Respiratorius has secured its second patent for the drug candidate VAL001, a new oral formulation of sodium valproate for the treatment of cancer. The company thus adds another important piece to the puzzle that will strengthen the project in the ongoing partnering, where discussions are currently underway with potential takers.
Biotech company Respiratorius has developed VAL001 as a potential treatment for diffuse large B-cell lymphoma (DLBCL), one of the most common forms of non-Hodgkin lymphoma. The intention is that VAL001 will be used as a pre-treatment before the standard treatment R-CHOP – a combination of chemotherapy and immunotherapy for DLBCL patients.
VAL001 is backed by strong preclinical data, and thanks to Orphan Drug Designation, the European Medicines Agency (EMA) has recommended the company to take the project from phase I/IIa directly to clinical phase III studies. With a completed formulation of VAL001, they have a strong development package, for which they are currently in the process of searching for a partner.
In an interview with BioStock this summer, the company’s CEO Johan Drott said that the company is engaged in ongoing discussions with several companies that are interested in the project. Furthermore, the company is actively looking for more potential partners. You can watch the full interview here.
Securing a second patent approval
In addition to strong clinical data, a crucial aspect of any development project is to protect the assets. Just over a year ago, Respiratorius received its first patent approval protecting VAL001 as a new oral formulation of sodium valproate for the pre-treatment of cancer. That approval applied to Japan and entails market exclusivity in the country until 2035.
Now, Canada becomes the second country to approve the same patent. The company recently announced that it had received a Notice of Allowance from the Canadian Intellectual Property Office. This means that the product is protected in the country until 2036.
Working to further strengthen the protection
However, this is only one part of Respiratorius’ patent strategy. Last year, the development of VAL001 was completed, which in its final version combines direct and sustained release of sodium valproate. The final step in the development was to conduct a pharmacokinetic study with the drug candidate.
The study showed a simplified dosage, i.e. fewer doses per day, while the exposure to sodium valproate was the same compared to the reference formulation. There are also indications that the effect of the new formulation may be better.
This summer, Respiratorius filed another patent application for the final formulation, taking the next step in the patent strategy. Once the application is approved, it is valid for at least 20 years from the priority date and will be processed by patent authorities around the world.
In short, the company continues to strengthen the protection of the project, while searching for a partner who can take the development further.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.