INmune Bio Receives Favorable Patentability Opinion for CORDStrom™ Platform Technology
INmune Bio (NASDAQ: INMB) has achieved a significant intellectual property milestone for its CORDStrom™ platform technology. The USPTO has issued a favorable written opinion on all claims in the company's international patent application PCT/US25/17028, confirming novelty, inventive step, and industrial applicability for their next-generation mesenchymal stromal cell (MSC) product.
CORDStrom™, comprising pooled, culture-expanded human umbilical cord-derived MSCs, is designed for infusion or injection across various inflammatory and degenerative diseases. The patent, once granted, will provide IP exclusivity through at least 2045. The company plans to expedite the U.S. application via the Patent Prosecution Highway program.
Recent Phase 2 trial data showed promising results, with CORDStrom™ demonstrating reductions in pain and itch, along with early signals of improved skin integrity and disease activity.
INmune Bio (NASDAQ: INMB) ha raggiunto un importante traguardo in ambito di proprietà intellettuale per la sua tecnologia CORDStrom™. L'USPTO ha emesso un parere favorevole su tutte le rivendicazioni della domanda di brevetto internazionale PCT/US25/17028 dell'azienda, confermando novità, attività inventiva e applicabilità industriale per il loro prodotto di nuova generazione a base di cellule stromali mesenchimali (MSC).
CORDStrom™, composto da MSC derivate da cordone ombelicale umano, coltivate e aggregate, è progettato per essere somministrato tramite infusione o iniezione in diverse patologie infiammatorie e degenerative. Una volta concesso, il brevetto garantirà l’esclusività della proprietà intellettuale almeno fino al 2045. L’azienda intende accelerare la procedura della domanda negli Stati Uniti attraverso il programma Patent Prosecution Highway.
I dati recenti della fase 2 hanno mostrato risultati promettenti, con CORDStrom™ che ha dimostrato riduzioni di dolore e prurito, oltre a segnali iniziali di miglioramento dell’integrità cutanea e dell’attività della malattia.
INmune Bio (NASDAQ: INMB) ha alcanzado un hito importante en propiedad intelectual para su tecnología CORDStrom™. La USPTO emitió una opinión favorable sobre todas las reivindicaciones de la solicitud internacional de patente PCT/US25/17028 de la compañía, confirmando novedad, actividad inventiva y aplicabilidad industrial para su producto de próxima generación basado en células madre mesenquimales (MSC).
CORDStrom™, que consiste en MSC derivadas de cordón umbilical humano, cultivadas y agrupadas, está diseñado para ser administrado por infusión o inyección en diversas enfermedades inflamatorias y degenerativas. Una vez concedida, la patente proporcionará exclusividad de propiedad intelectual al menos hasta 2045. La compañía planea acelerar la solicitud en EE.UU. a través del programa Patent Prosecution Highway.
Los datos recientes del ensayo de fase 2 mostraron resultados prometedores, con CORDStrom™ demostrando reducciones en el dolor y el picor, junto con señales tempranas de mejora en la integridad de la piel y la actividad de la enfermedad.
INmune Bio (NASDAQ: INMB)는 자사의 CORDStrom™ 플랫폼 기술에 대해 중요한 지식재산권 성과를 달성했습니다. 미국 특허청(USPTO)은 회사의 국제 특허 출원 PCT/US25/17028의 모든 청구항에 대해 긍정적인 의견을 발표하며, 차별성, 진보성, 산업적 적용 가능성을 확인했습니다. 이는 차세대 중간엽 줄기세포(MSC) 제품에 관한 것입니다.
CORDStrom™은 인간 제대혈 유래 MSC를 배양하여 풀링한 제품으로, 다양한 염증성 및 퇴행성 질환에 주입 또는 투여할 목적으로 개발되었습니다. 특허가 승인되면 최소 2045년까지 지식재산권 독점권을 확보하게 됩니다. 회사는 특허 심사 가속화 프로그램(Patent Prosecution Highway)을 통해 미국 출원 절차를 신속히 진행할 계획입니다.
최근 2상 임상 시험 데이터는 유망한 결과를 보여주었으며, CORDStrom™은 통증과 가려움증 감소뿐만 아니라 피부 건강과 질병 활성도의 초기 개선 신호를 나타냈습니다.
INmune Bio (NASDAQ : INMB) a franchi une étape importante en matière de propriété intellectuelle pour sa technologie CORDStrom™. L’USPTO a émis un avis favorable sur toutes les revendications de la demande de brevet internationale PCT/US25/17028 de la société, confirmant la nouveauté, l’activité inventive et l’application industrielle de leur produit de nouvelle génération à base de cellules stromales mésenchymateuses (MSC).
CORDStrom™, composé de MSC dérivées de cordon ombilical humain, cultivées en pool, est conçu pour être administré par perfusion ou injection dans diverses maladies inflammatoires et dégénératives. Une fois le brevet délivré, il garantira une exclusivité de propriété intellectuelle au moins jusqu’en 2045. La société prévoit d’accélérer la procédure américaine via le programme Patent Prosecution Highway.
Les données récentes des essais de phase 2 ont montré des résultats prometteurs, avec CORDStrom™ démontrant des réductions de la douleur et des démangeaisons, ainsi que des signes précoces d’amélioration de l’intégrité cutanée et de l’activité de la maladie.
INmune Bio (NASDAQ: INMB) hat einen bedeutenden Meilenstein im Bereich geistiges Eigentum für seine CORDStrom™-Plattformtechnologie erreicht. Das USPTO hat eine positive schriftliche Stellungnahme zu allen Ansprüchen der internationalen Patentanmeldung PCT/US25/17028 des Unternehmens erteilt und damit Neuheit, erfinderische Tätigkeit und gewerbliche Anwendbarkeit für ihr nächstes Generationenprodukt mit mesenchymalen Stromazellen (MSC) bestätigt.
