INKmune™ Demonstrates Excellent Safety and Increased NK-Cell Activity in First Dosing Cohort
INmune Bio Inc. (NASDAQ: INMB) has announced initial results from the first patient cohort in its Phase I/II trial of INKmune™, a Natural Killer (NK) cell therapy for metastatic Castration-Resistant Prostate Cancer (mCRPC). The trial, named CaRe PC, has shown excellent safety profile with all patients receiving treatment as out-patients without pre-medication. Even at the lowest dose, there is clear evidence of persistent immunologic effects.
Key findings include:
- Changes in phenotype and function of patients' NK cells
- Increase in circulating activated NK cells in 2 of 3 patients
- Increased NK cell function sustained for over 40 days after final infusion in all patients
- One patient showed a transient 21% decrease in PSA associated with increased NK cell activity
The second dosing cohort has completed, and the third cohort is expected to begin in about 30 days, with doses 3 and 5 times higher than the first cohort, respectively.
INmune Bio Inc. (NASDAQ: INMB) ha annunciato i risultati iniziali del primo gruppo di pazienti nel suo studio di fase I/II su INKmune™, una terapia cellulare Natural Killer (NK) per il cancro della prostata metastatico resistente alla castrazione (mCRPC). Lo studio, denominato CaRe PC, ha mostrato un ottimo profilo di sicurezza, con tutti i pazienti che hanno ricevuto il trattamento come pazienti ambulatoriali senza premedicazione. Anche alla dose più bassa, ci sono chiare evidenze di effetti immunologici persistenti.
I principali risultati includono:
- Cambiamenti nel fenotipo e nella funzione delle cellule NK dei pazienti
- Aumento nelle cellule NK attivate circolanti in 2 su 3 pazienti
- Aumentata funzionalità delle cellule NK sostenuta per oltre 40 giorni dopo la somministrazione finale in tutti i pazienti
- Un paziente ha mostrato una diminuzione transitoria del 21% del PSA associata a un aumento dell'attività delle cellule NK
Il secondo gruppo di dosaggio è stato completato e si prevede che il terzo gruppo inizi tra circa 30 giorni, con dosi 3 e 5 volte superiori a quelle del primo gruppo, rispettivamente.
INmune Bio Inc. (NASDAQ: INMB) ha anunciado resultados iniciales del primer grupo de pacientes en su ensayo de fase I/II de INKmune™, una terapia celular Natural Killer (NK) para el cáncer de próstata metastásico resistente a la castración (mCRPC). El ensayo, denominado CaRe PC, ha mostrado un excelente perfil de seguridad, con todos los pacientes recibiendo tratamiento como pacientes ambulatorios sin premedicación. Incluso con la dosis más baja, hay evidencias claras de efectos inmunológicos persistentes.
Los hallazgos clave incluyen:
- Cambios en el fenotipo y función de las células NK de los pacientes
- Aumento en las células NK activadas circulantes en 2 de 3 pacientes
- Función de las células NK aumentada sostenida por más de 40 días después de la infusión final en todos los pacientes
- Un paciente mostró una disminución transitoria del 21% en PSA asociada con un aumento en la actividad de células NK
Se ha completado el segundo grupo de dosificación, y se espera que el tercer grupo comience en aproximadamente 30 días, con dosis 3 y 5 veces más altas que el primer grupo, respectivamente.
INmune Bio Inc. (NASDAQ: INMB)는 전이성 호르몬 저항성 전립선 암(mCRPC)을 위한 자연 살해 세포(NK) 치료제 INKmune™의 1상/2상 시험에서 첫 번째 환자 집단에 대한 초기 결과를 발표했습니다. CaRe PC라는 이름의 이 시험은 모든 환자가 사전 약물 치료 없이 외래 환자로 치료를 받으며 우수한 안전성을 보였다고 합니다. 가장 낮은 용량에서도 지속적인 면역학적 효과의 명확한 증거가 있다고 합니다.
주요 발견 사항은 다음과 같습니다:
- 환자의 NK 세포의 표현형 및 기능 변화
- 3명 중 2명의 환자에서 순환 활성화된 NK 세포 증가
- 모든 환자에서 마지막 주사 후 40일 이상 지속된 NK 세포 기능 증가
- 한 환자가 NK 세포 활성 증가와 관련하여 PSA가 일시적으로 21% 감소
두 번째 투여 집단이 완료되었으며, 세 번째 집단은 약 30일 후에 시작될 것으로 예상되며, 첫 번째 집단에 비해 3배 및 5배 높은 용량이 될 것입니다.
INmune Bio Inc. (NASDAQ: INMB) a annoncé les premiers résultats du premier groupe de patients dans son essai de phase I/II sur INKmune™, une thérapie cellulaire Natural Killer (NK) pour le cancer de la prostate métastatique résistant à la castration (mCRPC). L'essai, nommé CaRe PC, a montré un excellent profil de sécurité, avec tous les patients recevant le traitement en tant que patients ambulatoires sans prémédication. Même à la dose la plus faible, il existe des preuves claires d'effets immunologiques persistants.
