INmune Bio Partners with Cell and Gene Therapy Catapult to Scale Up CORDStrom™ Manufacturing for Commercial Readiness
INmune Bio (NASDAQ: INMB) has partnered with Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for its cell therapy platforms. The collaboration focuses initially on scaling production of CORDStrom™, a therapy for recessive dystrophic epidermolysis bullosa (RDEB).
Recent Phase 2 trial results showed CORDStrom™ reduced pain and itch while potentially improving skin integrity and disease activity. The company estimates approximately 4,000 children with intermediate to severe RDEB in the US, UK, and EU could benefit from this treatment.
Following CORDStrom™, INmune Bio plans to transition production of INKmune®, its NK-priming cell medicine for solid tumors, to the same facility. The partnership leverages CGT Catapult's expertise at its Stevenage Manufacturing Innovation Centre, building on INmune Bio's existing manufacturing base at the Royal Free Hospital.
INmune Bio (NASDAQ: INMB) ha stretto una partnership con il Cell and Gene Therapy Catapult (CGT Catapult) per stabilire una produzione su larga scala, pronta per il mercato, per le sue piattaforme di terapia cellulare. La collaborazione si concentra inizialmente sull'aumento della produzione di CORDStrom™, una terapia per l'epidermolisi bollosa distrofica recessiva (RDEB).
I risultati recenti della fase 2 della sperimentazione clinica hanno mostrato che CORDStrom™ riduce il dolore e il prurito, migliorando potenzialmente l'integrità della pelle e l'attività della malattia. L'azienda stima che circa 4.000 bambini con RDEB da moderata a severa negli Stati Uniti, Regno Unito e UE potrebbero beneficiare di questo trattamento.
Dopo CORDStrom™, INmune Bio prevede di trasferire la produzione di INKmune®, il suo medicinale a base di cellule NK per tumori solidi, nella stessa struttura. La partnership sfrutta l'esperienza del CGT Catapult presso il suo Stevenage Manufacturing Innovation Centre, costruendo sulla base produttiva esistente di INmune Bio presso il Royal Free Hospital.
INmune Bio (NASDAQ: INMB) se ha asociado con Cell and Gene Therapy Catapult (CGT Catapult) para establecer una fabricación a gran escala, lista para el mercado, de sus plataformas de terapia celular. La colaboración se centra inicialmente en aumentar la producción de CORDStrom™, una terapia para la epidermólisis bullosa distrófica recesiva (RDEB).
Los resultados recientes del ensayo de fase 2 mostraron que CORDStrom™ redujo el dolor y la picazón, mientras que potencialmente mejoraba la integridad de la piel y la actividad de la enfermedad. La empresa estima que aproximadamente 4,000 niños con RDEB de moderada a severa en EE. UU., Reino Unido y UE podrían beneficiarse de este tratamiento.
Después de CORDStrom™, INmune Bio planea trasladar la producción de INKmune®, su medicina celular de activación de NK para tumores sólidos, a la misma instalación. La asociación aprovecha la experiencia de CGT Catapult en su Centro de Innovación de Fabricación de Stevenage, construyendo sobre la base de fabricación existente de INmune Bio en el Royal Free Hospital.
INmune Bio (NASDAQ: INMB)는 Cell and Gene Therapy Catapult (CGT Catapult)와 협력하여 자사의 세포 치료 플랫폼을 위한 대규모 상업 생산을 구축하고 있습니다. 이 협력은 처음에 CORDStrom™의 생산 확대에 초점을 맞추고 있으며, 이는 열성형 피부 수포증(RDEB) 치료제입니다.
최근 2상 시험 결과에 따르면 CORDStrom™은 통증과 가려움증을 줄이는 동시에 피부의 무결성과 질병 활동을 개선할 가능성이 있는 것으로 나타났습니다. 회사는 미국, 영국 및 EU에서 중증도에서 심각한 RDEB를 앓고 있는 약 4,000명의 아동이 이 치료의 혜택을 받을 수 있을 것으로 추정하고 있습니다.
