HLA

TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-203-A0201 Targeting PRAME

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Martedì, Agosto 29, 2023
HLA, MAGE-A1, Papillomaviridae, Neoplasm, Clinical trial, HPV16, Cancer, Head, PRAME, TCR, Non-small-cell lung cancer, Lung, Patient, Otorhinolaryngology, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Safety, Vaccine, Melanoma

In addition to being expressed in ~90% of melanomas, PRAME is also frequently expressed in various other solid tumors, including ~90% of head & neck cancers and ~50% of non-small cell lung cancers.

Key Points: 
  • In addition to being expressed in ~90% of melanomas, PRAME is also frequently expressed in various other solid tumors, including ~90% of head & neck cancers and ~50% of non-small cell lung cancers.
  • All four TCR-T cell products are designed to be used in combination with each other and are being developed under a single master clinical trial protocol.
  • Patients are administered specific combinations of TCR-T cell agents based on which targets and HLAs are expressed in their tumors.
  • PRAME is a particularly important target, as it is very frequently expressed in solid tumors and recent clinical trials targeting PRAME have shown promising results.

Outcomes Data Reveal Significant Impact of Etiometry Utilization in Liberating Patients from Invasive ICU Treatments

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Lunedì, Agosto 28, 2023
Managed Care, Software, Research, Technology, Hospitals, Health Technology, Surgery, Clinical Trials, Science, Cardiology, Nursing, Practice Management, Health, Hospice and palliative medicine, Risk, University of Alabama, Probability, University, HLA, Lactic acid, Perfusion, MSHA, Quality, Associate, Annals of Pediatric Cardiology, Harvard Medical School, Charles Mullins (pediatric cardiologist), Congress, Hospital, ERT, Metabolic acidosis, Assistant professor, Medical director, Patient, Division, Algorithm, Disease, ICU, Analytics, FDA, Weaning, MPH, Pelvic floor dysfunction, Automation, Medical device, Pharmaceutical industry, Pediatrics, MD

Etiometry’s Risk Analytics provide an individualized assessment of the patient’s condition, bringing attention to patients who need it most and revealing insight into the cause of potential deterioration or improvement to a patient's state.

Key Points: 
  • Etiometry’s Risk Analytics provide an individualized assessment of the patient’s condition, bringing attention to patients who need it most and revealing insight into the cause of potential deterioration or improvement to a patient's state.
  • Extubation failure is associated with significant morbidity, including prolonged total ventilation time and longer hospital length of stay.
  • The findings reveal the new automated standardized workflow in Etiometry informed data-driven decisions leading to an 18% reduction of time with vasoactive infusions.
  • The data are compelling, especially in terms of how our clinical intelligence can enhance patient care,” said Shane Cooke, CEO of Etiometry.

IMUNON Expands Scientific Advisory Board with the Addition of Dr. Sachet Shukla

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Lunedì, Agosto 14, 2023
SAB, HBM, HLA, Statistics, Cancer, Mutation, Monroe Dunaway Anderson, MD Anderson Cancer Center, Dana–Farber Cancer Institute, Assistant professor, Publication, Computation, Division, MD, University, Melanoma, Immune system, Research, Gene, Vaccine, Malignancy

LAWRENCEVILLE, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces the addition of Sachet A. Shukla, Ph.D. to the company’s scientific advisory board (SAB). Dr. Shukla is Assistant Professor, Department of Hematopoietic Biology and Malignancy (HBM), Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. He joins current advisory board members Dan H. Barouch, M.D., Ph.D., John W. Shiver, Ph.D., and Luke D. Handke, Ph.D.

Key Points: 
  • LAWRENCEVILLE, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces the addition of Sachet A. Shukla, Ph.D. to the company’s scientific advisory board (SAB).
  • Dr. Shukla is Assistant Professor, Department of Hematopoietic Biology and Malignancy (HBM), Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.
  • He joins current advisory board members Dan H. Barouch, M.D., Ph.D., John W. Shiver, Ph.D., and Luke D. Handke, Ph.D.
    “We are honored to add Dr. Shukla to our scientific advisory board and are grateful that a scientist of his stature has chosen to work with IMUNON,” said Dr. Corinne Le Goff, president and chief executive officer of IMUNON.
  • Dr. Shukla also worked in delineating mechanisms of response and resistance to immune therapies, particularly checkpoint blockade.

