ImmunityBio Announces Study of ANKTIVA® in Combination with the AdHER2DC Cancer Vaccine as a Potential Therapy to Control Endometrial Cancer
ImmunityBio (NASDAQ: IBRX) has announced a new clinical trial, QUILT 502, to study ANKTIVA® in combination with the AdHER2DC vaccine for endometrial cancer. This Phase 1/2 study, sponsored by the National Cancer Institute, will enroll 60 participants with HER2-positive endometrial cancer. The trial combines ANKTIVA, recently FDA-approved for bladder cancer, with the investigational AdHER2DC vaccine and FDA-approved drugs pembrolizumab and lenvatinib.
The study aims to evaluate the safety and efficacy of this combination therapy in controlling endometrial cancer, which affects over 65,000 women annually in the U.S. and has treatment options after second-line therapy. The AdHER2DC vaccine targets the HER2 protein, elevated in 30% of endometrial cancer cases. The trial is expected to be completed in 2026 and represents a potential breakthrough in immunotherapy for gynecological cancers.
ImmunityBio (NASDAQ: IBRX) ha annunciato un nuovo studio clinico, QUILT 502, per studiare ANKTIVA® in combinazione con il vaccino AdHER2DC per il cancro endometriale. Questo studio di fase 1/2, sponsorizzato dal National Cancer Institute, arruolerà 60 partecipanti con cancro endometriale HER2-positivo. La sperimentazione combina ANKTIVA, recentemente approvato dalla FDA per il cancro della vescica, con il vaccino investigativo AdHER2DC e farmaci approvati dalla FDA come pembrolizumab e lenvatinib.
L'obiettivo dello studio è valutare la sicurezza e l'efficacia di questa terapia combinata nel controllare il cancro endometriale, che colpisce oltre 65.000 donne ogni anno negli Stati Uniti e ha poche opzioni di trattamento dopo la terapia di seconda linea. Il vaccino AdHER2DC mira alla proteina HER2, elevata nel 30% dei casi di cancro endometriale. La sperimentazione dovrebbe concludersi nel 2026 e rappresenta una potenziale svolta nell'immunoterapia per i tumori ginecologici.
ImmunityBio (NASDAQ: IBRX) ha anunciado un nuevo ensayo clínico, QUILT 502, para estudiar ANKTIVA® en combinación con la vacuna AdHER2DC para el cáncer endometrial. Este estudio de fase 1/2, patrocinado por el National Cancer Institute, inscribirá a 60 participantes con cáncer endometrial HER2-positivo. El ensayo combina ANKTIVA, recientemente aprobado por la FDA para el cáncer de vejiga, con la vacuna investigacional AdHER2DC y medicamentos aprobados por la FDA como el pembrolizumab y el lenvatinib.
El objetivo del estudio es evaluar la seguridad y eficacia de esta terapia combinada para controlar el cáncer endometrial, que afecta a más de 65,000 mujeres anualmente en EE. UU. y tiene opciones de tratamiento limitadas después de la terapia de segunda línea. La vacuna AdHER2DC se dirige a la proteína HER2, que se encuentra elevada en el 30% de los casos de cáncer endometrial. Se espera que el ensayo se complete en 2026 y representa un avance potencial en la inmunoterapia para los cánceres ginecológicos.
ImmunityBio (NASDAQ: IBRX)가 ANKTIVA®와 AdHER2DC 백신의 조합을 연구하기 위한 새로운 임상 시험인 QUILT 502를 발표했습니다. 이 1/2상 연구는 National Cancer Institute가 후원하며, HER2 양성 자궁내막암 환자 60명을 모집할 예정입니다. 이 시험은 최근 방광암에 대해 FDA 승인을 받은 ANKTIVA와 임상 시험 중인 AdHER2DC 백신, 그리고 FDA 승인 약물인 pembrolizumab과 lenvatinib을 결합합니다.
이 연구의 목표는 자궁내막암을 조절하기 위한 이 조합 치료의 안전성과 효과를 평가하는 것입니다. 자궁내막암은 매년 미국에서 65,000명 이상의 여성에게 영향을 미치며, 2차 요법 이후 치료 선택이 제한적입니다. AdHER2DC 백신은 자궁내막암 사례의 30%에서 증가된 HER2 단백질을 표적으로 합니다. 이 시험은 2026년에 완료될 것으로 예상되며, 부인과 암에 대한 면역요법의 잠재적인 돌파구를 나타냅니다.
