Multicenter, Open-label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy

The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?

Start Date22 Jul 2024

Sponsor / Collaborator

Oncoverity, Inc.

NCT04264806

/ WithdrawnPhase 2

A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).

Start Date06 May 2021

Sponsor / Collaborator

Janssen Research & Development LLC

[+1]

NCT04241549

/ CompletedPhase 1

A Phase 1 Study of Cusatuzumab Plus Azacitidine in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment

The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are not candidates for intensive treatment.

Start Date25 Mar 2020

Sponsor / Collaborator

Oncoverity, Inc.

[+2]

100 Clinical Results associated with Cusatuzumab

100 Translational Medicine associated with Cusatuzumab

100 Patents (Medical) associated with Cusatuzumab

Literatures (Medical) associated with Cusatuzumab

01 Nov 2023·The Lancet. Haematology

Cusatuzumab plus azacitidine in newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy (CULMINATE): part one of a randomised, phase 2, dose optimisation study

Article

Author: Wei, Andrew H ; Doronin, Vadim ; Johnson, Amy J ; Xiu, Liang ; Gyan, Emmanuel ; Hamad, Nada ; Özcan, Muhit ; Vey, Norbert ; Langlois, Angélique ; Nottage, Kerri ; Demirkan, Fatih ; Ofran, Yishai ; Hultberg, Anna ; Herrera, Pilar ; Martinelli, Giovanni ; Müller, Rouven ; Jacobs, Julie ; Trudel, Géralyn C ; Samoilova, Olga ; Fogliatto, Laura M ; Pabst, Thomas ; Papayannidis, Cristina ; Arnan, Montserrat ; Guttke, Christina ; Ma, Xuewen ; Tolbert, Jaszianne A

BACKGROUND:

Cusatuzumab, a high-affinity anti-CD70 antibody, has shown preliminary activity as a treatment for acute myeloid leukaemia when combined with azacitidine. We aimed to determine the optimum dose for future trials of cusatuzumab in combination with azacitidine in patients with previously untreated acute myeloid leukaemia who are not eligible for intensive chemotherapy.

METHODS:

In this randomised, phase 2, open-label, dose-optimisation study we enrolled adult patients aged 18 years or older with newly diagnosed acute myeloid leukaemia not eligible for intensive chemotherapy, and with Eastern Cooperative Oncology Group scores of 0-2, from 40 hospitals and centres across seven countries. In part one of the trial, participants were randomly allocated 1:1 to 10 mg/kg or 20 mg/kg intravenous cusatuzumab on days 3 and 17, combined with subcutaneous or intravenous azacitidine 75 mg/m² on days 1-7 in 28-day cycles. The primary efficacy outcome was the rate of complete remission in the intention-to-treat group. The two dose cohorts were evaluated independently without between-cohort statistical comparison. Safety analyses were performed in all patients who received one dose of study drug. Part two of the trial was planned to be a single-arm expansion to evaluate cusatuzumab plus azacitidine at the cusatuzumab dose level selected in part one (primary hypothesis ≥35% rate of complete remission vs null hypothesis of 20%); however, changes in the acute myeloid leukaemia treatment landscape during this trial made it unlikely that enrolment to part two of the study would be clinically feasible, so the study stopped at the end of part one. The trial was registered at ClinicalTrials.gov, NCT04023526.

FINDINGS:

103 patients were enrolled between Aug 30, 2019, and Feb 25, 2020, and randomly assigned to either cusatuzumab 10 mg/kg (n=51) or 20 mg/kg (n=52). Median follow-up was 7·2 months (IQR 10·7 months). 57 of 103 (55%) patients were male and 46 (45%) patients were female, 78 (76%) were White, one (1%) was Asian, and 24 (23%) did not report their race. In the 10 mg/kg group, complete remission rate was 12% (six of 51 patients; 95% CI 6-23) and in the 20 mg/kg group was 27% (14 of 52; 17-40). Grade 3 or worse treatment-emergent adverse events (TEAEs) were similar between the cusatuzumab 10 mg/kg (n=51) and 20 mg/kg (n=51) cohorts and included thrombocytopenia (24 patients [47%] vs 29 [57%]), anaemia (24 [47%] vs 17 [33%]), and neutropenia (20 [39%] in both cohorts). Serious TEAEs were also similar in the two cohorts (44 [86%] vs 40 [78%]). Treatment-related TEAEs leading to death were reported in both groups (three patients [6%] in the 10 mg/kg group vs one patient [2%] in the 20 mg/kg group); the reported causes of death were pneumonia (n=2) and septic shock (n=2).

