Allotransplantation

Legacy Medical Consultants Announces Major Headquarters Expansion

Retrieved on: 
Wednesday, April 24, 2024

FORT WORTH, Texas, April 24, 2024 /PRNewswire/ -- Legacy Medical Consultants today announced plans to more than double the size of its headquarters facilities to accommodate its expanding operations and portfolio of allografts for wound care.

Key Points: 
  • FORT WORTH, Texas, April 24, 2024 /PRNewswire/ -- Legacy Medical Consultants today announced plans to more than double the size of its headquarters facilities to accommodate its expanding operations and portfolio of allografts for wound care.
  • "Our focus is on the well-being of patients who use our products," said Legacy Chief Executive Officer Jonathan Knutz .
  • "Training and culture are very important to us," said Legacy Chief Operating Officer David Cornell.
  • "Our new facility will help us embrace our culture and shows our commitment to wound care patients."

Tr1X Announces FDA Clearance of First Investigational New Drug Application for TRX103, an Allogeneic Regulatory T-Cell Therapy to Treat Autoimmune Diseases

Retrieved on: 
Wednesday, April 10, 2024

The company plans to initiate a Phase 1 study of TRX103, an investigational allogeneic off-the-shelf Tr1 Treg therapy, for this indication in the second quarter of 2024.

Key Points: 
  • The company plans to initiate a Phase 1 study of TRX103, an investigational allogeneic off-the-shelf Tr1 Treg therapy, for this indication in the second quarter of 2024.
  • Additionally, the company is on track to submit an IND for TRX103 for patients with refractory Crohn's disease in the third quarter of 2024.
  • This should enable Tr1X to develop further pipeline candidates that address even larger patient populations with equally unmet medical needs."
  • "Allogeneic stem cell transplantation is the only curative treatment for many advanced blood cancers and genetic and acquired diseases.

Engage with Pluri's Talent: Exciting Conference Appearances Ahead

Retrieved on: 
Tuesday, March 19, 2024

BIO-Europe Spring connects the global biopharma community to elevate life science partnerships, bringing together over 3,700 attendees from 2,000+ companies to engage in 20,000 one-on-one meetings.

Key Points: 
  • BIO-Europe Spring connects the global biopharma community to elevate life science partnerships, bringing together over 3,700 attendees from 2,000+ companies to engage in 20,000 one-on-one meetings.
  • The Advanced Therapies congress is Europe’s largest cell and gene therapy conference and exhibition.
  • Pluri’s Chief Executive Officer & President Yaky Yanay will be presenting at the conference on Thursday, March 28, 2024 at 2:20 PM.
  • CISH Impact Investments Holdings Conference is a global event on impact opportunities and investments in promising technology companies that have a positive impact on the community and the environment.

West Point Optical Group, LLC and Verséa Ophthalmics, Inc. Announce Partnership Supply Agreement for  BIOVANCE®and BIOVANCE® 3L Ocular

Retrieved on: 
Wednesday, April 3, 2024

BIOVANCE® and BIOVANCE® 3L Ocular, which are single-layer and three-layer (3L) allografts, respectively, are intended for use as a biological membrane covering that provides an extracellular matrix.

Key Points: 
  • BIOVANCE® and BIOVANCE® 3L Ocular, which are single-layer and three-layer (3L) allografts, respectively, are intended for use as a biological membrane covering that provides an extracellular matrix.
  • BIOVANCE® 3L Ocular is acellular and consists of three layers of amniotic basement membrane that supports treatment of advanced ocular surface disease.
  • As a barrier membrane, BIOVANCE® 3L Ocular is intended to protect the underlying tissue and preserve tissue plane boundaries.
  • “We are excited to partner with Verséa Ophthalmics allowing our eye care professionals to deliver the benefits of BIOVANCE® and BIOVANCE® 3L Ocular products to their patients,” said John Womack, OD, West Point Optical Group’s Chief Medical Officer.

Imugene Highlights Recent Achievements and Looks Ahead to Key Upcoming Immuno-oncology Catalysts

Retrieved on: 
Thursday, February 22, 2024

Imugene Managing Director & CEO Leslie Chong said: “We are encouraged by the initial safety and efficacy signals seen to date.

Key Points: 
  • Imugene Managing Director & CEO Leslie Chong said: “We are encouraged by the initial safety and efficacy signals seen to date.
  • Notably, in our Phase 1 MAST CF33 oncolytic virus trial, we’ve seen encouraging response rates during dose escalation, including one complete response in a patient with cholangiocarcinoma, and two partial responses in melanoma as we continue to dose escalate with no safety issues.
  • Importantly, two out of three of these responses were achieved with CF33 monotherapy.
  • onCARlytics uses an antigen/target-armed CF33, followed by treatment with a CD19 targeting therapy directed against that antigen or target.

Orphan designation: Allogeneic peripheral blood-derived haematopoietic stem and progenitor cells, regulatory T cells and conventional T cells Treatment in haematopoietic stem cell transplantation, 25/07/2023 Positive

Retrieved on: 
Sunday, February 4, 2024

EU/3/23/2815 - orphan designation for treatment in haematopoietic stem cell transplantation

Key Points: 
  • EU/3/23/2815 - orphan designation for treatment in haematopoietic stem cell transplantation
    Allogeneic peripheral blood-derived haematopoietic stem and progenitor cells, regulatory T cells and conventional T cells
    OrphanHuman
    Phortas GmbH
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Orphan designation: Allogeneic amniotic fluid-derived mesenchymal stem cells with lung specificity Prevention of primary graft dysfunction following lung transplantation, 13/12/2023 Positive

Retrieved on: 
Sunday, February 4, 2024

EU/3/23/2860 - orphan designation for prevention of primary graft dysfunction following lung transplantation

Key Points: 
  • EU/3/23/2860 - orphan designation for prevention of primary graft dysfunction following lung transplantation
    Allogeneic amniotic fluid-derived mesenchymal stem cells with lung specificity
    OrphanHuman
    Amniotics AB
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Century Therapeutics Presents Initial Data from CNTY-101 Phase 1 ELiPSE-1 Trial Supporting the Potential for a Multi-Dosing Strategy for CAR iNK Enabled by Allo-Evasion™ Edits

Retrieved on: 
Saturday, December 9, 2023

PHILADELPHIA, Dec. 09, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced the presentation of initial clinical data from a single-patient case study which Century believes support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12 in San Diego. The poster, titled, “Multiple Doses of CNTY-101, an iPSC-Derived Allogeneic CD19 Targeting CAR-NK Product, are Safe and Result in Tumor Microenvironment Changes Associated with Response: A Case Study”, is available on the Scientific Resources page of the Company’s website.

Key Points: 
  • “We are thrilled that the initial clinical evidence for CNTY-101 provides support for the potential for Allo-Evasion™ to enable a multi-dosing regimen without the need for continued lymphodepletion.
  • Cycles one and two included three days of lymphodepletion (LD), whereas cycles three through seven were given with no LD.
  • Importantly, tumor microenvironment initial analyses demonstrated a vigorous increase in T cells within 8 days of the 1st CNTY-101 cell infusion.
  • The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website.

Adaptive Biotechnologies and Collaborators to Present More than 30 Abstracts Demonstrating the Actionability of clonoSEQ® MRD Testing in Blood Cancer Patient Care and Drug Development at the 65th ASH Annual Meeting

