INmune Bio Opens Phase II in High Dose Cohort of INKmune™ Trial in Prostate Cancer
INmune Bio (NASDAQ: INMB) has successfully completed the Phase I portion of its CaRe PC trial for INKmune™, a Natural Killer (NK) cell therapy treating metastatic castration-resistant prostate cancer (mCRPC). The Scientific Review Committee (SRC) unanimously approved opening all Phase II cohorts after reviewing safety data from the third and highest dose cohort.
The trial, which follows a Bayesian design with three ascending dose cohorts, has demonstrated an exemplary safety profile in outpatient settings. Initial data from the low dose cohort has shown immunologic effects. The Phase II extension will include six patients at the two higher dose levels, with patient recruitment progressing as expected.
The company's CSO, Mark Lowdell, will present the trial data at the 10th Annual Innate Killer Summit in San Diego on March 4th.
INmune Bio (NASDAQ: INMB) ha completato con successo la fase I del suo trial CaRe PC per INKmune™, una terapia a base di cellule Natural Killer (NK) per il trattamento del cancro alla prostata metastatico resistente alla castrazione (mCRPC). Il Comitato Scientifico di Revisione (SRC) ha approvato all'unanimità l'apertura di tutti i gruppi della fase II dopo aver esaminato i dati di sicurezza del terzo gruppo, il più alto in termini di dose.
Il trial, che segue un disegno bayesiano con tre gruppi di dosaggio crescente, ha dimostrato un profilo di sicurezza esemplare in contesti ambulatoriali. I dati iniziali del gruppo a bassa dose hanno mostrato effetti immunologici. L'estensione della fase II includerà sei pazienti ai due livelli di dose più elevati, con il reclutamento dei pazienti che procede come previsto.
Il CSO dell'azienda, Mark Lowdell, presenterà i dati del trial al 10° Summit Annuale Innate Killer a San Diego il 4 marzo.
INmune Bio (NASDAQ: INMB) ha completado con éxito la fase I de su ensayo CaRe PC para INKmune™, una terapia con células Natural Killer (NK) que trata el cáncer de próstata metastásico resistente a la castración (mCRPC). El Comité de Revisión Científica (SRC) aprobó por unanimidad la apertura de todos los grupos de la fase II después de revisar los datos de seguridad del tercer grupo, el de mayor dosis.
El ensayo, que sigue un diseño bayesiano con tres grupos de dosis ascendentes, ha demostrado un perfil de seguridad ejemplar en entornos ambulatorios. Los datos iniciales del grupo de baja dosis han mostrado efectos inmunológicos. La extensión de la fase II incluirá a seis pacientes en los dos niveles de dosis más altos, con el reclutamiento de pacientes avanzando según lo previsto.
El CSO de la empresa, Mark Lowdell, presentará los datos del ensayo en la 10ª Cumbre Anual Innate Killer en San Diego el 4 de marzo.
INmune Bio (NASDAQ: INMB)는 INKmune™의 CaRe PC 시험의 1상 부분을 성공적으로 완료했습니다. 이는 전이성 호르몬 저항성 전립선암(mCRPC)을 치료하는 자연 살해(NK) 세포 치료법입니다. 과학 검토 위원회(SRC)는 세 번째이자 최고 용량 그룹의 안전성 데이터를 검토한 후 2상 모든 그룹의 개설을 만장일치로 승인했습니다.
이 시험은 세 개의 상승 용량 그룹을 가진 베이지안 설계를 따르며, 외래 환자 환경에서 모범적인 안전성 프로필을 보여주었습니다. 저용량 그룹의 초기 데이터는 면역학적 효과를 보여주었습니다. 2상 연장에는 두 개의 높은 용량 수준에서 6명의 환자가 포함되며, 환자 모집은 예상대로 진행되고 있습니다.
회사의 CSO인 Mark Lowdell은 3월 4일 샌디에고에서 열리는 제10회 연례 자연 살해자 정상 회담에서 시험 데이터를 발표할 예정입니다.
INmune Bio (NASDAQ: INMB) a réussi à compléter la phase I de son essai CaRe PC pour INKmune™, une thérapie à base de cellules Natural Killer (NK) pour traiter le cancer de la prostate métastatique résistant à la castration (mCRPC). Le Comité de Révision Scientifique (SRC) a approuvé à l'unanimité l'ouverture de tous les cohortes de la phase II après avoir examiné les données de sécurité du troisième groupe, le plus élevé en termes de dose.
L'essai, qui suit un design bayésien avec trois cohortes de dose ascendante, a démontré un profil de sécurité exemplaire dans des contextes ambulatoires. Les données initiales du groupe à faible dose ont montré des effets immunologiques. L'extension de la phase II comprendra six patients aux deux niveaux de dose les plus élevés, avec le recrutement des patients progressant comme prévu.
