A Growing Number of Antibody-drug Conjugates (ADCs) are Progressing Through the Clinic and Beyond

Monday, November 12, 2018 Drug News
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World-wide more than 600 clinical trials with Antibody-drug Conjugates (ADCs) have been or are currently being conducted. Building on their experience, researchers continue to advance these drugs as important therapeutic modalities, both as single agents and as part of various combination regimens.

CHANDLER, Ariz., Nov. 12, 2018 /PRNewswire-PRWeb/ -- A recent survey by the publishers of ADC Review | Journal of Antibody-drug

Conjugates confirmed that world-wide more than 600 clinical trials with Antibody-drug Conjugates (ADCs) have been or are currently being conducted. Approximately 40% of these investigational agents are in Phase I clinical trials, 32% in Phase I/II, 17% in Phase II, and 9% in Phase III. The remaining 2% of these novel, agents are in a pre-registration Phase. [1][2]

The survey results show that of the more than 200 different investigational Antibody-drug Conjugates entered into clinical trials, 116 are actively progressing. The survey also indicates that over the last 12 months 23 new ADCs have been entered into clinical trials. [1][2]

Indications The majority of Antibody-drug Conjugates, approximately 70%, are still in discovery and preclinical stages. An estimated 12% of all clinical stage ADCs are being developed for the treatment of Breast Cancer, including difficult to treat Triple-Negative Breast Cancer (TNBC), while around 10% are being developed for the treatment of Non-Hodgkin's Lymphoma. Approximately 14% of all ADCs in development target Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM). A number of ADCs are also being developed for indications like Glioblastoma, Lung Cancer, Colorectal Cancer and Prostate Cancer. [1][2]

Currently approved ADCs Today, there are 4 approved and commercially available ADCs, including Brentuximab vedotin (Adcetris®; Seattle Genetics); Ado-trastuzumab entansine (Kadcyla®; Genetech/Roche); Inotuzumab ozogamicin (Besponsa™, Wyeth Pharmaceuticals, a subsidiary of Pfizer) and Gemtuzumab ozogamicin (Mylotarg™; Wyeth Pharmaceuticals, a subsidiary of Pfizer).

The development these agents has allowed for a more targeted and tumor-specific therapy rather than a non-specific cytolytic chemotherapy or radiation therapy. Building on their experience, researchers continue to advance these drugs as important therapeutic modalities, both as single agents and as part of various combination regimens with immunotherapeutic agents such as checkpoint inhibitors.

What are Antibody-drug Conjugates? Antibody-drug conjugates (ADC) are a class of innovative and highly potent biopharmaceutical drugs composed of a monoclonal antibody linked, via a chemical linker, to a biologically active drug or cytotoxic (anti-cancer) compound. Often referred to as payload, these cytotoxic agents are designed to induce target cell death when internalized (into the target cell) and released.

By combining the unique and very sensitive targeting capabilities of monoclonal antibodies with the cell-killing ability of their payloads, ADCs are able to deliver highly cytotoxic drug directly to targeted cancer cells without causing 'collateral damage' to 'normal' or 'healthy' cells. As a result, ADCs are designed to overcome the disadvantages of conventional pharmacotherapy based on cytotoxic or immunomodulatory drug, which are not specific to tumor cells, affect normal cells, and may lead to life-threatening side effects.

Although the concept of Antibody-drug Conjugates seems relatively simple, designing a successful, clinically effective, ADCs is complex, requiring careful selection of the receptor antigen, monoclonal antibody, linker chemistry, and cytotoxic payload.

Beyond Oncology A number of Antibody-drug Conjugates are also being developed outside the domain of oncology and hematology. These agents, generally focusing on indications in immune modulation and anti-infection, are still limited in number and are mainly in (early) discovery and preclinical stage of development. [3]

One of the key differences between ADCs for oncological indications and non-oncological indications is that payloads for non-oncological indications are designed to modulate biological functions without affecting cell viability. These payloads are generally non-toxin-based and are largely less potent compared to cytotoxic payloads. Hence, to be effective, ADCs for non-oncological indications require a higher standard in terms of selection of targets, monoclonal antibodies and linker chemistry, as well as conjugation approaches, to achieve sufficient binding, efficient internalization, and payload release. [3]

About ADC Review | Journal of Antibody-drug Conjugates Launched in the summer of 2013 ADC Review / Journal of Antibody-drug Conjugates (ISSN 2327-0152) is an international, hybrid open-access, peer reviewed journal designed to serve the needs of a diverse community of individuals involved with the (early) discovery, development, clinical research, manufacturing and legal and regulatory aspects of Antibody-drug Conjugates. The purpose of the Journal is to present relevant information in an understandable and useful format to all stakeholders.

Guided by an Advisory and Editorial Board comprised of scientists, physicians and industry experts/Key Opinion Leaders (KOL) and legal/regulatory experts from a broad range of backgrounds and expertise, the Journal includes news, resources, editorials, and peer reviewed articles. Recently published peer reviewed articles include a review of progress made in the development of Antibody-drug Conjugates (ADCs – The Dawn of a New Era?), an overview of what we can expect from future developments (ADCs – Look Forward to a Potent Future) and a patent related discussion about Nonobviousness of ADC Inventions.

New Networking Tool: ADC Directory In addition to the online Journal, the publishers of ADC Review | Journal of Antibody-drug Conjugates recently launched a new networking tool: ADC Directory. The ADC Directory provides a seamless exchange of information between businesses and professionals focused on the research, development and manufacture of antibody-drug conjugates. Members have the opportunity to share reviews, articles, videos, events, products, career opportunities and much more.

Conference Coverage During the upcoming 9th Annual World ADC Conference, to be held in the Marriott Marquis & Marina, San Diego, California, November 12 - 15, 2018, one of the best learning experiences in the industry and an ideal forum to stay up to date with the latest developments and progress made in the area of ADCs as well as the opportunity to meet experts, editors of ADC Review | Journal of Antibody-drug Conjugates will be on site for interviews and more. [4]

For more information, or content of which is not part of this press release, please visit ADC Review | Journal of Antibody-drug Conjugates or ADC Directory. Contact our business development team for more information about sponsoring and underwriting.

Editorial Office | 4960 South Gilbert Rd, Suite 1-286, Chandler, AZ 85249 (USA)

Reference [1] ADC Review | J. Antibody-drug Conjugates | Drug Map Online Online [2] CPhI Annual Industry Report 2018: Expert Contribution [3] The Expanding Field of Antibody-Drug Conjugates [Article ] [4] 9th World ADC San Diego: What to Expect

 

SOURCE Journal of Antibody-drug Conjugates



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