Full Press Release Details
INmune Bio Partners with Cell and Gene Therapy
Catapult to Scale Up CORDStrom Manufacturing for Commercial Readiness
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."
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/.
Deeley, Senior Communications Manager, alice.deeley@ct.catapult.org.uk or April
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.
David Moss, Chief Financial Officer, (858) 964-3720, info@inmunebio.com
Daniel Carlson, Head of Investor Relations,
(415) 509-4590, dcarlson@inmunebio.com