INmune Bio, a Nasdaq-listed biotechnology firm, has entered into a partnership with Cell and Gene Therapy Catapult (CGT Catapult) to develop commercial-scale manufacturing capabilities for its investigational cell therapy platforms.
The agreement focuses initially on scaling production of CORDStrom, a cell-based therapy targeting the systemic manifestations of recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic condition.
The manufacturing arrangement leverages INmune Bio’s existing production operations at the Royal Free Hospital in London and incorporates infrastructure and technical expertise from CGT Catapult’s manufacturing innovation centre in Stevenage, England.
CGT Catapult is a non-profit organisation established through Innovate UK, which facilitates the industrial development of cell and gene therapies by working with academic and industry partners.
CGT Catapult chief executive Matthew Durdy said: “INmune Bio’s therapies address important healthcare challenges, and we are delighted to be working with them to support their journey to becoming a commercial scale developer and manufacturer of cell therapies and help them meet rising demand for their products.
“The decision to strengthen their presence in the UK will help ensure that patients here benefit from novel cell therapies and support the UK’s position as a global hub for advanced therapies.”
CORDStrom is currently under evaluation in a Phase 2 randomised clinical trial and has been developed to address multiple systemic symptoms of RDEB, including chronic pain and compromised skin integrity.
Preliminary clinical data suggest the therapy may contribute to symptom reduction and improvements in skin condition and disease progression.
INmune Bio has projected that approximately 4,000 paediatric patients with moderate to severe forms of the condition across the US, the UK, and European Union (EU) could be eligible for the therapy, subject to regulatory approval.
The company intends to use the partnership to support clinical trial supply and establish the foundation for regulatory submissions, including a biologics license application (BLA) in the US and a marketing authorisation application (MAA) in the UK and EU.
The organisation has stated that CORDStrom may become the first cell-based therapeutic to target the full systemic impact of RDEB.
INmune Bio chief scientific officer and co-founder Mark Lowdell said: “The collaboration with the team at CGT Catapult since starting to plan this transition has been a great experience of the sort of partnership needed to get these complex medicines from clinical trial to commercial delivery.
“The unmatched scale of this UK-based facility provides INmune Bio, with an exceptional platform to advance our next phase of corporate growth, developing and trialing UK-invented products.”
Following the manufacturing scale-up of CORDStrom, INmune Bio plans to transfer production of its NK-cell priming platform, INKmune, to the same facility.
INKmune is designed to stimulate the patient’s own natural killer cells to attack solid tumours and is currently undergoing clinical testing in the US and UK, including a Phase 2 trial in metastatic castration-resistant prostate cancer.
INmune Bio is pursuing a diversified portfolio of immune-modulating therapies for chronic inflammatory conditions and oncology indications. The company has active trials underway across multiple jurisdictions including the UK, EU, Australia, Canada and the US.
