Lymphatic system

GB2064 Shows Reduction in Fibrosis of the Bone Marrow in Patients with Myelofibrosis, Validating LOXL2 as a Clinical Fibrosis Target

Retrieved on: 
Thursday, September 29, 2022
Cirrhosis, IPF, Safety, Fibrosis, Biomarker, NSCLC, Lymphatic system, Idiopathic pulmonary fibrosis, Private Securities Litigation Reform Act, Ruxolitinib, U.S. Securities and Exchange Commission, Patient, Clinical trial, Cancer, Leukocytosis, LOXL2, Quality of life, Bone marrow, JAK, Collagen, Thrombocytopenia, Security (finance), Large-cell lung carcinoma, SEC, Galecto Biotech, Primary myelofibrosis, Blood, Mortality, Disease, Anemia, Medical imaging, Pharmaceutical industry, COVID-19

The MYLOX-1 clinical trial is an ongoing Phase 2, open-label, single-arm study in myelofibrosis patients who are ineligible, refractory or intolerant to JAK inhibitor therapy.

Key Points: 
  • The MYLOX-1 clinical trial is an ongoing Phase 2, open-label, single-arm study in myelofibrosis patients who are ineligible, refractory or intolerant to JAK inhibitor therapy.
  • These patients have a progressive disease with poor quality of life, high mortality rates, and very limited treatment options.
  • The primary endpoint of the ongoing MYLOX-1 trial is an assessment of safety and tolerability, while secondary endpoints focus on measurements of bone marrow fibrosis and hematological parameters.
  • In the intermediate assessment, GB2064 demonstrated target engagement and penetration into the fibrotic bone marrow.

Global Hematocrit Test Devices Market Report 2022: Rising Prevalence of Anemic Conditions Drives Sector - ResearchAndMarkets.com

Retrieved on: 
Thursday, September 29, 2022
Health, Seniors, Medical Supplies, Consumer, Conditional sentence, Polycythemia, Adoption, National Organization for Rare Disorders, American Society of Hematology, Incidence, COVID-19, Pancreatic serous cystadenoma, Prevalence, Hematology, Blood, Congenital heart defect, Association, National Organ Transplant Act of 1984, Society, Ventricular septal defect, Patient, Degenerative disease, Cell, Bone marrow, Life expectancy, Diagnosis, Lymphatic system, PV, Research, Hematocrit, Awareness, Mortality, CHD, Anemia, Pharmaceutical industry, Medical device, Renewable energy, Growth

The "Hematocrit Test Devices Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Hematocrit Test Devices Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)" report has been added to ResearchAndMarkets.com's offering.
  • The growing geriatric population and an increase in diseases related to blood among the geriatric population is one of the major factors driving the growth of the Hematocrit Test Devices market globally.
  • However, lack of skilled professionals, lack of awareness about the importance of hematocrit test, a stringent regulatory scenario for product approvals may impede the growth of the hematocrit test devices market.
  • North America holds the major share in the global hematocrit test devices market owing to the high adoption of hematocrit tests with other diagnostic tests and the high prevalence of chronic diseases.

Cellectis Appoints Mark Frattini, M.D., Ph.D. as Chief Medical Officer

Retrieved on: 
Wednesday, September 28, 2022
Adult, YouTube, U.S. Securities and Exchange Commission, Â, Securities & Exchange Commission of Pakistan, Molecular biology, Memorial, Gene editing, Columbia University, Research, University of Chicago, Lymphatic system, LinkedIn, American Society for Pharmacology and Experimental Therapeutics, CAR, Private Securities Litigation Reform Act, Hematology, Social media, University, Forward-looking statement, Patient, Leukemia, Euronext Growth, Cancer, Memorial Sloan Kettering Cancer Center, Physician, Technology, Oncology, Annual report, Internal medicine, NASDAQ, GLOBE, Experiment, Immune system, Nasdaq, Clinical Science (journal), Johns Hopkins Hospital, Pharmaceutical industry, Medicine, Cellectis, Biochemistry

Mark has been responsible for Cellectis clinical leadership including the clinical development strategy of the Companys current immune-oncology UCART product candidates.

Key Points: 
  • Mark has been responsible for Cellectis clinical leadership including the clinical development strategy of the Companys current immune-oncology UCART product candidates.
  • As Chief Medical Officer, Dr. Frattini will oversee clinical research and development for Cellectis UCART clinical trial programs.
  • He will remain based in Cellectis New York office and is joining the Companys executive committee.
  • Mark already had an impressive track record before joining Cellectis.

