Cereno Scientifics pipeline consists of three programs: CS1, CS014 and CS585. CS1, a histone deacetylase inhibitor (HDACi) that acts as an epigenetic modulator, is in Phase II development for pulmonary arterial hypertension (PAH), a rare cardiovascular disease. The first patient was recruited to the study in July 2022. Read more about this milestone hereCS014 – another HDACi with epigenetic effects – as well as CS585, a prostacyclin (IP) receptor agonist, are currently in preclinical development.
The company's goal is to initiate Phase I studies in 2023 with both of these preclinical candidates, pending continued progress in the second part of these development programs and subsequent IND applications and approvals.
Building a strong IPR position for CS1
As Cereno continues to develop its project portfolio, the company has been working to strengthen its intellectual property rights (IPR) for all of its programs. CS1, the lead candidate, has extended patent protection in most major global markets, including Europe, the US, Japan, Russia, Canada, Australia and Mexico.
Back in January, the company reported its first IP news of the year, when a patent for CS1's third patent family had been obtained for the Japanese market. This was followed in March by a granted patent for CS1's second patent family from the European Patent Office (EPO).
Cereno has announced several new patents for CS1 since the summer. In August, two new patents were granted for CS1's second and third patent families in the US, one of Cereno's most important markets. In the case of the second patent family, the new patent extends the protection already granted in the US and will be valid until 2035, with the possibility of a patent extension of up to five years.
Regarding CS1's third patent family, the new US patent will be valid until 2037, with the possibility of extension up to five years. On September 20, Cereno received two additional patent approvals for the third patent family, one for the Australian market and one for South Korea. These patents will also be valid until 2037, with the possibility of extension up to five years.
The latest patent news regarding CS1 came on October 18, this time regarding the candidate's second patent family. Two patents were granted, one in Israel and one in Malaysia. The patents will be valid until 2035, again with the possibility of patent extensions of up to five years.
Recently secured patents for CS585
Cereno has also received patent approvals for the preclinical candidate CS585. On September 9, the company was granted a new patent in the US for the second patent family for the preclinical prostacyclin receptor agonist program, which includes CS585.
Then, on September 23, Cereno announced that they had been granted a patent from the same patent family, but this time for the European market – another key market for cardiovascular diseases.
Comments from CIPO
Collectively, these new patents help Cereno build a strong IPR portfolio in its pursuit of a future partnering agreement and ultimately market entry. BioStock contacted Jonas Faijerson Säljö, Chief Intellectual Property Officer (CIPO) at Cereno Scientific, to learn more about the importance of building a solid IPR portfolio for all programs in the development portfolio. (The interview answers are translated from English).
Jonas, you are responsible for Cereno's IP strategy and management of the company's IPR.portfolio. Why is strong IPR important for life science companies in general and for Cereno in particular?
– Strong IPR is important for all knowledge-intensive companies, and particularly for life science companies due to the high costs associated with taking a drug candidate through clinical trials. For Cereno, as for other companies in the pharmaceutical industry, it is important to have commercial exclusivity to protect the significant development investments required for a drug program.
– A solid patent portfolio is also an important factor in a future out-licensing or deal with a major pharmaceutical company, along with clinical data and potential regulatory market exclusivity.
With new patents granted for CS1 in several key markets, how comprehensive is your IPR for the lead candidate CS1?
– We are very pleased with the significant progress in the CS1 patent portfolio that has been made recently and the overall IPR position that we have for this program with patents in most major global markets.
What are the potential implications of the patent approvals obtained this year for the preclinical program that includes CS585?
– The latest patent approvals represent an important validation of our preclinical prostacyclin receptor agonist program and we are pleased with the patent protection for the CS585 compound as well as for other compounds in the program already at this early stage of development.