INTERPRETATION:

Although part one of this study was not designed to formally compare the two dose cohorts for efficacy, the totality of clinical data for cusatuzumab studies performed to date indicate that cusatuzumab 20 mg/kg plus azacitidine represents the optimal dose for further studies. A phase 1b study investigating the triple combination of cusatuzumab with venetoclax and azacitidine is underway (NCT04150887).

FUNDING:

Janssen Research & Development and argenx.

01 Oct 2023·Cell death and differentiation

METTL3 inhibition induced by M2 macrophage-derived extracellular vesicles drives anti-PD-1 therapy resistance via M6A-CD70-mediated immune suppression in thyroid cancer

Article

Author: Gao, Ming ; Zheng, Xiangqian ; Ruan, Xianhui ; Ning, Junya ; Zhang, Wei ; Hao, Jie ; Huang, Yue ; Hou, Xiukun ; Shi, Yi

The treatment options for advanced papillary thyroid cancer (PTC) and anaplastic thyroid cancer (ATC) refractory to standard therapies are limited. Although anti-PD-1 therapy has a manageable safety profile and has been effective in a small percentage of patients with advanced PTC and refractory ATC, the majority of the patients either do not respond or develop resistance to anti-PD-1 therapy. N6-methyladenosine (m6A) modification is a critical determinant of the complexity of the tumor microenvironment (TME). However, it is unclear whether and how m6A modification in tumor cells shapes the immune landscape of PTC and ATC. In this study, we performed bulk and single cell RNA sequencing analysis of PTC and ATC tissues, and found that low METTL3 expression not only correlated to poor response to immune checkpoint blockade (ICB) but was also associated with increased TNF family-related ligand-receptor interactions in the immunosuppressive Tregs and exhausted T cells. Furthermore, overexpression of METTL3 in PTC and ATC cells enhanced the efficacy of anti-PD-1 therapy in a peripheral blood mononuclear cell humanized NCG (huPBMC-NCG) mouse model. Mechanistically, M2 macrophage-derived extracellular vesicles (M2 EVs) inhibited METTL3 expression in PTC and ATC cells via miR-21-5p. Downregulation of METTL3 promoted demethylation of CD70 mRNA, which prevented YTHDF2-mediated degradation of the transcripts. The stabilization of CD70 mRNA, and the subsequent upregulation in CD70 protein levels increased the abundance of the immunosuppressive Tregs and terminally exhausted T cells, thereby inducing resistance to anti-PD-1 therapy. Furthermore, blocking CD70 using cusatuzumab, a high-affinity monoclonal antibody, reversed the anti-PD-1 therapy resistance induced by M2 EVs in vivo. Finally, we demonstrated that METTL3 expression negatively correlated with CD70 expression and M2 macrophages and Tregs infiltration in PTC and ATC tissues. Our findings provide new insights into developing novel therapies for advanced PTC and ATC.

01 Feb 2021·Current hematologic malignancy reportsQ3 · MEDICINE

An Update on the Clinical Evaluation of Antibody-Based Therapeutics in Acute Myeloid Leukemia

Q3 · MEDICINE

Review

Author: Daver, Naval ; Ravandi, Farhad ; Venugopal, Sangeetha

PURPOSE OF REVIEW:

The advent of several targeted agents has revolutionized the treatment of acute myeloid leukemia (AML) in recent times; however, majority of patients are still not cured. In the ongoing quest for rationally targeted treatment strategies in AML, scientific endeavors have focused on identifying new antigen targets on the leukemic cells for therapeutic exploitation including strategies to directly deliver toxins into the leukemic blasts as well as strategies that harness host immunity to favorably impact clinical outcomes. Gemtuzumab ozogamicin, a CD33 directed antibody-drug conjugate, has provided the proof of concept for the potential efficacy of monoclonal antibody-based therapies in AML. This article provides an overview of immunologically relevant antigen targets expressed on the leukemic cells and synopsizes the clinical results evaluating targeted antibody-based therapeutic approach in AML.

RECENT FINDINGS:

AML blasts and leukemic stem cells express several antigens, including CD33, CD47, CD70, CD123, and CLEC12A. The past several years have seen the burgeoning of cell-specific immunotherapy concepts, including checkpoint inhibitors, antibody-toxin conjugates, and bispecific antibodies in the treatment of AML. The first-in-class anti-CD47 antibody magrolimab and anti-CD70 antibody cusatuzumab in combination with hypomethylating agent (HMA) azacitidine, in newly diagnosed AML, and flotetuzumab, a bispecific DART® (dual-affinity retargeting) antibody to CD3ε and CD123 as salvage option in relapsed/refractory AML appear promising. The development of antibody-based immunotherapeutic approach in AML has been encouraging. Ongoing research will define the choice of an appropriate complementary therapeutic agent in antibody-based combination therapy, and whether one or more than one antigen should be simultaneously targeted. Further studies will likely refine the role of antibody-based therapy in post hematopoietic cell transplant setting.

News (Medical) associated with Cusatuzumab

05 Feb 2025

·www.businesswire.com

CD70 Targeting Therapies Clinical Trials & Market Opportunity Insight 2025: Cusatuzumab Emerges as Leading Phase II Candidate for Leukemia Treatment, Paving the Way for CD70 Therapy Evolution - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "CD70 Targeting Therapies Clinical Trials & Market Opportunity Insight 2025" report has been added to ResearchAndMarkets.com's offering. CD70 targeting therapies are rapidly gaining recognition as a promising strategy for the treatment of various cancers and immune-related disorders, significantly transforming the therapeutic landscape. CD70, a cell surface protein, is crucial in regulating the immune system, making it an optimal target for therapies designed to selectively attack diseased cells while preserving healthy tissues. This movement towards precision medicine is particularly vital in oncology, where traditional treatments such as chemotherapy and radiation often lead to severe side effects and limited effectiveness. Global CD70 Targeting Therapies Clinical Trials & Market Opportunity Insight 2025 Report Highlights: CD70 Targeting Therapies In Clinical Trials: > 20 Therapies CD 70 Targeting Therapies Clinical Trials Insight By Company, Country, Indication and Phase Insight On CD70 Targeting Therapy Technology Platforms FDA & EMA Designations Insight: Orphan, FTD, RMAT Designation Global & Regional Market Development Insight Combination Strategies For CD70 Targeting Therapies In clinical practice, CD70 targeting therapies are demonstrating considerable potential in treating hematological malignancies, particularly acute myeloid leukemia (AML), as well as solid tumors like renal cell carcinoma (RCC). AML is particularly challenging to manage with standard therapies, especially in patients who are unsuitable for intensive chemotherapy. Clinical trials focused on CD70 targeted therapies have shown promise in addressing this issue, with monoclonal antibodies and engineered cell therapies offering new hope for patients with few treatment options. The most advanced CD70-targeting therapy currently in clinical development is Cusatuzumab, created by argenx, which is presently undergoing Phase 2 trials in conjunction with chemotherapeutic agents for AML patients. This combination strategy seeks to enhance the effectiveness of Cusatuzumab by tackling resistance mechanisms and improving overall patient outcomes. The application of CD70 targeting therapies extends beyond cancer treatment. These therapies are also being investigated for autoimmune diseases, viral infections, and graft-versus-host disease (GvHD), although they remain in the early stages of research. In these contexts, where immune responses are dysfunctional, CD70 targeting agents hold the potential to modulate the immune system and restore normal immune function. The expansion of therapeutic applications significantly fuels interest in this sector, as it broadens the potential market for these treatments. In commercial terms, the US stands as hub for CD70 targeting therapy research and development. A robust ecosystem comprising biotechnology companies, pharmaceutical enterprises, and research institutions has driven the advancement of these therapies. Notable