The Product-Hatchers
Wolf-Hagen Schunck has worked long and hard for this moment: OMT-28, an active pharmaceutical agent developed by him and the Omeicos team, entered the clinical trial phase in March 2017. “It’s a dream come true for me,” says the biochemist, MDC research group leader and co-founder of OMEICOS Therapeutics. After almost a decade, a promising discovery in Schunck‘s lab finally became a drug that could serve as a therapeutic agent for atrial fibrillation.
Researchers were analyzing the effects of Omega-3 fatty acids when they made a surprising discovery. It wasn’t the fatty acids per se that protected the heart, but rather, certain metabolic products (epoxyeicosanoids) which the body derives from these fatty acids. Some people’s bodies deal with this better than others, and the effect of these natural metabolic products is further limited by their rapid degradation. Omeicos developed OMT-28, a stable and orally ingestible candidate compound that bypasses the derivation step so patients suffering from atrial fibrillation can benefit from the protection the product provides. OMT-28 is now being tested on healthy subjects for side effects and tolerability.
According to the MDC law, part of its core mission is to transfer insights from its fundamental research into practical application. The MDC’s department of technology transfer is responsible for the requisite processes, identifying research findings with strong commercial potential and providing comprehensive support as products make their way to the market – a long and expensive process that requires the know-how of various experts and involves cooperation with businesses and diverse public funders.
Patents are key
Claudia Thurow, who has a Ph.D. in law, has been at the helm of the MDC’s technology transfer since 2014. This is how she describes her most important task: “Identifying projects with commercial potential as early as possible – in close coordination with all research groups.” Projects of particular interest include antibodies, biomarkers, novel compounds, and animal models.
Thurow and her team first verify whether the newly developed product is patentable – because in the field of biomedical marketing, proper protection of intellectual property is crucial. Timing is key, as well: “The patent must be submitted before we even announce a newly developed product, for example in a publication,” Thurow says. The process, which can take several years, also involves deciding in which countries a patent will be valid; patent rights cost extra for each country. MDC pays for these patents from a centralized fund in order not to strain the research groups’ budgets.
Promising discoveries also need a market
This is the point where Ascenion comes in. Ascenion GmbH is a technology transfer company headquartered on Campus Buch which supports MDC and numerous other institutions in the field of life sciences. The MDC is a stakeholder in Ascenion via a trust. Thurow’s team and Ascenion assess the commercial potential of newly developed products. Is there a market? Are similar drugs already available? What would a future product look like?
New technology transfer platform: the Helmholtz Innovation Lab MD-CEL
The “Max Delbrück Center Cell Engineering Lab” (MD-CEL)” was launched in spring 2017. Supported by the Helmholtz Association, this platform for application-oriented research facilitates close cooperation between science and industry, developing, for example, new genetic tools on a larger scale. The MD-CEL Innovation Lab, an initiative of Wolfgang Uckert’s and Zsuzsanna Izsvak’s MDC research groups, is currently being set up. The platform will also be open to other MDC groups.
There is no shortage of ideas. Currently, about twenty groups at the MDC are working on new approaches to medical therapies or diagnostics with the ultimate goal of commercial distribution. In addition to Omeicos, Berlin Cures, another spin-off, is cooperating with The Charité – Universitätsmedizin Berlin in the development of a “hot” candidate for a new a drug to treat the causes of chronic heart failure based on MDC research. The new substance, Aptamer BC007, is currently being tested on healthy subjects. Since January 2017, moreover, another pharmaceutical company has been developing a pharmaceutical agent to cure multiple myeloma, a form of bone cancer, based on an antibody identified by the MDC. Clinical trials are scheduled to begin in 2018.
Markers for kidney failure and cell therapy to treat leukemia
Kai-Martin Schmidt-Ott and his team are currently testing a biomarker that indicates acute kidney failure at an early stage: In 2010, the group identified a protein in urine which kidney cells produce in increased amounts when they are under stress. Mice models showed that as a biomarker, it is a fast and reliable indicator of an injury. Now, the first human studies are underway in cooperation with The Charité. “Several companies have expressed interest in the project,” says Jeanette Libera-Körner, who consults with the group on a regular basis. With a Ph.D. in biophysics, she has been a technology manager at MDC since 2014. The marker might be licensed out, i.e. exploited by a third party.
