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

Quantenna and Telefónica Reinforce Strategic Partnership with New Portfolio of 8x8 MIMO Wi-Fi 6 Products12.12.2018 23:00Pressemelding

SAN JOSE, Calif., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Quantenna Communications, Inc. (NASDAQ: QTNA) is further strengthening its strategic partnership with Telefónica. Through a long history of cooperation, the two companies have developed multiple generations of best-in-class products including gateways, repeaters and set-top boxes deployed in Europe and Latin America. Leveraging Quantenna’s 8x8 QSR10GU-AX, Telefónica is delivering a new portfolio of high-end fiber gateways and repeaters. The Wi-Fi 6 compliant QSR10GU-AX provides integrated dual-band, dual-concurrent 2.4GHz and 5GHz functionality in the same chipset, supporting up to a maximum speed of 10Gbps and 12 simultaneous streams. Thanks to its “Always-On DFS” feature, the QSR10GU-AX offers enhanced radar detection and spectrum analyzer capabilities with wide frequency range analysis. The QSR10GU-AX also supports advanced MU-MIMO, allowing for transmission to multiple devices at the same time, and providing higher throughput, inc

Improved Accuracy and Speed for Disease Research, Two Genomic Companies Integrate Kits and Software to Enable Deep Exploration of Epigenetic Data12.12.2018 21:16Pressemelding

OnRamp’s ROSALIND and Active Motif offer an improved ChIP-Seq data analysis experience for researchers with state-of-the-art dynamics track plots and advanced collaboration capabilities SAN DIEGO, Dec. 12, 2018 (GLOBE NEWSWIRE) -- OnRamp BioInformatics, a genomics company focused on scientist-friendly bioinformatics software solutions, today announced they are working with Active Motif to improve accuracies in data analysis for ChIP-Seq experiments. OnRamp’s flagship software, ROSALIND, provides a point-and-click experience to speed up and simplify the process of genomic data analysis from experiment setup to QC and interactive data visualization to interpretation. With this integration, researchers will now benefit from an optimized analysis that includes the unique characteristics of Active Motif kits and antibodies, including Unique Molecular Identifiers (UMI) and spike-in solutions. Active Motif customers will now be able to rapidly interpret their data with ROSALIND’s identificati

Markforged launches H13 tool steel for high-strength, high-temp tooling applications12.12.2018 15:00Pressemelding

New material for Metal X 3D printing system is first of many WATERTOWN, Mass., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Markforged, the Boston-area 3D printer company transforming manufacturing, today announced the launch of H13 tool steel for the Metal X, the world’s leading desktop-sized metal printer with over 150 systems shipped since March 2018. The expansion into H13 will enable customers to print parts in high-strength, high-temperature applications such as metal forming tools, dies and punches, and hardened inserts for fixtures, and even injection molds with conformal cooling channels. To learn more about H13 tool steel and place an order, please visit http://markforged.com/h13 “We designed the Metal X system to change the way things are made, and the launch of H13 is the next step down that path,” said Jon Reilly, Markforged VP of product. “For manufacturers of high-volume plastic parts this is a game changer, significantly accelerating the speed at which they can bring new products

XBiotech’s Results from Phase 2 Atopic Dermatitis Study Suggest New Drug to Treat Skin Disease12.12.2018 14:30Pressemelding

Bermekimab Therapy Rapidly and Significantly Reduces Disease AUSTIN, Texas, Dec. 12, 2018 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ: XBIT) announced today that its open label, proof of concept, multicenter study using bermekimab to treat patients with moderate to severe atopic dermatitis (AD) has completed and the study met all primary and secondary endpoints. Thirty eight patients in two treatment groups received a low (n=10) or high (n=28) dose of bermekimab once weekly for either a 4 or 7-week treatment regimen, respectively. Statistically significant improvement was seen for all efficacy endpoints in the high dose group; and a significant dose response for the high dose compared to low dose group was observed for key endpoints, including the Eczema Area and Severity Index (EASI), Global Individual Sign Score (GISS), Patient Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), and SCORing Atopic Dermatitis (SCORAD). While clinically and statistically significant

Cisco and UBS to host ESG Conference Call/Webcast for the Financial Community on 12/17/1812.12.2018 14:00Pressemelding

SAN JOSE, Calif., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Cisco and UBS will host an ESG (Environmental, Social and Governance) Conference Call/Webcast for the Financial Community, at 11:00 a.m. ET/ 4:00 p.m. GMT on Monday, December 17, 2018. Kathy Mulvany, Cisco’s VP of Corporate Affairs, and Darrel Stickler, Cisco’s Environmental Sustainability Lead, will provide an overview of Cisco’s Corporate Social Responsibility (CSR) strategy, priorities and goals, and explain why Cisco’s CSR initiatives play an important role in overall shareholder value creation. The call will be hosted by John Roy, Ph.D., UBS IT Hardware, Networking & Services Analyst, and Julie Hudson, CFA, and Victoria Kalb, UBS Global ESG & Sustainability Analysts. Interested parties can participate by dialing toll-free: 800 694 5649 or international: +1 303 223 2687, Code: 21910788, or listening to the webcast at investor.cisco.com. Further information and Cisco’s 2018 CSR Report can be found at csr.cisco.com About Cisco Cisco

Standard Lithium Makes First Pilot-Scale High Purity Lithium Carbonate and Commissions Crystallisation Pilot Prototype12.12.2018 09:01Pressemelding

VANCOUVER, British Columbia, Dec. 12, 2018 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. (“Standard Lithium” or the “Company”) (TSXV: SLL) (OTC-Nasdaq Intl. Designation: STLHF) (FRA: S5L), is pleased to announce that the Company has completed the commissioning process for its prototype crystallisation pilot plant and has produced its first quantity of high purity (>99.1%) lithium carbonate. The Company, via its technology partners, is currently designing and fabricating both halves of its full-scale Pilot Plant; the Lithium Extraction Pilot Plant is being designed and built by Zeton Inc. in Burlington, Ontario, Canada; the Lithium Carbonate Crystallisation Pilot Plant is being designed and built by Saltworks Technologies Inc., at their facility in Richmond, British Columbia, Canada. Both parts of the Pilot Plant are based on Standard Lithium’s proprietary technology. The newly-constructed crystallisation pilot prototype was operated using a relatively ‘impure’ feed solution similar to, but

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

Besøk vårt presserom