ADC Therapeutics SA is a clinical-stage biotechnology company. It engages in the research and development and commercialization of targeted antibody drug conjugates for patients with hematological malignancies and solid tumors. Its clinical-stage product candidates include loncastuximab tesirine, camidanlumab tesirine, and ADCT-602. The company was founded by Christopher Martin on June 6, 2011 and is headquartered in Epalinges, Switzerland.
相关临床试验
52
27 进行中
药物批准
1
批准总数
监管机构
1
监管机构数
成立时间
2011
进行中（未招募）
26
50.0%
已完成
6
11.5%
No Longer Available
1
1.9%
尚未招募
1
1.9%
招募中
5
9.6%
终止
11
21.1%
撤回
2
3.9%
- Vir Biotechnology appointed Timothy Coughlin, former CFO of Neurocrine Biosciences, to its Board of Directors and as Chair of the Audit Committee, effective June 9, 2026. - Coughlin brings extensive experience guiding companies from clinical-stage to fully integrated commercial enterprises, including navigating regulatory setbacks. - The appointment comes as Vir advances its potential best-in-class treatment for chronic hepatitis delta and its pipeline of masked T-cell engagers for solid tumors. - Coughlin currently serves on the boards of aTyr Pharma, ADC Therapeutics, and Travere Therapeutics, and previously served on boards including Fate Therapeutics and Peloton Therapeutics.
- The Phase 3 LOTIS-5 trial met its primary endpoint with ZYNLONTA plus rituximab showing statistically significant PFS improvement over R-GemOx (HR=0.73, p=0.008) in relapsed/refractory DLBCL. - Grade 5 treatment-emergent adverse events were higher in the ZYNLONTA arm (13.2%) versus the control arm (4.6%), with the majority of deaths occurring in patients aged 75 years or older. - ADC Therapeutics plans a pre-sBLA meeting with the FDA in August 2026 and a supplemental Biologics License Application submission in Q4 2026. - The company's stock fell more than 50% following the data release, as safety concerns overshadowed the positive efficacy findings.
- ADC Therapeutics reported updated LOTIS-7 Phase 1b trial data showing ZYNLONTA combined with glofitamab achieved an 89.8% overall response rate and 77.6% complete response rate in 49 patients with relapsed or refractory diffuse large B-cell lymphoma. - The combination demonstrated strong efficacy across both relapsed and primary refractory patient populations, with 100% response rate in relapsed patients and 80% in primary refractory patients. - The treatment was generally well-tolerated with manageable safety profile, including 36.7% cytokine release syndrome across all dose levels and only 4.1% immune effector cell-associated neurotoxicity syndrome. - Complete enrollment of approximately 100 patients is expected in the first half of 2026, with full data presentation planned at a medical meeting by end of 2026.
- ADC Therapeutics raised $60 million through a private placement led by TCGX with participation from Redmile Group and existing investors to support commercial expansion of ZYNLONTA. - The funds will strengthen the company's financial position ahead of a potential ZYNLONTA relaunch in 2027, with the transaction expected to close on October 27, 2025. - ZYNLONTA is the first and only CD19-directed antibody drug conjugate approved by FDA and EMA for treating relapsed or refractory large B-cell lymphoma after two or more lines of therapy. - The financing provides approximately $57.6 million in net proceeds and extends the company's cash runway into 2028, positioning it for long-term sustainable growth.
- The follicular lymphoma market is projected to grow at a 6% CAGR during 2025-2034, driven by increased disease awareness and rising number of clinical trials focused on this slow-growing B-cell malignancy. - Recent regulatory approvals include Japan's approval of EPKINLY (epcoritamab) as the first subcutaneous T-cell engaging bispecific antibody for relapsed/refractory follicular lymphoma, and FDA approval of tafasitamab-cxix combination therapy. - The market was valued at approximately $1.082 billion in 2024, with the United States representing the largest market and approximately 35,000 new cases diagnosed across seven major markets. - Over 45 companies are developing 50+ therapies in the pipeline, including innovative approaches like CAR-T cell treatments, bispecific antibodies, and targeted therapies from companies such as Regeneron, AstraZeneca, and Bristol Myers Squibb.
- ADC Therapeutics raised $100 million through a private placement financing to extend its cash runway into 2028 and fund ZYNLONTA clinical development programs. - The company will implement a strategic restructuring plan including a 30% workforce reduction and UK facility closure to reduce operating expenses by approximately $6-7 million. - Key clinical catalysts include LOTIS-7 Phase 1b trial results in second half of 2025 and LOTIS-5 Phase 3 confirmatory trial topline data expected in late 2025 or first half of 2026. - The company will advance its preclinical PSMA-targeting ADC program while discontinuing other solid tumor development efforts to focus resources on hematologic malignancies.
- ADC Therapeutics has completed enrollment for the LOTIS-5 Phase 3 trial evaluating Zynlonta plus rituximab in relapsed or refractory diffuse large B-cell lymphoma (DLBCL). - The LOTIS-5 trial is designed to confirm Zynlonta's accelerated approval and potentially support label expansion for second-line treatment of DLBCL in combination with rituximab. - Topline results for the primary endpoint, progression-free survival, are expected by the end of 2025, with potential FDA submission in Q1 2026. - Zynlonta, a CD19-directed antibody-drug conjugate, has shown promising early results with an 80% overall response rate in the safety run-in phase of the trial.
- A Phase 2 trial of ZYNLONTA® with rituximab in relapsed/refractory follicular lymphoma showed a 97% overall response rate (ORR) and 77% complete response (CR) rate. - After a median follow-up of 15.6 months, the 12-month progression-free survival (PFS) rate was 94.6%, indicating a sustained treatment effect. - In a separate trial, ZYNLONTA® monotherapy in relapsed/refractory marginal zone lymphoma achieved a 91% ORR and 70% CR. - These findings support ZYNLONTA's potential in treating indolent B-cell lymphomas beyond diffuse large B-cell lymphoma.
- Loncastuximab tesirine with rituximab demonstrates a 97% overall response rate and a 67% complete response rate in relapsed/refractory follicular lymphoma patients. - A phase II trial of loncastuximab tesirine alone shows a 91% overall response rate and a 70% complete response rate in relapsed/refractory marginal zone lymphoma. - The combination therapy overcomes adverse prognostic factors, including POD24, in follicular lymphoma, offering a potential new treatment option. - Both regimens exhibit manageable safety profiles, suggesting they could provide effective treatment with reduced toxicity for these lymphoma subtypes.
- ADC Therapeutics will present initial data from the LOTIS-7 Phase 1b trial on December 11, 2024, evaluating ZYNLONTA® with glofitamab in relapsed/refractory DLBCL. - The LOTIS-7 trial assesses the safety and efficacy of the combination therapy in patients who have previously undergone multiple lines of systemic therapy. - ZYNLONTA®, an antibody-drug conjugate (ADC) targeting CD19, has already received accelerated FDA approval for r/r DLBCL after two or more prior therapies. - The corporate update webcast will provide insights into the potential of this combination to improve outcomes for DLBCL patients.
