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ADC Therapeutics Announces Updated ZYNLONTA® Investigator-Initiated Trial Data in R/R Marginal Zone Lymphoma Presented at 18th International Conference on Malignant Lymphoma (ICML)
Prnewswire· 2025-06-16 11:15
Core Insights - ADC Therapeutics announced updated Phase 2 data for ZYNLONTA® showing an overall response rate (ORR) of 85% and a complete response (CR) rate of 69% in patients with relapsed/refractory marginal zone lymphoma (r/r MZL) [1][2] - The treatment was well tolerated, with safety profiles consistent with previous data [2][6] - The study is ongoing, with plans to expand enrollment to 50 patients across multiple sites [3][4] Study Details - The Phase 2 trial is a single-arm, open-label study led by Dr. Izidore S. Lossos at Sylvester Comprehensive Cancer Center [1][3] - As of February 10, 2025, 27 adult patients were enrolled, with 26 evaluable for response [2] - Among patients assessed for response, a CR rate of 61.5% was observed in high-risk POD24 patients [6] Efficacy and Safety - The longest duration of CR was 27 months from the start of treatment, with a progression-free survival (PFS) rate of 92.9% at 12 months [6] - Adverse events were consistent with the known safety profile of ZYNLONTA, with most being grade 1 or 2 [6] - Serious adverse events included neutropenia and RSV lung infection, with some patients requiring dose reductions [6] Regulatory and Future Plans - ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Medicines Agency for treating r/r large B-cell lymphoma [7][10] - The company plans to pursue regulatory pathways based on the ongoing trial results [4] - ZYNLONTA is also being evaluated in combination studies for other B-cell malignancies [8][10] Company Overview - ADC Therapeutics is a biotechnology company focused on developing targeted antibody drug conjugates (ADCs) for cancer treatment [9][10] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [11]
ADC Therapeutics Announces $100 Million Private Placement Extending Expected Cash Runway into 2028
Prnewswire· 2025-06-12 10:45
Core Viewpoint - ADC Therapeutics has announced a $100 million PIPE financing to support the development and commercialization of its ADC product ZYNLONTA and other strategic initiatives [1][2]. Financing Details - The PIPE involves the sale of 13 million common shares at $3.53 each and pre-funded warrants for 15.7 million common shares at $3.43 each, with gross proceeds expected to be approximately $100 million before fees [1][2]. - The financing is set to close on June 16, 2025, pending customary conditions [2]. Use of Proceeds - The net proceeds from the PIPE will be utilized for ZYNLONTA's clinical development, commercialization activities, working capital, and general corporate purposes [2]. Strategic Developments - The company will advance its preclinical exatecan-based ADC targeting prostate-specific membrane antigen (PSMA) while discontinuing other preclinical solid tumor programs [3]. - A workforce reduction of approximately 30% is planned, with the majority of this restructuring expected to be completed by September 30, 2025, incurring one-time cash charges of $6 to $7 million [3]. Long-term Growth Positioning - These strategic moves are anticipated to reduce operating expenses significantly and extend the company's cash runway into 2028 [4]. - Key anticipated catalysts include ongoing clinical trials such as LOTIS-7 and LOTIS-5, with significant data expected in the coming years [4][8]. Clinical Development Updates - LOTIS-7 Phase 1b trial data for ZYNLONTA plus glofitamab is expected in the second half of 2025, with full enrollment of 100 patients anticipated by the first half of 2026 [8]. - Topline results from the LOTIS-5 Phase 3 trial are expected in late 2025 or early 2026, with potential regulatory submissions following [8]. Company Overview - ADC Therapeutics is a leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for hematologic malignancies and solid tumors [14][15].
