Investigator's brochure

Adicet Bio Highlights ADI-001 Expansion, Persistence and Pharmacodynamic Profile from Ongoing Phase 1 Study at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Sunday, December 10, 2023
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, Science, Oncology, Cytokine, PST, ASH, AUC, ACET, PD, Stem cell factor, Patient, CD19, Tmax, Allele, HLA, Cancer, Cmax, NHL, Pharmacodynamics, Investigator's brochure, Pharmaceutical industry, Vaccine, Medical imaging, Generic drug, Persistence

The data will be provided during a poster presentation at the ASH Annual Meeting on Sunday, December 10, 2023.

Key Points: 
  • The data will be provided during a poster presentation at the ASH Annual Meeting on Sunday, December 10, 2023.
  • “Historically, expansion and persistence of cell therapy products and release of functional cytokines have correlated with patient outcomes.
  • We remain on track to provide a clinical update from the Phase 1 study in NHL patients in the second half of 2024."
  • Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
    Date/Time: Sunday, December 10, 2023, from 6:00 - 8:00 p.m. PST

Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Sunday, December 10, 2023
Webcast, Multiple myeloma, Associate, Immunomodulatory imide drug, Safety, SAN, DNA, TSCM, Prodrug, Therapy, Gene, International, CRS, Tissue, Artificial intelligence, SCR, Cytogenetics, Patient, Conference call, Blood, Haemophilia, Conference, Graft-versus-host disease, ORR, TCE, Cancer, Transposase, Partnership, Roche, Malignancy, Antibody, Neurotoxicity, Kinetics, Haemophilia A, RRMM, Cyclophosphamide, BCMA, Physician, Investigator's brochure, Bone marrow, ITT, Vanderbilt-Ingram Cancer Center, Cytokine release syndrome, Vaccine, Pharmaceutical industry, Broadcasting, Hematology

The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results.
  • They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."
  • Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
    Session Title: 704.

Fluidx Medical Reveals New Embolic Platform for Internal Bleeding, Tumor Treatment, and Other Uses

Retrieved on: 
Thursday, November 30, 2023
GPX, Aneurysm, Embolism, Research and development, Risk, Fistula, Tissue, Patient, Refrigeration, Medicine, Internal bleeding, Interventional radiology, ULTRA, Neoplasm, Blood, IDE, Birth, Heel, Investigational device exemption, Investigator's brochure, Uterine fibroid, Medical device, Medical imaging

SALT LAKE CITY, Nov. 30, 2023 /PRNewswire/ -- Fluidx Medical today released information about their new ULTRA™ embolic platform designed to make therapeutic embolization procedures safer, better, and faster. 

Key Points: 
  • SALT LAKE CITY, Nov. 30, 2023 /PRNewswire/ -- Fluidx Medical today released information about their new ULTRA™ embolic platform designed to make therapeutic embolization procedures safer, better, and faster.
  • "Embolic particles are hard to visualize during delivery, increasing the risk of off-target embolization and leading to unintended harm of nearby tissues."
  • "ULTRA is visible under x-ray giving clinicians greater control and visualization of the embolic to ensure safe, accurate delivery."
  • The success of the ULTRA embolic platform follows on the heels of another large milestone for Fluidx Medical, as their flagship product the GPX Embolic Device is currently under Investigational Device Exemption (IDE) review with the FDA.

IN8bio to Present New Positive Data from Phase 1 Trial of INB-100 at 2023 American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Bone marrow, CRS, Society, ASH, User experience, Safety, Patient, Investigator's brochure, Pharmaceutical industry

New data on the completed dose-escalation of this Phase 1 trial highlights promising efficacy of INB-100 in patients with hematologic malignancies; updated data on durability of responses and long-term complete responses (CRs) to be presented.