Gracell Biotechnologies Reports Second Quarter 2023 Unaudited Financial Results and Provides Corporate Update

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Lunedì, Agosto 14, 2023
Janus, Exercise, Lender option borrower option, IIT, RA, CD19, SCR, HLA, OrbiMed, DLBCL, ADS, Multiple myeloma, Cancer, Research, Commencement at Central Connecticut State University, ASCO, Patient, Investment, Graceling, B-ALL, SAN, TME, EHA, Webcast, BCMA, RRMM, SMART, ORR, Conference, Pharmaceutical industry, Security (finance), Vaccine, Cryptocurrency, Broadcasting

ET today

Key Points: 
  • ET today
    SAN DIEGO and SUZHOU, China and SHANGHAI, China, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune diseases, today reported second quarter unaudited financial results for the period ended June 30, 2023, and provided corporate updates.
  • “We are delighted with the significant milestones achieved in the past few months across our reprioritized pipeline.
  • The Phase 1b part of the RRMM US IND trial has commenced as patient screening is underway.
  • Financial Results for Second Quarter Ended June 30, 2023
    As of June 30, 2023, the Company had RMB1,188.0 million (US$163.8 million) in cash and cash equivalents and short-term investments.

CareDx Hosts Second Annual MEET Digital Health User Conference to Showcase Latest Innovations to Enhance Transplant Patient Care

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Giovedì, Agosto 17, 2023
Nursing, Health, Surgery, Health Technology, Genetics, General Health, Biotechnology, OPO, Elia del Medigo, Yale School of Medicine, Gift, Pharmacy, FAST, Education, HLA, Health equity, Medicine, Digital Solutions, Transplant, Patient, Former, OPOS, Organ, Acquisition, Laboratory, Quality, FACS, UNOS, Immunology, LIMS, Conference, Caregiver, Kidney, Dentistry, Faculty, MD

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced its second annual digital health user conference, the Management Expert Exchange in Transplantation (MEET) Conference, taking place August 27-29 in Dallas, Texas.

Key Points: 
  • CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced its second annual digital health user conference, the Management Expert Exchange in Transplantation (MEET) Conference, taking place August 27-29 in Dallas, Texas.
  • Transplant administrators, quality managers, transplant clinicians, and organ procurement organization (OPO) professionals will come together for this one-of-a-kind event.
  • At the conference, participants will share best practices, discuss emerging trends, and learn how to leverage the latest digital health innovations to improve transplant operations, quality improvement, patient management, and health equity.
  • “We look forward to hosting our yearly digital health conference, where thought leaders gather to share innovations as we collectively navigate the intricate tapestry of patient touchpoints in the transplant journey,” said Kashif Rathore, Chief of Patient and Digital Solutions.

FDA Grants Breakthrough Device Designation To Tempus’ HLA-LOH Companion Diagnostic Test

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Martedì, Agosto 15, 2023
Technology, Medical Devices, FDA, Health Technology, Other Health, Biotechnology, General Health, Health, Oncology, Artificial Intelligence, LOH, Diagnosis, Cancer, CDX, Intelligence, Safety, Patient, HLA, Biomarker, Doctor of Philosophy, Medicine, Medical imaging, Tempus

Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its HLA-LOH assay as a companion diagnostic (CDx) test.

Key Points: 
  • Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its HLA-LOH assay as a companion diagnostic (CDx) test.
  • The test uses a machine learning model to analyze sequence data produced by Tempus’ FDA-approved, next generation sequencing-based xT CDx assay.
  • “HLA-LOH provides a clear molecular distinction between cancer and non-cancer cells and is a potential biomarker for immune therapy resistance.
  • “This Breakthrough Device Designation from the FDA recognizes the novelty and potential clinical impact of our HLA-LOH test for this promising biomarker.

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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Martedì, Agosto 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.

