CUSTOMER STORY • START-UP

Precision Medicine in Action: Ourotech’s Revolutionary Way to Treat Late-Stage Breast Cancer

THE CHALLENGE

The majority of women treated for

late-stage breast cancer receive the

wrong treatment in the first year

because the only way to see if one

of 30 FDA-approved drugs will work

is for the patient to try it to see what

happens.

THE RESULT

Ourotech has developed a late-stage

tumor testing solution that subjects

tumors taken from the patient’s body

to a barrage of 30 individual and

combination cancer drugs to determine

which drug offers the safest, most

effective treatment with the fewest

side effects for each person. This

testing process takes only seven days.

COMPANY: Ourotech

FOUNDED: 2015

INDUSTRY: Medicine

RESULTS, OUTCOMES, AND ACHIEVEMENTS

Ourotech is selling its hydrogel to researchers, including Harvard Medical School and Dana Farber, for testing immunotherapies on tumors.

10+ new and existing drugs have been tested for efficacy.

Technology reduces the amount of time to test drug efficacy from one year for a single drug, to seven days for all 30 breast cancer drugs.

Featured at TechCrunch Disrupt (2017); selected as one of the world’s top 50 healthcare companies at Hello Tomorrow in Paris (2017).

Four patents pending: two for the hydrogel and two for the hardware and device.

Two pharmaceutical pilots with CCAB and Akrivis have been completed.

Ourotech co-founders nominated for Forbes 2018 Healthcare 30 Under 30.

“Exponential technology, business,

and social impact—all three are

exemplified by Singularity University.

So in 2016 we decided to apply to

SU’s Startup Accelerator, where

we hoped to learn how to build

a successful startup and make

important connections to help us

grow our business”

— Duleek Ranatunga, co-founder of Ourotech

It was a simple premise. What if you could test drugs on

tumors outside of the body in a week to find the best one,

rather than subject someone to a year-long treatment that

fails fifty percent of the time? This premise sparked the

founding of Ourotech, a revolutionary biotech startup

that creates medical devices and drug discovery tools

for doctors and pharmaceutical firms to test the efficacy

of drugs and drug treatments on individual cancers.

How an Aunt and a Grandma Inspired Ourotech

This journey of discovery was a personal one for Duleek Ranatunga, the co-founder of Ourotech, based in Waterloo, Canada. While at university researching synthetic materials known as hydrogels, Ranatunga’s aunt and grandmother were each diagnosed with late- stage breast cancer. Both women began year-long cancer treatments according to established treatment protocols for their type of cancer. A year later, their cancers had not abated but grown, and they each were facing many negative side effects from their treatment. Their doctors prescribed the next drug in the series to combat their cancers. Fortunately, the second course of treatment worked for each woman, and both survived. But for so many others, there is not a happy ending.

Ranatunga decided this trial-and-error treatment method needed to change. Late-stage HER2+ breast cancer patients don’t have the luxury of time to test each of the five primary and eight backup drugs the FDA has approved until the right one is found. Moreover, the cost of what essentially amounts to experimentation is high for patients, both physically and financially, as well as for the pharmaceutical and insurance companies that have researched the efficacy of these drugs and determined the acceptable treatment protocols.

Ranatunga realized the hydrogels he’d been researching at the University of Waterloo could become part of the answer. He had already been exploring the use of synthetic hydrogels as material to 3-D print artificial organs for surgeons to use in practicing their surgical techniques. When this approach proved unusable after four or five months, he and Ourotech co-founder William Lin began using the hydrogels to start growing human cells.

One of Ranatunga’s professors told him about Singularity University (SU) and he realized his mission and SU’s were aligned. Both wanted to use exponential technologies to impact a lot of people. Ranatunga also believed he could do this and also be profitable. “Exponential

technology, business, and social impact—all three are exemplified by Singularity University,” said Ranatunga. “So in 2016 we decided to apply to SU’s Startup Accelerator, where we hoped to learn how to build a successful startup and make important connections to help us grow our business.”

“The biggest issue that SU helped me plan for

was how to secure funding for every stage of

our company, so we could continue growing

as a company in an industry where the sales

cycles and the development times are so long.”

