ADC Therapeutics Announces Interim Phase I Data from its Novel Antibody-Drug Conjugate ADCT-301
ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, today announced clinical data from two ongoing Phase I clinical trials evaluating ADCT-301 (camidanlumab tesirine or “Cami-T”) in important subtypes of lymphoma and leukemia. The data were presented at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, USA.
1. Interim results of a Phase I open label, single agent, dose-escalating study of ADCT-301 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory B-cell Hodgkin’s or non-Hodgkin’s lymphoma
Dr. Steven M. Horwitz, Medical Oncologist at Memorial Sloan Kettering Cancer Center in New York City, and Principal Investigator, said: “Despite considerable advances in the treatment of lymphoma, a significant number of patients still relapse or become refractory to existing therapies and need new treatment options. We are excited by the 77 percent overall response rate (ORR) in Hodgkin Lymphoma (HL), including a 44 percent complete response rate. We are also seeing emerging efficacy signals in T-cell lymphomas (ORR: 33 percent) and B-cell lymphomas (ORR: 19 percent). Although still early, we are very encouraged by a median duration of response for HL patients of over 5 months to-date. The safety profile appears consistent with what we expect with this target and warhead. We are now working to determine the best dosing regimen for Phase II.“
Data were presented from 86 evaluable, heavily pre-treated patients who had failed, or were intolerant to, any established therapy known to provide clinical benefit. The median age of patients was 53 years and they had a median of 4 prior therapies. Data were reported from Part 1 and Part 2 of the Phase I study as of November 1, 2017. In Part 1 (dose escalation), 71 patients were treated at dose ranges from 3-150 µg/kg every three weeks. In Part 2 (dose expansion), 15 Hodgkin Lymphoma patients were treated at 45 µg/kg every 3 weeks.
Key findings presented at the poster presentation included:
- For the 27 response-evaluable patients with HL in Part 1, treated at doses greater than or equal to 45 µg/kg, the ORR was 77 percent (21/27 patients) with 12 patients achieving a complete response (44 percent) and 9 patients achieving a partial response (33 percent).
- For the 12 response-evaluable patients with HL in Part 1 and Part 2, treated at the 45 µg/kg dose, the ORR was 100 percent (12/12) with 6 patients achieving a complete response (50 percent) and 6 patients achieving a partial response (50 percent).
- For HL patients in Part 1 and Part 2, treated at doses greater than or equal to 45 µg/kg, a complete or partial response was achieved in 21 of 27 patients previously treated with brentuximab vedotin (77 percent), 13 of 18 patients previously treated with a checkpoint inhibitor (72 percent), 9 of 14 patients who had previously undergone a stem cell transplantation (64 percent), and 4 of 8 patients who had previously received all three of these treatments (50 percent).
- ADCT-301 has been reasonably well tolerated.
- The most common treatment-emergent adverse events of any grade occurring in at least 20 percent of patients in Part 1 and Part 2 were fatigue (30 percent), rash (26 percent), elevated gamma-glutamyltransferase (22 percent), and pyrexia (21 percent). The most common Grade 3 or 4 adverse events occurring in at least 5 percent of patients, regardless of attribution, were elevated gamma-glutamyltransferase (13 percent), reduced platelet count (9 percent), elevated alanine aminotransferase (6 percent), anemia (6 percent), and rash (6 percent). There were three heavily pre-treated patients diagnosed with auto-immune neurotoxicity, including two patients who developed Guillain-Barré syndrome.
- These encouraging preliminary safety and efficacy results support further characterization of the dosing regime to optimize the therapeutic window in Hodgkin Lymphoma for a Phase II study.
2. Interim results of a Phase I open label, single agent, dose-escalating study of ADCT-301 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory B-cell acute myeloid leukemia or acute lymphoblastic leukemia
Data were presented from 33 evaluable, heavily pre-treated, patients who had failed, or were intolerant to, any established therapy known to provide clinical benefit. The median age of patients was 67 years and they had a median of 3 prior therapies. In Part 1 (dose escalation), 33 patients were treated at dose ranges from 3-92 µg/kg every three weeks, or 30-37.5 µg/kg once weekly.
Key findings presented at the poster presentation included:
- One patient achieved a complete response with incomplete blood count recovery.
- ADCT-301 has shown an acceptable safety profile.
- The most common treatment-emergent adverse events of any grade occurring in at least 20 percent of patients were fatigue (30 percent), nausea (24 percent), febrile neutropenia (21 percent), and pneumonia (21 percent). The most common Grade 3 or 4 adverse events occurring in at least 10 percent of patients, regardless of attribution, were febrile neutropenia (21 percent), thrombocytopenia (15 percent), fatigue (12 percent), reduced neutrophil count (12 percent), and pneumonia (12 percent).
- Dose escalation will continue to investigate weekly dosing.
ADCT-301 is an antibody-drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax®-TAC, licensed from Genmab A/S), conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. CD25 is an attractive target for an ADC approach as it is expressed in a wide range of hematological malignancies, including certain forms of lymphomas and leukemias, while its expression in healthy organs is restricted. ADCT-301 is being evaluated in two ongoing phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL), and in patients with relapsed or refractory CD25-positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). (www.adct-301.com)
About ADC Therapeutics
ADC Therapeutics SA (ADCT) is an oncology drug development company that specializes in the development of proprietary antibody drug conjugates (ADCs) targeting major types of hematological malignancies and solid tumors. The Company’s ADCs are highly targeted biopharmaceutical drugs that combine monoclonal antibodies specific to surface antigens present on particular tumor cells with a novel class of highly potent pyrrolobenzodiazepine (PBD) based warheads via a chemical linker. The Company has four PBD-based antibody drug conjugates in six ongoing Phase Ia and Ib clinical trials in the USA and in Europe, and a deep pipeline of other preclinical ADCs in development. ADCT enjoys strong relationships with world class partners, including AstraZeneca and its global biologics research and development arm, MedImmune. The Company is based in Lausanne (Biopôle), Switzerland and has operations in London, San Francisco and New Jersey. (www.adctherapeutics.com).
