New CDMO projects – where we are today
Our contract development and manufacturing business, branded as Bramble Bio, continues to gain momentum. Alongside expanding work with existing partners, we are securing new CDMO projects that collectively support our ambition to triple revenues in 2026. Below is a snapshot of where we currently stand across several key client programmes.
In September last year, we partnered with Keli Therapeutics (Lithuania) to support the development and manufacture of KELI-101, a placentally derived MSC therapy for acute kidney injury following bypass surgery. The programme is expected to enter a Phase Ib/II clinical trial in early 2026. We are close to completing the review of their preliminary manufacturing process and will shortly begin optimisation activities. Manufacturing work to support the clinical trial is planned to start later this year.
During Q4 2025, we geared up to support Dystrogen Therapeutics (USA) with their lead candidate DT-DEC01 for the treatment of Duchenne Muscular Dystrophy. DMD is a severe genetic disorder characterised by progressive muscle degeneration, affecting approximately one in every 3,500–5,000 live male births worldwide. DT-DEC01 uses a novel myoblast fusion-based approach aimed at restoring and preserving muscle function. Manufacturing is currently underway, and the first patient is expected to be treated in March, using the HE-ATMP pathway in Poland.
More recently, MesenBio (UK) has committed to working with us to characterise their FT-01 MSC cell line for the production of extracellular vesicles (EVs). The focus is on achieving improved consistency and scalability, with the initial clinical target being rheumatoid arthritis, where the therapy aims to reduce inflammation and support tissue regeneration. The majority of the analytical work will be carried out by Crioestaminal in Cantanhede, Portugal, with PBKM coordinating and supporting the overall programme.
If you’d like to learn more about what we’re doing, check out our website here or just give us a call!