Key Points: 
  • New data on the completed dose-escalation of this Phase 1 trial highlights promising efficacy of INB-100 in patients with hematologic malignancies; updated data on durability of responses and long-term complete responses (CRs) to be presented.
  • NEW YORK, Nov. 02, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced an abstract detailing new, positive data from the Phase 1 investigator-sponsored trial of INB-100 in patients with hematologic malignancies has been selected for poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 9-12, 2023.
  • Details for the ASH 2023 presentation are as follows:
    Title: INB-100: A Pilot Study of Donor Derived, Ex-Vivo Expanded/Activated Gamma-Delta T Cell (EAGD) Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-Transplant Cyclophosphamide (PTCy)
    Session Name: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
    Ten patients have been treated, completing the dose-escalation of this Phase 1 trial as of the abstract data cutoff of July 14, 2023.
  • Updated data on safety and efficacy, including CRs and durability of response will be presented in December.

Allogene Therapeutics Announces Poster Presentations at the 65th Annual Meeting of the American Society of Hematology

Retrieved on: 
Thursday, November 2, 2023
CAR, Kite Pharma, Malignancy, FC, International Conference on Nuclear Disarmament, Oslo, 2008, B-cell lymphoma, Safety, Research and development, American Society of Clinical Oncology, Conference, Chair, Society, Development, ASH, Risk, Allotransplantation, Follicular lymphoma, Annual general meeting, Kinetics, Cancer, University, ICML, H. Lee Moffitt Cancer Center & Research Institute, Immunotherapy, Therapy, MD Anderson Cancer Center, Investigator's brochure, ASCO, SAN, Pharmaceutical industry, Vaccine, Patient

“All CAR T cells require lymphodepletion to support the expansion and persistence needed to eradicate malignant cells.

Key Points: 
  • “All CAR T cells require lymphodepletion to support the expansion and persistence needed to eradicate malignant cells.
  • Data from the 12 patients, a subset of these 33 CAR T naïve patients, who received the regimen being utilized in ongoing Phase 2 trials was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.
  • This study compared expansion kinetics among 11 allogeneic CAR T recipients treated with investigational ALLO-501A in the ALPHA2 trial.
  • Results of this study could help define strategies to improve allogeneic CAR T expansion, persistence, and efficacy.

Multiple Clinical and Preclinical Presentations at ASH 2023 Highlight Vor Bio’s Novel eHSC and CAR-T Platform

Retrieved on: 
Thursday, November 2, 2023
Acute myeloid leukemia, Doctor of Philosophy, Cell, HIV disease progression rates, Division, Abstract (summary), Abstract, Head, HCT, Exposition, Hospital, CAR, Janssen, Bone marrow, CHOP, Haematopoiesis, University, Toxicity, Safety, Therapy, Transplant, MSCE, Pediatric Transplantation, Lymphoma, ASH, Clinical trial, Prognosis, Cytokine release syndrome, Biomarker, CRS, Investigator's brochure, The Relapse, University of Colorado School of Medicine, CRISPR, Phenotype, Society, National Cancer Institute, CD33, Associate, AML, Nursing, Rare-earth element, Dentistry, Vaccine, Mobile phone, Pharmaceutical industry, Child, Pediatrics, Diagnosis, Patient, MD, Leukemia

An abstract providing a clinical update from the VBP101 clinical trial (NCT048499910), a Phase 1/2a multicenter, open-label, first-in-human study of trem-cel (VOR33) in patients with AML, was accepted by ASH for oral presentation.

Key Points: 
  • An abstract providing a clinical update from the VBP101 clinical trial (NCT048499910), a Phase 1/2a multicenter, open-label, first-in-human study of trem-cel (VOR33) in patients with AML, was accepted by ASH for oral presentation.
  • This data supports robust neutrophil engraftment of trem-cel and provides evidence of hematologic protection from MylotargTM, a CD33-targeted antibody drug conjugate.
  • An updated data release from VBP101 is expected by the Relapse After Transplant and Cellular Therapy (HSCT²) conference taking place November 10-11, 2023.
  • Dr. Tasian commented: “The interim results from our CD33 CAR T cell immunotherapy clinical trial are very encouraging.

