8-K: INmune Bio Partners with Cell and Gene Therapy Catapult to Scale Up CORDStrom Manufacturing

INmune Bio has partnered with Cell and Gene Therapy Catapult to establish large-scale manufacturing for its cell therapy platforms, initially focusing on CORDStrom for RDEB.

Summary

• INmune Bio has partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to scale up manufacturing for its cell therapy platforms.
• The collaboration aims to establish commercial-ready manufacturing, initially focusing on CORDStrom for recessive dystrophic epidermolysis bullosa (RDEB).
• CORDStrom has shown promise in a Phase 2 trial, reducing pain and itch and improving skin integrity in RDEB patients.
• INmune Bio estimates that approximately 4,000 children with intermediate to severe RDEB in the US, UK, and EU could benefit from CORDStrom.
• Following CORDStrom, INmune Bio plans to transition production of INKmune, its NK-priming cell medicine for solid tumors, to the same facility.
• This partnership is expected to accelerate INmune Bio's path to commercialization while preserving operational control.

Sentiment

Score: 8

Explanation: The announcement is positive due to the strategic partnership that supports commercialization efforts and leverages established expertise. The focus on promising therapies and expansion into the UK market further contributes to the positive sentiment.

Positives

• The partnership with CGT Catapult provides INmune Bio with access to expertise and facilities for large-scale manufacturing.
• CORDStrom has shown promising results in a Phase 2 trial for RDEB.
• The collaboration supports INmune Bio's goal of commercializing its cell therapy platforms.
• The UK location supports the development and trialing of UK-invented products.
• The partnership helps to meet the rising demand for INmune Bio's products.

Risks

• Clinical trials are in early stages, and there is no assurance that any specific outcome will be achieved.
• CORDStrom, XPro1595 (XPro), and INKmune are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved.
• The company's ability to produce more drug for clinical trials is a risk.
• The availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization is a risk.

Future Outlook

INmune Bio aims to advance its cell therapy platforms towards commercialization, starting with CORDStrom for RDEB and then transitioning to INKmune for solid tumors.

Management Comments

• Matthew Durdy, Chief Executive of the CGT Catapult, said that they are delighted to be working with INmune Bio to support their journey to becoming a commercial scale developer and manufacturer of cell therapies.
• Professor Mark Lowdell, CSO and co-founder of INmune Bio 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.'

Industry Context

This announcement reflects the growing trend of biotechnology companies partnering with specialized manufacturing organizations to scale up production and accelerate commercialization of cell and gene therapies. The CGT Catapult plays a key role in supporting the UK's position as a global hub for advanced therapies.

Comparison to Industry Standards

• The partnership between INmune Bio and CGT Catapult is similar to other collaborations in the cell and gene therapy space, where companies leverage specialized manufacturing expertise to overcome production bottlenecks.
• For example, companies like Novartis and Gilead have invested heavily in their own manufacturing facilities and partnerships to support the commercialization of CAR-T cell therapies.
• CGT Catapult's Stevenage Manufacturing Innovation Centre is a leading facility in the UK, comparable to other advanced therapy manufacturing hubs globally, such as the Center for Innovation in Manufacturing of Biopharmaceuticals (CIMB) in the US.

Stakeholder Impact

• Shareholders: Positive impact due to the potential for commercialization and revenue generation.
• Patients: Potential access to new and innovative therapies for RDEB and solid tumors.
• Employees: Opportunity for growth and development within the company.
• UK: Supports the UK's position as a global hub for advanced therapies.

Next Steps

• Scale up production of CORDStrom at CGT Catapult's Stevenage Manufacturing Innovation Centre.
• Transition production of INKmune to the same facility.
• Advance clinical trials for CORDStrom and INKmune.
• Prepare for Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions for CORDStrom.

Key Dates

Keywords

INmune Bio, Cell and Gene Therapy Catapult, CORDStrom, INKmune, RDEB, Manufacturing, Cell Therapy, Commercialization, Clinical Trials, Biotechnology