Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2187 |
| INN | Bermekimab |
| Status | Terminated |
| Drug code(s) | JNJ-77474462, CV-18C3, RA-18C3, CA-18C3, T2-18C3, MABp1 |
| Brand name | Xilonix |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Human B cell-derived |
| Target(s) | IL-1 alpha |
| Indications of clinical studies | Systemic sclerosis, Atopic dermatitis, Hidradenitis Suppurativa, Colorectal cancer, Restenosis, Psoriasis, diabetes, Acne Vulgaris, cachexia in cancer patients, pyoderma gangrenosum, Neutrophilic Dermatoses |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at regulatory review |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2009 |
| Start of Phase 2 | |
| Start of Phase 3 | March 15, 2013 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | XBiotech Inc. |
| Licensee/Partner | Janssen |
| Comments about company or candidate | NCT04988308 Phase 2 in Hidradenitis Suppurativa started in Oct 2021 Terminated as of Dec 2022 (Study has been prematurely terminated as the Interim Analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint.) NCT04990440 Phase 2 in atopic dermatitis Terminated (Premature study termination (efficacy). NCT04791319 Phase 2 in atopic dermatitis Terminated (Premature Termination due to Interim Analysis (100 patients at Week 16). Sep 2020: Janssen posts data for 2 Phase 1 studies on clinicaltrials.gov On December 7, 2019 XBiotech Inc. announced today that it has entered into a definitive agreement with Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, to sell XBiotech’s bermekimab. Janssen will acquire all rights to bermekimab under the terms of the agreement, and XBiotech will be free to use its True Human Antibody discovery program to develop new antibody therapeutics that target IL-1⍺ to treat non-dermatological diseases. Oct 2019: XBiotech announced the first patient was enrolled in a clinical study evaluating bermekimab therapy in adults with systemic sclerosis (SSc), otherwise known as scleroderma, an inflammatory syndrome characterized by chronic inflammation in the blood vessels, skin, and other organs. NCT04021862 Phase 2 in atopic dermatitis not yet recruiting as of July 16 2019. NCT03512275 Phase 2 study in Hidradenitis Suppurativa and NCT03496974 Phase 2 study in Atopic Dermatitis recruiting as of Sep 2018. Jan. 26, 2018 : XBiotech Inc. announced today additional data analysis of its Phase 2 study evaluating XBiotech’s True Human™ antibody, MABp1, as a treatment for Hidradenitis Suppurativa (HS). The study achieved its primary endpoint, showing significant treatment benefit using the HiSCR endpoint, which is the method used in the development of the only therapy currently approved for the treatment of HS. However, other methods of evaluating disease severity and response to treatment have been proposed. The iHS4 scoring system has recently been proposed as a new measure of HS disease severity 1 but its usefulness as a clinical measure has not been extensively studied. Investigators used data from the Phase 2 study to evaluate the iHS4 scoring method to see how it correlates with the HiSCR findings. Sep 20 2017: XBiotech Inc. announced today its agreement with Cedars-Sinai Medical Center located in Los Angeles, California, whereby XBiotech will provide its interleukin-1 alpha antagonist, MABp1, for a Phase I single arm study evaluating the maximum tolerated dose of OnivydeⓇ (Irinotecan liposome injection) and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia. A marketing application for this indication was considered by EMA’s Committee for Medicinal Products (CHMP), which adopted a negative opinion, recommending the refusal of a marketing authorization, in May 2017. The opinion was based on study results that did not show clear improvements in lean body mass or quality of life; increased risk of infection in patients who received the drug; and inadequate controls of the manufacturing process. Upon the request of the applicant, XBiotech Germany GmbH, CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorization in September 2017. June 09, 2017: XBiotech Inc. announced today that an Independent Data Monitoring Committee (IDMC) has performed its second prospectively planned, unblinded analysis of the Phase 3 XCITE study for the Company’s novel candidate antibody therapy for the treatment of colorectal cancer. The IDMC had no safety concerns from the unblinded analysis. However, the committee recommended the early termination of the study since the findings were not sufficient to meet efficacy or the threshold for continuation. Sep 2017: EMA's outcome of re-examination. Refusal of the marketing authorisation for Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech. At the time of the initial review, the CHMP had a number of concerns. Firstly, the study did not show clear improvements in either lean body mass or quality of life. Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care. Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials. During the re-examination, the Committee was reassured that no commonly reported side effects appear to be directly linked to this medicine. However, insufficient safety data are available to properly assess its overall risks and the committee still had concerns about the medicine’s benefits and manufacturing controls. The CHMP therefore maintained its opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation. March 27, 2017: XBiotech Inc. announced today that it completed on time and confirmed receipt of its March 22, 2017 submission of responses to the remaining EMA queries related to its marketing authorization application. The Company feels confident it has addressed all outstanding issues raised in the application for its candidate antibody therapy for the treatment of colorectal cancerThe Company’s marketing authorization application for Xilonix for the treatment of colorectal cancer remains on schedule to achieve a decision in 2016 by the European Medicines Agency Committee for Medicinal Products for Human Use. On May 18, 2017, XBiotech Inc. announced that it has received a negative opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its Marketing Authorization Application for its lead product candidate in Europe. March 7, 2016: company granted eligibility by the European Medicines Agency (EMA) to submit a Marketing Authorization Application (MAA) for its candidate therapy Xilonix™ for the treatment of advanced colorectal cancer. Recd Fast Track designation in Oct 2012; XBiotech anticipates launching a Phase III randomized, controlled study under the FDA's Fast Track program to evaluate overall survival in advanced colorectal cancer patients, suffering from cachexia; study due to start in May 2014. Phase 3 started in March 2013 |
| Full address of company | Austin, Texas North America United States of America http://www.xbiotech.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |