer, Survivor, Toxicity, Osteosarcoma, Immunotherapy, Children's Hospital of Philadelphia, University, University of California, Canadian Aviation Regulations, Hospital, Brain, Child, Food, Vaccine, Cell adhesion, Bone marrow, Dana–Farber Cancer Institute, Leukemia, Medicine, Baylor College of Medicine, Acute myeloid leukemia, Food security, Lymphoma, Research, Baylor University, Immune system

The St. Baldrick's Foundation granted over $1.1 million in Fellow awards to nurture emerging childhood cancer researchers dedicated to overcoming pediatric cancers.

Key Points: 
  • The St. Baldrick's Foundation granted over $1.1 million in Fellow awards to nurture emerging childhood cancer researchers dedicated to overcoming pediatric cancers.
  • The $1.1 million was distributed to seven researchers making strides in discovering new cures for pediatric cancers.
  • The St. Baldrick's Foundation 2024 Fellows are:
    Dr. Vanja Cabric at Memorial Sloan Kettering Cancer Center, New York, NY
    Hepatoblastoma, common in childhood, lacks effective immunotherapy due to limited understanding of pediatric immune response to tumors.
  • Since 2005, St. Baldrick's has granted more than $342 million to support the development of childhood cancer treatments that have the potential to impact every kid diagnosed with cancer.

AbelZeta Announces Formation of Scientific Advisory Board to Support Inflammatory and Immunological Diseases

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星期三, 一月 3, 2024
Arthritis, Quality of life, University, Canadian Aviation Regulations, Honorary, CD20, SLE, SAB, Society, Innovation, Cancer, Autoimmune disease, UCSF, Skin condition, Hospital for Special Surgery, B cell, Weill Cornell Medicine, Safety, Journal, Lupus nephritis, Human musculoskeletal system, Biomarker, Arthritis Foundation, Intramural sports, Patient, Hospital, Preventive healthcare, Division, Research, Jean, BCMA, Postgraduate education, Catholic League (German), Rheumatoid arthritis, Lupus Research Alliance, Conditional sentence, Bangladesh Technical Education Board, American College, Cell, CD19, Lee, Culture, Pharmaceutical industry

These four industry experts are distinguished scientific leaders with vast experience in the autoimmune disease field."

Key Points: 
  • These four industry experts are distinguished scientific leaders with vast experience in the autoimmune disease field."
  • Members of the SAB include:
    Peter Lipsky, M.D., served on the Board of Directors of the American College of Rheumatology.
  • She was President of the American College of Rheumatology, President of the Henry Kunkel Society, and Chair of the Scientific Advisory Board of the Lupus Research Alliance.
  • "AbelZeta is advancing promising new therapies for inflammatory and immunological diseases through innovative cell therapy platforms that provide custom-tailored treatment for each individual patient.

Sana Biotechnology Highlights Preclinical Data Supporting Tumor Control and Immune Evasion Capabilities of Hypoimmune-Modified Allogeneic CAR T Cells in Presentations at the American Society of Hematology Annual Meeting

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星期一, 十二月 11, 2023
Patient, CIITA, Canadian Aviation Regulations, Treatment, Immune system, GPRC5D, HIP, IND, Biotechnology, CD47, Graft-versus-host disease, MD, Society, Therapy, ASH, B2M, Dose, Escape Room, CD22, Cytolysis, Multiple myeloma, Vaccine

SEATTLE, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced preclinical data supporting the anti-tumor and immune evasion capabilities of allogeneic CAR T cells engineered with Sana’s proprietary hypoimmune (HIP) technology were presented at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, CA.

Key Points: 
  • “HIP-modified allogeneic CAR T cells remain well-tolerated in preclinical models.
  • CD22 HIP CAR T cells were well tolerated with no signs of graft-versus-host disease (GvHD).
  • Sana submitted the investigational new drug (IND) application and intends to begin human testing of SC262 in early 2024.
  • Additionally, these GPRC5D CAR T cells controlled multiple myeloma tumor cells both in vitro and in vivo, demonstrating efficacy that is on par with clinical benchmark GPRC5D CAR T cells.

Appia Bio to Present Data on API-192 at the 65th American Society for Hematology Annual Meeting and Exposition

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星期二, 十二月 5, 2023
Malignancy, Research, Non-Hodgkin lymphoma, Canadian Aviation Regulations, ASH, Health, HSC, IND, Gold, Patient, LOS, ACUA, Cancer, Society, Stem cell, Lymphoma, Pharmaceutical industry, Kite

LOS ANGELES, Dec. 5, 2023 /PRNewswire/ -- Appia Bio, Inc., a biotechnology company developing allogeneic chimeric antigen receptor (CAR)-engineered invariant natural killer T (CAR-NKT) cell therapies from hematopoietic stem cells (HSCs) for patients with cancer, today announced that it will present preclinical data on API-192, a first-in-class CAR-NKT allogeneic cell therapy for the treatment of a broad array of B-cell mediated malignancies including non-Hodgkin lymphoma, one of the most common cancers in the U.S.

Key Points: 
  • These data will be delivered in a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023 in San Diego, CA.
  • API-192 is the first development candidate out of a 2021 collaboration and license agreement between Appia Bio and Kite, a Gilead Company.
  • Under the terms of the agreement, Appia Bio is responsible for preclinical and early clinical research of HSC-derived CAR-NKT product candidates engineered with CARs provided by Kite.
  • "It has been a fantastic team effort to bring API-192 forward as our first development candidate out of our ACUA technology platform.

MiNK Therapeutics Reports Third Quarter 2023 Results

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星期四, 十一月 9, 2023
Hereditary diffuse gastric cancer, Survival, Periodic breathing, CGMP, NSCLC, Stomach, Inflammation, Cell, Memorial Sloan Kettering Cancer Center, Webcast, Canadian Aviation Regulations, Mink, TCR, Cancer, Autoimmunity, Therapy, Patient, HLA, Medical imaging, Pharmaceutical industry, Cryptocurrency

MiNK plans for expansion in autoimmune and inflammatory diseases.

Key Points: 
  • MiNK plans for expansion in autoimmune and inflammatory diseases.
  • NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today reported financial results for the third quarter 2023.
  • MiNK executives will host a conference call and webcast at 8:30 a.m.
  • We ended the third quarter with a cash balance of $6.4 million as compared to $10.6 million at June 30, 2023, and $19.6 million at December 31, 2022.