相关临床试验
42
8 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
8
19.1%
已完成
16
38.1%
招募中
10
23.8%
暂停
1
2.4%
终止
6
14.3%
撤回
1
2.4%
暂无批准数据
- The oncology landscape added 278 new bi- and multispecific drugs during 2024/25, alongside more than 8,566 events across 2,120 drug programs. - Over 800 drugs were associated with new events, underscoring the accelerating pace and complexity of bi- and multispecific drug development. - A new analytical tool tracks 481 therapeutic targets, 167 tumor types, 1,481 clinical trials, and 350 deals, with Amgen, Roche/Genentech, and J&J among leading developers. - The platform leverages an AI-enhanced intelligence system with over 25 years of oncology expertise to support competitive, clinical, and business decision-making.
- Knight Therapeutics submitted a supplemental application to ANVISA seeking approval for MINJUVI (tafasitamab) plus lenalidomide added to R-CHOP as first-line treatment for previously untreated DLBCL and HGBL. - The supplemental application was selected for review under Project Orbis, reflecting a coordinated regulatory pathway across participating agencies. - The submission builds on results from the Phase 3 frontMIND trial, which enrolled 899 adults and evaluated tafasitamab plus lenalidomide added to R-CHOP versus R-CHOP alone. - The filing addresses a significant unmet need, as roughly 40% of DLBCL patients do not respond to initial therapy or relapse thereafter.
- Xencor reported second quarter 2026 financial results, including $51.2 million in revenue and a net loss of $21.7 million, while advancing its wholly owned clinical pipeline. - Phase 1 results for XmAb819 in advanced clear cell renal cell carcinoma were accepted for a proffered paper oral presentation at ESMO Congress 2026 in Madrid. - XmAb541 monotherapy showed an approximate 14% overall response rate in ovarian cancer and 28% in germ cell tumors, supporting prioritization of its combination with XmAb808. - The U.S. FDA granted Fast Track designation to XmAb541 in July 2026 for germ cell tumors relapsed or refractory after two or more lines of platinum therapy.
- Marengo Therapeutics has nominated the first development candidate under its June 2024 TriSTAR strategic collaboration with Ipsen, marking the second TriSTAR program to enter IND-enabling development. - The TriSTAR platform employs a differentiated two-in-one mechanism combining selective Vβ T-cell activation and tumor-directed engagement to overcome limitations of traditional CD3-directed T-cell engagers. - Saso Cemerski, Ph.D., formerly Head of Discovery Immune Cell Engagement at AstraZeneca, has been appointed Senior Vice President, Head of Immunology to accelerate pipeline expansion. - Ipsen will assume responsibility for all activities following the development candidate nomination, with Marengo eligible for milestone payments under the collaboration.
- The Supreme Court's 2023 Amgen v. Sanofi ruling invalidated broad functional genus claims, requiring concrete disclosure to support the full scope of what is claimed. - Means-plus-function (MPF) claims offer a middle path between narrow structural claims and vulnerable broad genus claims by covering only disclosed structures and their equivalents. - The USPTO's 2024 Ex parte Chamberlain decision confirmed that a single disclosed structure can satisfy written description requirements for MPF claims without needing to describe equivalents. - MPF claims can leverage both statutory equivalents under § 112(f) and the doctrine of equivalents, potentially capturing after-arising technologies in rapidly evolving fields like biologics.
- Vir Biotechnology will present complete Week 96 data from the Phase 2 SOLSTICE trial evaluating tobevibart and elebsiran combination therapy for chronic hepatitis delta at EASL Congress 2026. - The oral presentation has been selected for inclusion in "Best of EASL 2026" by the European Association for the Study of the Liver. - Chronic hepatitis delta is the most severe form of chronic viral hepatitis with no approved treatments in the U.S. and limited options globally. - The investigational combination therapy targets multiple points in the hepatitis delta virus life cycle through monthly subcutaneous injections.
- Incyte announced that positive Phase 3 frontMIND study results for tafasitamab in first-line diffuse large B-cell lymphoma will be presented at the 2026 ASCO Annual Meeting. - The pivotal study evaluated tafasitamab plus lenalidomide and R-CHOP in patients with newly diagnosed DLBCL, with results supporting global regulatory submissions. - Tafasitamab is a humanized CD19-targeting monoclonal antibody already approved in multiple regions for relapsed or refractory lymphomas. - The oral presentation is scheduled for May 30, 2026, during the Hematologic Malignancies session at ASCO in Chicago.
- The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma after at least one prior therapy. - Phase 3 inMIND trial results demonstrated statistically significant improvement in progression-free survival, with patients achieving median PFS of 22.4 months compared to 13.9 months in the control arm (HR: 0.43, P<0.0001). - If approved by the European Commission, Minjuvi would represent the first CD19- and CD20-dual-targeted immunotherapy for European patients with relapsed or refractory follicular lymphoma. - The treatment was well tolerated with a manageable safety profile, offering a chemotherapy-free alternative for second-line treatment in a disease affecting 2-4 out of every 100,000 people in Western countries.
- Xencor presented initial Phase 1 dose-escalation data for XmAb819, a first-in-class ENPP3 x CD3 bispecific T-cell engager targeting clear cell renal cell carcinoma patients. - The most common treatment-emergent adverse events were cytokine release syndrome, rash, and gastrointestinal toxicities, primarily Grade 1 or 2 in severity. - Dosing preparation errors led to higher than expected drug concentrations in 18 patients, resulting in increased Grade 3 cytokine release syndrome rates. - XmAb819 utilizes Xencor's XmAb 2+1 format with two tumor-antigen binding domains targeting ENPP3, which is highly expressed on kidney cancers.
- Vir Biotechnology will present Week 48 endpoint results from the Phase 2 SOLSTICE trial evaluating tobevibart alone or in combination with elebsiran for chronic hepatitis delta at AASLD 2025. - The presentation follows positive Week 24 data from AASLD 2024 that demonstrated rapid and sustained virologic suppression rates in patients with chronic hepatitis delta. - The company will also showcase its registrational ECLIPSE program, currently enrolling patients to evaluate the safety and efficacy of the tobevibart-elebsiran combination therapy. - Tobevibart is a broadly neutralizing monoclonal antibody targeting hepatitis B surface antigen, while elebsiran is an siRNA designed to degrade hepatitis B virus RNA transcripts.
