Finding success in the shadows of Big Pharma and large research facilities, CleveXel serves as a bridge in the industry, specializing on selecting promising molecules for investment, and developing them for the CNS market, and especially Parkinson disease. Christian Bloy shares his entrepreneurial spirit and the vision for CleveXel, a company he founded in 2013, and why the role of efficient drug development is critical in the pharmaceutical industry.
In 2013, CleveXel was founded on the concept of developing existing know-how and added value. What was the vision behind the establishment of Clevexel and what have been some of the key milestones for the business these last few years?
Following the foundation of the company a few years ago, we at CleveXel have strived to establish a new business model in regards to pharmaceutical development with an approach of investing in a drug at the early stage of its development or in the repositioning of existing drugs. Our expertise focuses on establishing the value of a drug as it transitions from concept approval in animal testing to gaining approval for human clinical trials. CleveXel’s strategy directs its focus to disorders of the central nervous system, particularly complications arising from movement disorders and Parkinson’s disease. With the support of TEVA, we have received a grant worth 27 million Euros (USD 29.4 million). Because of the expertise, knowledge, and experience of our team, CleveXel is establishing itself as a reputable source within the world of pharmaceutical development.
CleveXel appears to put strong emphasis on the fact that the company works as an intermediary in the pharmaceutical industry, primarily specializing in the work of drug development. What are the key differences of the company’s strategy compared to those focused more exclusively on research?
Putting this in terms of R&D, our capabilities lend themselves to the field of development, which requires additional specializations than those used for research. Development strategy involves analyzing market positioning and preparing a drug for production. CleveXel is exemplary within the industry as it focusses on development, and thereby stands out from biotech companies that specialize only in research. Whereas research-focused labs stress academic studies and animal trials as a main focus, the creation of an actual marketable drug may not be the ultimate result. This is where the expertise of CleveXel is unique, as we specialize in the crucial next step of bridging these studies into the development of marketable pharmaceutical products thanks to our deep know-how in “drugability” of selected compounds.
The logic behind our process begins with analyzing which molecules are deserving of investment. Only if they meet specific criteria, do we allocate funds for further development. As a result, there is a difference of mindset between specialists focusing in research, and those in development. While researchers may strive through trial and error to maintain the life of a project, from a developer’s perspective, if a molecule under consideration for development fails to meet established standards, the project is terminated. Working with a molecule that has prohibitive costs, or will enter into a market with high barriers of entry due to strong competition, may qualify as criteria that would permit ending the development process.
What are some of these products that CleveXel is currently adding to its portfolio?
CleveXel currently has two molecules in its portfolio associated with ameliorating the complications of Parkinson’s disease, and these molecules are notable for being non-dopaminergic. For the past two decades, dopamine drugs have been the basis for Parkinson’s treatments. The two treatments CleveXel is developing include the first approaches targeting Parkinson’s disease in years to not focus primarily on dopamine. One is a glutamate release inhibitor with demonstrated potential to increase the Quality of Life for Parkinson’s disease patients and the other molecule is a dual A2A/A1 antagonist, for motor and non-motor symptoms treatment in Parkinson’s disease.
CleveXel operates under a crafted business model called OPTIMIZED SELECTION PROCESS based on 4 key steps: Prospection, Selection, Proposition, and Maturation, where the company acquires pharmaceutical molecule candidates at the stage of hit lead, lead target or early development. How does the company decide which molecule has commercial potential and that the timing is right?
Several factors come into play to determine whether a molecule has the potential to be developed into a marketable product, including meetings with biotech companies and consultations over different studies. Under a non-binding offer, we continue our analysis of a molecule throughout a ‘maturation phase,’ after which, if we come up with satisfactory data, we negotiate a contract. Once we acquire the rights of a molecule within the portfolio, CleveXel owns a certain percentage of the molecule rights, as well as full control of business proceedings and development, with the research facility earning ten percent of earnings once the molecule is sold. The final stage of the business model entails selling the rights of the developed molecule to a pharmaceutical company, considering factors such as establishing licensing or co-development business schemes.
Over the last few years, CleveXel has collaborated with numerous industry players from across the world such as Umecrine Cognition from Sweden, and Fosun Pharma from China. How would the company describe its global partnership strategy?
CleveXel has the capacity to adapt to different systems. Through our partnership with Umecrine, we have provided support for pre-clinical trials, as well as investment demonstrated by our initial five percent share in the company. The partnership with Fosun in China followed a different approach, beginning with discussions on Fosun’s challenges formulating anti-malarial drugs, primarily to follow OMS guidelines and develop the molecule at a subsidiary in Africa. Over a series of months, collaborations were set forth to develop formulations of the drugs to meet impurity standards, and to date, four other contracts have been negotiated under our partnership, which clearly validates CleveXel’s skills. In terms of sourcing for molecules, CleveXel works worldwide and is consistently establishing relations with new global partners. New molecules are in evaluation in Europe and US, and CleveXel will only continue to seek out more opportunities worldwide in the future.
With more than 20 years of involvement in R&D, manufacturing, and regulatory affairs on chemical and biological products, what are some practical experiences that have proven most useful during the initial years at CleveXel?
Real experience in development with a global approach is critical to have in today’s market. The company now has a global view on management, and it is important to be able to offer input based off real life experiences. When determining investments, or establishing partnerships, capitalizing on experience garnered from day to day is integral to successful decision making.
At CleveXel, we have a well-established team in place with many having relations among each other for ten or twenty years. The stability and the congeniality of our team has prompted our success in an industry, and we pride ourselves on our flexibility in communication within our company as well as with our partners. Five key managers own 95 percent share in the company, further exemplifying the biotech spirit and commitment to our communal goals.
Clevexel was founded just a few years’ ago; yet has quickly made very big strides. What do the coming years look like for CleveXel?
We are fully committed to continuing the development of CleveXel and to ensure that good molecules are developed into products that can help patients in need. It is also possible that a larger pharmaceutical company becomes interested in CleveXel and its portfolio. This is the nature of the business, and if an opportunity arises it is worth studying.