INmune Bio Inc. Expands INKmune Trial in Prostate Cancer to Veterans
INmune Bio (NASDAQ: INMB) has expanded its Phase I/II trial for metastatic castration-resistant prostate cancer (mCRPC) to include the West Los Angeles VA Medical Center, with the first patient treated in the Phase II portion. The trial, known as CarePC, represents a novel NK-targeted biologic therapy approach using INKmune treatment.
The patient received the 'medium' dose of INKmune as an outpatient under Dr. Matthew Rettig's care, who serves as Chief of Hematology-Oncology at VA Greater Los Angeles Healthcare System. The VA system treats approximately 15,000 Veterans diagnosed with prostate cancer annually, with over 200,000 Veterans being prostate cancer survivors. Under Dr. Rettig's leadership, 900 patients have participated in over two dozen clinical trials at the West LA VA Medical Center.
This treatment activates NK cells, which target tumor cells abundant in prostate cancer, and is administered on an outpatient basis with minimal reported side effects.
INmune Bio (NASDAQ: INMB) ha ampliato il suo trial di Fase I/II per il cancro alla prostata resistente alla castrazione metastatica (mCRPC) includendo il VA Medical Center di West Los Angeles, con il primo paziente trattato nella parte di Fase II. Il trial, noto come CarePC, rappresenta un approccio innovativo alla terapia biologica mirata sulle cellule NK usando il trattamento INKmune.
Il paziente ha ricevuto la dose 'media' di INKmune come paziente ambulatoriale sotto la cura del Dr. Matthew Rettig, che ricopre il ruolo di Capo della Ematologia-Oncologia presso il VA Greater Los Angeles Healthcare System. Il sistema VA tratta annualmente circa 15.000 Veterani diagnosticati con cancro alla prostata, con oltre 200.000 Veterani che sono sopravvissuti al cancro alla prostata. Sotto la guida del Dr. Rettig, 900 pazienti hanno partecipato a oltre due dozzine di trial clinici presso il VA Medical Center di West LA.
Questo trattamento attiva le cellule NK, che mirano alle cellule tumorali abbondanti nel cancro alla prostata, ed è somministrato in regime ambulatoriale con effetti collaterali riportati minimi.
INmune Bio (NASDAQ: INMB) ha ampliado su ensayo de Fase I/II para el cáncer de próstata resistente a la castración metastásico (mCRPC) para incluir el VA Medical Center de West Los Angeles, con el primer paciente tratado en la parte de Fase II. El ensayo, conocido como CarePC, representa un enfoque novedoso de terapia biológica dirigida a células NK usando el tratamiento INKmune.
El paciente recibió la dosis 'media' de INKmune como paciente ambulatorio bajo el cuidado del Dr. Matthew Rettig, quien es Jefe de Hematología-Oncología en el VA Greater Los Angeles Healthcare System. El sistema VA trata anualmente aproximadamente 15,000 Veteranos diagnosticados con cáncer de próstata, con más de 200,000 Veteranos que son sobrevivientes de cáncer de próstata. Bajo la dirección del Dr. Rettig, 900 pacientes han participado en más de dos docenas de ensayos clínicos en el VA Medical Center de West LA.
Este tratamiento activa las células NK, que se dirigen a las células tumorales abundantes en el cáncer de próstata, y se administra de manera ambulatoria con efectos secundarios mínimos reportados.
INmune Bio (NASDAQ: INMB)는 전이성 거세 저항성 전립선암(mCRPC)에 대한 임상 1/2상을 확장하여 웨스트 로스앤젤레스 VA 메디컬 센터를 포함하고, 2상 부분에서 첫 번째 환자가 치료를 받았습니다. CarePC로 알려진 이 임상 시험은 INKmune 치료를 사용한 새로운 NK 세포 표적 생물학적 요법 접근 방식을 나타냅니다.
환자는 Dr. Matthew Rettig의 관리 하에 환자 외래로 '중간' 용량의 INKmune를 받았습니다. Rettig 박사는 VA Greater Los Angeles Healthcare System의 혈액종양학 책임자입니다. VA 시스템은 매년 약 15,000명의 전립선암 진단을 받은 재향군인을 치료하며, 20만 명 이상의 재향군인이 전립선암 생존자입니다. Rettig 박사의 지도 아래, 900명의 환자가 West LA VA 메디컬 센터에서 20개 이상의 임상 시험에 참여했습니다.
