TEL AVIV, Israel—BioLineRx Ltd. announced recently that it is kicking off its first in-licensed project under the auspices of its strategic collaboration with Novartis, which is centered on the screening and development of novel drug candidates. Specifically, BioLineRx has inked an exclusive worldwide agreement with Hadasit, the Technology Transfer Company of Hadassah Medical Organization to in-license BL-1210, a drug candidate for the treatment of liver fibrosis, especially non-alcoholic steatohepatitis (NASH).
BioLineRx and Novartis have a multiyear strategic collaboration underway to co-develop select Israeli-sourced novel drug candidates, which was established in December 2014. Under the agreement, Novartis will evaluate projects that BioLineRx identifies and presents for co-development and potential future licensing, and also made an equity investment in BioLineRx of $10 million. BioLineRx and Novartis are aiming to co-develop several preclinical and early clinical projects through clinical proof of concept. In this instance, BioLineRx will be responsible for handing preclinical and clinical development of BL-1210 until proof of concept, says Philip Serlin, chief financial and operating officer at BioLineRx.
“After jointly screening and evaluating a wide range of preclinical and clinical therapeutic candidates, we are excited with the selection of this potential treatment for non-alcoholic steatohepatitis to be developed as part of our multiyear partnership with Novartis, especially since there are no approved treatments for this prevalent condition,” Dr. Kinneret Savitsky, CEO of BioLineRx, noted in a press release. “Under the collaboration, Novartis will provide us with valuable professional advice and consultancy throughout the development process. This project fits our strategic focus on the immunology space, since it works through modulation of the immune system. Upon successful completion of the feasibility stage, we plan to advance the project at full steam. We also expect to bring additional promising projects to the collaboration by the end of the year.”
BL-1210 is a preclinical project developed by Prof. Rifaat Safadi, head of the Liver Unit in the Department of Medicine at Hadassah Medical Center in Jerusalem. The drug candidate offers a new approach of mitigating liver fibrosis by modulating the immune system. As BioLineRx advances development of the project, the company will work on the novel drug target that can modulate the immune system to reduce liver fibrogenesis and, by extension, liver scarring, which in turn could control disease progression.
“The unique approach of BL-1210 utilizes an existing antifibrotic propensity of the immune natural killer (NK) cells in the liver. This antifibrotic function is attenuated in NASH patients and BL-1210 is meant to restore and ameliorate NK cells activity and thus halt liver fibrosis progression and NASH aggravation,” Serlin explains.
NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD). In NASH, fat gathers in the liver, leading to inflammation and damage. In many cases, the liver scarring typical of NASH is associated with liver cirrhosis. Current estimates are that 2 percent to 5 percent of people worldwide suffer from NASH, and the U.S. Association of Liver Disease forecasts that of those with the disease, 15 percent to 25 percent will progress to end-stage liver disease and hepatocellular carcinoma over 10 to 20 years. By and large, people with NASH live with few if any symptoms until the late, severe stages of the disease, and the increase in prevalence is attributed at least partially to rising obesity rates. NASH accounts for a third of all cases of hepatocellular carcinoma and liver transplants, and is expected to be the leading case for the latter by 2020. No U.S. Food and Drug Administration-approved treatments exist at present for either NASH or NAFLD.