Drugs / anti-OX40
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01303705 | Oct 2010 → Jul 2016 | metastatic prostate carcinoma | Providence Health & Services | Completed | No outcome recorded |
| Phase 1 | NCT01644968 | Nov 2003 → May 2009 | cancer of unknown primary site | Providence Health & Services | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01416844 | Sep 2012 | metastatic melanoma | Providence Health & Services | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-09-08 | Amgen | Results AMGEN AND KYOWA KIRIN ANNOUNCE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 ASCEND LONG-TERM EXTENSION STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS amgen.com ↗
Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD). |
| 2025-03-08 | Amgen | Results AMGEN AND KYOWA KIRIN PROVIDE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 IGNITE STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS amgen.com ↗
The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. |
| 2024-09-25 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Top-line Data from Rocatinlimab Phase 3 ROCKET HORIZON Trial for Adults with Moderate to Severe Atopic Dermatitis kyowakirin.com ↗
Tokyo, Japan, September 25, 2024 -- Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor. |
| 2024-04-07 | HiFiBiO Therapeutics | Results HiFiBiO Therapeutics Presents Two Posters at the 2024 American Association for Cancer Research Annual Meeting hifibio.com ↗
HiFiBiO has successfully constructed semi-mechanistic PKPD models for an anti-TNFR2 agonist and an anti-OX40 agonist that advocate for pulsatile agonism to achieve optimal anti-tumor efficacy. |
| 2023-03-15 | Shanghai Henlius Biotech | Regulatory Henlius Novel anti-OX40 HLX51 Received Clinical Trial Approval in China henlius.com ↗
the phase 1 clinical trial for the company’s self-developed HLX51, a novel humanized agonistic anti-OX40 monoclonal antibody (mAb) for the treatment of patients with advanced/metastatic solid tumours and lymphomas has been approved by the National Medical Products Administration (NMPA). |
| 2022-08-30 | Amgen | Results AMGEN TO PRESENT NEW, POSITIVE CLINICAL AND REAL-WORLD DATA ACROSS INFLAMMATION PORTFOLIO AT EADV 2022 amgen.com ↗
KHK4083/AMG 451 (rocatinlimab), an anti-OX40 monoclonal antibody, provides durable transcriptomic improvement in skin with atopic dermatitis patients |
| 2021-10-02 | Kyowa Kirin, Inc. | Results Kyowa Kirin and Amgen Present Positive Late-Breaking Data from Phase 2 Study of KHK4083/AMG 451 in Adult Patients with Moderate-to-Severe Atopic Dermatitis at EADV Congress The study met its primary objective of demonstrating statistically greater improvement from baseline in Eczema Area and Severity Index score at 16 weeks versus placebo Patients receiving KHK4083/AMG 451 showed statistically greater improvements in additional secondary efficacy endpoints versus placebo KHK4083/AMG 451 also showed progressive improvement in efficacy beyond 16 weeks kyowakirin.com ↗ |
| 2021-10-02 | Amgen | Results Amgen And Kyowa Kirin Present Positive Late-Breaking Data From Phase 2 Study Of AMG 451/KHK4083 In Adult Patients With Moderate-to-Severe Atopic Dermatitis At EADV Congress amgen.com ↗
Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE:4151) today announced that positive data from a Phase 2 study of AMG 451/KHK4083 were presented at the European Academy of Dermatology and Venereology 30 th Virtual Congress on Oct. 2, 2021 . |
| 2021-06-25 | Elpiscience Biopharma, Ltd. | Regulatory Elpiscience Announces CDE Clearance of IND Application for ES102 in Combination of Toripalimab elpiscience.com ↗
the Center of Drug Evaluation (CDE) has approved the IND application for ES102, a next generation anti-OX40 antibody, in combination with toripalimab (TUOYI®) an anti-PD1 antibody, in patients with advanced solid tumor. |