institutions such as Baylor College of Medicine, the National Institutes of Health, and cancer centers like City of Hope are conducting crucial clinical trials. Furthermore, regulatory support from the US FDA, including the Fast Track Designation for Adicet Bio's ADI-270 and the Regenerative Medicine Advanced Therapy designation for Allogene Therapeutics' ALLO-316, has expedited the development and commercialization processes. This regulatory endorsement is vital in facilitating access to new treatments, positioning the US as the heart for both clinical development and market introduction. China is emerging as a significant contender in the global CD70 targeting therapy landscape. The country's rapidly growing biotechnology sector, bolstered by increased investments and partnerships with international companies, has enabled swift advancements in innovative therapies. Chinese research institutions are increasingly involved in clinical trials, while local biotech firms are progressing towards the commercialization of CD70 targeting therapies. The intensifying competition within the CD70 targeting therapy market is fostering innovation, with several companies, including Allogene Therapeutics, Seagen (Pfizer), and CRISPR Therapeutics, developing novel treatments. These organizations are engaged in comprehensive preclinical and clinical research to assess the safety and efficacy of their therapies, thereby enhancing the therapeutic potential of CD70 targeted interventions. As more therapies enter clinical trials and yield favorable outcomes, the commercial opportunities for CD70 targeting therapies are expanding. In conclusion, the integration of favorable clinical results and a dynamic commercial landscape establishes CD70 targeting therapies as a crucial component of the future of precision medicine. As an increasing number of companies and research organizations dedicate resources to these therapies, their capacity to tackle a diverse array of diseases expands, indicating the prospect of both clinical and commercial achievements ahead. Key Topics Covered: 1. Introduction To CD70 Targeting Therapy 1.1 CD70 Targeting Therapy Overview 1.2 The Prerequisite For CD70 Targeting Therapy 1.3 Dual Role of CD70 As Diagnostic & Prognostic Biomarker 2. CD70 Targeting Therapeutic Approaches 2.1 Monoclonal Antibody 2.2 Bispecific Antibody 2.3 Tetraspecific Antibody 2.4 CAR T Cell Therapy 2.5 Antibody Drug Conjugate 2.6 CAR-NK Therapy 3. CD70 Targeting Therapies Clinical Research & Development By Indications 3.1 Leukemia 3.2 Lymphoma 3.3 Gynecologic Cancer 3.4 Renal Cell Carcinoma 3.5 Lung Cancer 3.6 Autoimmune & Inflammatory Disease 3.7 Viral Infections 4. Global CD70 Targeting Therapies Clinical Trials Overview 4.1 By Phase 4.2 By Country 4.3 By Company 4.4 By Indication 4.5 By Priority Status 4.6 Patient Segment 5. CD70 Targeting Therapies Regulatory Designations: Fast Track & Orphan Designation 6. Global CD70 Targeting Therapies Clinical Trials Insight 6.1 Preclinical 6.2 Phase I 6.3 Phase I/II 6.4 Phase II 7. CD70 Targeting Therapies Development Platforms By Company & Technology 7.1 AlloCAR T Platform 7.2 Gamma Delta Cell Platform 7.3 Tailwind Platform 7.4 DARPin Platform 7.5 SIMPLE Antibody Platform 7.6 Potelligent Technology 7.7 Off The Shelf Allogeneic Manufacturing 8. Global CD70 Targeting Therapies Current Market Trend & Developments 8.1 Current Market Outline 8.2 Future Market Forecast 9. CD70 Targeting Therapies Market Opportunity & Clinical Trends By Region 9.1 US 9.2 China 9.3 Europe 10. Combination Strategies For CD70 Targeting Therapies 10.1 In Combination With Immunotherapy 10.2 In Combination With Epigenetic Modulators 10.3 In Combination With Targeted Therapy 10.4 In Combination With Oncolytic Virus Therapy 10.5 In Combination With Chemotherapy 11. Global CD70 Targeting Therapies Market Dynamics 11.1 Market Drivers 11.2 Market Challenges 12. Competitive Landscape Adaptimmune (TCR2 Therapeutics ) Adicet Bio Allogene Therapeutics Ambrx (Johnson & Johnson) Chongqing Precision Biotech Chinook Therapeutics (Novartis) CRISPR Therapeutics ImmuneOnco Biopharma Pfizer Poseida Therapeutics For more information about this report visit https://www.researchandmarkets.com/r/9qx332 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ImmunotherapyPhase 2Fast TrackOrphan DrugCell Therapy

