ADC Therapeutics Presents Interim Phase I Data from its Novel Antibody-Drug Conjugate ADCT-402
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-402 (loncastuximab tesirine or “Lonca-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-402 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma
Dr. Brad Kahl, M.D., Professor for Medical Oncology at the Washington University School of Medicine in St. Louis, said: “A significant number of Diffuse Large B-Cell Lymphoma (DLBCL) patients become relapsed or refractory to existing therapies and have no approved treatment options. As a result, we are very excited about the 60 percent overall response rate (ORR) of Lonca-T at 120 µg/kg or higher, including a 35 percent complete response rate, in this difficult-to-treat patient population. Although the data are still maturing, we are also very encouraged by a median duration of response so far of approximately 5 months. Overall, these results justify the rapid development of the Lonca-T clinical program to address this unmet need.”
Data were presented from 138 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 64 years, and they had a median of 3 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), 88 patients were treated at dose ranges from 15-200 µg/kg. In Part 2 (dose expansion), 50 patients were treated in two cohorts at either 120 or 150 µg/kg.
Key findings presented at an oral presentation included:
- For the 68 response-evaluable patients in Part 1 at doses greater than or equal to 120 μg/kg, the ORR was 60 percent (41/68) with 24 patients achieving a complete response (35 percent) and 17 patients achieving a partial response (25 percent).
- For the 49 response-evaluable patients in Part 1 with Diffuse Large B-Cell Lymphoma at doses greater than or equal to 120 µg/kg the ORR was 55 percent (27/49) with 18 patients achieving a complete response (37 percent) and 9 patients achieving a partial response (18 percent).
- ADCT-402 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 (44 percent), nausea (28 percent), elevated gamma-glutamyltransferase (27 percent), anemia (25 percent), and peripheral edema (25 percent). The most common Grade 3 or 4 adverse events occurring in at least 5 percent of patients, regardless of attribution, were reduced neutrophil count (15 percent), elevated gamma-glutamyltransferase (15 percent), anemia (12 percent), reduced platelet count (12 percent), neutropenia (12 percent), thrombocytopenia (9 percent), elevated blood alkaline phosphatase (5 percent), fatigue (5 percent), reduced lymphocyte count (5 percent), and reduced white blood cell count (5 percent).
- Dose expansion in Part 2 of the Phase I study may continue using the recommended doses from Part 1 (i.e. 120 or 150 µg/kg).
2. Elucidating Exposure-Response (Safety and Efficacy) of ADCT-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-containing Antibody Drug Conjugate, for Recommended Phase 2 Dose Determination in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
This poster presented pharmacokinetic (PK) data elucidating the relationship between drug exposure and response in terms of safety and efficacy.
3. Interim results of a Phase I open label, single agent, dose-escalating study of ADCT-402 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia
Data were presented from 29 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 50 years, and they had a median of 2 prior therapies. Data were reported from Part 1 of the Phase I study as of November 1, 2017. In Part 1 (dose escalation), patients were treated at dose ranges from 15-150 µg/kg every three weeks, or at a dose of 50 µg/kg once weekly.
Key findings presented at a poster session included:
- Four patients achieved a complete bone marrow response.
- ADCT-402 has been reasonably well tolerated.
- The most common treatment-emergent adverse events of any grade occurring in at least 20 percent of patients were nausea (31 percent), fatigue (24 percent), febrile neutropenia (24 percent), and headache (24 percent). The most common Grade 3 or 4 adverse events occurring in at least 10 percent of patients, regardless of attribution, were febrile neutropenia (24 percent), reduced neutrophil count (14 percent), bacteremia (10 percent), abdominal pain (10 percent), lung infection (10 percent), and sepsis (10 percent).
- Dose escalation will continue using weekly dosing.
ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD)-dimer toxin. Once bound to a CD19- expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in two ongoing Phase I clinical trials in patients with relapsed or refractory B-cell lineage non-Hodgkin lymphoma and relapsed or refractory B-cell lineage acute lymphoblastic leukemia. (www.adct-402.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).
