ADCT ADC Therapeutics SA

32.54
-0.46  -1%
Previous Close 33
Open 33.26
52 Week Low 25.105
52 Week High 56.5899
Market Cap $2,496,424,806
Shares 76,718,648
Float 27,020,115
Enterprise Value $2,115,284,805
Volume 215,926
Av. Daily Volume 236,119
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Upcoming Catalysts

Drug Stage Catalyst Date
Loncastuximab Tesirine
Diffuse Large B-Cell Lymphoma
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
Loncastuximab Tesirine + Ibrutinib (LOTIS-3)
Diffuse Large B-Cell or Mantle Cell Lymphoma
Phase 1/2
Phase 1/2
Phase 1/2 interim data noted ORR in all patients was 62.9% - December 7, 2020.
Camidanlumab tesirine
Hodgkin lymphoma (HL)
Phase 2
Phase 2
Phase 2 interim data presented at ASH December 6, 2020.
Camidanlumab Tesirine and pembrolizumab
Solid Tumors
Phase 1b
Phase 1b
Phase 1b data released at ESMO September 17, 2020.
Loncastuximab Tesirine
Follicular Lymphoma
Phase 2
Phase 2
Phase 2 pivotal trial to be initiated 1H 2021.

Latest News

  1. ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, announced today the initiation of an expanded access program (EAP) for loncastuximab tesirine (Lonca, formerly ADCT-402) for patients in the U.S. with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The EAP is for patients who cannot be treated by currently available drugs, cell therapy, or clinical trials.

    "We are pleased to offer an expanded access program for Lonca in the U.S., which will enable access to the therapy for eligible patients with relapsed or refractory…

    ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, announced today the initiation of an expanded access program (EAP) for loncastuximab tesirine (Lonca, formerly ADCT-402) for patients in the U.S. with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The EAP is for patients who cannot be treated by currently available drugs, cell therapy, or clinical trials.

    "We are pleased to offer an expanded access program for Lonca in the U.S., which will enable access to the therapy for eligible patients with relapsed or refractory DLBCL," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "This program reflects ADC Therapeutics' commitment to confronting cancer with the full potential of our science and bringing unique, targeted therapies and hope to patients and their families."

    Lonca is an investigational agent for which safety and efficacy have not yet been established. A Biologics License Application for Lonca for the treatment of relapsed or refractory DLBCL is currently under review with the U.S. Food and Drug Administration (FDA) and has been granted priority review status. The FDA has set a Prescription Drug User Fee Act target date of May 21, 2021.

    To qualify for the Lonca EAP, patients with relapsed or refractory DLBCL are required to meet certain inclusion / exclusion criteria. Requests for expanded access to Lonca must be made by a licensed, treating physician in the U.S.

    For more information about the Lonca EAP, please visit https://adctherapeutics.com/expanded-access-program/. For inquiries about the Lonca EAP, please contact .

    About Loncastuximab Tesirine

    Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

    A Biologics License Application for Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is currently under review with the U.S. Food and Drug Administration (FDA) and has been granted priority review status. The FDA has set a Prescription Drug User Fee Act target date of May 21, 2021. Lonca is being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.

    About ADC Therapeutics

    ADC Therapeutics SA (NYSE:ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

    Loncastuximab tesirine (Lonca, formerly ADCT-402), the Company's lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. On November 20, 2020, the U.S. Food and Drug Administration accepted the Biologics License Application, granting priority review and setting a Prescription Drug User Fee Act (PDUFA) target action date of May 21, 2021. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company's second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) for which preliminary data have demonstrated an 83% ORR, consistent with the Phase 1 clinical trial. The Company is also evaluating Cami in a Phase 1b clinical trial as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

    ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

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  2. ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, announced today that management will participate in a pre-recorded presentation and host one-on-one meetings through the SternIR Virtual Corporate Access Event taking place January 11-14, 2021.

    The presentation will be available for on-demand viewing beginning Monday, January 11, 2021, at 7:00 a.m. ET. The recording can be accessed via the Events & Presentations page in the Investors section of ADC Therapeutics' website, ir.adctherapeutics.com, and will be available for approximately…

    ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, announced today that management will participate in a pre-recorded presentation and host one-on-one meetings through the SternIR Virtual Corporate Access Event taking place January 11-14, 2021.