Le CSO de l'entreprise, Mark Lowdell, présentera les données de l'essai lors du 10ème Sommet Annuel des Natural Killers à San Diego le 4 mars.
INmune Bio (NASDAQ: INMB) hat erfolgreich den Phase-I-Teil seiner CaRe PC-Studie für INKmune™, eine Therapie mit natürlichen Killerzellen (NK) zur Behandlung von metastasiertem kastrationsresistentem Prostatakrebs (mCRPC), abgeschlossen. Das Scientific Review Committee (SRC) hat einstimmig die Eröffnung aller Phase-II-Kohorten genehmigt, nachdem es die Sicherheitsdaten der dritten und höchsten Dosisgruppe überprüft hatte.
Die Studie, die einem bayesianischen Design mit drei aufsteigenden Dosisgruppen folgt, hat ein vorbildliches Sicherheitsprofil in ambulanten Settings gezeigt. Erste Daten aus der niedrig dosierten Gruppe haben immunologische Effekte gezeigt. Die Phase-II-Erweiterung wird sechs Patienten in den beiden höheren Dosisstufen umfassen, wobei die Rekrutierung der Patienten wie erwartet voranschreitet.
Der CSO des Unternehmens, Mark Lowdell, wird die Studiendaten am 4. März auf dem 10. jährlichen Innate Killer Summit in San Diego präsentieren.
- Successful completion of Phase I with no safety issues reported
- Unanimous SRC approval to proceed with Phase II cohorts
- Treatment can be administered in outpatient setting
- Patient recruitment meeting expectations
- Low dose cohort showing immunologic effects
- Therapeutic benefits still unknown and pending higher dose cohort results
Insights
The successful completion of INKmune™'s Phase I safety evaluation marks a important milestone in INmune Bio's clinical development program. The trial's progression to Phase II with a clean safety profile across all dose cohorts is particularly noteworthy in the NK cell therapy landscape, where safety concerns often present significant hurdles.
The trial's Bayesian design is strategically significant, as it allows for more efficient patient allocation and potentially faster development timelines compared to traditional trial designs. The implementation of three ascending dose cohorts, followed by six-patient Phase II extensions at higher doses, demonstrates a sophisticated approach to dose optimization while maintaining patient safety.
A key differentiator for INKmune™ is its outpatient administration capability. This feature could provide a significant competitive advantage in the mCRPC treatment landscape, where many cellular therapies require complex hospital-based administration. The observed immunologic effects even in the low-dose cohort suggest potential efficacy, though the higher dose cohorts will be important for establishing the therapy's true therapeutic potential.
The trial's progression aligns with expected timelines, with patient recruitment meeting targets - a critical factor in the competitive oncology space. The expansion into Phase II high-dose cohorts positions INmune Bio to potentially generate meaningful efficacy data in the coming months, which could be pivotal for the company's market position in the rapidly evolving NK cell therapy sector.
- Medical review of Phase 1 cohorts demonstrated no safety issues
- Data to be presented at the 10th Annual Innate Killer Summit, March 3-5
BOCA RATON, Fla, Feb. 12, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, continues to advance its Natural Killer (NK) cell therapy, INKmune™, in a Phase I/II trial (the “CaRe PC” trial) for men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce completion of the third and highest dose cohort of the Phase I portion of the trial allowing opening of the Phase II high dose cohort.
The Scientific Review Committee (SRC) charter is to review the safety data from the patients treated in the Phase I portion of the trial as required by the FDA. Yesterday, the SRC held the third meeting evaluating the safety in INKmune™ therapy in men with mCRPC. The SRC unanimously voted to open all Phase II cohorts of the CaRePC trial to enrollment.
“INKmune™ can be given to men with mCRPC in an out-patient setting and so far has an exemplary safety profile,” said RJ Tesi, MD CEO of INmune. “Data from the low dose cohort has shown immunologic effects of INKmune™ therapy. The higher dose cohorts will help us understand the therapeutic benefits of INKmune™ therapy in treating men with mCRPC.”
Mark Lowdell, CSO of INMB and inventor of INKmune™, has been invited to speak at the 10th Annual Innate Killer Summit in San Diego on March 4th on the use of INKmune™ to treat men with mCRPC in the CaRe PC trial. The trial has a Bayesian design with three ascending dose cohorts. Now that the initial three patients in each cohort have passed medical review, there is a six patient Phase II extension at the two higher dose levels. Patient recruitment continues to meet expectations.
About INKmune™
INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune™ treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune™ primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to up-regulated nutrient receptors and mitochondrial survival proteins.
INKmune™ is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune™ is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune™ is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US.
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 trials in metastatic castration-resistance prostate cancer. 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. INmune Bio’s product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and cancer. 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
Co-founder and Chief Financial Officer
(858) 964-3720
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
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