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ShiftBio Partners with RoosterBio to Accelerate Development of a Novel Genetically Engineered Exosome, SBI-102 for Rare Diseases and Cancer

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RoosterBio’s MSC-derived exosome bioprocess technology platform enables accelerated development of ShiftBio’s lead therapeutic candidate via a scalable cGMP manufacturing process in bioreactors, downstream purification, and analytical characterization.

Seoul, South Korea and Frederick, MD, April 26, 2022 – ShiftBio, a leader in the development of innovative exosome platform technologies, announced today a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (MSCs), highly engineered media, and bioprocess development services. This partnership will accelerate ShiftBio’s therapeutic candidates, starting with SBI-102 (Stem cell-derived exosomes expressing a therapeutic ligand), into the clinic. [Read more…]

FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial

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AUSTIN, Texas, April 21, 2022 – Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV company to receive FDA Phase 3 approval for an Investigational New Drug (IND) indication to date.
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Exosomes: Company Spotlights from “A” to “Z”

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Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells.

In recent years, exosomes have gained attention as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering the cells to patients.

With at least 22,143 scientific articles published about exosomes and 253 clinical trials underway, these small vesicles have intriguing potential to be used within a range of therapeutic applications. [Read more…]

Ciloa secures €5 million for the development of its new generation of biomedicines and vaccines using exosomes

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  • The company finalized a €3.5 million fundraising and obtained €1.5 million in public funding as part of the “Emerging Infectious Diseases and CBRN Threats” call for proposals of the France 2030 investment plan, operated on behalf of the French government by Bpifrance. This aid was more specifically granted for the development of a natural vaccine against the Covid-19 delta variant.
  • With its own production unit to meet GMP (Good Manufacturing Practices) standards, Ciloa is now positioned as a major player in the development of therapeutic and preventive products using its tailor-made exosome modification technology.

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Exogenus Therapeutics and Boehringer Ingelheim Collaboratively Explore Extracellular Vesicles for Regenerative Medicine Applications

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Cantanhede, Portugal, March 2, 2022 – Exogenus Therapeutics is proud to announce a new research collaboration with Boehringer Ingelheim to explore the use of extracellular vesicles as therapeutic tools for regenerative medicine. This joint effort led by Boehringer Ingelheim’s Research Beyond Borders (RBB) Unit focuses on pre-clinical testing of Exogenus Therapeutics’ lead candidate Exo-101, in various regenerative medicine indications. [Read more…]

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