Cell therapy weekly: regulatory boost for automated cell therapy production platform
This week: bluebird bio (MA, USA) received a competing acquisition bid worth 50% more per share than its existing offer, the FDA (MD, UDA) granted Advanced Manufacturing Technology designation to Cellares’ (CA, USA) Cell Shuttle. Plus, Coya Therapeutics (TX, USA) provided an update on its regulatory T cell-derived exosome (Treg exosome) platform.
The news highlights:
- Bluebird bio: an acquisition, a competing bid and a new partnership
- Cellares’ Cell Shuttle receives Advanced Manufacturing Technology designation
- Update on Treg exosome platform
Bluebird bio: an acquisition, a competing bid and a new partnership
bluebird bio announced on 21 February 2025 that it had entered into a definitive agreement to be acquired global investment firms Carlyle (DC, USA) and SK Capital (NY, USA) for US$3.00 per share in cash, plus a contingent value right of $6.84 per share if certain sales targets are met. The acquisition is expected to close in the first half of 2025, pending regulatory approvals.
However, bluebird announced on 28 March 2025 that Ayrmid Ltd (London, UK) – the parent company of Gamida Cell (MA, USA) – has made an unsolicited proposal to acquire bluebird for $4.50 per share plus the same contingent value right. bluebird’s Board of Directors is reviewing Ayrmid’s offer but has not changed its recommendation and states it will update its stockholders as appropriate.
Since then, Xcellbio (CA, USA) has partnered with bluebird to support the commercialization of its gene therapy for sickle cell disease, LYFGENIA. Through a commercial license and supply agreement, bluebird bio will integrate Xcellbio’s AVATAR™ cell manufacturing technology into its potency assay, which predicts the therapy’s effectiveness. AVATAR’s proprietary HYPERPRESS™ incubation technology mimics the body’s microenvironment where red blood cell sickling occurs.
“We’re humbled to play a small part in what is a transformative treatment option for patients suffering from sickle cell disease,” said Brian Feth, CEO of Xcellbio. “This agreement advances our business strategy of supporting new modalities in order to bring transformative treatment options to patients.”
Cellares’ Cell Shuttle receives Advanced Manufacturing Technology designation
Cellares announced that its Cell Shuttle™ has received the Advanced Manufacturing Technology designation from the FDA’s Center for Biologics Evaluation and Research. This designation recognizes the Cell Shuttle’s ability to automate and streamline cell therapy manufacturing, improving efficiency, quality and scalability. As a result, cell therapy developers using Cellares’ Integrated Development and Manufacturing Organization (IDMO) services will benefit from prioritized FDA review, potentially accelerating regulatory approvals and patient access.
“The FDA’s AMT designation for the Cell Shuttle validates Cellares’ quality-by-design methodology and provides therapy developers an expedited regulatory pathway,” said Eric Fulmer, Vice President of Quality at Cellares. “By automating cell therapy manufacturing on the Cell Shuttle, our clients will have a streamlined and cost-effective pathway from clinical development to commercial manufacture, ultimately accelerating patient access to these critical therapies.”
Update on Treg exosome platform
Coya Therapeutics provided an update on its Treg exosome platform, which is being developed as a potential treatment for systemic and neurodegenerative diseases driven by chronic inflammation. These exosomes have shown promise in preclinical studies, demonstrating the ability to suppress inflammatory responses and potentially slow disease progression. Unlike traditional Treg therapies, exosomes are not susceptible to losing their suppressive function in highly inflammatory environments.
Key progress updates include:
- Manufacturing: In Q1 of 2025, Coya produced initial engineering batches of Treg exosomes using expanded Tregs from healthy donors.
- Optimization: The Johnson Center is now working on additional manufacturing runs to characterize the product’s attributes and ensure reproducibility.
- Scaling up: Once optimization is complete, GMP manufacturing of larger-scale clinical batches is planned before the end of 2025, moving the therapy closer to clinical trials.
Chief Medical Officer Fred Grossman commented: “Our Treg focused pipeline continues its advancement with the goal of manufacturing an allogeneic (off-the-shelf) specific modality that has the potential to be a first-in-class disease-modifying treatment for devastating neurodegenerative diseases of high unmet need. This approach complements and adds to our pipeline of therapies, including COYA-302, that aim to enhance Tregs and suppress neuroinflammation to slow progression in several neurodegenerative diseases.”