Nasdaq GlobeNewswire

ADC Therapeutics Doses First Patient in Pivotal Clinical Trial of ADCT-402 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Del

Phase II trial evaluating efficacy and safety of CD19-targeting antibody drug conjugate intended to support submission of Biologics License Application

Top-line data expected in third quarter of 2019

LAUSANNE, Switzerland, Aug. 07, 2018 (GLOBE NEWSWIRE) -- ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in its Phase II clinical trial intended to support the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The clinical trial is evaluating the efficacy and safety of ADCT-402 (loncastuximab tesirine) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

At the 2017 American Society of Hematology (ASH) Annual Meeting, the Company presented interim Phase I data on ADCT-402 in 138 evaluable, heavily pre-treated lymphoma patients who had failed, or were intolerant to, any established therapy known to provide clinical benefit, with a median of three prior therapies. At the time, for the 49 response-evaluable patients in Part 1 of the study (dose escalation) with DLBCL who received ADCT-402 at doses greater than or equal to 120 μg/kg, the overall response rate (ORR) was 55 percent (27/49), with 18 patients achieving a complete response (37 percent) and 9 patients achieving a partial response (18 percent).

The primary endpoint of the Phase II, multi-center, open-label, single-arm trial is the ORR in patients treated with ADCT-402, as confirmed by central review. Secondary endpoints include assessments of duration of response, complete response rate, relapse-free survival, progression-free survival and overall survival, as well as safety, pharmacokinetics and health-related quality of life. The trial will enroll approximately 140 patients with relapsed or refractory DLBCL at multiple centers in the USA and Europe.

“We are pleased to have dosed the first patient in our registrational Phase II clinical trial evaluating ADCT-402 in patients with DLBCL who have relapsed and have refractory disease after two or more multi-agent treatment regimens. Our Phase I clinical trial of ADCT-402 in non-Hodgkin lymphoma showed significant activity in patients with DLBCL and an acceptable safety profile,” said Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics. “Unfortunately, there is no effective treatment for patients with multiple relapsed and refractory DLBCL, so we are excited about the potential to improve outcomes in these patients with ADCT-402 in a single-arm trial. We anticipate reporting results from the Phase II trial in the third quarter of 2019 and are hopeful that the data will support our submission of a BLA to the FDA.”

Alex Spira, MD, PhD, FACP, Director of Virginia Cancer Specialists Research Institute and Clinical Assistant Professor of Oncology at Johns Hopkins School of Medicine, added, “Patients with DLBCL who have relapsed or are refractory after second-line chemotherapy face a very poor prognosis. There is a significant unmet need for an effective new treatment option for this patient population, and we believe ADCT-402 has the potential to help impact patient outcomes in this disease.”

For more information about the Phase II clinical trial, please visit www.clinicaltrials.gov (identifier NCT03589469).

ADC Therapeutics also plans to initiate multiple combination studies with ADCT-402 in the fourth quarter of 2018.

About Diffuse Large B-Cell Lymphoma (DLBCL)

Non-Hodgkin lymphoma (NHL) is the seventh most common type of cancer in the U.S., and accounted for an estimated 4.3 percent of new cancer cases in 2017.1 Diffuse large B-cell lymphoma (DLBCL) accounts for nearly one-third (32.5 percent) of NHL.2 The most common initial treatment for patients with DLBCL is chemo-immunotherapy. Response to initial treatment is high, but more than half of patients do not have long-term disease control.3 The current standard of care for relapsed DLBCL is additional chemotherapy, which can be followed by stem cell transplantation (SCT). The prognosis for relapsed patients is poor, especially for those with chemotherapy-refractory disease with a short interval between remission and relapse or those who relapse after high-dose therapy and SCT. There is a significant unmet need for an effective treatment for patients with relapsed or refractory DLBCL.

About ADCT-402

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. Preliminary data from a Phase I clinical trial in relapsed or refractory B-cell non-Hodgkin lymphoma demonstrate ADCT-402 has significant activity in patients with diffuse large B-cell lymphoma (DLBCL). ADCT-402 is also being evaluated in an ongoing Phase I clinical trial in patients with relapsed or refractory B-cell lineage acute lymphoblastic leukemia (B-ALL). The U.S. Food and Drug Administration has granted orphan drug designation to ADCT-402 for the treatment of DLBCL and mantle cell lymphoma.

About ADC Therapeutics

ADC Therapeutics SA is an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs) targeting major 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 multiple PBD-based ADCs in ongoing clinical trials in the USA and Europe, and a deep pipeline of other preclinical ADCs in development. ADC Therapeutics has 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. For more information, visit www.adctherapeutics.com.

1 Siegel et al., 2017
2 Al-Hamadani et al., 2015
3 Gisselbrecht et al., 2010

               
Investors Contact      EU Media Contact     USA Media Contact  
Dr. Chris Martin     Alexandre Müller     Tony Plohoros  
Chief Executive Officer     Dynamics Group     6 Degrees  
Chris.martin@adctherapeutics.com     amu@dynamicsgroup.ch     tplohoros@6degreespr.com  
Tel.: +41 (0) 21 653 0200     Tel: +41 (0) 43 268 3231     Tel.: +1 908-591-2839  

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

SoftServe’s Research Team Takes Prize at Samsung AI Challenge16.10.2018 21:16Pressemelding