    The presentation will be available for on-demand viewing beginning Monday, January 11, 2021, at 7:00 a.m. ET. The recording can be accessed via the Events & Presentations page in the Investors section of ADC Therapeutics' website, ir.adctherapeutics.com, and will be available for approximately 30 days.

    About ADC Therapeutics

    ADC Therapeutics SA (NYSE:ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its

    targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

    Loncastuximab tesirine (Lonca, formerly ADCT-402), the Company's lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. On November 20, 2020, the U.S. Food and Drug Administration accepted the Biologics License Application, granting priority review and setting a Prescription Drug User Fee Act (PDUFA) target action date of May 21, 2021. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company's second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) for which preliminary data have demonstrated an 83% ORR, consistent with the Phase 1 clinical trial. The Company is also evaluating Cami in a Phase 1b clinical trial as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

    ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

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  3. NEW YORK, Dec. 15, 2020 /PRNewswire/ -- M.S.Q. Ventures ("MSQ") is pleased to announce that its client, ADC Therapeutics SA (NYSE:ADCT), has successfully entered into an agreement to jointly form a new company, Overland ADCT BioPharma (CY) Limited with Overland Pharmaceuticals, a fully integrated, biopharmaceutical company backed by Hillhouse Capital. 

    Under the terms of the agreement, ADC Therapeutics licensed exclusive development and commercialization rights to Lonca, ADCT-602, ADCT-601 and ADCT-901 for greater China and Singapore to Overland ADCT Biopharma, in which Overland Pharmaceuticals has invested $50 million. Overland Pharmaceuticals will have a 51% stake and ADC Therapeutics a 49% stake. ADC Therapeutics can also earn milestone payments and royalties from the license agreement with Overland ADCT BioPharma. 

    "As we prepare for the potential U.S. launch of Lonca in 2021, we are delighted that Overland ADCT BioPharma will expand access to the therapy, as well as three of our other pyrrolobenzodiazepine (PBD)-based antibody drug conjugates, to address patient needs in greater China," said Chris Martin, CEO of ADC Therapeutics. "The MSQ team has been working from A to Z to help us understand China's market, develop a plan, execute strategic objectives, and advise on this transaction. Their systematic approach and laser focus on results contributed to our success."

    Ed Zhang, Co-founders of Overland Pharmaceuticals, stated, "We are excited to bring these first four candidates into Overland ADCT BioPharma's portfolio and look forward to developing this new company into a leading oncology player in China. We are pleased to work with ADC Therapeutics, a pioneer in the field of ADCs, on this strategic venture. MSQ's professionalism and understanding of both parties' objectives helped to expedite this successful transaction especially during COVID-19."

    As ADC Therapeutics embarks on this exciting phase of its global plan, Echo Hindle-Yang, CEO of MSQ reflected on the transaction, "This new cross-border venture is another example that even in the era of COVID-19, global innovators such as ADC Therapeutics and Overland Pharmaceuticals have joined forces. We are heartened by what this could mean for cancer patients.  We congratulate both teams and look forward to more breakthroughs from them in the future."

    About MSQ  

    M.S.Q. Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights into the China market.  

    Echo Hindle-Yang, CEO, MSQ

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/adc-therapeutics-and-overland-pharma-form-strategic-jv-to-expand-adc-drugs-development-and-commercialization-in-greater-china-and-singapore-advised-by-msq-ventures-301192815.html

    SOURCE MSQ Ventures

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  4. - Hillhouse-backed Overland Pharmaceuticals to initially contribute $50 million to fund operations and development

    ADC Therapeutics SA (NYSE:ADCT) and Overland Pharmaceuticals, a fully integrated biopharmaceutical company backed by Hillhouse Capital, today announced that they have jointly formed a new company, Overland ADCT BioPharma (CY) Limited, to develop and commercialize four of ADC Therapeutics' antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (Lonca), ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore. Overland Pharmaceuticals has invested $50 million in Overland ADCT BioPharma to fund operations, including development plans for approval of Lonca…

    - Hillhouse-backed Overland Pharmaceuticals to initially contribute $50 million to fund operations and development