Microbot Medical Reveals Successful Short Term Follow Up Outcomes from its Pivotal Pre-Clinical Study

Retrieved on: 
Tuesday, October 31, 2023
FDA, ZEUS robotic surgical system, Investigational device exemption, V&V, Human, IDE, Clinical trial, Animal, Safety, Investigator's brochure, Nursing

The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a total of 48 animal targets.

Key Points: 
  • The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a total of 48 animal targets.
  • This new data follows the recently announced successful initial outcomes from the pivotal pre-clinical study.
  • A total of 6 LIBERTY Systems were used in the study, each was used to reach a total of 8 targets.
  • "We are excited to share additional positive outcomes of our pivotal pre-clinical study.

Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial

Retrieved on: 
Monday, October 9, 2023
Cordella, Incidence, Pressure, III, Mercury (element), Death, Risk, Hospital, Trial of the century, Vanderbilt University Medical Center, Safety, Congestion, Heart rate, Randomized controlled trial, Patient, HF, FDA, Heart failure, New York Heart Association Functional Classification, IDE, Clinical trial, Blood pressure, Investigator's brochure, Pulmonary hypertension, External carotid artery, Pulmonary artery, Investigational device exemption, Pharmaceutical industry, NYHA

"The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years.

Key Points: 
  • "The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years.
  • "The randomized arm of PROACTIVE-HF 2 will be the first study to compare PA pressure-guided therapy to a telehealth control arm.
  • The PROACTIVE-HF 2 prospective, open-label randomized controlled clinical trial will enroll up to 1,500 patients in the U.S. and Europe.
  • "We are establishing a strong foundation of compelling clinical evidence for Cordella with early PROACTIVE-HF data.

Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial

Retrieved on: 
Monday, October 9, 2023
Cordella, Incidence, Pressure, III, Mercury (element), Death, Risk, Hospital, Trial of the century, Vanderbilt University Medical Center, Safety, Congestion, Heart rate, Randomized controlled trial, Patient, HF, FDA, Heart failure, New York Heart Association Functional Classification, IDE, Clinical trial, Blood pressure, Investigator's brochure, Pulmonary hypertension, External carotid artery, Pulmonary artery, Investigational device exemption, Pharmaceutical industry, NYHA

"The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years.

Key Points: 
  • "The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years.
  • "The randomized arm of PROACTIVE-HF 2 will be the first study to compare PA pressure-guided therapy to a telehealth control arm.
  • The PROACTIVE-HF 2 prospective, open-label randomized controlled clinical trial will enroll up to 1,500 patients in the U.S. and Europe.
  • "We are establishing a strong foundation of compelling clinical evidence for Cordella with early PROACTIVE-HF data.

Framework Incorporating DecisionDx®-SCC Test Results into Clinical Decision-Making for Patients with High-Risk Cutaneous Squamous Cell Carcinoma Published in Clinical, Cosmetic and Investigational Dermatology

Retrieved on: 
Monday, June 5, 2023
Science, Other Science, Biotechnology, Research, Oncology, Health, Genetics, Clinical Trials, Investigator's brochure, Neoplasm, National Comprehensive Cancer Network, Cosmetic, NCCN, Guideline, Patient, Risk, Lymph node, Recurrence, Metastasis, Disease, Medical imaging

“The algorithm that we developed is not meant to challenge these established guidelines.

Key Points: 
  • “The algorithm that we developed is not meant to challenge these established guidelines.
  • In the study, three private-practice Mohs surgeons, who routinely use the test to risk-stratify their high-risk cSCC patients, merged their management approaches for three real-world, high-risk cSCC patients into a singular algorithm that provides a framework for incorporating each of the test’s three potential results into current NCCN guidelines.
  • In all three cases presented in the study, use of the algorithm incorporating DecisionDx-SCC test results led to no evidence of disease recurrence or metastasis post-treatment, based on the timing described in the study.
  • The study findings support the use of DecisionDx-SCC test results within established guidelines to enable personalized, risk-aligned management of high-risk cSCC patients and the allocation of healthcare resources to patients at the highest risk of a poor outcome.