22 Nov 2024

·pipelinereview.com

OncoVerity Secures Extended Series A to Advance Cusatuzumab in Newly Diagnosed AML

First patients dosed in OV-AML-1231, a Phase 2 randomized controlled trial of cusatuzumab in newly diagnosed AML AURORA, CO, USA I November 21, 2024 I OncoVerity, a pioneer in applying advanced bioinformatics to drug development, announced today the closing of a Series A extension financing led by existing investors, argenx and RefinedScience. With this funding, OncoVerity aims to advance its mission to address the unmet medical need of cancer patients, leveraging a unique computational approach to inform a development strategy that seeks breadth and depth of response. The proceeds from the Series A extension will fund the Phase 2 OV-AML-1231 trial of cusatuzumab, a novel, first-in-class high-affinity monoclonal anti-CD70 antibody, in combination with venetoclax and azacitidine for the treatment of newly diagnosed acute myeloid leukemia (AML). The trial is enriched explicitly for patients with limited treatment options who show potential for responding to a cusatuzumab-based regimen, as informed by OncoVerity’s computational approach to guide its development. Patient enrollment is underway, and the first eight patients have been dosed. “This financing round is a critical step forward in accelerating the development of cusatuzumab,” said Max Colao, Chief Executive Officer at OncoVerity. “Cusatuzumab has the potential to treat a broad range of tumors, demonstrating a strong biologic rationale in AML. We are particularly excited about the potential of the Phase 2 trial, and look forward to sharing results from the interim analysis in the second half of 2025. These results will bring us closer to potentially offering a breakthrough new treatment option for AML patients. “This randomized phase 2 clinical trial was based on insights derived from machine learning-based approaches and will be analyzed using cutting-edge single cell omics technologies for depth and breadth of responses. This novel strategy was designed to optimize trial design and execution, address patient heterogeneity and other key patient specific needs and provide important insights into critical clinical and biologic areas. Together we hope this will help advance care for persons with AML and other cancers where there is urgent unmet medical need.” About OV-AML-1231 OV-AML-1231 is a randomized, open-label, multicenter, multinational, Phase 2 trial evaluating the safety and efficacy cusatuzumab combined with venetoclax, and azacitidine (VAC) to venetoclax and azacitidine (VA) in newly diagnosed AML patients not eligible for intensive chemotherapy. The planned enrollment is 120 newly diagnosed AML patients, randomized 2:1 to VAC (80 patients) and VA (40 patients). The trial population will be enriched for patients with adverse cytogenetic and molecular risk features. The primary end point is overall survival. Secondary endpoints include event-free survival, response rates including CR, CR+CRh, and rates of MRD negativity. About Cusatuzumab Cusatuzumab is a first-in-class high-affinity humanized monoclonal antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors, and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement-dependent cytotoxicity, enhance antibody-dependent cell-mediated phagocytosis, enhance antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors (Silence K. et al. mAbs 2014; 6 (2):523-532) . Cusatuzumab is currently being evaluated in patients with hematologic malignancies, including a Phase 2 trial in combination with azacitidine and a Phase 1b trial in combination with azacitidine and venetoclax in patients with newly diagnosed AML. About Acute Myeloid Leukemia Acute myeloid leukemia (AML) is a cancer of the bone marrow and the blood that progresses rapidly without treatment. It is a heterogeneous disease with variable prognosis for different patient subpopulations. Despite the advancements in medical research, there is still a significant need for new effective therapies to treat AML. The five-year survival rate for patients remains the lowest of all blood malignancies (5-20%), and relapse is common. Innovative therapies and targeted treatment approaches that can improve survival rates, reduce toxicity, and target specific subtypes of AML are urgently needed to address this unmet need. About OncoVerity OncoVerity is pioneering the use of computational tools applied to clinical and biological data to advance therapies that transform hope into reality for cancer patients. Through a strategic collaboration with Refined Science , OncoVerity’s approach leverages an advanced bioinformatics platform that applies single-cell multi-omics and machine learning technologies to a large AML patient database to identify biologic drivers to therapeutic resistance and insights on patient-specific risk factors. This approach not only holds promise for accelerating the development of cusatuzumab in AML, but also has the potential to be applied to its development in other hematologic malignancies, signifying a broader impact on the future of cancer treatment by bringing new hope to a wider range of patients. SOURCE: OncoVerity