이 치료법은 전립선암에서 풍부한 종양 세포를 표적으로 하는 NK 세포를 활성화하며, 외래 환자에게 최소한의 부작용이 보고된 상태에서 진행됩니다.
INmune Bio (NASDAQ: INMB) a élargi son essai de Phase I/II pour le cancer de la prostate résistant à la castration et métastatique (mCRPC) en y incluant le VA Medical Center de West Los Angeles, avec le premier patient traité dans la partie Phase II. L'essai, connu sous le nom de CarePC, représente une approche novatrice de thérapie biologique ciblée sur les cellules NK utilisant le traitement INKmune.
Le patient a reçu la dose 'moyenne' d'INKmune en tant que patient ambulatoire sous la supervision du Dr. Matthew Rettig, qui est Chef de l'Hématologie-Oncologie au VA Greater Los Angeles Healthcare System. Le système VA traite chaque année environ 15 000 vétérans diagnostiqués avec un cancer de la prostate, avec plus de 200 000 vétérans survivants du cancer de la prostate. Sous la direction du Dr. Rettig, 900 patients ont participé à plus de deux douzaines d'essais cliniques au VA Medical Center de West LA.
Ce traitement active les cellules NK, qui ciblent les cellules tumorales abondantes dans le cancer de la prostate, et est administré sur une base ambulatoire avec des effets secondaires rapportés minimes.
INmune Bio (NASDAQ: INMB) hat seine Phase I/II-Studie für metastasierenden kastrationsresistenten Prostatakrebs (mCRPC) erweitert, um das West Los Angeles VA Medical Center einzubeziehen, wobei der erste Patient im Phase-II-Teil behandelt wurde. Die Studie, bekannt als CarePC, stellt einen neuartigen NK-zielgerichteten Biologika-Ansatz mit der INKmune-Behandlung dar.
Der Patient erhielt die 'mittlere' Dosis von INKmune als ambulanter Patient unter Betreuung von Dr. Matthew Rettig, der als Chefarzt der Hämatologie-Onkologie im VA Greater Los Angeles Healthcare System fungiert. Das VA-System behandelt jährlich etwa 15.000 Veteranen, bei denen Prostatakrebs diagnostiziert wurde, wobei über 200.000 Veteranen Prostatakrebs-Überlebende sind. Unter der Leitung von Dr. Rettig haben 900 Patienten an mehr als zwei Dutzend klinischen Studien im West LA VA Medical Center teilgenommen.
Diese Behandlung aktiviert NK-Zellen, die Tumorzellen, die in Prostatakrebs reichlich vorhanden sind, anvisieren und wird ambulanter Basis mit minimal berichteten Nebenwirkungen verabreicht.
- First patient treated in Phase II portion of the trial, advancing clinical development
- Expansion to VA system provides access to large patient population (15,000 new prostate cancer patients annually)
- Outpatient administration with minimal side effects improves treatment accessibility
- None.
Insights
The expansion of INmune Bio's INKmune trial to the Veterans Administration system marks a strategic milestone that significantly enhances the trial's potential impact and commercial viability. The VA system's inclusion, with its pool of 15,000 annual prostate cancer diagnoses and 200,000 survivors, provides an exceptional platform for patient recruitment and data collection.
The trial's progression to Phase II with the 'medium' dose cohort, coupled with the outpatient administration format and reported minimal side effects, positions INKmune favorably in the competitive landscape of prostate cancer treatments. NK cell-targeted therapy represents an innovative approach in prostate cancer treatment, where traditional immunotherapies have shown success. This novel mechanism of action, targeting abundant NK cells in prostate cancer microenvironment, could potentially address an unmet medical need in metastatic castration-resistant prostate cancer (mCRPC).
The timing aligns strategically with the Cleland-Dole Act's implementation, which mandates improved prostate cancer care in the VA system. This legislative backing, combined with the VA's new prostate cancer clinical pathway and registry development, creates a supportive regulatory environment that could accelerate trial completion and potential adoption within the VA system. The integrated nature of the VA healthcare system offers unique advantages for long-term patient monitoring and real-world evidence collection, potentially strengthening the therapy's value proposition for both regulatory approval and market acceptance.
