Using synthetic biomarkers for early cancer detection

The intersection of science and technology

Swarna explained that Accenture has been looking across multiple disease areas from their perspective as a technology firm, acknowledging that we might be at a unique point in history where science and technology are continuing to develop and advance.

"There's a change in the pace of how science is advancing, and that's sort of the culmination of a lot of the work that's been done by amazing people over the last several decades."

For example, in the oncology landscape, the convergence of technology and rapidly advancing science has contributed to the rapid development of cancer vaccines and immune checkpoint inhibitors.

Beyond rapidly advancing science and technology, Swarna acknowledges that we are at a unique point regarding data. More than ever, the healthcare industry has access to large quantities of data at the individual and population levels, which have contributed to a better understanding of disease progression and driven initiatives for intervention.

Finally, Swarna notes that access to computing and analytics technology and an unprecedented pace have also driven these changes in healthcare.

"The intersection of biology, engineering and software will drive some of the most fundamental changes. We will see that impact humanity in the next 20 years when these worlds collide," added Roeding.

Understanding oncology

Although cancer has been around for centuries, the ability to detect and diagnose cancer early remains a challenge across the healthcare industry.

"Unfortunately, we often marshal our resources and act heroically once we know that somebody has been diagnosed with cancer that has progressed," noted Swarna.

While healthcare has made a lot of progress in being able to extend life once cancer has been diagnosed, late-stage cancer treatments are unable to cure the condition completely.

In the last 20 years, pharmaceutical companies have spent a lot of time and money on biomarker discovery to identify natural biomarkers on tumor cell membranes and make them druggable targets. While this approach has been effective in some respects, Roeding explained that not all cancers have naturally occurring biomarkers on their tumor cell membranes. He added that variations in cancer subtypes caused by rapidly mutating cells mean that even cancer that does possess biomarkers on cell membranes might not have them for all patients.

"Cancer is a mutation of cells. Therefore, the biomarkers also keep mutating. And that's why no single drug works for all cancer patients," elaborated Roeding, identifying another challenge in targeting naturally occurring biomarkers.

In understanding these challenges, the question remained: how can researchers stop chasing after the ever-mutating natural biomarkers?

Earli's role in early detection

With this question in mind, the team that founded and inspired Earli set out to find a way to get ahead of the mutating biomarkers.

"What if we stopped the entire cat-and-mouse game? What if, instead, we went into the cancer? In fact, [what if we] enter the cancer cell nucleus where the mutation happens that causes the whole disease? And what if we could use a genetic construct inside the nucleus that turns on only when it's cancer to force the cancer to produce any protein we choose that we encode into the sequence," posed Roeding.

Essentially, Roeding explained that Earli's primary function is based on the process of getting a cancer cell to express a particular protein on the outside of the cell. For example, if researchers could genetically program cancer cells to express an epitope on the outside of a tumor cell that acts as a docking station for an external radioactive contrast agent, clinicians could inject patients with the agent and visualize the tumor more clearly on a PET scan.

Beyond that, the cancer cells could also be programmed to express cytokine proteins that trigger the immune system to start attacking the cancer cells.

"In other words, Earli would become the first synthetic target platform where we determine what the cancer has to make and not the cancer telling us what it came up with recently."

Roeding describes the system as having several main components. The first is a nucleic acid vector, which acts as a cargo container for genetic content.

Lipid nanoparticles are nonviral delivery agents used in multiple ways, including COVID-19 vaccines. However, they typically go to one area of the body: the liver.

"They go because the liver is made to flush out anything foreign that gets injected or somehow into your body system. Therefore, it lands in the liver and gets cleared out very fast. But we do not want to limit our ability to liver cancer. We want to have a construct that works elsewhere in the body."

While it might have been easier to start with liver cancer, which is an easy target, Roeding explained that they opted to start with lung cancer instead, which can be a more difficult target. Over 4.5 years, Roeding and his team at Earli worked to identify lipid nanoparticles that can go into the lung and target lung tumors.

"Many companies have been trying to do this," Roeding noted. "This is very hard. So, we partnered with some of the best people in the field, including those who help with the BioNTech lipid nanoparticle. [We] also built our own team of experts."

"Inside that cargo container, we're putting in an if-then clause: if [it is] cancer, then make something," he stated.

The "if" part of that equation is a promotor that is only activated when cancer is present. Meanwhile, the "then" part acts as a reporter, which expresses the protein of choice.

Using this technology, Earli can detect cancer early by getting the cells to express specific biomarkers that can assist imaging. The company can then work on developing treatments that target these synthetic biomarkers.

The benefits of collaboration

Although Earli is still in the midst of research, Swarna and Roeding commented on how the investment from Accenture and the partnership between the two organizations will be beneficial.

"Accenture is one of the top players in the world in terms of two things. One is the understanding of software and its disruptive factor on industries. And two, its network is close to unparalleled across many industries," said Roeding, describing how the investment from Accenture will benefit Earli.

"What we hope to do with Earli is to help them understand how to bring this into human clinical trials, how to design clinical trials, and how to expand on their data collection efforts," Swarna remarked.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.