Eureka Therapeutics Announces New England Journal of Medicine Publication of Clinical Study Demonstrating GPRC5D as an Active Target for the Treatment of Multiple Myeloma

Retrieved on: 
Thursday, September 29, 2022
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Dana–Farber Cancer Institute, Lymphatic system, Multiple myeloma, Neurotoxicity, Therapy, Program, Patient, Cancer, The New England Journal of Medicine, Pediatrics, Memorial Sloan Kettering Cancer Center, Roswell Park Comprehensive Cancer Center, GPRC5D, MSK, Death, Medicine, CAR, Canadian Aviation Regulations, Pharmaceutical industry, San Francisco Bay Area, BCMA, Sanofi

The GPRC5D binder used in the study was developed by Eureka using its proprietary E-ALPHA platform in collaboration with MSK.

Key Points: 
  • The GPRC5D binder used in the study was developed by Eureka using its proprietary E-ALPHA platform in collaboration with MSK.
  • Eureka and MSK licensed the binder to Juno Therapeutics/Bristol Myers Squib in 2016 for CAR use, and to Sanofi in 2021 for non-CAR use.
  • The data confirms GPRC5D as an active immunotherapeutic target in multiple myeloma, said Eric Smith, M.D., Ph.D., and co-inventor of CARs for the targeting of multiple myeloma.
  • Eureka Therapeutics, Inc. is a privately held clinical-stage biotechnology company focused on developing novel T cell therapies to treat cancers.

CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX130™ for the Treatment of Cutaneous T-Cell Lymphomas (CTCL)

Retrieved on: 
Wednesday, September 28, 2022
Adult, Regenerative medicine, Risk, Safety, Gene editing, Lymphatic system, FDA, Food, CRISPR, FACP, U.S. Securities and Exchange Commission, Knowledge, Bayer, Form 10-K, Review, CD70, Private Securities Litigation Reform Act, Degenerative disease, Therapy, Program, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Vertex Pharmaceuticals, T-cell lymphoma, Breakthrough therapy, Clinical trial, Technology, Uncertainty, Nasdaq, Coronavirus, Drug development, CRSP, DNA, BLA, GLOBE, Hemoglobinopathy, SEC, CRISPR Therapeutics, Annual report, 21st Century Cures Act, Mycosis fungoides, Disease, CAR, Cas9, Pharmaceutical industry

The COBALT-RCC trial is evaluating the safety and efficacy of CTX130 for the treatment of relapsed or refractory renal cell carcinoma.

Key Points: 
  • The COBALT-RCC trial is evaluating the safety and efficacy of CTX130 for the treatment of relapsed or refractory renal cell carcinoma.
  • CTX130 has received Orphan Drug and Regenerative Medicine Advanced Therapy designations from the FDA.
  • CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases.
  • CRISPR THERAPEUTICS standard character mark and design logo, CTX130 and COBALT are trademarks and registered trademarks of CRISPR Therapeutics AG.

Vor Bio Initiates In-house Clinical Manufacturing at Cambridge, MA Headquarters

Retrieved on: 
Wednesday, September 28, 2022
Time, Engineering, Efficiency, Stem cell, CGMP, Knowledge, IND, Company, Private Securities Litigation Reform Act, Forward-looking statement, U.S. Securities and Exchange Commission, Patient, Investment, Clinical trial, Technology, Standard of care, Good manufacturing practice, Lymphatic system, Research, Security (finance), GLOBE, Fine chemical, Pharmaceutical industry

CAMBRIDGE, Mass., Sept. 28, 2022 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today announced the opening of its new in-house clinical manufacturing facility in Cambridge, Mass.

Key Points: 
  • CAMBRIDGE, Mass., Sept. 28, 2022 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today announced the opening of its new in-house clinical manufacturing facility in Cambridge, Mass.
  • The Vor Bio facility will enable end-to-end oversight of drug product for planned clinical trials, initially manufacturing clinical supply to support the IND for VCAR33allo, which is on-track for submission in the first half of 2023.
  • Initiating manufacturing at our own in-house facility represents an exciting and important milestone for Vor Bio, said Michael Pinaud, Head of GMP Operations.
  • Internalizing manufacturing has been a key part of Vor Bios strategy to increase efficiency and control and decrease overall expenditure of its manufacturing process.