First patient treated in Phase II portion of clinical trial in metastatic prostate cancer at the West Los Angeles Veterans Administration Hospital
Boca Raton, Florida, Jan. 28, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, has an ongoing Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce the participation of a patient at the West Los Angeles VA Medical Center in the trial. The participant received the investigational intervention, as an out-patient per the protocol, under the care of Matthew Rettig, MD., Chief, Hematology-Oncology, VA Greater Los Angeles Healthcare System, Professor of Medicine and Urology, Medical Director Prostate Cancer Program, David Geffen School of Medicine and the Jonsson Comprehensive Cancer Center at the UCLA.
The VA Health Care System provides medical care to the Veterans of the US military. Every year, approximately 15,000 Veterans are diagnosed and treated at the VA for prostate cancer and over 200,000 Veterans are prostate cancer survivors. Under Rettig’s leadership, 900 patients with prostate cancer have participated in over two dozen clinical trials at the West LA VA Medical Center. The Care PC trial is the first using a NK targeted biologic therapy. The Veteran received the “medium” dose of INKmune initiating the Phase II portion of the trial.
“The INmune Bio study represents a new immune therapy approach to treating advanced prostate cancer. The study involves the use of cellular therapy treatment that activates NK cells, which are immune cells known to target tumor cells and are in relative abundance in prostate cancer,” said Rettig, Principal Investigator, about the the CarePC program. “Unlike most immunotherapies, this study involves treatment that is given as an outpatient and appears to have minimal side effects, which helps the management of prostate cancer among Veterans and the US population at large.”
In 2022, Congress signed into law the Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022, also known as the Cleland-Dole Act. In response to the Cleland-Dole Act, which requires VA to make strides in prostate cancer care, the VA has published a prostate cancer clinical pathway, which expressly considers incorporation of clinical trials, and patient educational materials, and is in the process of creating a national prostate cancer registry. “The Veterans Health Administration is an ideal place to perform clinical trials,” said RJ Tesi MD, CEO of INmune Bio, “it is a large integrated health care system that provides high-quality medical care to a diverse population of patients.”
About CaRe PC
CaRe PC is an open label Phase I/II trial that will test up to three dose levels of INKmune™ in men with mCRPC. INKmune™ is given in the out-patient setting via an intravenous infusion three times in the first two weeks of treatment (days 1, 8 and 15). No pre-medication or additional cytokines are needed for INKmune therapy. The patient is followed for six months with careful study of immunologic and anti-cancer responses to INKmune™ treatment. Immune responses include changes in numbers of tumor killing memory-like NK cells in the patient’s blood and how long these specialized NK cells remain in the circulation. Anti-tumor responses will be monitored by following the level of prostatic surface antigen (PSA) in the blood. Additionally, we will leverage Artificial Intelligence (AI) to quantify the number and size of metastatic lesions using piflufolastat F 18 - a PSMA (prostate-specific membrane antigen) imaging agent developed by Lantheus marketed as Plarify® and by measuring circulating tumor DNA (ctDNA) in the blood. Up to 30 patients will receive one of three levels of dose of INKmune™.
The study uses a novel modified Bayesian design that allows for a 3x3 dose escalation design. Once the Phase I portion is complete, the doses that are safe will be tested simultaneously in the Phase II portion of the trial. Up to 10 patients can be enrolled at each dose level. There are two primary goals of the trial. The first is to demonstrate the safety of INKmune™ in the patient population, men with mCRPC. The second is to determine which dose of INKmune™ should be used in a blinded, randomized registration trial. Determining the best dose of INKmune™ to use in future clinical trials will depend on a combination of immunologic and anti-tumor responses seen in the men treated with INKmune™ therapy.
About INKmune™
INKmune is an NK cell targeted therapy that is not an NK cell. INKmune is a product designed to improve the function of the patient’s own NK cells. INKmune™ is a patented, pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination. INKmune™ is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. These INKmune-primed NK cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune therapy does not require any type of conditioning, pre-medication, or cytokine support.
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 the 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
Chief Financial Officer
(858) 964-3720
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
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