TScan Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

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Giovedì, Agosto 10, 2023
Novartis Institute for Tropical Diseases, Gene, HLA, ALL, MAGE-A1, Papillomaviridae, Clinical trial, HPV16, Cancer, Biomedical Research, PRAME, TCR, MDS, E7, ASCO, Acute myeloid leukemia, Trial of the century, AML, American Society of Clinical Oncology, Patient, Syndrome, Annual general meeting, Cell, Acute leukemia, IND Culver Line, Toxic shock syndrome toxin-1, Poster, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Safety, Society, Food, Pharmaceutical industry, Life insurance, Video game, Amgen

WALTHAM, Mass., Aug. 10, 2023 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor-engineered T cell therapies (TCR-Ts) for the treatment of patients with cancer, today reported financial results and provided a corporate update for the second quarter ended June 30, 2023.

Key Points: 
  • Revenue for the second quarter ended June 30, 2023, was $3.1 million, compared to $4.1 million for the second quarter ended June 30, 2022 (2022 Quarter).
  • Research and development expenses for the second quarter ended June 30, 2023, were $21.2 million, compared to $14.5 million for the 2022 Quarter.
  • General and administrative expenses for the second quarter ended June 30, 2023, were $6.5 million, compared to $4.8 million for the 2022 Quarter.
  • For the second quarter ended June 30, 2023, TScan Therapeutics reported a net loss of $24.0 million, compared to a net loss of $15.1 million for the 2022 Quarter.

City of Hope receives $32.3 million from the California Institute for Regenerative Medicine to advance innovative therapies for patients

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Mercoledì, Agosto 9, 2023
City of Hope, Diabetes, Bone marrow, California Institute for Regenerative Medicine, University of California, San Diego Performance-Based Skills Assessment, Patient, Division, CIRM, Canadian Aviation Regulations, Sickle cell disease, University, Gene, Endocrine & Metabolism Research Institute, Aplastic anemia, Research, Transplant, Immunology, Luca Zaia, Distinguishing, Safety, Cytomegalovirus, HLA, Cancer, Morgan, UCSD, Cell, Acute myeloid leukemia, CAR, CD33, Immune system, Food and Drug Administration, Mortality, LOS, B cell, Radiation, HIV, Clinical trial, Person, Irell & Manella Graduate School of Biological Sciences, Regenerative medicine, AML, City, Beckman Research Institute, Aaron, Haematopoietic system, Food, Vaccine, Pharmaceutical industry, Dentistry, Hope, Leukemia, Hematology

LOS ANGELES, Aug. 9, 2023 /PRNewswire/ -- Researchers at City of Hope, one of the largest cancer research and treatment organizations in the United States and a leading research center for diabetes and other life-threatening illnesses, were awarded $32.3 million from the California Institute for Regenerative Medicine (CIRM) to support three novel Phase 1 clinical trials evaluating innovative cell and gene therapy treatments for patients with HIV, acute myeloid leukemia and severe aplastic anemia. 

Key Points: 
  • Beckman Research Institute of City of Hope was awarded two-thirds of the $50 million in this latest round of CIRM awards, the highest of any entity in the state.
  • City of Hope is a leader in gene therapies, including bone marrow and blood stem cells transplants.
  • "We are hopeful that this will provide another treatment option for patients with this devastating disease and thankful for CIRM's funding."
  • City of Hope has treated patients with sickle cell diseases using this novel therapy in a clinical trial also funded by CIRM.

Marker Therapeutics Reports Non-Clinical Proof-of-Concept Data and Update on Clinical Readiness for the MT-401 Off-the-Shelf Program

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Lunedì, Agosto 7, 2023
Immortalised cell line, Graft-versus-host disease, Marker, OTS, GVHD, Blood, HLA, Leukemia, Allele, Baylor University, HSCT, Assistant, THP-1 cell line, Development, AML, Patient, Risk, Baylor College of Medicine, VST, FDA, Therapy, Biomedical Advanced Research and Development Authority, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Bone marrow, Vaccine, Medical imaging, Pharmaceutical industry, Medical device, Research

Leukemic cell growth was significantly reduced when treated with MT-401 OTS.

Key Points: 
  • Leukemic cell growth was significantly reduced when treated with MT-401 OTS.
  • Marker has established a cellular inventory of 8 lines manufactured from healthy donors, with ongoing efforts to further expand the inventory.
  • Marker anticipates that the first patient will be treated with MT-401 OTS during the first half of 2024.
  • If MT-401 OTS is successful in clinical trials, we will consider expanding the OTS multiTAA-specific T cell program to other indications with unmet medical needs,” concluded Dr. Vera.