CORDStrom™ 이후, INmune Bio는 고형 종양을 위한 NK-프라이밍 세포 의약품인 INKmune®의 생산을 같은 시설로 이전할 계획입니다. 이 파트너십은 INmune Bio가 Royal Free Hospital에서 보유한 기존 제조 기반을 바탕으로 Stevenage Manufacturing Innovation Centre에서 CGT Catapult의 전문성을 활용하고 있습니다.
INmune Bio (NASDAQ: INMB) a établi un partenariat avec le Cell and Gene Therapy Catapult (CGT Catapult) pour mettre en place une fabrication à grande échelle, prête pour le marché, de ses plateformes de thérapie cellulaire. La collaboration se concentre initialement sur l'augmentation de la production de CORDStrom™, une thérapie pour l'épidermolyse bulleuse dystrophique récessive (RDEB).
Les résultats récents des essais de phase 2 ont montré que CORDStrom™ réduisait la douleur et les démangeaisons tout en améliorant potentiellement l'intégrité de la peau et l'activité de la maladie. L'entreprise estime qu'environ 4 000 enfants souffrant de RDEB modéré à sévère aux États-Unis, au Royaume-Uni et dans l'UE pourraient bénéficier de ce traitement.
Après CORDStrom™, INmune Bio prévoit de transférer la production de INKmune®, son médicament à base de cellules NK pour les tumeurs solides, dans la même installation. Ce partenariat tire parti de l'expertise de CGT Catapult dans son Stevenage Manufacturing Innovation Centre, s'appuyant sur la base de fabrication existante d'INmune Bio au Royal Free Hospital.
INmune Bio (NASDAQ: INMB) hat eine Partnerschaft mit dem Cell and Gene Therapy Catapult (CGT Catapult) geschlossen, um eine großangelegte, marktreife Herstellung für seine Zelltherapie-Plattformen zu etablieren. Die Zusammenarbeit konzentriert sich zunächst auf die Skalierung der Produktion von CORDStrom™, einer Therapie für die rezessive dystrophische Epidermolysis bullosa (RDEB).
Die aktuellen Ergebnisse der Phase-2-Studie zeigten, dass CORDStrom™ Schmerzen und Juckreiz reduzierte und möglicherweise die Hautintegrität und die Krankheitsaktivität verbesserte. Das Unternehmen schätzt, dass etwa 4.000 Kinder mit mittelschwerer bis schwerer RDEB in den USA, Großbritannien und der EU von dieser Behandlung profitieren könnten.
Nach CORDStrom™ plant INmune Bio, die Produktion von INKmune®, seinem NK-primierenden Zellmedikament für solide Tumoren, in dieselbe Einrichtung zu verlagern. Die Partnerschaft nutzt die Expertise von CGT Catapult im Stevenage Manufacturing Innovation Centre und baut auf der bestehenden Produktionsbasis von INmune Bio im Royal Free Hospital auf.
- Expansion of manufacturing capabilities to commercial scale
- Positive Phase 2 trial results for CORDStrom™
- Large addressable market of 4,000 potential RDEB patients
- Strategic partnership with established manufacturing expert CGT Catapult
- Significant investment required for manufacturing scale-up
- Products still in clinical trial phase, not yet commercially approved
Insights
INmune Bio's partnership with CGT Catapult represents a significant strategic advancement in their commercialization journey. Moving from clinical-scale to commercial-ready manufacturing is one of the most challenging transitions for cell therapy companies, often becoming a critical bottleneck that delays market entry.
The collaboration builds upon INmune's existing manufacturing foundation at Royal Free Hospital while leveraging CGT Catapult's specialized expertise and infrastructure at their Stevenage Manufacturing Innovation Centre. This dual-facility approach provides both immediate capacity scaling and long-term manufacturing security - a prudent strategy for cell therapy developers.
For CORDStrom™, which has shown promising Phase 2 results for RDEB, establishing robust commercial manufacturing capabilities is essential before submitting regulatory applications like BLA and MAA. The estimated market of 4,000 children with intermediate to severe RDEB across key markets represents a focused initial commercial opportunity that aligns well with specialized manufacturing processes for rare disease treatments.
The planned transition of INKmune® production to the same facility demonstrates manufacturing consolidation that typically yields operational efficiencies and quality control standardization across the portfolio. This signals manufacturing maturity and preparation for multi-product commercialization.