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
The Brightline Initiative, Project Management Institute and The Boston Consulting Group Host The Economist Events for Davos Panel20.1.2018 00:13 | Tiedote
The Brightline™ Initiative, a non-commercial coalition dedicated to helping organizations bridge the gap between strategy design and strategy delivery, along with Project Management Institute (PMI) and The Boston Consulting Group are hosting The Economist Events on the panel discussion, “The Business Case for Openness: Implementing Strategy in a Drawbridge up World.” This event marks Brightline’s debut at Davos. Dovetailing with the World Economic Forum’s overarching theme, “Creating a Shared Future in a Fractured World,” the discussion will address how business leaders can better adapt and implement strategies to promote openness and collaboration. PMI, a founding coalition member of Brightline, is particularly passionate about this topic, given the fact that they focus on collaborating with world-leading organizations to improve infrastructure initiatives in developing and mature communities around the world. “Today the challenges to sustainable growth through strategy implementation
New US Patent for Solidia Technologies’ CO2-cured Concrete Advances Performance and Sustainability of Building Materials19.1.2018 21:07 | Tiedote
The U.S. Patent and Trademark Office issued a patent for the structure of CO2-cured Solidia Concrete™, advancing the performance and sustainability of materials available to the global construction and materials industries. Solidia Technologies® holds the exclusive licensing rights to the patent, which is held by Rutgers University, where the original generation of the material was invented. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005608/en/ Solidia Concrete™ pavers. (Photo: Business Wire) U.S. Patent No. 9,868,667, "Bonding Element, Bonding Matrix and Composite Material Having the Bonding Element and Method of Manufacturing Thereof," covers the composition of matter of the non-hydraulic concrete. “The hydrate bonds in conventional concrete can compromise that material’s strength and durability,” explained Solidia Chief Technology Officer Nicholas DeCristofaro, Ph.D. “With CO2-cured concrete, bonding elements bas
Schlumberger Announces Full-Year and Fourth-Quarter 2017 Results19.1.2018 15:00 | Tiedote
Schlumberger Limited (NYSE:SLB) today reported results for full-year 2017 and the fourth quarter of 2017. Full-Year Results (Stated in millions, except per share amounts) Twelve Months Ended Change Dec. 31, 2017 Dec. 31, 2016 Year-on-year Revenue $30,440 $27,810 9% Pretax operating income $3,921 $3,273 20% Pretax operating margin 12.9% 11.8% 111 bps Net loss (GAAP basis) $(1,505) $(1,687) n/m Net income, excluding charges and credits* $2,085 $1,550 35% Diluted EPS (loss per share) (GAAP basis) $(1.08) $(1.24) n/m Diluted EPS, excluding charges and credits* $1.50 $1.14 32% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Full-year 2017 revenue of $30.4 billion increased 9% year-on-year. This included a full year’s activity from the acquired Cameron businesses as compared to three quarters of activity in 2016. Excluding the addition of Cameron, revenue growth was driven by land activity in North America, which increa
The Coca-Cola Company Announces New Global Vision to Help Create a World Without Waste19.1.2018 14:55 | Tiedote
The Coca-Cola Company announced today that it is fundamentally reshaping its approach to packaging, with a global goal to help collect and recycle the equivalent of 100% of its packaging by 2030. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005104/en/ In 2017, employees from Heartland Coca-Cola Bottling Co. joined with other volunteers in St. Louis to collect and sort 14,480 pounds of debris; 63 percent was diverted for recycling. Coca-Cola then partnered with manufacturer Phoenix Technologies to convert plastic bottles into recycled PET plastic for use in new bottles. (Photo: Business Wire) This goal is the centerpiece of the Company’s new packaging vision for a World Without Waste, which the Coca-Cola system intends to back with a multi-year investment that includes ongoing work to make packaging 100% recyclable. This begins with the understanding that food and beverage containers are an important part of people’s m
Researchers and Scientists from Five Countries Named Winners of King Faisal Prize 201819.1.2018 13:33 | Tiedote
Five researchers and scientists from Malaysia, Jordan, Tunisia, the US and the UK have been named winners of the King Faisal Prize 2018 as the 40th edition of the renowned award recognized their distinguished contributions towards humanity. The Prize honours exceptional achievements in five categories: Service to Islam, Islamic Studies, Arabic Language & Literature, Medicine, and Science. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005245/en/ His Royal Highness Prince Khalid Al-Faisal, Chairman of King Faisal Prize Board, Abdulaziz (Photo: AETOSWire) Professor Irwandi Jaswir, Deputy Dean of the International Institute for Halal Research and Training (INHART) and Secretary of Council of Professors at the International Islamic University Malaysia (IIUM), has been named the winner in the Service to Islam category for contributions to the development of ‘Halal Science’ and Halal food and consumer goods. Professor Bashar
E.ON Chooses Corinex Broadband over Powerline Technology for their Smart Metering Rollout19.1.2018 09:00 | Tiedote
E.ON, an international energy company that serves 32 million customers across multiple countries, has decided to use broadband over powerline (BPL) as the key technology in their communication mix, in the smart metering communication infrastructure for the low voltage part of their grid. E.ON chose Corinex as the solution provider for the initial two years of the deployment. The initial deployment will be several ten thousands of repeaters and head ends providing secure communication for a couple of hundred thousands of households. Corinex Grid Value network management based on IBM Tivoli platform will manage the network. “After extensive field trials, we found that Corinex broadband over powerline technology meets our requirements for mass rollout of smart metering services. We are convinced BPL is ideally suited to address the needs of many other utilities, so E.ON is interested in supporting BPL industry standardization in order to create a broad ecosystem of silicon and system vend
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme