Our Investment in Xilis: How Xilis is Bolstering the Global Effort to Overcome Cancer

The Precision and Predictability Problem in Cancer

The devastating facts surrounding cancer are well-known, and its burden on society globally cannot be underestimated. With nearly 19 million new cases and 10 million cancer-related deaths annually [1], cancer is a major challenge facing humanity. Despite significant improvements and notable achievements in the fight against cancer over the past decades, the statistical trends remain troubling: by 2040, the global burden of cancer will grow to over 29 million new cases annually, and deaths will exceed 16 million [2].

Beyond these disturbing statistics, there remain untapped technological upsides that have the potential of making the current paradigm of cancer care and drug discovery and development more efficient for patients, physicians, pharma companies, payors, and investors.

For patients, cancer is perhaps one of the most devastating diagnoses they can receive. Being diagnosed with cancer is a source of distress that is intensified by common stories and pain associated with the loss of loved ones after months of trial-and-error treatments.

From the physicians’ perspective, cancer is one of the most difficult diseases to treat. While an oncologist’s arsenal may contain several approved treatment options, they have limited ability to know with certainty which of these options will be the most optimal for their patient. It is only after a treatment is administered to the patient that the effect of the treatment is determined, and by then, precious time has already been lost.

We often celebrate the approval of new cancer treatments as they signal hope for patients and oncologists, but the reality is more discouraging. The availability of one or multiple safe and approved drugs does not always translate to tangible results for the patients receiving them. In fact, a review of 59 cancer drugs approved based on response rate (i.e., the percentage of patients experiencing tumor shrinkage beyond an accepted threshold), shows a median response rate of 41%, with a range of 12% to 86% [3], meaning that for some drugs only a subset of patients, as low as 12%, experience a shrinkage of their tumor. While these are valuable and likely life-saving drugs, the reality of cancer is that patient populations are heterogeneous, so patients diagnosed with the same cancer type may respond differently to the same drug.

Imagine being diagnosed with cancer and learning that, while there are multiple life-saving drugs approved for your indication, your oncologist has no way of confidently knowing which one of these drugs will be the most effective. Conversely, imagine if your oncologist had a reliable tool that provided them with timely insights on how your specific tumor will respond to a specific drug and how that response compares with other approved drugs. Such a tool could fundamentally transform cancer care, saving not only precious time, but countless lives.

A similar challenge exists for biopharma companies working to bring new cancer treatments to the market. Drug discovery and development is riddled with trial-and-error issues, stemming from the lack of appropriate preclinical models to test drugs and from the challenge of enrolling the right patient populations for clinical trials. Consequently, hundreds of millions of dollars are spent on lengthy human clinical trials, while the overall failure rate for oncology clinical trials is a staggering 97% [4] due to safety and efficacy issues observed in the patient population receiving the treatments.

Imagine the frustration of scientists who dedicate their lives to develop drugs for cancer, and yet, continually witness their drugs fail in clinical trials.

Despite scientific advancements, uncertainty about outcomes remains an unfortunate reality of cancer care and how cancer drugs are discovered and developed. Underlying this uncertainty is one of the key challenges facing oncology today: the lack of cost-effective, scalable, and reliable models to predict how a specific patient will respond to a specific drug.

Enter Xilis

Xilis was founded in 2019 by Drs. Xiling Shen, David Hsu, and Hans Clevers, marking the culmination of years of biomedical, oncology, and stem cell research. Dr. Shen is a biomedical engineering expert focused on scaling computational and biological tools for precision oncology. Dr. Hsu is a medical oncologist using patient-derived models to develop new cancer therapies and diagnostics. Dr. Clevers is one of the world’s leading researchers on adult stem cells, and the one who invented organoid technologies.

Xilis is scaling a technology platform that helps guide treatment decisions for oncologists, thus improving treatment outcomes for patients. Additionally, the platform supports drug developers by accelerating drug discovery and development. Above all, Xilis is empowering patients, oncologists, and pharma partners with three of the most valuable tools when it comes to fighting cancer and improving outcomes: optionality, predictability, and time.

The platform Xilis developed to address the key source of uncertainty in oncology utilizes an optimal model for testing and evaluating response to drugs: living, miniaturized replicas of the patient’s cancer that retain the original tissue structure, genetic heterogeneity, and immune microenvironment. Through a single patient tumor biopsy, Xilis’ MicroOrganoSphereTM (MOS) technology can create thousands of miniaturized, patient-derived tumors that can then be used to test drugs rapidly and efficiently.

The microscale encapsulation system uses state-of-the-art microfluidics, robotics, and customized assays that capture each patient’s genetic mutations, histopathology, and most importantly, the entire tumor microenvironment — from stromal cells to immune cells. Unlike most other patient-derived models used to test drug formulations, Xilis’ technology is automated and scalable leading to improved outcomes through more optionality in drug choice, accurate prediction of drug response, and saving precious time. Here’s how they’re doing it:

• To improve cancer care outcomes for patients, the platform will offer physicians precision oncology assays that predict and compare a patient’s response to a panel of FDA-approved drugs. While in the early product development stages and not launched yet, this diagnostic product will be a highly effective tool for guiding personalized therapy decisions. Starting with a tumor biopsy, clinicians will receive insights that are of high clinical utility within 14 days, enabling them to select the most advantageous treatment for the patient.
• For pharma partners, Xilis’ platform will be able to streamline development efforts at the pre-clinical stage, enabling high-throughput screening of novel drug formulations, including immuno-oncology therapies. The platform will be able to be used to screen patients who are candidates for trial enrollment, vastly supporting clinical development and increasing the probability of success for bringing a drug to market.

Investing in Xilis

Mubadala is deeply humbled to have led Xilis’ $70 million Series A financing. This new partnership will help support Xilis’ mission to personalize cancer treatments for patients and address the bottlenecks facing pharma partners in bringing life-saving drugs to the market.

Our mission at Mubadala Capital is to partner with visionary founders building transformative companies, supporting them with Mubadala’s global scale, resources, and capital.

Xilis’ team encompasses the entire spectrum of expertise required to deliver on its mission. The team has not only developed a groundbreaking platform, but also designed this platform with clinical and commercial applications in mind. Their expertise, in-field track record, long-term commitment and obsession with improving cancer outcomes, coupled with their unique ability to connect with patients, oncologists, and drug developers, provide Xilis with an exceptional founder-market fit and an unfair advantage to win in this space.

With over two dozen life sciences and healthcare companies in our portfolio, we are deeply familiar with the challenges facing the industry, including the problem Xilis is working to resolve. We are also constantly evaluating technologies that have the potential of fundamentally uplifting entire fields. It’s a humbling position, and in the case of Xilis, one I felt particularly close to having worked on microfluidics, lab-on-a-chip systems, and high-throughput automation early in my career.

Our work is not done. We will continue to support companies leveraging breakthrough platforms to overcome the toughest challenges in life sciences and healthcare.

Through our thesis-driven approach, global platform, and network, we aim to generate value as life-cycle investors, helping companies build leading technologies and reach scale. We are honored to welcome Xilis to the Mubadala family and congratulate them on their milestones to date. We are thrilled to see the value they will bring to cancer care and drug discovery and development!

Learn more about Xilis and our investment as seen in Forbes, Endpoints News, Fierce Biotech, and MedCity News.

Works Cited

[1] International Agency for Research on Cancer, “Cancer Today”

[2] International Agency for Research on Cancer, “Cancer Tomorrow”

[3] EY Chen, V Raghunathan, V Prasad, An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate. JAMA Internal Medicine, Volume 179, Issue 7, May 2019, Pages 915–921, https://doi.org/10.1001/jamainternmed.2019.0583

[4] CH Wong, KW Siah, AW Lo, Estimation of clinical trial success rates and related parameters, Biostatistics, Volume 20, Issue 2, April 2019, Pages 273–286, https://doi.org/10.1093/biostatistics/kxx069