| 2021-03-08 | Galectin Therapeutics Inc. | Results OncoImmunology Publishes Pre-clinical Research Showing Galectin Therapeutics’ Belapectin Galectin-3 Inhibitor Reduces Tumor Progression in Combination with Anti-OX40 Therapy galectintherapeutics.com ↗
today announced that a paper published in the peer-reviewed journal OncoImmunology demonstrates how belapectin, a potent galectin-3 inhibitor, in combination with an anti-OX40 (CD134) monoclonal antibody, significantly reduces tumor progression compared to either agent alone. |
| 2020-10-18 | UbiVac | Results Dr Bernard Fox Joins CCFDIE Immunotherapy Workshop to Talk UbiVac's Combination Immunotherapy for Advanced Breast Cancer ubivac.com ↗
Dr. Fox also noted the failure of clinical trials for advanced cancer that relied on vaccines as the only treatment and presented data from Dr. Hong-Ming Hu, UbiVac’s co-Founder and CSO, showing how combining UbiVac’s vaccine technology with anti-OX40 significantly increased survival in a difficult to treat model of breast cancer. |
| 2019-04-01 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Showcases Data on BXCL701 in Combination with OX40 Agonist in Late-breaking Poster Presentation at AACR Annual Meeting bioxceltherapeutics.com ↗
These results support the Company’s belief that the combination of BXCL701 and an OX40 agonist represents a new potential treatment approach against multiple cancer types, and provide rationale for a clinical efficacy study of the combination therapy. |
| 2019-03-22 | Galectin Therapeutics Inc. | Results Providence Cancer Institute to Present Findings on GR-MD-02 at the 2019 Keystone Symposia on Molecular and Cellular Biology galectintherapeutics.com ↗
Galectin-3 inhibition with GR-MD-02 synergizes with agonist anti-OX40 mAb therapy leading to reduced immune suppression and improved overall survival. |
| 2018-12-05 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-OX40 Monoclonal Antibody IBI101 innoventbio.com ↗
IBI101 is the third molecule from Innovent approved for clinical trials by FDA. |
| 2018-10-19 | Glenmark Pharmaceuticals Ltd. India | Results Data on Glenmark’s GBR 830, First-in-Class, Investigational, Anti-OX40 Monoclonal Antibody in Development for Treatment of Atopic Dermatitis, to be Presented at the Fall Clinical Dermatology Conference glenmarkpharma.com ↗
GBR 830 induces progressive and sustained improvements in atopic dermatitis skin biomarkers and clinical parameters |
| 2018-07-26 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives IND Approval to Initiate Clinical Trials in China with its anti-OX40 Agonistic Antibody IBI101 and its anti-RANKL Antibody IBI307 innoventbio.com ↗
Innovent’s IBI101, is the first OX40-targeted molecule to receive IND approval in China. |
| 2018-01-26 | Verastem, Inc. | Results Verastem Presents Preclinical Data at ASCO-SITC Highlighting the Synergistic Effects of Duvelisib in Combination with Immune Checkpoint or Co-Stimulatory Antibodies in B Cell Lymphoma Model verastem.com ↗
When duvelisib and anti-OX40 were combined, tumor regression was observed which correlated with strong reduction of tumor Tregs, M2 macrophages and myeloid-derived suppressor cells. |
| 2017-03-02 | Incyte Corporation | Results Incyte’s Targeted Therapy and Immuno-oncology Portfolio to be Featured in 20 Abstracts at the AACR Annual Meeting 2017 incyte.com ↗
Agonist Antibodies Targeting OX40 and GITR Enhance the Activity of the IDO1-Selective Inhibitor Epacadostat in Preclinical Models |
All press releases naming this drug 21 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Anti-OX40 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01303705 ↗ |
| Action | Activate | “a mouse monoclonal antibody (mAb) that agonizes human OX40 signaling” PMID 24177180 ↗ Oct 2013 |
| Modality | Monoclonal antibody | “Monoclonal Antibody to OX40” NCT01303705 ↗ |
| Route | Intravenous | “Anti-OX40 will be administered intravenously” NCT01303705 ↗ |