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
SIFLEX Switches to Rimini Street Support for Its SAP Application23.4.2018 23:00 | Pressemelding
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced that SIFLEX, a leading global printed circuit board (PCB) manufacturer headquartered in South Korea, has switched its SAP ERP support to Rimini Street from the vendor. By making the switch, SIFLEX was able to reduce its maintenance fees by 50% and can now maximize its current, stable and robust ERP ECC 5.0 system for a minimum of 15 years from the time the company transitioned to Rimini Street support. SIFLEX was also able to free up internal IT personnel to focus on more pressing initiatives within the organization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180423006227/en/ Leading Korean manufacturer of printed circuit boards, SIFLEX, Switches to Rimini Street Support for its SAP Application (Photo: Business Wire) Seeking
REPLY S.p.A.: Shareholders’ Meeting Approves the 2017 Financial Statements23.4.2018 15:10 | Pressemelding
Consolidated turnover of €884.4 million (+13.3%); Group net profits of €77.9 million (+ 15.3%). The proposal to distribute a dividend of €0.35 per share has been approved. The Board of Directors and the Board of Statutory Auditors have been appointed for the three-year period 2018-2020. Resolutions in relation to the purchase and/or sale of own shares. Reply S.p.A. Shareholders’ meeting [MTA, STAR: REY] today approved the Financial Statements for the financial year 2017, confirming the distribution of a gross dividend of €0.35 per share (up 21.7% compared to the previous year, taking into consideration the equity split occurred in October 2017, which converted each ordinary share, having a nominal value of €0.52 into 4 new ordinary shares, nominal value of €0.13). The dividend will be paid on 9 May 2018, with dividend detachment date set on 7 May 2018 and record date 8 May 2018. Financial Statements of the 2017 financial year The Reply Group closed the 2017 financial year with a consol
ABB and the Economist Launch Automation Readiness Index, Global Ranking for Robotics and Artificial Intelligence23.4.2018 14:35 | Pressemelding
South Korea, Germany and Singapore are the world’s top-ranked nations in their preparations for smoothly integrating intelligent automation into their economies, according to an index and report released today by ABB and The Economist Intelligence Unit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180423005873/en/ The report "The Automation Readiness Index (ARI): Who Is Ready for the Coming Wave of Innovation?" finds that even the best-prepared countries must develop even more effective education policies and training programs, as well as place a new emphasis on continual learning over the course of a career. Those policies and programs, the report recommends, must ensure that the rapid adoption of automation technologies and artificial intelligence (AI) will not leave people unprepared for the new, more human-oriented jobs that will be needed as robots and algorithms take on more of the routine tasks that can be and will
Finablr Launched To Accelerate Customer-Focused Technology Innovations23.4.2018 12:55 | Pressemelding
Noted UAE-based businessman and philanthropist, Dr. Bavaguthu Raghuram Shetty announced the creation of “Finablr”, a new holding company which, subject to regulatory approvals, will consolidate his global portfolio of financial services brands under one single umbrella. Incorporated in the UK, Finablr will provide strategic direction and oversight for the category-leading brands across its network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180423005741/en/ Finablr Leadership Team (L-R): Binay Shetty (Executive Director, Finablr), Dr. B.R. Shetty (Founder and Chairman, Finablr) and Promoth Manghat (Executive Director, Finablr) (Photo: AETOSWire) Finablr also seeks to drive financial enablement and empowerment by accelerating customer-focused technology innovation through R&D efforts, industry ecosystem engagements, investments and potential acquisitions. As a diversified network, Finablr will combine the cumulative indus
Abu Dhabi Fund for Development Finances US$192 Million Sheikh Khalifa bin Zayed City in Afghanistan23.4.2018 12:37 | Pressemelding
His Excellency Mohammad Ashraf Ghani, President of Afghanistan, inaugurated the Abu Dhabi Fund for Development (ADFD) financed Sheikh Khalifa bin Zayed City Housing Complex in Afghanistan. Located in the Qasaba district of Afghanistan’s capital Kabul, ADFD contributed an estimated US$192 million to the social housing development project. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180423005711/en/ His Excellency Mohammed Saif Al Suwaidi, Director General of ADFD, during the official inauguration ceremony of the 3,330-residential unit Sheikh Khalifa bin Zayed City in Afghanistan (Photo: AETOSWire) Aimed at increasing the supply of affordable accommodation options in the country, the crucial project encompasses 3,330 residential units. Including extensive infrastructure works such as roads, water, and electricity networks and support services, the project seeks to elevate living standards for its residents through its power
Rockwell Automation Simplifies Analytics for Industrial Productivity23.4.2018 12:00 | Pressemelding
Industrial organizations must be able to quickly identify ways to tighten production schedules and maximize revenue. Gaining insight into operations and production capabilities to make informed decisions has often involved time-intensive IT projects and a highly specialized skillset. Today, Rockwell Automation expands the FactoryTalk® Analytics portfolio, a robust advanced analytics environment that empowers users with the ability to quickly and confidently make informed decisions. These latest advancements were developed to reduce the complexity of the operations environment for manufacturers and producers and their employees who are driving operations. FactoryTalk Analytics has been developed for scale, discovering and connecting data sources from the edge of the network up through the enterprise, and then intelligently fusing the information to resolve issues close to the source. At the edge or the device, this can result in near-immediate resolution of production issues. Empowered