Another exciting field is BCMA CAR-T-cell therapy, a new method to treat non-Hodgkin’s lymphoma originating from mature B-cells (B-NHL). This very specific therapy is Armin Rehm’s and Uta E. Höpken’s research focus. “Our research group conducted animal experiments that suggested a therapeutic effect,” Jeanette Libera-Körner reports. Compared to competing product developments in the USA, this therapy is expected to be tolerated better, create no new resistances and could be the first product used for the general treatment of a variety of B-non-Hodgkin’s lymphoma. “Our discussions with the drug approval authorities have confirmed that our pre-clinical data is accurate and complete and that we can start a clinical trial,” says Jeanette Libera-Körner. The MDC research group is currently raising funds and then plans to produce the BCMA CAR-T-cells in the cell culture lab for clinical testing at the Experimental and Clinical Research Center (ECRC).
Fundamental decisions are made at the very beginning of the process
The journey of a newly developed drug to market is long: It takes about 15 years from patent registration to a drug that is commercially available. The MDC operates at the very beginning of this path, which means researchers soon have to make some fundamental decisions: Should they enter into a licensing agreement and let others develop their invention further? Should they opt for a spin-off or a partnership with a corporation? Ascenion provides valuable connections with pharmaceutical companies at home and abroad as well as the necessary market know-how. Even if the MDC chooses to license the product out, it initially has to clear the first hurdle by providing a proof of concept to confirm that the drug has the potential to work in practice.
This is why the technology transfer staff drive their projects in close cooperation with researchers as well as with Ascension, procuring any necessary external expertise, searching for academic and corporate partners, and assisting in raising third-party funding. The MDC also has its own funding programs to provide at least temporary financial support. Since 2008, PreGoBio has been facilitating in-house development of application-oriented research projects by providing 150,000 euros annually for equipment and personnel for a period of up to three years.
PreGoBio takes on two or three new projects each year, among them Wolf-Hagen Schunck’s endeavor. Thanks to this internal funding mechanism, Schunck and his team had discovered a dozen highly effective substances by the end of 2011. It took a further two years before Omeicos Therapeutics could be launched in mid-2013. In the interim, Schunck kept his team afloat with funds from sources such as the MDC, Helmholtz Enterprise, and the Investitionsbank Berlin’s ProFIT-Program.
Newly approved drugs based on MDC research
In the past two years, two drugs based on MDC research have come on the market: Cancer drug Blincyto treats a rare form of leukemia by helping the patient’s immune system detect and destroy cancer cells. It was approved for the European market in November 2015. VONVENDI, which has also been available since late 2015, treats the most common form of hereditary blood coagulation disorders and is based on MDC research on serotonin modulators.
More than ten million patients suffer from atrial fibrillation in Europe and the USA
Hopes have been running high – and continue to do so: Atrial fibrillation is one of the most common forms of cardiac arrhythmia, affecting about one percent of the population. “We have about ten million patients in Europe and the USA who could benefit from a new, well tolerated drug,” says Schunck. Private and public funders seem to agree with him, as they invested a total of 6.2 million euros in the development of the drug between 2014 and 2016. These funds allowed OMEICOS to conduct complex pre-clinical trials to determine the best candidate drug compound.
They also secured funding for the next phase of clinical trials: In the spring of 2017, OMEICOS raised 8.3 million euros for Phase I and Phase II studies, in which OMT-28 will first be tested on healthy subjects, then on a select number of sick patients. Moreover, the company has been receiving financial support from the Federal Ministry of Education and Research since 2014.
Meanwhile, Omeicos Therapeutics is making plans beyond OMT-28 and the treatment of atrial fibrillation. “Our substances could potentially be used to treat other cardiovascular conditions or inflammations,” Schunck explains. “Our animal experiments also showed that Omeicos’ compound candidates can be beneficial in ophthalmology – for conditions like macular degeneration.” Investors are already showing interest.
Further Information
- OMEICOS Therapeutics
- Department for Technology Transfer at the MDC
- Ascenion GmbH
- Berlin Cures
- ProFIT program of the Investitionsbank Berlin
- Helmholtz Enterprise
Featured Image: Peter Himsel