— Duleek Ranatunga

Mapping out the Future: The 10-Year Plan

After an application process involving the submission of a 10-page research summary containing citations about their work to date, the Ourotech founders were accepted into the SU Accelerator in early 2017.

What they learned during the Accelerator proved invaluable. They received a curated Board of Advisors and mentors consisting of pharmaceutical company representatives, cancer researchers, and experts in the latest developments in the fields of nanotechnology, bioengineering, and natural language processing. They received briefings on FDA regulations, processes, and certifications. Perhaps most important, they learned how to plan for a successful future.

“The biggest issue that SU helped me plan for was how to secure funding for every stage of our company, so we could continue growing as a company in an industry where the sales cycles and the development times are so long,” explained Ranatunga. “So, we have a 10-year go to mar-ket strategy, a phased plan that lets us sell testing services and hydrogels while we wait for the various levels of FDA approval to test human tumors.”

“Thanks to SU, we can see how we are going

to get there and in what order we need to

do things.”

— Duleek Ranatunga

“There’s a lot of foundational work for a healthcare company before we can begin impacting actual patients,” explained Ranatunga. “We’ve got to do the research and development of the materials and the hardware, perfect them, stay aware of other scientific breakthroughs we might apply as they occur, do pilots and field testing, apply for FDA compliance, and protect our intellectual property with patents. We’ll then rely on our pharmaceu-tical partners to help us distribute the technology globally. Thanks to SU, we can see how we are going to get there and in what order we need to do things.”

The First 5 Years: Perfecting the Technology, Getting the Patents, Working with Pharmas and the FDA

Ourotech’s strategic plan is mapped out in two five-year periods. In 2017, the founders developed a process to manufacture the hydrogel at scale and patented it, so instead of taking one week to make the hydrogels it now takes only one or two days. Ourotech also needed to find the expertise to help prototype the hardware testing device, including the tumor module and liver module chip. For this, the founders relied on an SU community member with a PhD and MD in tissue engineering who had attended the SU Global Solutions Program the year before they took part in the Accelerator. Her expertise was in combining tumor and liver samples together for drug testing in order to see the potential side effects of the drugs on the liver.

The Ourotech five-year plan includes beginning to sell the hydrogels to pharma companies. In September of 2017, at TechCrunch Disrupt, the founders announced they would be selling their hydrogels to pharma companies. The company has also completed pilots with CCAB and Akrivis to ensure Ourotech could meet their specific testing needs before offering drug testing services to their target list of thirty pharmaceutical companies.

In addition, Ourotech has filed and is awaiting certification for four patents: one for the hydrogel composition, another for the specific hydrogel formulation for breast cancer, one for the device’s extruder used to inject soft materials which can be 3D-printed, and one for the device itself. In 2018, Ourotech will file for FDA approval to grow tumor samples from patients and after that grow tumor samples for late-stage breast cancer. Ourotech will also conduct its first clinical trials for late-stage breast cancers. Rounding out the first five years, Ourotech will spend the remaining three years extending the technology and the process for FDA approval to include colorectal cancer testing.

The Next 5 Years: Machine Learning to Customize Dosages/Treatments, Other Cancers

During the next five years, from 2022-2027, Ourotech plans to identify the right drugs earlier in the current one-week process and, through machine learning, predict with great accuracy the best dosages for each type of cancer and each individual patient.

In addition to determining the correct individual dosages, Ourotech will also be exploring how to identify the proper combination of treatment protocols—immunotherapy, chemotherapy, radiation, stem cell, etc. —for cancer patients. During the Demo Faire that marked the end of the 2017 SU Startup Accelerator, the Ourotech founders met represen-tatives of Harvard Medical School and Dana Farber who were looking for breakthrough technologies that could help them with their immunotherapy cancer research and treatment. Ranatunga sent the company’s hydrogels to Harvard to test out immunotherapies on patient tumor samples. Immunotherapy is one of the hottest areas in cancer, in which immune cells from a patient are modified to target his or her cancer cells and then placed back into the patient to kill the cancer.

As was the case with chemotherapy, the Ourotech technology is proving valuable for immunotherapy, as there is no good way currently to test whether an immunotherapy is going to be effective on patients before they undergo treatment. In the future, however, Ourotech expects that cancer patients will be

treated with a personalized combination of therapies, making it vitally important to know how each form of therapy will perform by testing tumors outside the body.