ADC Therapeutics Announces Updated Data from LOTIS-7 Clinical Trial Presented at the European Hematology Association 2025 Congress
Prnewswire· 2025-06-12 10:30
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b trial, showing a 93.3% overall response rate (ORR) and an 86.7% complete response (CR) rate in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with ZYNLONTA® and glofitamab [1][3][4] Efficacy Data - Among 30 efficacy evaluable patients, 28 achieved an overall response, with 26 achieving complete responses [3] - 25 out of 26 patients who achieved CR remained in CR at the data cut-off [1][3] - Median time to CR was 80 days for the 120 µg/kg dose and 42 days for the 150 µg/kg dose [3] - 12 patients converted from stable disease or partial response to CR over time [3] - Of 6 patients previously treated with CAR-T, 5 achieved CR [3] Safety Profile - The combination treatment was generally well tolerated, with no dose-limiting toxicities (DLTs) reported [3] - Among 41 safety evaluable patients, the most common grade 3 or higher treatment-emergent adverse events (TEAEs) included neutropenia (24.4%), anemia (9.8%), and increased liver enzymes [3] - Cytokine release syndrome (CRS) was observed in 23.8% of patients at the 150 µg/kg dose, all Grade 1, while 55% experienced CRS at the 120 µg/kg dose [3] Study Expansion - The company is expanding enrollment for the LOTIS-7 trial to 100 patients at the 150 µg/kg dose of ZYNLONTA [1][4] - The updated data will be presented at the European Hematology Association 2025 Congress and the 18th International Conference on Malignant Lymphoma [4] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy [9][13] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]
ADC Therapeutics(ADCT) - 2025 Q1 - Earnings Call Presentation
2025-05-14 12:07
1Q 2025 Earnings Call May 14, 2025 Agenda Financial Update Pepe Carmona Chief Financial Officer 01 Introduction Ameet Mallik Chief Executive Officer 02 Chief Medical Officer Clinical Highlights Mohamed Zaki 03 04 Q&A 2 Forward-Looking Statements This presentation and any accompanying oral presentation have been prepared by ADC Therapeutics SA ("ADC Therapeutics", "we" or "us") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, ...
ADC Therapeutics Reports First Quarter 2025 Financial Results and Provides Operational Update
Prnewswire· 2025-05-14 12:00
Core Insights - ADC Therapeutics reported promising data from the LOTIS-7 trial, showing an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% for ZYNLONTA® in combination with glofitamab in patients with relapsed/refractory DLBCL [1][3][9] - The company expects its cash runway to extend into the second half of 2026, allowing for multiple catalysts to be funded [1][9] - The CEO expressed confidence in ZYNLONTA's potential as a best-in-class treatment in a dynamic market, particularly as the company progresses with the LOTIS-5 confirmatory trial [2][3] Financial Performance - For Q1 2025, ZYNLONTA generated net product revenues of $17.4 million, slightly down from $17.8 million in Q1 2024 [9][21] - License revenues and royalties increased significantly to $5.6 million from $0.2 million in the same period last year, driven by a milestone payment related to ZYNLONTA's approval in Canada [9][21] - Research and development expenses rose to $28.9 million from $25.7 million year-over-year, reflecting increased spending on next-generation ADCs [9][21] - The net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024 [9][21] Clinical Development Updates - The LOTIS-7 trial has reached 40 patient enrollments in its dose expansion arm, with updates expected in the second half of 2025 [1][3] - The LOTIS-5 trial's safety run-in data will also be presented at EHA2025, showing no new safety signals and encouraging antitumor activity [3] - An abstract for marginal zone lymphoma data will be presented at ICML, highlighting the high rate of complete responses in a phase 2 study [3] Company Overview - ADC Therapeutics is a leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for hematologic malignancies and solid tumors [11][12] - ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory DLBCL after two or more lines of systemic therapy [8][12]
ADC Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Operational Update
Prnewswire· 2025-03-27 11:30
Core Insights - ADC Therapeutics reported significant progress in clinical trials for ZYNLONTA, with a 94% overall response rate (ORR) and a 72% complete response (CR) rate in the LOTIS-7 Phase 1b trial [1][5] - The company completed enrollment in the LOTIS-5 Phase 3 trial, with data updates expected in late 2025 [1][5] - Financial results for Q4 and full year 2024 showed a net product revenue of $16.4 million for Q4 and $69.3 million for the full year, indicating a slight increase compared to 2023 [8][22] Operational Updates - The LOTIS-7 trial demonstrated promising initial data, with 94% ORR and 72% CR in patients with relapsed or refractory non-Hodgkin lymphoma [5] - Enrollment for the LOTIS-5 trial was completed in December 2024, with data updates anticipated once progression-free survival (PFS) events are reached [5] - The company is also advancing its early research solid tumor program to the IND-enabling stage [2] Financial Performance - Q4 2024 net product revenues were $16.4 million, compared to $16.6 million in Q4 2023, while full-year revenues increased from $69.1 million in 2023 to $69.3 million in 2024 [8][22] - Research and development expenses decreased to $27.1 million for Q4 2024 from $30.3 million in Q4 2023, and full-year expenses dropped from $127.1 million to $109.6 million [8][22] - The net loss for Q4 2024 was $30.7 million, a significant reduction from $85.0 million in Q4 2023, and the full-year net loss decreased from $240.1 million to $157.8 million [8][22] Cash Position - As of December 31, 2024, the company had $250.9 million in cash and cash equivalents, down from $278.6 million in 2023, providing a runway expected to fund operations into the second half of 2026 [1][8]