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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• 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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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…]

• Astellas Institute for Regenerative Medicine (AIRM) is a subsidiary of Astellas Pharma Inc., a top 20 global pharmaceutical company

• Initial services will seek to validate Exopharm’s LEAP, LOAD and EVPS technology platforms to manufacture exosomes for Astellas, firstly at Exopharm’s facilities in Melbourne followed by the Astellas facilities in Massachusetts USA

• Future potential collaboration is anticipated following validation

• This is Exopharm’s first collaboration services agreement with a major pharmaceutical company

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Paris, 18 November 2021 — EVerZom, a biopharmaceutical company specialized in the biomanufacturing of extracellular vesicles (or exosomes), announced today that it has obtained non-dilutive funding of €2.5 million as the winner of the European EIC Accelerator competition (Horizon Europe). This funding will enable the company to transfer its extracellular vesicle biomanufacturing technology for a first clinical grade batch production and to accelerate the scale-up of its production capabilities by developing a process compatible with clinical Phase 2/3 for the pharmaceutical industry. [Read more…]