Retrieved on: 
Tuesday, December 5, 2023

Updated Results of the Phase I BALLI-01 Trial of UCART22 Process 2 (P2), an Anti-CD22 Allogeneic CAR-T Cell Product Manufactured By Cellectis Biologics, in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Key Points: 
  • Updated Results of the Phase I BALLI-01 Trial of UCART22 Process 2 (P2), an Anti-CD22 Allogeneic CAR-T Cell Product Manufactured By Cellectis Biologics, in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
    Undetectable MRD Status in Patients with R/R CLL/SLL with Stable Disease after Lisocabtagene Maraleucel Treatment: Exploratory Analysis of the TRANSCEND CLL 004 Study
    Fixed-Duration Pirtobrutinib Combined with Venetoclax ± Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia: Updated Results, Including MRD Data, from the BRUIN Phase 1b Study
    Impact of Sequence Uniqueness on MRD Monitoring in NGS Immunoglobulin Sequencing: An Analysis of Ig Loci Among >1200 Diffuse Large B-Cell Lymphoma Patients Tested By ClonoSEQ
    Epcoritamab SC Monotherapy Leads to Deep and Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma: First Data Disclosure from the Epcore NHL-1 Follicular Lymphoma Dose-Expansion Cohort
    Early Peripheral Blood Minimal Residual Disease Status By NGS in Patients with Newly Diagnosed Multiple Myeloma (MM) on a Phase 2 Trial Receiving Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd)
    Primary Endpoint Analysis from a Response Adaptive Phase II Clinical Trial of Carfilzomib, Lenalidomide, Dexamethasone Plus Daratumumab (KRd-Dara) in Patients with Newly Diagnosed Multiple Myeloma (NDMM)
    Sequential T-Cell Engagement for Myeloma (“STEM”) Trial: A Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell Therapy
    A Phase II Study of Isatuximab, Once Weekly Carfilzomib, Lenalidomide, Dexamethasone, in Newly Diagnosed, Transplant-Eligible Multiple Myeloma (The SKylaRk Trial)
    Longitudinal Assessment of Minimal Residual Disease (MRD) in the ATLAS Randomized Phase 3 Trial of Post-Transplant Treatment with Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Versus Lenalidomide (R) Alone in Patients with Newly Diagnosed Multiple Myeloma (NDMM)
    Final Analysis of a Phase 2 Trial of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma (NDMM) without Autologous Stem Cell Transplantation (ASCT)
    Phase II Trial of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma
    Update for the "Watch" Registry, a Real-World Observational Study Using clonoSEQ® to Monitor MRD in Lymphoid Malignancies

ALLOSOURCE ANNOUNCES FIRST IMPLANT OF ACECONNEX™ PRE-SUTURED FASCIA DEVICE IN HIP LABRAL RECONSTRUCTION PROCEDURE

Retrieved on: 
Wednesday, November 8, 2023

CENTENNIAL, Colo., Nov. 8, 2023 /PRNewswire/ -- AlloSource®, one of the largest allograft providers creating innovative tissue products to help surgeons heal their patients, today announced the first implant of AceConnex Pre-Sutured Fascia device for hip labral reconstruction and augmentation. The labral reconstruction procedure was conducted by Dr. Winston Gwathmey at University of Virginia Health as part of AceConnex's limited market release, and marks the next step in the advancement of AlloSource's products to support hip arthroscopy. 

Key Points: 
  • CENTENNIAL, Colo., Nov. 8, 2023 /PRNewswire/ -- AlloSource®, one of the largest allograft providers creating innovative tissue products to help surgeons heal their patients, today announced the first implant of AceConnex Pre-Sutured Fascia device for hip labral reconstruction and augmentation.
  • "I appreciated having AceConnex Pre-Sutured Fascia for this labral reconstruction procedure because it made my process in the operating room more efficient versus the extra time suturing myself," said Dr. Gwathmey
    "I appreciated having AceConnex Pre-Sutured Fascia for this labral reconstruction procedure because it made my process in the operating room more efficient versus the extra time suturing myself," said Dr. Gwathmey.
  • For years, fascia allografts have been documented as an effective allograft for labral reconstruction.
  • 1,2
    "The AceConnex Pre-Sutured Fascia allograft device represents a commitment to developing patient specific solutions to treat hip labral injuries as part of our comprehensive sports medicine and hip arthroscopy portfolio," said Kevin Whitten, AlloSource Chief Commercial Officer.