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Antibody drug conjugates (ADCs) offer a way to deliver a cytotoxic or an immuno-stimulatory payload directly to tumors to maximize the anti-tumor efficacy of the payload with reduced systemic toxicities. The development of ADCs has occurred over several decades. ADCs have been through several highs and lows where there was substantial excitement for the promise ADCs hold only to be followed by disinterest when there were disappointing results in the clinic. This resulted in several companies abandoning their internal ADC development efforts. Twelve ADCs globally have been approved to treat hematologic or solid tumors. The renewed interest in ADCs, is due, in part, to the recent clinical success of ADCs, the development of improved ADC technologies, and the identification of new ADC targets.

This is what happened in June 2024 in the world of ADcs,

Required adaptations to clinical trial design and execution, implemented during the COVID-19 pandemic, have put a new focus on the development of patient-focused, decentralized...

One hundred years ago, Paul Ehrlich*, a German biochemist and Nobel laureate who created the field of chemotherapy, coined the term “magic bullet.” He...

Transitioning from lab manufacture to commercialization presents significant challenges, no matter what area you’re working in. Cell and gene therapies are no different and production quantities must scale at multiple stages, first to support clinical trials and then when they reach the market.

Over the past decade, site-specific chemical conjugation has emerged as a promising strategy to produce antibody-drug conjugates (ADCs) in the field of oncology [1]. Daiichi-Sankyo's chemical conjugation method, which uses high drug-to-antibody ratio (DAR) technology, was approved by the U.S. Food and Drug Administration as the first site-specific ADC (fam-trastuzumab-deruxtecan-nxki; Enhertu® | Daiichi Sankyo and AstraZeneca).

Since Antibody-drug Conjugates (ADC) are already approved for the treatment of relapsed Hodgkin’s lymphoma, HER2-positive metastatic breast cancer and B cell lymphoma, among others, high expectations are placed on this class of bioconjugates. Indeed, more than 100 different ADCs have been studied for various applications by 2022, presumably with several more to follow.

Biologics are changing the way we treat disease, affecting where companies invest, and, most importantly, impacting patients’ lives. Last year, nearly half of the 37 new drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) were biologics, while its partner agency—the U.S. [1] Center for Biologics Evaluation and Research (CBER)—approved a dozen additional products. [2] These approvals span many modalities and cover a range of conditions, including many rare and hard-to-treat diseases.

In early February this year, the U.S. Food and Drug Administration (FDA) approved  sacituzumab govitecan-hziy (Trodelvy®; Gilead Sciences) for the treatment of adult patients with...

Antibody drug conjugates (ADCs) are touted for their ability to site selectively deliver a small molecule chemotherapeutic directly to a tumor cell, bypassing off target side effects from systemic circulation. To date, eleven ADCs have been FDA approved in the United States and >200 more in the clinical pipeline (clinicaltrials.gov).