ImmunityBio (NASDAQ: IBRX) a annoncé un nouvel essai clinique, QUILT 502, pour étudier ANKTIVA® en combinaison avec le vaccin AdHER2DC pour le cancer de l’endomètre. Cette étude de phase 1/2, sponsorisée par le National Cancer Institute, recrutera 60 participants souffrant de cancer de l’endomètre HER2-positif. L'essai combine ANKTIVA, récemment approuvé par la FDA pour le cancer de la vessie, avec le vaccin expérimental AdHER2DC et des médicaments approuvés par la FDA tels que le pembrolizumab et le lenvatinib.
L'objectif de l'étude est d'évaluer la sécurité et l'efficacité de cette thérapie combinée pour contrôler le cancer de l’endomètre, qui affecte plus de 65 000 femmes chaque année aux États-Unis et offre peu d'options de traitement après la thérapie de seconde ligne. Le vaccin AdHER2DC cible la protéine HER2, qui est élevée dans 30 % des cas de cancer de l’endomètre. L'essai devrait être terminé en 2026 et représente une avancée potentielle dans l'immunothérapie pour les cancers gynécologiques.
ImmunityBio (NASDAQ: IBRX) hat eine neue klinische Studie, QUILT 502, angekündigt, um ANKTIVA® in Kombination mit dem AdHER2DC-Impfstoff bei Endometriumkrebs zu untersuchen. Diese Phase 1/2-Studie, die vom National Cancer Institute gesponsert wird, wird 60 Teilnehmer mit HER2-positivem Endometriumkrebs rekrutieren. Die Studie kombiniert ANKTIVA, das kürzlich von der FDA für Blasenkrebs zugelassen wurde, mit dem investigativen AdHER2DC-Impfstoff sowie mit den von der FDA zugelassenen Medikamenten Pembrolizumab und Lenvatinib.
Ziel der Studie ist es, die Sicherheit und Wirksamkeit dieser Kombinationstherapie zur Kontrolle von Endometriumkrebs zu bewerten, der jährlich über 65.000 Frauen in den USA betrifft und nur begrenzte Behandlungsmöglichkeiten nach der Zweitlinientherapie bietet. Der AdHER2DC-Impfstoff zielt auf das HER2-Protein ab, das in 30 % der Fälle von Endometriumkrebs erhöht ist. Es wird erwartet, dass die Studie 2026 abgeschlossen sein wird und einen potenziellen Durchbruch in der Immuntherapie für gynäkologische Krebserkrankungen darstellt.
- ANKTIVA recently received FDA approval for BCG-unresponsive non-muscle invasive bladder cancer CIS
- The study combines ANKTIVA with an investigational vaccine and two FDA-approved drugs, potentially enhancing efficacy
- The trial targets HER2-positive endometrial cancer, affecting 30% of patients and over 50% of high-risk subtypes
- ImmunityBio is partnering with the National Cancer Institute, leveraging expertise and resources
- The study is in early stages (Phase 1/2) and results won't be available until 2026
- Efficacy of the combination therapy is yet to be proven
- The trial only addresses a subset of endometrial cancer patients (HER2-positive)
Insights
This study represents a significant development in endometrial cancer treatment. The combination of ANKTIVA with the AdHER2DC vaccine targets two critical aspects of cancer immunotherapy:
- Activation of NK and T cells through IL-15 stimulation
- Specific targeting of HER2, overexpressed in
30% of endometrial cancers
The potential synergy with pembrolizumab and lenvatinib could address the efficacy of current post-second-line treatments. If successful, this approach could dramatically improve the
The QUILT 502 trial design is noteworthy for several reasons:
- It's a Phase 1/2 study, allowing for both safety and preliminary efficacy assessments
- The 60-patient enrollment is substantial for an early-phase trial in this indication
- The primary endpoint of 6-month progression-free survival is clinically relevant
However, the 2026 completion date suggests a lengthy trial duration, which could delay potential market entry. The use of autologous dendritic cells in the vaccine may also present manufacturing and logistical challenges for widespread implementation if successful.
For ImmunityBio (NASDAQ: IBRX), this trial could significantly expand ANKTIVA's market potential beyond its recent FDA approval in bladder cancer. Key financial considerations include:
- Endometrial cancer affects 65,000+ women annually in the U.S., representing a substantial market
- Partnering with the NCI potentially reduces R&D costs and adds credibility
- If successful, this combination therapy could command premium pricing in a high-unmet-need indication
However, investors should note the long timeline to potential commercialization and the competitive landscape in oncology. The complex nature of the therapy may also impact profit margins if approved.
