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EQS-News: ERFOLGE VON DEFENCE BEI SEINEM ACCUTOX®-ARM(TM)-VAKZIN ZUR KREBSBEKÄMPFUNG FÜHREN ZUR ENTWICKLUNG EINES WIRKUNGSVOLLEN ARM-002(TM)-KREBSIMPFSTOFFS DER ZWEITEN GENERATION

Retrieved on: 
Wednesday, April 10, 2024

Bei Tests als therapeutisches Vakzin bei einem Melanom-Modell führte ARM-002TM in Kombination mit dem Immuncheckpoint-Inhibitor Anti-PD1 in 80 % der Fälle zu einer vollständigen Reaktion.

Key Points: 
  • Bei Tests als therapeutisches Vakzin bei einem Melanom-Modell führte ARM-002TM in Kombination mit dem Immuncheckpoint-Inhibitor Anti-PD1 in 80 % der Fälle zu einer vollständigen Reaktion.
  • Darüber hinaus können entwickelte Immunzellen zu einem lang anhaltenden immunologischen Gedächtnis führen, das Patienten vor späteren Krebsrückfällen schützen kann.
  • Defence hat sich dafür entschieden, seinen AccuTOX®-Leitkandidaten zu testen, um einen Krebsimpfstoff der zweiten Generation zu entwickeln, da dieser bei einer intratumoralen Verabreichung in geringeren Dosierungen nachweislich die Antigenpräsentation in Krebszellen verbessert.
  • Der Kern der Defence Therapeutics-Plattform besteht in der ACCUM®-Technologie, die einen präzisen Transport von Impfantigenen oder ADCs in intakter Form zu den Zielzellen ermöglicht.

EQS-News: DEFENCE’S SUCCESSFUL RESULTS ON ITS  ACCUTOX® ANTI-CANCER ARMTM VACCINE CREATES A POTENT SECOND-GENERATION ANTI-CANCER ARM-002TM VACCINE

Retrieved on: 
Wednesday, April 10, 2024

When tested as a therapeutic vaccine in a melanoma cancer model, ARM-002TM leads to an 80% complete response when combined with the anti-PD-1 immune-checkpoint inhibitor.

Key Points: 
  • When tested as a therapeutic vaccine in a melanoma cancer model, ARM-002TM leads to an 80% complete response when combined with the anti-PD-1 immune-checkpoint inhibitor.
  • Compared to current anti-cancer strategies, vaccination can stimulate specific immune responses capable of potentially curing established tumors.
  • In addition, developed immune cells can lead to a long-lasting memory response capable of further protecting the patient from subsequent cancer relapses.
  • Although the ARMTM vaccine can effectively present antigens to responding T cells, the large amount of antigen preparation required to generate the cellular vaccine might represent challenges in the clinic.

Longeveron Issues Letter to Shareholders Highlighting Corporate Strategy, Clinical Pipeline and 2024 Key Priorities and Goals

Retrieved on: 
Monday, April 8, 2024

MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.

Key Points: 
  • MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.
  • Today, I am excited to update you on our overall strategy, business objectives, approach to capital allocation, and 2024 key priorities and goals.
  • Our focus remains steadfast on raising the funds necessary to continue our operations and delivering transformative solutions to patients and creating sustainable value for our shareholders.
  • In 2024, we are focusing our efforts on two of our most promising programs: Hypoplastic Left Heart Syndrome (HLHS); and Alzheimer’s Disease.

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Retrieved on: 
Tuesday, April 9, 2024

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). 

Key Points: 
  • (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).
  • The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.
  • We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."
  • The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS.

Celularity Submits Request to U.S. FDA for Orphan Drug Designation for PDA-002 Asset Treating Facioscapulohumeral Muscular Dystrophy

Retrieved on: 
Wednesday, March 20, 2024

FLORHAM PARK, N.J., March 20, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ: CELU) (“Celularity”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for orphan drug designation for its off-the-shelf, placental-derived cell therapy, PDA-002, for treating Facioscapulohumeral Muscular Dystrophy (FSHD).

Key Points: 
  • FLORHAM PARK, N.J., March 20, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ: CELU) (“Celularity”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for orphan drug designation for its off-the-shelf, placental-derived cell therapy, PDA-002, for treating Facioscapulohumeral Muscular Dystrophy (FSHD).
  • Orphan drug designation is a status given to drugs that show the potential to treat, prevent or diagnose serious or life-threatening diseases that affect fewer than 200,000 people in the U.S.
  • Earlier, Celularity received FDA Investigational New Drug Application clearance for PDA-002 in FSHD and plans to commence a phase 1/2 study in the second half of 2024.
  • The trial serves as an important component for submitting a Biologics License Application (BLA) to the FDA in the future as a potential treatment for FSHD and other types of muscular dystrophy.

CytoMed Therapeutics to Launch Complimentary Cell Banking for Qualified Shareholders for Future Precision Therapies

Retrieved on: 
Monday, March 18, 2024

Recent advances in cell science and technology have enabled researchers to produce specialized cellular therapies from PBMCs.

