{"id":"obi-999","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Data not available","Hepatic impairment":"Data not available"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT04084366"],"_chembl":{"hba":9,"hbd":4,"psa":"125.58","alogp":"1.21","source":"ChEMBL","chemblId":"CHEMBL5779754","maxPhase":null,"moleculeType":null,"molecularWeight":"427.44","oralBioavailable":false},"_pubmed":{"count":2,"papers":[{"date":"2023 Jan","pmid":"36701651","title":"First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors.","authors":"Tsimberidou AM","journal":"JCO precision oncology"},{"date":"2021 Jun","pmid":"33722855","title":"Preclinical Studies of OBI-999: A Novel Globo H-Targeting Antibody-Drug Conjugate.","authors":"Yang MC","journal":"Molecular cancer therapeutics"}]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T15:55:17.621006","offLabel":[],"timeline":[{"date":"2021-06-01","type":"positive","milestone":"Preclinical studies published in Molecular Cancer Therapeutics","regulator":"none","description":"Preclinical characterization of OBI-999 as a Globo H-targeting ADC demonstrated in vitro and in vivo efficacy"},{"date":"2023-01-01","type":"neutral","milestone":"First-in-human study results published in JCO Precision Oncology","regulator":"none","description":"Phase 1 clinical trial data presented showing preliminary activity and safety profile in patients with advanced solid tumors"},{"date":"2024-01-01","type":"negative","milestone":"Program discontinued","regulator":"none","description":"OBI Pharma discontinued development of OBI-999; reasons for discontinuation not publicly disclosed"}],"aiSummary":"OBI-999 is a Globo H-targeting antibody-drug conjugate (ADC) developed by OBI Pharma for advanced solid tumors. The drug works by binding to Globo H, a carbohydrate antigen overexpressed on cancer cells, and delivering a cytotoxic payload to induce tumor cell death. OBI-999 entered clinical development with a first-in-human study published in JCO Precision Oncology (2023), demonstrating preliminary activity in patients with advanced solid tumors. The program has been discontinued, indicating the company did not advance the asset to later-stage development or chose to reallocate resources. As a Globo H-targeting ADC, OBI-999 represented a differentiated approach to solid tumor treatment, though clinical efficacy or safety concerns likely contributed to the discontinuation decision. The asset remains notable in the ADC landscape as an example of carbohydrate antigen targeting in oncology.","brandName":"OBI-999","companyId":"obi-pharma-inc","ecosystem":[],"mechanism":{"target":"Globo H (globoside carbohydrate antigen)","novelty":"first-in-class","modality":"monoclonal antibody","drugClass":"Antibody-drug conjugate (ADC)","explanation":"OBI-999 functions as an antibody-drug conjugate (ADC), a biotherapeutic combining monoclonal antibody specificity with chemotherapy potency. The antibody component recognizes and binds to Globo H, a carbohydrate antigen that is overexpressed on the surface of many advanced solid tumors but has limited expression on normal tissues. Once the OBI-999 antibody binds to Globo H on tumor cells, the complex is internalized through receptor-mediated endocytosis. Inside the cell, the linker connecting the antibody to the cytotoxic payload is cleaved, releasing the active drug to disrupt microtubule dynamics and induce apoptosis. This mechanism allows selective delivery of chemotherapy to tumor cells while minimizing exposure to healthy tissue, potentially improving the therapeutic window compared to conventional chemotherapy.","oneSentence":"OBI-999 is an antibody-drug conjugate targeting Globo H carbohydrate antigen on cancer cells to deliver cytotoxic payload.","technicalDetail":"OBI-999 is a humanized monoclonal antibody conjugated to a tubulin-disrupting cytotoxic agent via a cleavable linker, targeting Globo H (a globoside carbohydrate antigen). The ADC achieves selective tumor cell killing through antibody-mediated internalization followed by intracellular payload release. Globo H is overexpressed in epithelial cancers including ovarian, breast, and pancreatic tumors, providing a differentiated target from protein-based antigens. The non-oral route of administration (intravenous) is typical for ADCs of this class."},"commercial":{"notes":"Program discontinued; no commercial revenue generated","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"OBI Pharma, Inc","competitors":[{"name":"Trastuzumab deruxtecan (Kadcyla)","slug":"trastuzumab-deruxtecan","company":"Roche/Genentech","advantage":"HER2-targeting ADC with established clinical efficacy in breast and gastric cancers; approved indication"},{"name":"Sacituzumab govitecan (Trodelvy)","slug":"sacituzumab-govitecan","company":"Immunomedics/Gilead","advantage":"TROP-2-targeting ADC approved for triple-negative breast cancer and urothelial carcinoma"},{"name":"Glembatumumab vedotin (Vibecotamab)","slug":"glembatumumab-vedotin","company":"Pfizer","advantage":"GPNMB-targeting ADC in development for melanoma and other solid tumors"}],"genericName":"OBI-999","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Advanced solid tumors","notes":"First-in-human study published in JCO Precision Oncology (2023); program subsequently discontinued","phase":"Phase 1","status":"completed"}]},"_fixedFields":["pubmed(2)"],"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04084366","phase":"PHASE1, PHASE2","title":"Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors","status":"TERMINATED","sponsor":"OBI Pharma, Inc","startDate":"2019-11-25","conditions":"Locally Advanced Solid Tumor","enrollment":44,"completionDate":"2023-10-27","primaryEndpoint":"Objective Response Rate (ORR) (CR+PR)"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💉","route":"IV","frequency":"Data not available","formulation":"Injection"},"_hyperScrapedAt":"2026-03-27T18:34:44.435007","crossReferences":{"chemblId":"CHEMBL5779754"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Taiwan-based biopharmaceutical company focused on cancer immunotherapy and ADC development","period":"2000–present","companyName":"OBI Pharma, Inc","relationship":"Originator"}],"publicationCount":2,"therapeuticAreas":["Oncology"],"trialPhaseCounts":{"PHASE1, PHASE2":1},"biosimilarFilings":[],"firstApprovalDate":"","recentPublications":[],"_hyperScrapedFields":["patents","pricing","trials","ema","mhra","who","safety-signals","recalls","dailymed","pubmed","drugbank","chembl","rxnorm","medicare","pharmgkb","sec","company-ir","wikipedia","drug-website","google"],"companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}