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Asembia 2025 

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Sales and Marketing

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GenAI is on the precipice of breaking new ground in regulatory intelligence;  making strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.

Using GenAI as a Co-Pilot for Regulatory Intelligence

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

What Are the Core Tenets of Diagnostics 2.0?

Pharmaceutical Executive: How have recent developments in genomic research transformed cancer care?

 There’s been a lot of change in diagnostics in general, but particularly in oncology over the last five years. It’s clear that next gen sequencing has created a new paradigm that has enabled us to come up with new tests and put them in clinical use. The way that the industry has transformed has gone from a model driven by volume (even if the test was painful) to a more responsible model that generates evidence in a way that ensure durable ongoing reimbursement for a test, having it released to the marketplace, and having it adopted by physicians.

 Diagnostics 2.0 is responsible launching of molecular diagnostic tests that focuses on strong, robust scientific evidence that demonstrates not just the clinical validity of a test, but that it has use for physicians. It changes the way that physicians practice. We’re very focused on physicians as our allies and the people we’re enabling to do their job the way they need to do it.

Diagnostics 2.0 is a focus on developing evidence very early on.

PE: What are the core tenets of diagnostics 2.0?

 The core are robust science supported by machine learning and AI technology. It is robustly completely clinical studies and ensuring that those studies are focused on the patient population for which the test is intended. It’s also about making sure that the data demonstrates clear patient and physician benefit in the treatment path and an ongoing commitment to generate evidence during the life of the test.

PE: What diagnostic areas are investors focusing on?

 There’s a few areas that investors have been focused on for several years. Some of them have come and gone. Early detection was getting a lot of focus, and it hasn’t gone away. It’s still getting a lot of attention from investors and companies. Today, however, in oncology, areas like prognostic and predictive diagnostic clinical tests that fit into the physician workflow and provide additional insights are clearly getting attention.

Another area is minimum residual disease (MRD), which is getting a lot of traction for a number of reasons. It’s very helpful for patients who have been treated, whether by therapy or surgery, and you’re looking for residual disease state or recurrence. This test can be used at multiple time points after the treatment. It’s an interesting new area and getting a lot of attention.

One thing we’re seeing is that the existence of MRD could be a potential endpoint in clinical studies because it’s proving to be a good indicator.

Marc Stapley, CEO of Veracyte, discusses the importance of ongoing evidence collection.

What are Diagnostics 2.0?

Marc Stapley, CEO of Veracyte, discusses new approaches to diagnostics and how its transforming cancer care.

What Diagnostic Areas are Investors Focusing On?

Marc Stapley, CEO of Veracyte, explains how investors are reacting to recent advancements in cancer care.

What are the Plans for Diagnostics 2.0?

Recent advancements in genomic research have significantly transformed cancer care, particularly through next-generation sequencing, which has shifted the industry from a volume-driven model to one focused on evidence-based diagnostics. Diagnostics 2.0 emphasizes the responsible launch of molecular diagnostic tests, supported by robust scientific evidence and AI technology, to ensure clinical validity and utility for physicians. Investors are particularly interested in early detection, prognostic and predictive diagnostics, and minimum residual disease (MRD) testing, which is gaining traction as a potential endpoint in clinical studies due to its effectiveness in monitoring residual disease.

Marc Stapley, CEO of Veracyte, reviews upcoming developments in the diagnostic space.

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic therapies. Multidisciplinary approaches are essential for optimizing treatment plans, considering factors such as genetic mutations, patient performance status, and potential side effects. Ongoing research continues to refine these strategies, aiming for improved survival and quality of life.

Venkatraman “Bala” Balasubramanian, PhD

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