    ADC Therapeutics SA (NYSE:ADCT) and Overland Pharmaceuticals, a fully integrated biopharmaceutical company backed by Hillhouse Capital, today announced that they have jointly formed a new company, Overland ADCT BioPharma (CY) Limited, to develop and commercialize four of ADC Therapeutics' antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (Lonca), ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore. Overland Pharmaceuticals has invested $50 million in Overland ADCT BioPharma to fund operations, including development plans for approval of Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the licensed territory.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201214005195/en/

    "ADC Therapeutics' Biologics License Application for Lonca, which was recently granted priority review status, is currently under review with the U.S. Food and Drug Administration," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "As we prepare for the potential U.S. launch of Lonca in 2021, we are delighted that Overland ADCT BioPharma will expand access to the therapy, as well as three of our other pyrrolobenzodiazepine-based ADCs, to address patient needs in greater China."

    Under the terms of the agreement, ADC Therapeutics licensed exclusive development and commercialization rights to Lonca, ADCT-602, ADCT-601 and ADCT-901 for greater China and Singapore to Overland ADCT BioPharma. Overland Pharmaceuticals has invested $50 million in Overland ADCT BioPharma and Overland Pharmaceuticals will have a 51% stake and ADC Therapeutics a 49% stake. As part of the strategic business plan, Overland ADCT BioPharma may consider additional private investors and/or a potential public offering in the future. Both parties will appoint an equal number of nominees to the Board of Directors and a search is underway for a Chief Executive Officer for Overland ADCT BioPharma. ADC Therapeutics can also earn milestone payments and royalties from the regional license agreement with Overland ADCT BioPharma.

    "We are pleased to work with ADC Therapeutics, a pioneer in the field of ADCs, on this strategic venture to enable the development and commercialization of multiple targeted therapies for the treatment of patients with difficult-to-treat hematological and solid tumor cancers in greater China and Singapore," said Hua Mu, MD, PhD, Co-founder of Overland Pharmaceuticals. Ed Zhang, MBA, Co-founder of Overland Pharmaceuticals, added, "Overland is committed to developing breakthrough medicines with a mission to bring innovative medicines to patients in Asia. We are excited to bring these first four candidates into the Overland ADCT BioPharma portfolio and look forward to developing this new company into a leading oncology player in greater China."

    The Overland ADCT BioPharma pipeline is led by Lonca, an ADC composed of a humanized monoclonal antibody directed against human CD19. Lonca has been evaluated by ADC Therapeutics in a pivotal Phase 2 clinical trial in patients with relapsed or refractory DLBCL and is in two ongoing trials – a Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma and a Phase 3 confirmatory trial in combination with rituximab in patients with relapsed or refractory DLBCL. The Overland ADCT BioPharma portfolio also includes the clinical-stage candidates ADCT-602 targeting CD22, which is currently in a Phase 1/2 clinical trial in patients with relapsed or refractory acute lymphoblastic leukemia, and ADCT-601 targeting AXL, which is currently in a Phase 1 clinical trial in patients with selected advanced solid tumors. ADCT-901 targeting KAAG1 is in preclinical development for the treatment of advanced solid tumors with high unmet medical needs.

    MSQ Ventures served as an advisor to ADC Therapeutics on the China strategy and business development process.

    About ADC Therapeutics

    ADC Therapeutics SA (NYSE:ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

    Loncastuximab tesirine (Lonca, formerly ADCT-402), the Company's lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. In September 2020, ADC Therapeutics submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for Lonca for the treatment of patients with relapsed or refractory DLBCL. On November 20, 2020, the FDA accepted the BLA, granting priority review and setting a Prescription Drug User Fee Act (PDUFA) target action date of May 21, 2021. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company's second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an 86.5% ORR in HL patients at the dose selected for Phase 2. The Company is also evaluating Cami as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

    ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

    About Overland Pharmaceuticals

    Overland Pharmaceuticals is building a fully integrated biopharma company with a mission to bring innovative medicines to underserved patients in Asia and around the world. By leveraging our resources, global network, and local expertise across the biopharma ecosystem in Asia, Overland is establishing a portfolio of differentiated therapeutic candidates in a few carefully selected therapeutic areas. Through formative partnerships, Overland will move forward the development and commercialization of the most promising advances in medicine. www.overlandpharma.com