By partnering with CGT Catapult rather than building entirely independent facilities, INmune Bio has chosen a capital-efficient approach that accelerates timeline to market readiness while maintaining operational control over their manufacturing processes - a balanced strategy that serves both near-term clinical supply needs and longer-term commercial objectives.
This manufacturing partnership has particular significance for RDEB patients, who currently have few effective treatment options for this devastating genetic disorder. CORDStrom™ addresses the systemic nature of RDEB - a critical therapeutic advantage since the condition affects multiple body systems beyond just skin manifestations.
The Phase 2 randomized trial results mentioned show meaningful symptom improvements in pain and itch reduction while demonstrating potential to improve skin integrity and disease activity. These outcomes directly address the most debilitating aspects of RDEB that severely impact quality of life.
With approximately 4,000 children suffering from intermediate to severe RDEB across major markets, CORDStrom™ targets a significant unmet medical need in a population with therapeutic options. The manufacturing scale-up through this partnership ensures that if regulatory approvals are secured, the therapy can be produced in sufficient quantities to serve this vulnerable patient population.
From a regulatory perspective, establishing commercial-ready manufacturing is a prerequisite for BLA and MAA submissions. This partnership positions INmune Bio to advance through these regulatory pathways with manufacturing capabilities already in place - potentially accelerating time to market.
The company's statement that CORDStrom™ "could be the first cell therapy to address the systemic nature of RDEB" highlights its potential first-mover advantage in this treatment category. By securing robust manufacturing capacity now, INmune Bio demonstrates confidence in their clinical results and commitment to delivering this therapy to patients who urgently need new treatment options.
Stevenage, UK, and Boca Raton, Florida, US, April 14, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system has partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for its cell therapy platforms. CGT Catapult is an independent technology and innovation organization specializing in the advancement of the cell and gene therapy industry. It was established by and works in partnership with Innovate UK.
INmune Bio’s therapies harness the innate immune system, the body’s first line of defense, to treat diseases including Alzheimer’s, prostate cancer, and recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disorder. With active trials across the UK, Europe, Australia, Canada and the US, the company is advancing a diversified portfolio addressing significant unmet medical needs.
The collaboration builds on INmune Bio’s existing manufacturing base at the Royal Free Hospital and leverages CGT Catapult’s expertise at its Stevenage Manufacturing Innovation Centre. The initial focus is on scaling production of CORDStromTM, a promising therapy for RDEB. In a recent Phase 2 randomized trial, CORDStromTM reduced pain and itch while showing potential to improve skin integrity and disease activity. INmune Bio estimates that approximately 4,000 children with intermediate to severe RDEB in the US, UK and EU could benefit, positioning CORDStromTM for clinical trial supply and eventual Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions. The Company believes that CORDStrom™ could be the first cell therapy to address the systemic nature of RDEB.
Following CORDStromTM, INmune Bio plans to transition production of INKmune®, its NK-priming cell medicine for solid tumors, to the same facility, supporting ongoing and future trials in the US and UK, including the Phase 2 study in metastatic castration-resistant prostate cancer.
This partnership with CGT Catapult accelerates the Company’s path to commercialization by delivering efficient, scalable manufacturing while preserving operational control.
Matthew Durdy, Chief Executive of the CGT Catapult, 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.”
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. 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. This partnership stands as an excellent example of cross-border collaboration, harnessing global expertise to potentially deliver groundbreaking treatments to market.”
About the Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of the cell and gene therapy industry with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. The Cell and Gene Therapy Catapult was established by and works in partnership with Innovate UK. For more information, please visit https://ct.catapult.org.uk/ or https://www.ukri.org/councils/innovate-uk/.
Contact: Alice Deeley, Senior Communications Manager, alice.deeley@ct.catapult.org.uk or April Six cgtcatapult@aprilsix.com
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune® developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer and is currently in phase II trial in metastatic castration-resistance prostate cancer in the US. The third program, CORDStrom™, is a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa in the UK. To learn more, please visit www.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. 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 factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; 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; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
Contact:
David Moss, Chief Financial Officer, (858) 964-3720, info@inmunebio.com
Daniel Carlson, Head of Investor Relations, (415) 509-4590, dcarlson@inmunebio.com
FAQ
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