Les principales conclusions incluent :
- Changements dans le phénotype et la fonction des cellules NK des patients
- Augmentation des cellules NK activées circulantes chez 2 des 3 patients
- Fonction des cellules NK augmentée maintenue pendant plus de 40 jours après l'infusion finale chez tous les patients
- Un patient a montré une diminution transitoire de 21 % du PSA associée à une augmentation de l'activité des cellules NK
Le deuxième groupe de dosage a été complété et le troisième groupe devrait commencer dans environ 30 jours, avec des doses 3 et 5 fois plus élevées que celles du premier groupe, respectivement.
INmune Bio Inc. (NASDAQ: INMB) hat erste Ergebnisse aus der ersten Patientengruppe seiner Phase I/II-Studie zu INKmune™, einer natürlichen Killerzellen (NK) Therapie für metastasierendes kastrationsresistentes Prostatakarzinom (mCRPC), bekannt gegeben. Die Studie namens CaRe PC hat ein ausgezeichnetes Sicherheitsprofil gezeigt, da alle Patienten ambulant ohne Vorbehandlung behandelt wurden. Selbst bei der niedrigsten Dosis gibt es eindeutige Beweise für anhaltende immunologische Effekte.
Wesentliche Ergebnisse umfassen:
- Änderungen im Phänotyp und in der Funktion der NK-Zellen der Patienten
- Erhöhung der zirkulierenden aktivierten NK-Zellen bei 2 von 3 Patienten
- Erhöhte NK-Zellfunktion, die in allen Patienten über 40 Tage nach der letzten Infusion anhält
- Ein Patient zeigte einen vorübergehenden Rückgang des PSA um 21 % in Verbindung mit einer erhöhten NK-Zellaktivität
Die zweite Dosierungsgruppe ist abgeschlossen, und die dritte Gruppe wird voraussichtlich in etwa 30 Tagen beginnen, mit Dosen, die 3 und 5 Mal höher sind als in der ersten Gruppe.
- Excellent safety profile demonstrated in the first dosing cohort
- Clear evidence of persistent immunologic effects even at the lowest dose
- Increased NK cell activity and function observed in patients
- One patient showed a 21% decrease in PSA associated with increased NK cell activity
- Trial progressing as planned with higher dose cohorts underway
- Only a small number of patients (3) in the first cohort limits the statistical significance of the results
- PSA decrease was observed in only one patient and was transient
Insights
The initial results from INmune Bio's Phase I/II trial for INKmune™ in metastatic Castration-Resistant Prostate Cancer (mCRPC) are promising. Key findings include:
- Excellent safety profile with out-patient treatment and no pre-medication required
- Evidence of persistent immunologic effects, even at the lowest dose
- Increased circulating activated NK cells in 2 out of 3 patients
- Enhanced NK cell function sustained for over 40 days post-treatment in all patients
- One patient showed a transient
21% decrease in PSA, correlating with increased NK cell activity
The trial is progressing well, with the second cohort completed and the third expected to begin soon. These cohorts will test doses 3 and 5 times higher than the initial cohort, respectively. While it's too early to draw definitive conclusions, the preliminary data suggests INKmune™ may have potential in treating mCRPC by activating the patient's own NK cells. However, investors should note that further data from higher dose cohorts and larger patient samples will be important in determining the therapy's efficacy and commercial viability.
From a financial perspective, these initial results are encouraging for INmune Bio (NASDAQ: INMB). The positive safety profile and early signs of efficacy, even at the lowest dose, could potentially de-risk the INKmune™ program to some extent. This may positively impact investor sentiment and the company's valuation.
Key financial implications include:
- Potential for increased investor interest and possible share price appreciation
- Improved prospects for future partnerships or licensing deals if results continue to be positive
- Possible reduction in the perceived risk of the company's pipeline
However, it's important to note that INMB is still a clinical-stage company with a market cap of approximately
BOCA RATON, Fla., Sept. 26, 2024 (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 initial results from the first patient cohort in the trial.
Mark Lowdell, CSO and inventor of INKmune™, said, “The enrollment of the first cohort ran entirely in-line with our predicted timelines and confirmed the excellent safety profile with all patients receiving treatment as out-patient without the need for pre-medication of any kind. Furthermore, even at this lowest dose of INKmune™, there is clear evidence of persistent immunologic effects of INKmune™ treatment in these men with mCRPC.
Blinded analysis of the monitoring blood samples from the first three patients showed changes in the phenotype and function of the patient’s NK cells. Although this is the lowest dose cohort, 2 of 3 patients showed an increase in circulating activated NK cells and all three showed increased NK cell function sustained for more than 40 days after the final INKmune™ infusion. One patient showed a transient
The CaRe PC trial has recently completed dosing the last patients in the second of its three dose-escalation cohorts. The third cohort is expected to begin in approximately 30 days. The dose of INKmune™ in the second and third cohort is 3 and 5 times the dose of INKmune™ in the first cohort. All eight clinical sites are now open and additional results from the trial will be released from the higher dose cohorts as they become available.
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 upregulated 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 United States.
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 two product platforms that are both in clinical trials: 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 cancer (INB03™), Early Alzheimer’s disease 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. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. 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. INB03™, 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.
INmune Bio Contact:
David Moss, CFO (858) 964-3720
info@inmunebio.com
Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
FAQ
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