    ADC Therapeutics Forward-Looking Statements

    This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, addressable patient population, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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  5. Lonca LOTIS 2 subgroup data include updated median duration of response of 12.58 months

    LOTIS 3 interim results highlight potential of Lonca in combination with ibrutinib in relapsed or refractory diffuse large B-cell lymphoma and mantle cell lymphoma patients

    Preliminary pivotal Cami data demonstrate 83% overall response rate and no new safety signals in patients with relapsed or refractory Hodgkin lymphoma

    Company to host conference call and webcast today at 8 a.m. ET

    ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today…

    Lonca LOTIS 2 subgroup data include updated median duration of response of 12.58 months

    LOTIS 3 interim results highlight potential of Lonca in combination with ibrutinib in relapsed or refractory diffuse large B-cell lymphoma and mantle cell lymphoma patients

    Preliminary pivotal Cami data demonstrate 83% overall response rate and no new safety signals in patients with relapsed or refractory Hodgkin lymphoma

    Company to host conference call and webcast today at 8 a.m. ET

    ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced updated clinical data from its two lead programs, loncastuximab tesirine (Lonca) and camidanlumab tesirine (Cami), which were presented at the 62nd American Society of Hematology (ASH) Annual Meeting.

    "The encouraging data presented at the 2020 ASH Annual Meeting reinforce the significant progress we have made with our PBD-based ADCs for patients with hematological malignancies," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "The U.S. Food and Drug Administration recently accepted our Biologics License Application for Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma and granted priority review status with a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2021, based on the data from our pivotal LOTIS 2 clinical trial. As we rigorously prepare for potential approval and launch in 2021, we look forward to continuing to evaluate the potential of Lonca, as a single agent and in combination, in heavily pretreated patients, in earlier lines of therapy and in additional indications such as follicular lymphoma. As for Cami, our pivotal Phase 2 trial in Hodgkin lymphoma is now more than 50 percent enrolled, and the preliminary data presented at ASH highlight its potential to address an unmet need in heavily pretreated Hodgkin lymphoma patients."

    Lonca LOTIS 2 Subgroup Analysis (Abstract 1183)

    In LOTIS 2, a single-arm, open-label, 145-patient Phase 2 clinical trial in patients with relapsed or refractory DLBCL who had failed ≥2 established therapies, Lonca demonstrated substantial antitumor activity and an acceptable safety profile. Updated results, including analysis of response in subgroups with high risk of poor prognosis, were presented in a poster at ASH 2020 by Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University.

    Key data at the August 6, 2020, data cut include:

    • Overall response rate (ORR) was 48.3% and complete response rate (CRR) was 24.8%
    • Median duration of response (mDoR) of 12.58 months for the 70 responders, and mDoR of 13.37 months for patients achieving a complete response
    • Durable responses in high-risk patient groups, including:
      • Those who had progression after prior CAR-T therapy: ORR was 46.2% (6/13 patients)
      • Double or triple hit: ORR was 33.3% (5/15 patients)
      • Transformed DLBCL: ORR was 44.8% (13/29 patients)
    • No new safety concerns were identified during the study and no increase in toxicity was observed in patients aged ≥65 years compared with younger patients

    Lonca LOTIS 3 Interim Results (Abstract 2099)

    LOTIS 3, a Phase 1/2, two-part, open-label, single-arm clinical trial that is intended to support the submission of a Biologics License Application, is evaluating Lonca in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL). Updated interim data for patients receiving the 60 µg/kg Phase 2 dose of Lonca every three weeks and ibrutinib 560 mg/day were presented in a poster at ASH 2020. As of the data cut-off date of August 20, 2020, 37 patients had received the Phase 2 dose and 35 were evaluable for efficacy.