Gamida Cell Announces Entry into Commitment Letter with Highbridge for $25 Million Financing

Retrieved on: 
Wednesday, September 28, 2022
Oncology, Health, Stem Cells, General Health, Pharmaceutical, Biotechnology, Hospital, Risk, Therapy, Safety, Infection, Trial of the century, COVID-19, Transplant, Twitter, Lymphatic system, FDA, ADCC, LLC, Hematology, Phenotype, LinkedIn, Population, Highbridge, Breakthrough therapy, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, NK, Patient, Clinical trial, Facebook, Immunotherapy, Letter (message), Letter, Technology, Instagram, Cell, Bone marrow, B cell, Security (finance), BLA, Graft-versus-host disease, SEC, Mortality, NAM, Highbridge Capital Management, Bank, Pharmaceutical industry, Vaccine, EU

The Commitment Letter does not represent a definitive credit facility and is subject to certain conditions, including the consummation of a Gamida Cell equity offering resulting in gross proceeds of not less than $20 million.

Key Points: 
  • The Commitment Letter does not represent a definitive credit facility and is subject to certain conditions, including the consummation of a Gamida Cell equity offering resulting in gross proceeds of not less than $20 million.
  • Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers.
  • For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn , Twitter , Facebook or Instagram at @GamidaCellTx.
  • Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell.

Gamida Cell Announces Pricing of Approximately $20 Million Public Offering of Ordinary Shares

Retrieved on: 
Wednesday, September 28, 2022
Health, Oncology, Stem Cells, Other Health, Risk, Suite, Sale, LLC, Hematology, Private Securities Litigation Reform Act, Nicollet Mall, U.S. Securities and Exchange Commission, NK, Patient, Immunotherapy, SEC filing, Cell, Montgomery Street, Lymphatic system, Telephone, Form, Security (finance), Prospectus, Attention, SEC, NAM

In addition, Gamida Cell has granted the underwriters a 30-day option to purchase up to an additional 1,935,750 ordinary shares at the public offering price, less the underwriting discounts and commissions.

Key Points: 
  • In addition, Gamida Cell has granted the underwriters a 30-day option to purchase up to an additional 1,935,750 ordinary shares at the public offering price, less the underwriting discounts and commissions.
  • The offering is expected to close on or about September 30, 2022, subject to satisfaction of customary closing conditions.
  • 333-259472) relating to the ordinary shares has been filed with the Securities and Exchange Commission and declared effective on April 1, 2022.
  • Gamida Cell undertakes no obligation to update any such forward-looking statements after the date hereof, except as required by law.

Gamida Cell Announces Launch of Public Offering of Ordinary Shares

Retrieved on: 
Tuesday, September 27, 2022
Health, Oncology, Other Health, Risk, Suite, Sale, LLC, Hematology, Private Securities Litigation Reform Act, Nicollet Mall, U.S. Securities and Exchange Commission, NK, Patient, Immunotherapy, SEC filing, Cell, Montgomery Street, Lymphatic system, Telephone, Form, Security (finance), Prospectus, Attention, SEC, NAM

Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced the launch of a follow-on public offering of its ordinary shares.

Key Points: 
  • Gamida Cell Ltd. (Nasdaq: GMDA), the global leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced the launch of a follow-on public offering of its ordinary shares.
  • In addition, Gamida Cell expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the ordinary shares to be sold in the offering on the same terms and conditions.
  • All of the shares in the offering are to be sold by Gamida Cell.
  • Gamida Cell undertakes no obligation to update any such forward-looking statements after the date hereof, except as required by law.

Oncternal Therapeutics Initiates Global Registrational Phase 3 Study of Zilovertamab for Patients with MCL

Retrieved on: 
Tuesday, September 27, 2022
Chronic lymphocytic leukemia, SD, Venetoclax, IV, Risk, FDA, Endpoint security, IND, Company, Review, Private Securities Litigation Reform Act, Therapy, Docetaxel, Forward-looking statement, Patient, Clinical trial, Securities and Exchange Commission (Philippines), DOR, CEO, CD19, ORR, Castration, Relapse, Progression-free survival, Nasdaq, Lymphatic system, MCL, MCRPC, CLL, ROR1, Drug development, SAN, BLA, Prostate cancer, GLOBE, IRB, PR, PFS, Trial of the century, Cancer, CAR, Pharmaceutical industry

The Company obtained its first Institutional Review Board (IRB) approval for the study and expects to promptly begin patient screening and enrollment.

Key Points: 
  • The Company obtained its first Institutional Review Board (IRB) approval for the study and expects to promptly begin patient screening and enrollment.
  • The initiation of the first Phase 3 study of zilovertamab, ZILO-301, represents a key milestone for Oncternal, our partners, investors and patients with R/R MCL, said James Breitmeyer, M.D., Ph.D., Oncternals President and CEO.
  • Across 50-100 international sites, the study aims to enroll 365 patients and to randomize approximately 250 patients after the 4-month lead-in phase.
  • ZILO-301, a global Phase 3 Study to evaluate zilovertamab in combination with ibrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) has been initiated (NCT05431179).