Phase 2Immunotherapy

17 May 2024

·www.biospace.com

Emergence Of Anti CD70 Antibodies Clinical Trials

The emergence of immunotherapy has revolutionized cancer treatment by harnessing the power of the immune system to target and eliminate cancer cells. Among the diverse array of immune checkpoints and targets under investigation, CD70 has garnered significant attention as a promising therapeutic target in oncology. CD70, a member of the tumor necrosis factor (TNF) superfamily, is a cell surface protein that plays a crucial role in immune regulation and tumor biology. According to preliminary research, CD70 is mainly expressed on immune cells that have been activated, including dendritic cells, natural killer (NK) cells, T and B lymphocytes, and others. These cells use CD70 as a co-stimulatory molecule to help T cells activate and survive. Nonetheless, it has been noted that aberrant expression of CD70 occurs in cancer, either on the tumor cells themselves or in the surrounding tissue. “More Than 20 CD70 Targeting Antibodies Are In Clinical Trials With Some Antibodies Designated Orphan Drug & Fast Track Status” Renal cell carcinoma, glioblastoma, and B-cell lymphoma are among the cancers where increased proliferation, invasion, and metastasis have been associated with CD70 overexpression. Additionally, by encouraging the growth of regulatory T cells and preventing antitumor immune responses, CD70-mediated signaling pathways support immune evasion mechanisms. This increases the need for anti-CD70 targeting antibodies in the management of numerous illnesses. Download Research: Currently, the monoclonal antibody targeting CD70 protein exist in the laboratory and clinical stage of development, however continued research will aid to launch the novel therapeutic intervention in clinical market and, subsequently, in commercial market for the treatment of cancer and other disease across the globe. By binding CD70 on the surface of tumor cells, monoclonal antibodies inhibit CD70 mediated signaling pathways, thereby disrupting pro-tumorigenic signaling cascades involved in cell proliferation, survival, and metastasis. Monoclonal antibodies targeting CD70 have shown promising preclinical and clinical results in various cancer types. These antibodies are being investigated either as monotherapy or in combination with other treatment modalities, including chemotherapy, radiation therapy, and immune checkpoint inhibitors. The market for anti CD70 targeting antibodies is in its early stages, spurred by a variety of factors. The quest for increased efficacy and fewer adverse effects drives the development of novel drugs such as CD70 targeting antibodies. The involvement of the key players, such as OncoVerity, Argenx, Janssen Research & Development, ImmuneOnco Biopharmaceuticals (Shanghai), Seagen (a subsidiary of Pfizer), UTC Therapeutics and other in the market further aids in expanding the realm of anti CD70 antibody. While the role of anti-CD70 antibodies is primarily investigated in the context of cancer therapy, emerging evidence suggests their potential utility in other diseases beyond cancer treatment. CD70 is implicated in the pathogenesis of autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), and multiple sclerosis. In these conditions, aberrant expression of CD70 on immune cells contributes to immune dysregulation and chronic inflammation. Anti-CD70 antibodies could potentially modulate immune responses, restore immune tolerance, and attenuate disease activity in autoimmune disorders. All these studies exemplify that the frontier of anti-CD70 antibodies is augmenting. The development of anti CD70 antibodies not only bestows to treat cancer disorders but also other ailments including autoimmune disease, viral infections and other diseases. The landscape of anti-CD70 antibody therapy is rapidly evolving, driven by advances in antibody engineering, preclinical research, and clinical development. Anti-CD70 antibodies hold promise as a novel immunotherapeutic approach for the treatment of cancer and other diseases characterized by dysregulated CD70 expression. In summation, anti CD70 targeting antibody therapy represents a promising avenue for cancer treatment, leveraging the dual benefits of directly inhibiting tumor cell growth and enhancing antitumor immune responses. Continued research efforts aimed at elucidating CD70 biology, optimizing therapeutic strategies, and conducting clinical trials will be instrumental in realizing the clinical utility of anti-CD70 targeting antibodies. By addressing the complexities of tumor-host interactions and overcoming therapeutic challenges, CD70 targeting has the potential to transform the landscape of cancer therapy and improve patient outcomes. The ongoing efforts to elucidate the role of CD70 in cancer biology and advance CD70 targeted therapies offer exciting prospects for improving patient outcomes. Future research should focus on refining therapeutic approaches, including the development of next-generation CD70 targeted agents with enhanced efficacy and reduced off-target effects. Ultimately, harnessing the therapeutic potential of CD70 inhibition clenches promise for realizing the full potential of immunotherapy for cancer and other disorder treatment.