    Key data include:

    • ORR in all patients was 62.9%
      • In non-germinal center B-cell DLBCL patients, ORR was 66.7% (16/24 patients) and CRR was 37.5% (9/24 patients)
      • In germinal center B-cell DLBCL patients, ORR was 20% (1/5 patients)
      • In all DLBCL patients, ORR was 58.6% (17/29 patients)
      • In all MCL patients, ORR was 83.3% (5/6 patients)
    • Lonca in combination with ibrutinib had manageable toxicity, with the most common grade ≥3 treatment-emergent adverse events (TEAEs) in ≥5% of patients being anemia (10.8%), neutropenia (10.8%), thrombocytopenia (5.4%), and fatigue (5.4%)
    • Pharmacokinetic profiles demonstrated good Lonca exposure coverage throughout the dosing interval

    "The need for a later line of therapy that is both effective and tolerable is underscored by the significant number of patients with DLBCL or MCL who relapse after treatment and have a poor prognosis," said Julien Depaus, MD, Department of Hematology, CHU UCL Namur. "It is very encouraging to see that Lonca in combination with ibrutinib, at the Phase 2 dose identified as the maximum tolerated dose in the initial Phase 1 portion of the clinical trial, continues to demonstrate antitumor activity and manageable toxicity in patients with relapsed or refractory DLBCL and MCL."

    Cami Pivotal Phase 2 Preliminary Results (Abstract 474)

    Cami is being evaluated in a multicenter, open-label, single-arm, 100-patient Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL) who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT) including prior treatment with brentuximab vedotin and a checkpoint inhibitor. Preliminary efficacy and safety data were reported in an oral presentation at ASH 2020. As of the data cut-off date of August 24, 2020, 51 patients had been treated with Cami and the median number of Cami cycles was five.

    Key data include:

    • ORR was 83% (39/47 patients) and CRR was 38.3% (18/47 patients)
    • Five patients (10.6%) went on to consolidation with HSCT
    • No new safety signals have been identified and the most common grade ≥3 TEAEs in ≥5% of patients were hypophosphatemia (11.8%), gamma-glutamyltransferase increased (9.8%), alanine aminotransferase increased (5.9%), and maculopapular rash (5.9%)
    • Three cases of Guillain-Barré syndrome have been reported

    "Patients with relapsed or refractory HL who do not respond, or experience disease progression after initial response, to treatments such as brentuximab vedotin and PD-1 blockade have limited therapeutic options," said Alex Herrera, MD, Assistant Professor, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope Medical Center. "The encouraging antitumor activity Cami has demonstrated as a single agent and its safety profile, which has been consistent with the Phase 1 trial, warrant the continued evaluation of this CD25-targeted ADC in relapsed or refractory HL patients."

    ADC Therapeutics anticipates reporting interim results from the pivotal Phase 2 trial of Cami in HL in the first half of 2021. A Phase 1b clinical trial of Cami as monotherapy or in combination with pembrolizumab is currently enrolling patients with selected advanced solid tumors.

    Conference Call and Webcast

    ADC Therapeutics will host a live conference call and webcast today, December 7, 2020, at 8 a.m. ET, to highlight the Lonca and Cami data presented at ASH. The event will feature presentations from ADC Therapeutics management and key opinion leader Mehdi Hamadani, MD, Professor of Internal Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology. To access the conference call, please dial (833) 303-1198 (domestic) or +1 914 987-7415 (international) and provide the pin number 1486164. A live webcast of the presentation will be available on the Investors section of the ADC Therapeutics website at www.adctherapeutics.com. The archived webcast will be available on the ADC Therapeutics website after the completion of the event.

    About Loncastuximab Tesirine (Lonca)

    Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

    A Biologics License Application for Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is currently under review with the U.S. Food and Drug Administration (FDA) and has been granted priority review status. The FDA has set a Prescription Drug User Fee Act target date of May 21, 2021. Lonca is being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.

    About Camidanlumab Tesirine (Cami)

    Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax®-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based warhead killing the cell. This applies to CD25-expressing tumor cells, and also to CD25-expressing Tregs. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL), as well as in a Phase 1a/1b clinical trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

    About ADC Therapeutics

    ADC Therapeutics SA (NYSE:ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

    Loncastuximab tesirine (Lonca, formerly ADCT-402), the Company's lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. In September 2020, ADC Therapeutics submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for Lonca for the treatment of patients with relapsed or refractory DLBCL. On November 20, 2020, the FDA accepted the BLA, granting priority review and setting a Prescription Drug User Fee Act (PDUFA) target action date of May 21, 2021. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company's second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an 86.5% ORR in HL patients at the dose selected for Phase 2. The Company is also evaluating Cami as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

    ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, addressable patient population, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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