“If you want to become a successful biotech company, hire people who are committed to the company and fascinated by its science. That’s a challenge, especially for startups, but, you need the best skills and the best human beings possible. Don’t compromise too much,” says Patrick Tricoli, CEO of Nanobiotix US. He says that focus is key to the company’s success. Nanobiotix was formed in 2003 to develop a novel way to fight cancer. It grew by promising something different than big pharma offered. “We shared our passion,” Tricoli says. “Working here is a lot of work, and a lot of fun, and our staff gets to be a part of our journey.”
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"The Nanobiotix approach to treating cancer combines one tried-and-true therapy—radiation—with something new—nanoparticles—that are injected once into the tumor. The lead product NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to immunogenic cell death leading to specific activation of the immune system,” Tricoli says. This product appears to be a viable option to treat a large number of solid tumors like head and neck cancer, liver cancers, rectum cancer, prostate cancer and Soft Tissue Sarcoma (STS).
Recently Nanobiotix announced positive phase II/III topline data in STS with NBTXR3. By meeting primary and secondary end points, the product demonstrates significant superiority and clinical benefits for patients versus standard of care. These findings open avenues for further use of the product and acceleration of the development in Europe as well as in the USA.
In late December 2017, the FDA approved a Phase I/II trial of NBTXR3 as a treatment for non-small cell lung cancer and head and neck squamous cell carcinoma treated with an anti-PD1 antibody. The goal is to turn non-responders into responders.
Nanobiotix has filed for a CE Mark in Europe and has partnered with PharmaEngine to develop and commercialize the compound in Asia.
Nanobiotix’s unique approach is the direct result of its founder’s expertise in physics, chemistry, and biophotonics. “By combining physics and nanotechnology, the result is markedly different from traditional chemistry or biology-based treatments,” Tricoli says. Patrick Tricoli is also a speaker on the Thursday, September 6, afternoon panel at BioPharm America™: “Partnering in Oncology.”
To maximize efficiency, the research process is based on discovery by design rather than random discovery. “We design the particles to have particular properties,” Tricoli says. “Then, the use of physics ensures more predictable and broader effects than biology.” As he points out, “When you expose a cancer cell to radiation, you always kill it as long as you expose it to the right dose.” Chemo cytotoxic agent or targeted therapies, in contrast, have more variability and are often linked with one of the specific pathways of the complex cancer biology network.
Young company shifted standard of care
The company’s scientific premise grew from research conducted by founder Laurent Levy, PhD, during his post-doctoral fellowship in lasers, photonics, and biophotonics at the State University of New York (SUNY). When he returned to France in 2003, Laurent incorporated Nanobiotix and has been able to develop and grow the company as CEO for the last 15 years.
“Laurent ’s challenge was to develop a first-in-class therapeutic in a field where nothing like this had been done. There were no major references. This was a paradigm shift,” Tricoli emphasizes.
“That made raising the first round of investment especially challenging,” he continues. However, the EU has become a good place to start companies at that level, so we’ve been able to grow.”
While European financial markets’ increased acceptance of risk certainly was a factor in Nanobiotix’s growth, the company’s ability to demonstrate its approach—“which exceeds standard of care,” Tricoli points out—was equally important. “This brings a new product to 60% of the total of cancer patients who are treated with radiation in the course of their treatment.”
The “first-in-man” in 2011 was a major milestone, he recalls. “It gave us the capacity to convince more surgeons, radiation oncologists, and medical oncologists to start considering this innovation.”
One year later, in 2012, Nanobiotix signed its first partnering deal. “We had proved the viability of the science and the company,” Tricoli says. In October it went public, listing on the Euronext Paris stock exchange.
Earlier in 2018, Nanobiotix was selected for the EuroNext Tech 40. This recognizes the top 40 young European technology companies, based on their performance. “For us, this means we’re on the right track,” Tricoli says. “This rewards our historic commitment to innovation and should enable us to further increase our visibility among institutional investors worldwide,” he says.
“Recently, the positive Phase II/III study is another major milestone achieved by the company. In our industry, the validation through a randomized trial of a first-in-class mode of action of an innovative product is always a rare and transformative moment.”
Key considerations to share with young startup along the way
To reach this point, Tricoli says, “both teams and financing must be adapted to what you are trying to achieve. Enabling technologies or drugs are very different in terms of development and need different growth strategies.” Drug development, for instance, requires more capital than selling a platform as a service or through partnership. And the amount of funding you need depends upon whether you advance a product internally or develop it with a strategic partner. Therefore, think about your goals early, because decisions made now affect future opportunities. For example, how the company is structured in terms of initial investors may affect its ability to attract venture funding or other capital later on.
“After receiving the initial private investment, begin considering the best time to go public,” Tricoli advises. “The timing can be affected by your national and international regulatory pathway, how you operate, and your patent position. Interact early with the regulatory bodies to find the quickest path to market (including any accelerated options) and track their thinking as it evolves, in relation to your work, he says.
“Once you have proof of concept in an indication where the regulatory path is very clear, you may be able to raise subsequent funding,” he adds. With first in class products, however, creating additional product value can yield greater funding. Therefore, “create additional value, before approaching subsequent investors or partners.”
This also is a good time to think about your global strategy. With proof of concept established, you can identify your primary markets. With Nanobiotix, for example, although the company is French, the US is a major market. “Having a product developed in the EU is key but having clinical trials under the FDA regulation creates value readily,” Tricoli points out.
First-in-class innovators, especially, should “talk with key opinion leaders and principal investigators very early. It’s very important to work with and to listen to them throughout the product’s development.” Their input can help shape its medical development strategy.
Companies aspiring to be top biotech firms should—but often don’t—develop their patient engagement strategy early. The plan should include not only physicians, and investigators, but also patients. “More and more they are stakeholders playing a key role in clinical development, regulatory process and in shaping market access and, therefore, the success of a product.”
Market access and pricing strategy today and in the future in your territories of interest are also key elements. Even though market norms are changing significantly, and it can be years before your product is commercialized, you must anticipate those changes and develop a flexible strategy very early. “This ensures you won’t be disconnected when it’s time to discuss those points,” Tricoli says.
Meet Patrick Tricoli along with other industry experts at BioPharm America ™, September 5–6 in Boston, as he speaks on partnering in the oncology space.