ImmunotherapyFast TrackOrphan DrugClinical Study

100 Deals associated with Cusatuzumab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adult Acute Myeloblastic Leukemia	Phase 2	China	argenx SE	30 Jan 2022
Chronic Myelomonocytic Leukemia	Phase 2	United Kingdom	Janssen Research & Development LLC	27 Feb 2020
Acute Myeloid Leukemia	Phase 2	France	Oncoverity, Inc.	29 Jul 2019
Acute Promyelocytic Leukemia	Phase 2	Australia	Oncoverity, Inc.	29 Jul 2019
Acute Promyelocytic Leukemia	Phase 2	Brazil	Oncoverity, Inc.	29 Jul 2019
Acute Promyelocytic Leukemia	Phase 2	France	Oncoverity, Inc.	29 Jul 2019
Acute Promyelocytic Leukemia	Phase 2	Israel	Oncoverity, Inc.	29 Jul 2019
Acute Promyelocytic Leukemia	Phase 2	Italy	Oncoverity, Inc.	29 Jul 2019
Acute Promyelocytic Leukemia	Phase 2	Russia	Oncoverity, Inc.	29 Jul 2019
Acute Promyelocytic Leukemia	Phase 2	Spain	Oncoverity, Inc.	29 Jul 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04023526 (CULMINATE, CTgov)	Phase 2	Acute Myeloid Leukemia \| Acute Promyelocytic Leukemia	103	Cusatuzumab+Azacitidine (Cusatuzumab 10 mg/kg Plus Azacitidine)	noyswqqprj = kkohddipjy mnwppeospk (kipbjrfzkj, xzmmsimqgh - sjixnydpnp) View more	-	30 Jul 2024
				Cusatuzumab+Azacitidine (Cusatuzumab 20 mg/kg Plus Azacitidine)	noyswqqprj = bvkwsxtgfp mnwppeospk (kipbjrfzkj, dpyynsgbzh - qnfsbmpobi) View more
NCT04023526 \| NCT04150887 (Pubmed \| Lancet Haematol)	Not Applicable	Acute Myeloid Leukemia	-	Cusatuzumab 10 mg/kg	gjuqzlafzb(hmwvbzmbyc) = reported causes of death in the 10 mg/kg group: n=2 tmtaqiorbl (clkjaixbqz ) View more	-	01 Nov 2023
				Cusatuzumab 20 mg/kg
NCT04023526 (CULMINATE, Corporate Publications) Manual	Phase 2	Acute Myeloid Leukemia	52	Azacitidine+cusatuzumab (cohort where patients received at least two treatment cycles)	tjiaiuwdmu(mxixbfjsvt) = jnlcyglafd ktqbzktoad (mbejpbpdpp ) View more	Positive	08 Jan 2021
				Azacitidine+cusatuzumab (20 mg/kg)	tjiaiuwdmu(mxixbfjsvt) = omafpfszbl ktqbzktoad (mbejpbpdpp ) View more
NCT03030612 (Pubmed \| Nat Med)	Phase 1/2	Acute Myeloid Leukemia	12	Cusatuzumab monotherapy	orcdkfsinh(ltgmpltffn) = cusatuzumab treatment substantially reduced LSCs xoqsadxgmx (odejhozpco )	-	29 Jun 2020
NCT03030612 (ASH 12018 \| ASH 22018) Manual	Phase 1/2	Acute Myeloid Leukemia First line	12	Azacitidine+Argx-110	ijtrysspep(sertfiysmb) = rvexzyuewn cgceinfakq (itlozfenjr ) View more	Positive	29 Nov 2018
NCT01813539 (ASCO2014)	Phase 1	Hematologic Neoplasms	19	ARGX-110	mtulfsezpd(ojuwqrwhgr) = 16% yyyldrqovz (afjcscwxcm ) View more	-	20 May 2014

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