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Akari Therapeutics Announces $2.5 Million Registered Direct Offering
Globenewswire· 2025-10-15 12:30
Core Points - Akari Therapeutics has entered into a definitive agreement for the issuance and sale of 3,125,000 American Depositary Shares (ADSs) at a price of $0.80 per ADS in a registered direct offering [1] - The gross proceeds from the offering are expected to be approximately $2.5 million, which will be used for working capital, general corporate purposes, and continued research and development [4] Offering Details - Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering [2] - The company will also issue unregistered Series E and Series F Warrants to purchase up to 3,125,000 ADSs at an exercise price of $0.98 per share [3] - The offering is expected to close on or about October 16, 2025, subject to customary closing conditions [3] Research and Development Focus - The funds from the offering will be used to generate differentiated data on the novel ADC payload, which targets cancer cells and aims to highlight its unique action against cancer [4] - Akari's lead candidate, AKTX-101, utilizes a novel spliceosome modulator payload designed to disrupt RNA splicing within cancer cells, showing significant activity in preclinical studies [8][9] Company Overview - Akari Therapeutics is focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [8] - The company aims to advance its lead asset, AKTX-101, and other undisclosed targets with its novel payload [9]
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 Presentation of LOTIS-7 Clinical Trial Data at the European Hematology Association 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML)
Prnewswire· 2025-05-14 11:45
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b clinical trial, showing an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% among 22 evaluable patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [1][4] - The combination of ZYNLONTA and glofitamab demonstrated a manageable safety profile, with adverse events consistent with known profiles of the individual agents [2][4] - Updated data will be presented at the European Hematology Association 2025 Congress (EHA2025) and the International Conference on Malignant Lymphoma (ICML) [1][5] Efficacy and Safety Data - In the efficacy evaluable population, the ORR was 95.5% (21 out of 22 patients), and the CR rate was 90.9% (20 out of 22 patients) [4] - Among 31 patients treated, the most common Grade ≥3 treatment-emergent adverse event (TEAE) was neutropenia at 32.3% [4] - Other notable Grade 3/4 TEAEs included generalized edema, pericardial effusion, photosensitivity reaction, rash, sepsis, and pneumonia, each at 3.2% [4] Presentation Details - The LOTIS-7 data will be presented in a poster session at EHA2025 on June 14, 2025, with the presenting author being Juan Pablo Alderuccio, MD [3][5] - An oral encore presentation will take place at ICML on June 20, 2025, also featuring Juan Pablo Alderuccio as the presenting author [5] Study Overview - LOTIS-7 is a Phase 1b global multicenter study evaluating ZYNLONTA in combination with various agents, including glofitamab, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma [6] - The study includes a dose escalation phase and a dose expansion phase, with primary endpoints focusing on safety and tolerability [6] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy [9][12] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]
ADC Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Prnewswire· 2025-04-01 11:15
Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is focused on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3] Recent Developments - CEO Ameet Mallik will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025, at 8:00 a.m. ET [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [2] Product Pipeline - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - The company has multiple ADCs in ongoing clinical and preclinical development [4] Company Operations - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London, the San Francisco Bay Area, and New Jersey [5]
ADC Therapeutics to Host Fourth Quarter and Year-End 2024 Financial Results Conference Call on March 27, 2025
Prnewswire· 2025-03-20 11:15
Core Insights - ADC Therapeutics SA is a global leader in antibody drug conjugates (ADCs) and will host a conference call on March 27, 2025, to report financial results for Q4 and the year ended December 31, 2024 [1][2] - The company is advancing its proprietary ADC technology to improve treatment for patients with hematologic malignancies and solid tumors [3] - ADC Therapeutics' ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma [4] Company Overview - ADC Therapeutics is based in Lausanne, Switzerland, with operations in London and New Jersey [5] - The company is focused on developing multiple ADCs that are currently in clinical and preclinical stages [4] Upcoming Events - The conference call will provide operational updates and is accessible via a live webcast on the company's investor relations website [2]