During this second half of the ten-year plan, Ourotech will also apply its technology to brain and other cancers, conduct testing for many more pharmaceutical companies, and continue to provide its hydrogels for related research studies.

“In short, the next five years all about

getting the drug right and using today’s

approved dosages. But for the remainder

of the ten year plan, we’ll be taking a

personalized medicine approach to find

out the specific dosage and combination

of treatments that will work best for a patient,

and we’ll apply our approach beyond breast

cancer to include colorectal and brain cancers.”

— Duleek Ranatunga

A Revolutionary New Way of Testing Cancer Drugs

Traditionally, biotech researchers have used hydrogels they extract from naturally occurring materials like bacteria, algae, or, the most popular, cancers in mice. Since the genome and tumor micro-environment of mice are not representative of humans, Ranatunga and Lin have taken a different approach. They’ve synthetically modified hydrogels derived from bacteria—and have a patent pending—so that their hydrogel behaves and has the same chemical structure and properties as substances found naturally in the human body.

“Most of our competitors rely on running farms of mice and extracting the material from mouse cancer for their hydrogels,” noted Ranatunga. “But we think this is needlessly expensive and inhumane. As nanotech engineers working in chemistry, we decided to manufacture a synthetic hydrogel more closely aligned to the human body in which to grow human tumor cells.”

Ranatunga started out by applying on lab websites to get the initial human cell lines. He and Lin found a few professors doing scientific research who offered them tumor samples. After receiving prize money from several scientific research pitch competitions, Ranatunga had the financial resources in early 2015 to leave university and continue his work full-time.

Ourotech takes tumor samples, liver samples, and blood samples from patients and inputs them into its medical device. Drugs are then injected into a reservoir of blood and circulated around a simulated bloodstream. The blood passes through a chip containing the tumor and liver samples which have been submerged in a proprietary hydrogel that keeps the tumor alive and mimics the cancer environment in the human body. The device automatically injects new drugs to test the impact of individual drugs and drug combinations.

“Thanks to SU, we have a 10 year-plan for bringing our advances to patients,” said Ranatunga. “SU has helped us make the connections to pharmaceutical companies, researchers, and mentors who are helping to refine and broaden the impact of our work. They have helped us understand the process for protecting our innovations and making them compliant. And, most importantly, our work with SU has meant we are having a positive disruptive influence on how to maximize the impact cancer drugs and therapies have on individual patients.”

“Thanks to SU, we have a

10 year-plan for bringing our

advances to patients. SU has

helped us make the connections

to pharmaceutical companies,

researchers, and mentors

who are helping to refine and

broaden the impact of our work.

They have helped us understand

the process for protecting our

innovations and making them

compliant. And, most importantly,

our work with SU has meant we

are having a positive disruptive

influence on how to maximize

the impact cancer drugs and

therapies have on individual

patients.”

About Singularity University

Singularity University (SU) is a global learning and innovation community using exponential technologies to tackle the world’s biggest challenges and build an abundant future for all. SU’s collaborative platform empowers individuals and organizations across the globe to learn, connect, and innovate breakthrough solutions using accelerating technologies like artificial intelligence, robotics, and digital biology. A certified benefit corporation headquartered at NASA Research Park in Silicon Valley, SU was founded in 2008 by renowned innovators Ray Kurzweil and Peter H. Diamandis with program funding from leading organizations including Google, Deloitte, and UNICEF. To learn more, visit SU.org, join us on Facebook, follow us on Twitter @SingularityU, and download the SingularityU Hub mobile app.

SU PROGRAMS

Startup Accelerator (2017)

EXPONENTIAL TECHNOLOGIES

Digital Biology

Nanotechnology

Machine Learning

Precision Medicine

3D Printing

GLOBAL GRAND CHALLENGES

Health

SU and Ourotech At-a-Glance

NASA Research ParkBuilding 20 S. Akron Rd.Moffett Field, CA 94035-0001 USA+1-650-200-3434

Rev 07-18 ©2018 Singularity University. All rights reserved.

su.org @singularityu