Key Points: 
  • Recent advances in cell science and technology have enabled researchers to produce specialized cellular therapies from PBMCs.
  • In most cell therapies, using matched donor cells (allogeneic) is required to minimize transplant rejection and maximize therapeutic efficacy.
  • Hence, banking one’s own PBMCs provides a valuable matched cell source for the individual’s own future medical needs.
  • Number of Qualified Shareholders: The Program will be limited to 200 Qualified Shareholders on a first come first served basis.

Global Cord Blood & Tissue Banking Industry Market Size, Segmentation & Forecast Report 2024 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 15, 2024

The "Global Cord Blood & Tissue Banking Industry Report - Market Size, Segmentation, & Forecasts, 2024" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Cord Blood & Tissue Banking Industry Report - Market Size, Segmentation, & Forecasts, 2024" report has been added to ResearchAndMarkets.com's offering.
  • There are now over 800,000 cord blood units stored in public cord blood banks and more than 6.75 million cord blood and tissue units stored within private banks worldwide.
  • Today, nearly all U.S. cord blood banks and approximately one-third of global cord blood banks offer cord tissue storage.
  • The report presents findings on the following topics:
    Rate per cord blood unit in the U.S. and Europe
    Number of clinical trials, number of published scientific papers, and amount of NIH funding for cord blood research
    Number and types of patents for cord blood, cord tissue, and placental products
    The report presents a comprehensive analysis of the global cord blood and tissue banking market.

ShareGate by Workleap Releases Microsoft 365 Tenant-to-Tenant Mailbox Migration

Retrieved on: 
Tuesday, March 12, 2024

MONTRÉAL , March 12, 2024 /PRNewswire/ -- ShareGate by Workleap, the out-of-the-box management solution for Microsoft 365, now includes tenant-to-tenant mailbox migration, to lighten the load of big migration projects with simplicity and ease. As a leader in SharePoint and Teams migration, with the addition of Exchange Online migrations, ShareGate by Workleap is now the complete package for streamlined tenant-to-tenant transitions to Microsoft 365.

Key Points: 
  • With this long-awaited feature, ShareGate users have a single, trusted tool to simplify and accelerate migration projects
    MONTRÉAL , March 12, 2024 /PRNewswire/ -- ShareGate by Workleap, the out-of-the-box management solution for Microsoft 365, now includes tenant-to-tenant mailbox migration , to lighten the load of big migration projects with simplicity and ease.
  • As a leader in SharePoint and Teams migration, with the addition of Exchange Online migrations, ShareGate by Workleap is now the complete package for streamlined tenant-to-tenant transitions to Microsoft 365.
  • ShareGate by Workleap's new mailbox migration offering takes the complexity out of moving to Microsoft 365, so businesses can pivot faster than the speed of change.
  • Over 75,000 IT professionals trust ShareGate by Workleap to simplify daily operations for Microsoft 365 and SharePoint environments.

Celularity to Present Data Showing Cancer Tumor Reduction by Off-the-Shelf Cell Therapy Derived from Human Placental Cells

Retrieved on: 
Thursday, March 7, 2024

These data, which highlight the platform’s robust anti-tumor activity against gastric cancer will be presented on April 9th, 2024.

Key Points: 
  • These data, which highlight the platform’s robust anti-tumor activity against gastric cancer will be presented on April 9th, 2024.
  • Celularity is developing a platform to combine a broad portfolio of cell therapies with various approved antibodies to address multiple cancers and other conditions.
  • Celularity’s preclinical asset, PT-CD16VS, is initially being developed in combination with trastuzumab, a cancer drug, for treating HER2-positive cancers.
  • “These data demonstrate the promise and potential of combining Celularity’s cell therapy assets with currently available therapies to address difficult-to-treat cancers,” said Dr. Robert Hariri, Celularity’s CEO and Founder.

CytoMed Therapeutics Limited Announces Research Collaboration with Singapore Sengkang General Hospital to Advance Injectable Umbilical Cord-Derived Mesenchymal Stem Cells for Cartilage Diseases and Repair

Retrieved on: 
Monday, March 4, 2024

Osteoarthritis of the knee is a debilitating disease affecting Singapore’s aging population and the clinical trial will pioneer stem cell use for regenerative medicine in Singapore.

Key Points: 
  • Osteoarthritis of the knee is a debilitating disease affecting Singapore’s aging population and the clinical trial will pioneer stem cell use for regenerative medicine in Singapore.
  • UC-MSCs are a type of adult stem cells that can be isolated from the umbilical cord tissue after childbirth.
  • UC-MSCs are considered multipotent and are able to differentiate into different cell types, including bone, cartilage, fat, and muscle cells.
  • "Our collaboration with CytoMed marks a significant step in advancing research on allogeneic in-vivo UC-MSC for cartilage repair, including osteoarthritis of the knee.