Artificial intelligence leveraged to deblur and dehaze photos and videos with exceptional quality AUSTIN, Texas, Oct. 16, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, announced its researchers won second place at the Samsung AI Challenge 2018 with innovative neural image restoration enhancement for mobile and embedded devices. “Artificial intelligence is at the center of future-proofing technologies for many businesses today,” said Serge Haziyev, senior vice president for Advanced Technology at SoftServe. “The opportunities for AI are endless and we are proud of our team and their commitment to creating an innovative AI algorithm that pushed the boundaries of existing deblurring and dehazing technologies as part of Samsung’s AI Hackathon.” The winning team, made up of SoftServe research engineers, Volodymyr Budzan and Orest Kupyn, participated in the worldwide event developing a solution that uses state-of-the-art deep learning and computer vi

IRYStec Selected as CIX Top 20 Innovator for 2018!16.10.2018 17:52Pressemelding

MONTREAL, Oct. 16, 2018 (GLOBE NEWSWIRE) -- IRYStec Software Inc., today announced it was selected as one of the CIX Top 20 most innovative companies of 2018 in Canada. Chosen from hundreds of profiles by industry experts and investors, the winner will represent Canada at the Start-up World Cup Grand Finale In 2019! The CIX Top 20 program is Canada’s largest national showcase of the 20 hottest and most innovative tech companies. Hundreds of applications are submitted each year from across Canada and the CIX Selection Committee evaluates and selects 20 based on 5 criteria: Business Model, Quality of Product and Service Offering, Innovation, Market Opportunity and Depth of Management. CTO and Co-founder, Tara Akhavan, will be presenting at CIX 2018 on Oct 23 at 1 PM. Both Tara and Simon Morris, CEO, will be attending both days demonstrating why all displays in the near future will be perceptual displays driven by IRYStec’s Perceptual Display Platform technology. A crowd of over 800 inves

Strategic Tax Leaders are Preparing Now for Tax Reform 2.016.10.2018 15:15Pressemelding

ATLANTA, Oct. 16, 2018 (GLOBE NEWSWIRE) -- This year organizations adjusted their tax approach due to the passing of the Tax Cuts and Jobs Act. Strategic tax teams are continuing to prepare for another round of amendments with the potential for Tax Reform 2.0. “Change is inevitable, so organizations can’t get complacent with their tax strategy,” said Nick Alexander, Senior Product Manager at PowerPlan. “Tax teams should maximize their use of technology to help them stay ahead of future modifications of tax code to minimize disruption to their financials, processes and compliance.” PowerPlan has published a new article, Get Ready: Reform Isn’t Over, which further covers the potential impacts of Tax Reform 2.0 and shares how tax teams can prepare. To access the article, please visit: http://bit.ly/2NE8ZDO. About PowerPlan PowerPlan software provides financial insight into how complex rules and regulations impact your organization – empowering you to make credible decisions that improve o

€1.6bn investment project kickstarts Lithium Werks’ battery gigafactories vision16.10.2018 14:38Pressemelding

THE HAGUE, Netherlands, Oct. 16, 2018 (GLOBE NEWSWIRE) -- Dutch energy storage and battery company Lithium Werks B.V. (www.lithiumwerks.com) and Chinese Zhejiang Jiashan Economic and Technological Development Zone Industry Corporation have signed a framework agreement with the intention to construct a 60 hectares battery gigafactory in the Yangtze river Delta. Total investments required are estimated at €1.6 billion. The Lithium Werks factory and related facilities will produce battery cells for lithium-ion batteries, enabling the energy transition from fossil fuels to clean energy in order to reduce CO2 emissions. Lithium Werks expects to have installed production capacity of 500 GWh per annum by 2030 as it continues to contribute to the shift to a carbon neutral world. “With our Chinese partners’ help, and as we continue to grow both organically and through acquisitions, we will deliver the energy storage solutions that our customers increasingly ask for as the world transitions to c

Global Beverage and Food Launches With Stevia Are Up Sharply In 201816.10.2018 14:00Pressemelding

New Products Launched Globally with Stevia Post a +27% Increase in the First Half of 2018 vs the Same Period in 2017 CHICAGO, Oct. 16, 2018 (GLOBE NEWSWIRE) -- PureCircle (LSE: PURE), the world's leading producer and innovator of great-tasting stevia sweeteners, reports launches of new food and beverage products containing stevia leaf sweeteners increased significantly in the first six months of 2018 vs the comparable period in 2017. The data used in this release was provided by Mintel Global New Products Database (GNPD)*. Specifically, new product launches with stevia rose +27% globally. About one-third of foods and beverages launched using high-intensity sweeteners** contained stevia this year, nearly double the rate when compared to the first six months in 2012. Looking at results separately for global beverages and foods, launches of beverage products containing stevia grew 33% in the first half of 2018. Launches of food products with stevia grew 23%. As evidenced by this growth da

Checkpoint Therapeutics Appoints Christian Béchon to its Board of Directors16.10.2018 14:00Pressemelding

NEW YORK, Oct. 16, 2018 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, today announced that it has appointed Christian Béchon to its Board of Directors. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “I am very pleased to welcome Christian to Checkpoint’s Board of Directors. His experience as Chairman and CEO of LFB S.A., a major European biopharmaceutical company with global operations, will make him a valuable addition to our Board. We look forward to leveraging Christian’s expertise as we continue to advance toward pivotal Phase 3 clinical trials next year.” Mr. Béchon brings more than two decades of business experience to Checkpoint. He is currently Chairman and Chief Executive Officer of ChB Consultants, a privately held life science consul

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom