With over 300 antibody-drug conjugates (ADCs), immune-oncology (IO) agents, and T-cell engagers currently in development, competition in the solid tumor space has never been more intense. As biopharma companies aim to differentiate their therapies, demonstrating superior efficacy, safety, and patient-centric outcomes is paramount.

To date, much of the industry’s innovation has focused on the structural design of therapeutic molecules to enhance potency and reduce toxicity. However, one area that remains underutilized is the deployment of novel, blood-based biomarker strategies—especially those that offer real-time insights into tumor biology. The primary barrier? Fresh tumor tissue is notoriously difficult to obtain from pretreated or metastatic patients, making it challenging to evaluate therapy impact longitudinally.

The Opportunity:

There is a growing need for fresh, real-time, and multidimensional tumor profiling—not reliant on archival FFPE tissue or limited fine-needle biopsies. We introduce a new paradigm: Cell Biopsies—blood-based assays that enable the capture and single-cell multiomic analysis of live circulating tumor cells (CTCs), including protein, RNA, and DNA. In addition, ctDNA and circulating immune cells such as T cells can also be analyzed in parallel from the same blood draw.

Why It Matters:

Cell Biopsies offer a non-invasive, real-time view of both primary and metastatic tumor biology. This approach is poised to become the new standard in next-generation clinical trials by enabling pre-, on-, and post-treatment molecular monitoring. These insights are essential not only for understanding therapeutic mechanisms of action and resistance, but also for meeting clinical endpoints, accelerating drug development, and improving patient experience.

Conclusion:

Next-generation IO drug development demands next-generation biomarker strategies. Cell Biopsies from 1Cell.Ai enable comprehensive, dynamic tumor profiling—empowering biopharma to differentiate their therapies, enhance trial design, and deliver more precise, patient-friendly cancer care.