INmune Bio Partners with Cell and Gene Therapy Catapult to Scale Up CORDStrom(TM) Manufacturing for Commercial Readiness
MWN-AI** Summary
INmune Bio Inc. has announced a strategic partnership with the Cell and Gene Therapy Catapult (CGT Catapult) aimed at enhancing large-scale production of its proprietary cell therapy, CORDStrom™, to ensure commercial readiness. Based in both Stevenage, UK, and Boca Raton, Florida, INmune Bio is focused on advancing therapies that leverage the innate immune system to address inflammation and various diseases, including Alzheimer’s and rare genetic disorders such as recessive dystrophic epidermolysis bullosa (RDEB).
Through this collaboration, INmune Bio will utilize CGT Catapult’s Manufacturing Innovation Centre to scale up production processes, particularly for CORDStrom™, which has shown promising results in alleviating symptoms of RDEB during Phase 2 trials. Approximately 4,000 children in the US, UK, and EU are estimated to benefit from this therapy, making it a potential contender for future regulatory approvals, including Biologics License Applications (BLA).
In addition to CORDStrom™, INmune Bio plans to transition the production of its NK-priming cell therapy, INKmune®, to the facility to support ongoing and future clinical trials in solid tumors. The partnership enhances INmune Bio’s path to commercialization by improving manufacturing efficiency while maintaining operational control.
CGT Catapult's Chief Executive, Matthew Durdy, praised INmune Bio’s efforts to address critical healthcare challenges, emphasizing the potential benefits of their collaboration in generating advanced therapies in the UK, a significant hub for this industry.
Overall, the partnership exemplifies cross-border cooperation, potentially accelerating the availability of innovative treatments for patients, indicative of INmune Bio’s commitment to advancing healthcare solutions through its specialized expertise in cell therapy technologies.
MWN-AI** Analysis
INmune Bio Inc. (NASDAQ: INMB) is making significant strides in the biotechnology arena, particularly through its recent partnership with the Cell and Gene Therapy Catapult (CGT Catapult) aimed at scaling the manufacturing of CORDStrom™, its innovative cell therapy targeting Recessive Dystrophic Epidermolysis Bullosa (RDEB). This collaboration leverages CGT Catapult’s extensive expertise in manufacturing while enhancing INmune’s operational capabilities essential for commercial readiness.
The implications of this partnership are considerable for investors. Firstly, INmune Bio's focus on the innate immune system uniquely positions it to address substantial unmet medical needs across various diseases, including Alzheimer’s and cancer. The potential commercial release of CORDStrom™, which shows promising results from early trials, could dramatically alter INmune's financial trajectory. With an estimated patient population of 4,000 children in need of effective RDEB treatments, CORDStrom™ could capture a significant share of this niche market.
Furthermore, the decision to centralize production in the UK aligns with advantageous regulatory frameworks and the growing reputation of the UK as a hub for advanced therapies. This regulatory readiness could expedite the path to critical approvals, such as the Biologics License Application (BLA) and Marketing Authorization Application (MAA), thereby providing a clearer timeline for potential revenue streams.
Investors should closely monitor upcoming clinical trial results and regulatory updates related to CORDStrom™. A successful roll-out is likely to not only bolster INmune's market position but also enhance investor confidence in the company's innovative pipeline, particularly as it transitions to advanced therapies like INKmune® for oncology applications.
In summary, INmune Bio represents an intriguing opportunity for investors seeking exposure to innovative therapeutics in the biotechnology sector. Those willing to navigate the inherent risks associated with clinical-stage companies could find significant upside as the company progresses towards commercial manufacturing and potential drug approval.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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 CORDStrom TM , a promising therapy for RDEB. In a recent Phase 2 randomized trial, CORDStrom TM 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 CORDStrom TM 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 CORDStrom TM , 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**
How has the partnership between INmune Bio Inc. (NASDAQ: INMB) and the Cell and Gene Therapy Catapult in Stevenage, UK, influenced the advancement of cell therapy manufacturing, particularly for CORDStrom™?
What strategic advantages does INmune Bio Inc. (NASDAQ: INMB) gain from establishing its presence in Stevenage, UK, in terms of clinical trials and patient access compared to its operations in Boca Raton, Florida?
Given the ongoing clinical trials for therapies like CORDStrom™ in multiple regions, how does INmune Bio Inc. (NASDAQ: INMB) plan to manage regulatory challenges in the US and UK markets?
In what ways might the advancements in cell therapy manufacturing at the CGT Catapult in Stevenage, UK, impact the commercialization timeline for INmune Bio Inc.'s (NASDAQ: INMB) therapies targeting diseases like RDEB and prostate cancer?
**MWN-AI FAQ is based on asking OpenAI questions about INmune Bio Inc. (NASDAQ: INMB).
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