CORDStrom™, bestehend aus gepoolten, kultivierten MSCs aus menschlicher Nabelschnur, ist für die Infusion oder Injektion bei verschiedenen entzündlichen und degenerativen Erkrankungen konzipiert. Nach Erteilung des Patents wird ein geistiges Eigentumsrechtsschutz mindestens bis 2045 gewährleistet sein. Das Unternehmen plant, das US-Anmeldeverfahren über das Patent Prosecution Highway-Programm zu beschleunigen.
Jüngste Phase-2-Studien zeigten vielversprechende Ergebnisse, wobei CORDStrom™ eine Verringerung von Schmerzen und Juckreiz sowie erste Anzeichen für eine verbesserte Hautintegrität und Krankheitsaktivität demonstrierte.
- Favorable USPTO patent opinion securing potential IP protection until 2045
- Promising Phase 2 trial results showing efficacy in pain and itch reduction
- Fast-track patent examination status via Patent Prosecution Highway
- None.
Insights
The favorable USPTO patentability opinion for INmune Bio's CORDStrom™ platform represents a significant intellectual property milestone that substantially strengthens the company's competitive position. The written opinion confirming novelty, inventive step, and industrial applicability across all claims is remarkably positive—achieving this trifecta on a first examination is uncommon in the biotech space.
The company's strategy to accelerate prosecution via the Patent Prosecution Highway (PPH) is particularly astute. This fast-track mechanism typically reduces time-to-grant by 50-60% and substantially lowers prosecution costs. While not yet a granted patent, this favorable opinion dramatically increases the probability of issuance with broad claim scope.
Most crucially, the potential exclusivity through 2045 (plus possible extensions) provides INmune Bio with an extensive runway for commercialization. For context, this represents nearly two decades of potential market protection—far superior to typical small molecule exclusivity periods. Such extensive IP protection significantly enhances licensing potential, partnership leverage, and ultimate commercial value of the CORDStrom platform across multiple therapeutic applications.
The CORDStrom™ platform's differentiated approach to mesenchymal stromal cell (MSC) therapy addresses several long-standing challenges in this therapeutic class. By utilizing pooled, culture-expanded human umbilical cord-derived MSCs, INmune Bio potentially overcomes the inconsistency and scalability issues that have historically MSC therapy adoption.
What's technically impressive is the platform's apparent ability to deliver batch-to-batch consistency—a critical manufacturing advantage for cell therapies where product variability has been a significant commercial hurdle. The "pooled" approach suggests they've developed methods to combine multiple donor sources while maintaining quality control, potentially solving the single-donor limitations that plague many cell therapies.
The Phase 2 data showing reductions in pain and itch with improved skin integrity suggests potential applications in dermatological or autoimmune conditions. While specific efficacy metrics aren't disclosed, even modest improvements in these parameters could represent meaningful clinical benefits for conditions with treatment options.
Combined with the extensive IP protection potential, this platform could position INmune Bio to capture significant value in the rapidly evolving cell therapy landscape, particularly for inflammatory and degenerative diseases where current treatment paradigms remain suboptimal.
Boca Raton, Florida, US, April 16, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system, today announced a major intellectual property milestone with respect to its next-generation mesenchymal stromal cell (MSC) product, CORDStrom™.
The United States Patent and Trademark Office (USPTO), acting as the International Search Authority, has issued a favorable written opinion on all claims in INmune Bio’s international patent application PCT/US25/17028, titled “THERAPEUTIC COMPOSITIONS COMPRISING POOLED, CULTURE-EXPANDED HUMAN UMBILICAL CORD DERIVED MESENCHYMAL STROMAL CELLS.” The written opinion, received April 8, 2025, confirms that all claims possess novelty, inventive step, and industrial applicability – key requirements for patentability under international standards.
The CORDStrom™ platform represents an important advance in cell therapy. Unlike traditional MSC products, CORDStrom™ comprises pooled, culture-expanded human umbilical cord-derived MSCs (hucMSCs) designed for infusion or injection, potentially offering scalable, tunable, and consistent therapeutic performance across a wide range of inflammatory and degenerative diseases.
“We are encouraged with the examination results and the examiner’s favorable opinion of patentability concerning all submitted claims,” said Joshua Schoonover, General Counsel of INmune Bio. “CORDStrom is a first-in-class, pooled hucMSC medicine that offers batch-to-batch consistency and tunability across multiple disease indications. This patent application, once granted, will form the basis of IP exclusivity for our CORDStrom product platform through at least 2045, subject to patent term extension or adjustments.”
INmune Bio plans to accelerate prosecution of the U.S. national application via the Patent Prosecution Highway (PPH), a fast-track examination program that enables efficient and expedited review based on favorable rulings from international patent offices.
The favorable patent news follows promising data from a recent randomized Phase 2 trial, where CORDStrom™ demonstrated reductions in pain and itch, with early signals of improved skin integrity and disease activity. The company views this development as a pivotal step toward unlocking the full therapeutic and commercial potential of its MSC platform.
About CORDStrom™
CORDStrom™ is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom™ platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory diseases. CORDStrom™ products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent of donor characteristics.
Initially developed at the INKmune® manufacturing facilities utilizing UK academic grant funding, CORDStrom™ is an MSC product platform that shows promise as a first systemic therapy for potentially treating RDEB and many other debilitating conditions. While the first generation CORDStrom™ product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.
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 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 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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