Following the closing of a $70 million series A in July 2021, Xilis—the biotechnology company behind MicroOrganoSphere (MOS) technology, which generates thousands of miniature patient-derived tumors that capture the original heterogeneity and microenvironment for therapeutic profiling—announced today the closing of an extension of more than $19 million to its financing round.
Founded in 2019 by Xiling Shen, PhD, David Hsu, MD, PhD, and Hans Clevers, MD, PhD, Xilis is based on decades of biomedical, oncology, and stem cell research by its co-founders. Clevers, the newly appointed head of pharma research & early development at Roche, is considered by many to be the inventor and pioneer of organoid technology. Shen and Hsu are accomplished engineering and medical professors at Duke University and experts in precision medicine. They have developed the scalable MOS technology to analyze patients’ own tumors in their native microenvironment.
New investor FPV Ventures led the extension, which will support and expedite the approval of the automated and scalable MOS technology as a clinical diagnostic. Fellow new investor Alexandria Venture Investments and existing investors EQT Life Sciences, Mubadala Capital Management, Pear Ventures, GV (formerly Google Ventures), the Duke Angel Network, Catalio Capital Management, Two Sigma Ventures, Felicis Ventures, Alix Ventures, and other strategic partners also joined in on the funding extension, which brought the total amount raised to more than $89 million.
Precision oncology for the people
The vision behind the Xilis platform is to deliver personalized precision oncology treatment strategies for patients and accelerate drug discovery and development for pharmaceutical companies. “Everyone’s cancer is different,” said Shen. “So how does a provider pick the right drug for the patient? How do clinical trials select the right patients to test a drug on?”
The Xilis founder and CEO says it all comes down to whether you have a good model to represent the patient’s tumor before putting the drug into the patient. “While genomics has been a surrogate to predict patient response, the reality is that really fewer than 10% of patients actually benefit from sequencing because most patients don’t have a targetable mutation,” said Shen. “When a patient starts an oncology treatment like chemo, the response rate can range anywhere from 5% to 35%. That means that, on the one hand, most patients are taking a drug that doesn’t work, and, on the other hand, 95% of oncology drugs fail clinical trials. The drugs work beautifully on cell lines and small animal models but fail big time in clinical trials.”
Similarly, a big challenge for cell therapy is knowing whether expanded T cells will still work when put back into the patient and recognize the patient tumor. Xilis’ technology is based on a biopsy and encapsulating tumor cells and the stromal immune cells with the whole tumor microenvironment inside this little droplet called a MicroOrganoSphere.
“These MicroOrganoSpheres can be used for drug testing and to find out what drug work best on a patient in 10 days, allowing providers to get back to the patient within 14 days and pick the optimal drug in the clinic,” said Shen.
The key offering of this technology is to enable scientists in clinical labs or in drug development settings to examine cancer cell responses in its native microenvironment. This opens up the ability to understand the influence of certain interacting factors, such as the non-mutated cells in the surrounding microenvironment.
Tumor agnostic automated assays
Xilis aims to get into the healthcare scene by developing a diagnostic platform for clinicians to use to determine the best drug for a cancer patient with customization at the assay level, such as the drugs and cancer type. For ease of use, Xilis is creating a fully automated workflow using MOSs.
“We design and build a whole system with automated imaging that is analyzed by AI and can be coupled with genomics. We have software and data analysis for this whole analytical pipeline. We do not sell just an instrument or a kit. It’s a diagnostic assay that will be able to be ordered to make clinical decisions,” Shen said.
Shen says that the platform is agnostic to cancer types and worked very well to model both solid and liquid tumors. “You can make MOS from all sorts of different cancer cell and tumor types—even liquid tumors,” said Shen. “While the impression is that liquid tumors are solely in the blood, such as multiple myeloma, the renewing cancer stem cells actually require a niche, sometimes even in the bone marrow. The cancer is not just floating in the blood and dividing all the time. It has been a significant challenge for people to actually culture patient blood cancer cells.”
Delivering the diagnostic
Using MOS and AI-driven algorithms, the company is developing a Xilis Response Score™ for the clinic, enabling oncologists to make informed and timely treatment decisions. Additionally, the MOS technology is speeding up cancer drug development and clinical trials by enabling analysis of authentic tumor microenvironments, high-throughput preclinical modeling, and clinical patient selection capabilities. “We are partnering with big pharma on drug discovery to discover new drugs, the best usage of existing drugs, and identify the patient population that will most likely respond to treatment,” said Shen.
“The additional funding allows us to accelerate and expand the sites for our clinical trials, especially supporting our European trials,” said Shen. “A part of that funding will really help us scale up those operations, increasing patient numbers and capturing a more diverse population. The funding will also be used to increase the capacity of our whole automated drug screening platform because we’re getting all kinds of requests from pharmaceutical companies that want to work with us. So, we need to expand that capability.”