- The QUILT 502 trial is testing ImmunityBio’s N-803 (ANKTIVA®) in combination with the AdHER2DC investigational vaccine for endometrial cancer, a gynecological cancer with lower survival rates and limited effective post-second-line treatment.
-
The AdHER2DC vaccine targets the HER2 protein, which is elevated in
30% of endometrial cancer. - ANKTIVA, recently approved for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, is designed to activate the immune cells that kill tumor cells to provide long-term immune response.
- The Phase1/2 interventional study will enroll 60 participants with HER2-positive endometrial cancer (EC), who will also receive pembrolizumab and lenvatinib, two FDA approved drugs for endometrial cancer.
- The study is expected to be completed in 2026.
This Phase 1/2 QUILT 502 trial (NCT06253494) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether the AdHER2DC vaccine in combination with ANKTIVA, pembrolizumab (checkpoint inhibitor), and lenvatinib (kinase inhibitor) can be safely administered in combination and provide preliminary clinical efficacy before a larger, more definitive study.
Endometrial cancer is the most common gynecological cancer in the
The AdHER2DC vaccine targets the HER2 protein, which is elevated in
Phase 1 of the open-label, two-arm Phase 1/2 study will determine recommended dose of pembrolizumab, lenvatinib, ANKTIVA and AdHER2DC in participants with HER2 positive endometrial cancer. The Phase 2 portion of the study will assess the efficacy of the combination of pembrolizumab, lenvatinib, ANKTIVA and the AdHER2DC vaccine in qualified participants as determined by the proportion of participants without disease progression at six months. The study will enroll 60 subjects and is expected to be completed in 2026.
“We are pleased to partner with the NCI on this important cancer control study involving ANKTIVA, which has demonstrated in clinical trials that activation of memory T cells may help deliver long-duration response well beyond that of checkpoint inhibitors alone,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “We are hopeful that the AdHER2DC investigational vaccine plus ANKTIVA will ‘rescue’ the checkpoint inhibitor pembrolizumab and kinase inhibitor lenvatinib and lead to an improved response compared with the current standard of care in this high risk population.”
ImmunityBio is already partnered with the NCI to study the use of ANKTIVA in cases of Lynch syndrome, a genetic condition that is linked with significantly increased incidence of cancers, particularly colon cancer. These studies along with the recent approval of ANKTIVA for bladder cancer signal the advent of the era of cytokines as the next-generation of immunotherapies.
To learn more about this study, please visit https://clinicaltrials.gov/study/NCT06253494.
For patients interested in enrolling in this study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the website: https://trials.cancer.gov and/or NCIMO_referrals@mail.nih.gov.
The AdHER2DC vaccine is investigational. Safety and efficacy of this investigational agent have not been established by any health authority, including the FDA.
How ANKTIVA Works
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.
ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long-duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
For more information, please visit: www.immunitybio.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding commercial launch activities and timing, product demand, patient treatment, data and results from clinical trials and potential implications therefrom, product availability and supply, potential regulatory pathways and approval requests and submissions, the regulatory review process and timing thereof, market and prevalence data, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, information regarding ongoing pre-clinical studies and clinical trials, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, ImmunityBio’s financial condition, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this presentation that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) the risks and uncertainties associated with commercial launch execution, success and timing, (ii) risks and uncertainties related to the regulatory submission and review process, (iii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (iv) potential delays in product availability and regulatory approvals, (v) risks and uncertainties associated with third party collaborations and agreements, (vi) potential delays in sales activity and pace, (vii) ImmunityBio’s ability to retain and hire key personnel, (viii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio’s ability to successfully commercialize its approved product and product candidates and uncertainties around regulatory reviews and approvals, (xi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the
View source version on businesswire.com: https://www.businesswire.com/news/home/20240806552447/en/
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media
Greg Tenor
Salutem
+1 717-919-6794
Gregory.Tenor@Salutemcomms.com
Source: ImmunityBio, Inc.
FAQ
What is the purpose of ImmunityBio's QUILT 502 trial for endometrial cancer?
When is the QUILT 502 trial for IBRX's ANKTIVA expected to be completed?
How many participants will be enrolled in ImmunityBio's endometrial cancer study?
What recent FDA approval has ANKTIVA received from ImmunityBio (IBRX)?
