NextCure, Inc. is a clinical-stage biopharmaceutical company, which engages in discovering and developing immunomedicines to treat cancer and other immune-related diseases. Its novel FIND-IO discovery technology identifies targets based on immunomodulatory function and on which the company is building a proprietary pipeline of immunomedicines. The company was founded by Michael S. Richman and Lie Ping Chen in September 2015 and is headquartered in Beltsville, MD.
相关临床试验
8
0 进行中
药物批准
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批准总数
监管机构
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监管机构数
成立时间
2015
已完成
1
12.5%
招募中
2
25.0%
终止
4
50.0%
撤回
1
12.5%
暂无批准数据
- Avere Therapeutics is merging with NextCure to gain a Nasdaq listing, accompanied by a $320 million private placement led by Fairmount and Hansoh Pharma. - The combined company will advance AVR-001, a once-weekly oral IL-23 antagonist licensed from Hansoh for moderate-to-severe plaque psoriasis and ulcerative colitis. - AVR-001 has completed a Phase 1b trial in China, with a Phase 2b study underway there and a U.S. Phase 2b trial expected to start in 2027. - Avere's leadership team previously led Akero Therapeutics through its $4.7 billion acquisition by Novo Nordisk.
- Halia Therapeutics announced final Phase 2 results for ofirnoflast (HT-6184) showing 67% hematological improvement rate in 30 evaluable patients with lower-risk myelodysplastic syndrome. - The first-in-class NEK7 inhibitor demonstrated 55% transfusion independence for at least 8 weeks among transfusion-dependent patients, with median duration of 28.5 weeks. - The trial reported no treatment-related serious adverse events, with treatment-related adverse events occurring in only 27% of patients. - The company appointed Han Myint, MD, FACP, as Chief Medical Officer to lead clinical development as ofirnoflast advances toward pivotal trials.
- NextCure reports Phase 1 dose escalation data for its novel CDH6-targeted ADC SIM0505 is expected in Q2 2026, focusing on gynecological cancers including platinum-resistant ovarian cancer. - The company's second ADC program, LNCB74 targeting B7-H4, has expanded into higher dose cohorts with proof-of-concept data now delayed to the second half of 2026 to accommodate enrollment. - NextCure maintains a strong financial position with approximately $41.8 million in cash and securities as of December 31, 2025, providing runway into the first half of 2027.
- Raludotatug deruxtecan achieved a 51% confirmed overall response rate across three doses in 107 platinum-resistant ovarian cancer patients in the phase 2 portion of the Rejoice-Ovarian01 trial. - The 5.6mg/kg dose was selected for phase 3 testing based on optimal risk-benefit profile, showing 50% response rate with manageable safety concerns. - Treatment-related interstitial lung disease occurred in patients across dose levels, including one grade 3 case at the lowest 4.8mg/kg dose, highlighting ongoing safety considerations. - The phase 3 portion will compare raludotatug deruxtecan at 5.6mg/kg versus physician's choice chemotherapy, with overall response rate and progression-free survival as co-primary endpoints.
- Vicero, a preclinical biopharmaceutical company, has appointed Dr. Han Myint as Chief Medical Officer to lead clinical strategy for its VINCOBODY immunotherapy portfolio. - Dr. Myint brings over 30 years of experience in oncology drug development, including roles at NextCure, NexImmune, and Celgene/Bristol Myers Squibb. - His immediate focus will be advancing VCR-036, a bispecific PD-1 + CTLA-4 program, into clinical trials with the goal of achieving combination efficacy while reducing immune-related toxicities.
- NextCure's NC605, a novel anti-Siglec-15 antibody, demonstrated improved bone microarchitecture and reduced fracture incidence in preclinical studies of osteogenesis imperfecta mice. - The treatment showed superior bone quality outcomes compared to current anti-resorptive therapies by both inhibiting bone loss and producing new bone with increased quality and density. - NC605 represents a potential breakthrough for osteogenesis imperfecta patients, as there is currently no FDA-approved standard of care for this rare brittle bone disease. - NextCure is seeking financial support to advance NC605 toward an Investigational New Drug submission within 12 to 18 months.
- NextCure gains global rights to SIM0505, a novel antibody-drug conjugate targeting CDH6 for solid tumors, while Simcere Zaiming retains Greater China rights. - The partnership includes potential milestone payments up to $745 million plus tiered royalties, with U.S. Phase 1 trials expected to begin in Q3 2025. - SIM0505 features a proprietary topoisomerase 1 inhibitor payload designed for broad anti-tumor activity with high systemic clearance to improve the therapeutic window. - Initial Phase 1 clinical data is anticipated in the first half of 2026, following ongoing dose escalation studies in China.
- NextCure has dosed the first patient in a Phase 1 study of LNCB74, an antibody-drug conjugate (ADC) targeting B7-H4, for various cancers. - The study aims to evaluate the safety, tolerability, and preliminary anti-tumor activity of LNCB74 in patients with multiple cancers. - LNCB74 received FDA clearance for its Investigational New Drug application in December 2024 and is being co-developed with LigaChem Biosciences. - NextCure is focused on developing innovative medicines for cancer patients who have not responded to or progressed on current therapies.
- The FDA has accepted NextCure's IND application for LNCB74, an antibody-drug conjugate (ADC) targeting B7-H4, paving the way for Phase 1 clinical trials. - LNCB74, co-developed with LigaChem Biosciences, aims to treat multiple cancers, including breast, ovarian, and endometrial cancers, by targeting B7-H4 overexpressed in cancer cells. - Preclinical data demonstrated LNCB74's potential with complete tumor eradication at low doses and superior anti-tumor efficacy compared to other B7-H4-targeting ADCs. - Phase 1 trials, led by NextCure, will begin early next year, including dose escalation and expansion studies to determine safe dosing and confirm therapeutic dosage.
- NextCure's anti-Siglec-15 antibody NC605 demonstrated significant reduction in fractures in preclinical osteogenesis imperfecta models, with 90% of treated male mice and 80% of treated female mice showing no fractures post-sacrifice. - The treatment enhanced bone quality by increasing trabecular and cortical tissue mineral density while improving mechanical properties, contrasting with current anti-resorptive treatments that increase density but compromise bone quality. - Male mice showed particularly pronounced benefits including increased trabecular bone volume, cortical thickness, and improved mechanical bone strength measures of max load and stiffness. - The preclinical data positions NC605 as a potential transformative therapy for both male and female osteogenesis imperfecta patients, addressing an unmet medical need in this rare bone disorder.
