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Biotech startup offers new hope for burn victims

Interview with Dr. Daniela Marino, CEO of CUTISS.

Dr. Daniela Marino explains how winning the 2015 >>venture>> competition propelled biotech startup CUTISS in the development of customized, minimally scarring skin grafts engineered from a small piece of patient's skin.

The story of Cutiss begins with a lack of funds. In 2011, the young postdoc researcher Daniela Marino was again on the lookout for new funding for a research project a the Children’s Hospital Zurich. After years of research, her team had finally succeeded in cultivating larger, living pieces of skin from a few dermal and epidermal cells. Sterile production facilities were now needed if they were to test this skin substitute from the lab on the first patients.

Around fifty million people worldwide are suffering from the effects of deep skin injuries. Whether caused by fire, chemicals, or scalding, extensive burn injuries are often life-threatening. Survivors struggle their whole lives with the consequences.

The most common therapy involves trans-planting thin strips of the patient’s own skin, but there are many disadvantages and risks associated with this procedure. The “harvested” skin consists only of thin layers of epidermis and the remains of the dermis and is stretched to cover a larger surface area. In comparison to healthy skin, this “substitute skin” is much too thin, particularly in the case of injuries in which the subcutaneous tissue was also destroyed. The transplanted areas often scar badly and can severely limit the patient’s mobility. The surfaces harden and require meticulous daily care. Children whose burn scars do not grow with them can suffer for years on end. In many cases, new operations are needed in order to extend the tissue.

In 2001, Professor Martin Meuli, now director of the surgical clinic at the Children’s Hospital Zurich, and cell biologist Ernst Reichmann founded the Tissue Biology Re-search Unit at the hospital. They were joined by biologist Daniela Marino in 2009. Their shared goal is to develop a skin substitute that allows patients with skin injuries to enjoy a reasonably normal life.

When the team were looking around for new funding, Marino also approached the EU and met with serious interest. But the EU conditions stipulated that for the grant she would also have to submit a business plan by a certain date. Marino still adopts a desperate expression when she thinks back to that time: “I had no idea how to write a business plan. As far back as I can remember, all I had wanted was to be a research professor.” Instead of giving up, Marino decided to take part in an EU-financed startup workshop in 2014. “The course took place in southern France in September. I took my family with me. We wanted to enjoy ourselves a bit, and I hoped to learn enough to be able to write a satisfactory application for my research.” But the workshop was a real wake-up call. On the first day, the young researcher had to find someone to explain to her what a “pitch” was. By the end of the week, however, the jury of experts was enthusiastic about her presentation. Her husband and child spent the holiday on the beach without her.

The seed had been planted. Upon her return from Nice, Marino approached her boss Ernst Reichmann and explained to him that she was thinking of setting up a company. At first, he was somewhat bewildered, but he soon got behind the idea. There had never been any discussion about founding a company based on their shared research. “We weren’t thinking that far ahead,” Marino explains.

They decided that she should try to pitch the company concept at a couple of startup events. Marino immediately began picking up awards. In 2015, she won the >>venture>> prize for the best business plan, which helped push the project forward. “That was a big endorsement,” Marino says be-fore adding, “But what really helped us was the CHF 60,000 in prize money.” This enabled her to write the regulatory applications and arrange meetings with American and European testing authorities. With these came the first milestone payments, because the FDA and EMA had awarded an “orphan drug designation” to the Cutiss skin graft treatment for burn victims, which meant the company was eligible for a fast-tracked review, smoothing the path to approval.

Cutiss successfully completed its first small-scale clinical trial in late 2016. The patients’ bodies accepted the living skin from the lab as their “own” and displayed no signs of rejection, as Fabienne Hartmann-Fritsch happily explains. As head of clinical development, she is responsible for expediting patient studies. She, too, began her research career at the Tissue Biology Research Unit at the Children’s Hospital Zurich, and, as a co-founder of Cutiss, she now invests all of her energy in implementing the project plans. The most recently published results look very promising, and at present, patients are being sought for three additional studies in specialized clinics in various countries. Should these phase II studies show that the substitute skin is stable and effective, the treatment could come on the market as early as 2022.

One of the distant goals on the Cutiss wish list is to improve the skin’s characteristics. At present, the substitute skin lacks pigment cells to protect it from the sun’s rays, and a spectrum of tones needs to be introduced to cover all the different kinds of skin coloring. In the meantime, Cutiss is in the process of uncoupling itself from the University of Zurich and from the Wyss Zurich institute, which has provided substantial financial backing since 2016. The startup has set up shop in the biotech hotspot of Schlieren and now employs more than twenty staff members.

It may have been smooth sailing for Cutiss so far, but the need for new funding never goes away. At present, Marino and Hartmann-Fritsch are in search of CHF 30 million to enable the company to complete the application process for marketing approval, develop an automated production process, and construct sterile production facilities. “Our product has to be safe and cost efficient,” says Marino. As far as she is concerned, the potential of the denovoSkin product brings with it a certain obligation: it should be made available to as many people as possible. There are still some obstacles to be overcome before the company wins final approval for the treatment, but the chances are now looking relatively good.

For Marino, founding the company and participating in various competitions was an intense journey of self-discovery: “When you’re starting out, you’re a nobody. Sometimes the startup competitions are a bit like a reality show, but they also tested my entrepreneurial mettle. Did I have the skills? Was this something I really wanted? That was something I first had to find out, and the competitions were very helpful in that respect.” Marino brushes a strand of dark hair behind her ear and says: “Events like >>venture>> brought out my Sicilian genes. Talking to people and winning them over are the skills you need to be a company director. And I can do that.”

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