BioLineRX CEO Morris Laster: Once you have a critical mass of projects in the pipeline and you can sell a compound every year or so, it becomes self sustaining.The people at leading Israeli biotech company BioLineRx must have a lot of baskets in their Jerusalem offices. Because, unlike most biotech companies which put all their eggs in one basket by focusing on a compound and hoping to develop it into a blockbuster drug, BioLineRx is taking its eggs and spreading them around in a myriad of baskets. And the strategy is paying off.
Its flagship compound, BL-1020 for the treatment of schizophrenia, has shown promise in Phase I clinical trials. In a presentation last month at the American Psychiatric Association in San Diego, BioLineRx disclosed that the trials demonstrated that the compound, which introduces a much-needed drug called GABA into the brain, was well tolerated, and demonstrated biochemical evidence of dopamine blockade, an indication of efficacy.
“Schizophrenics have too much dopamine and not enough GABA in the brain. All the drugs currently available block the dopamine, but when you block it, and there’s not enough GABA, the result is that the patient begins suffering physical symptoms like ticks and other involuntary movements,” CEO Dr. Morris Laster told ISRAEL21c.
“Then the patient stops taking the drugs. Other newer drugs which attempt to solve this problem have been shown to cause weight gain, diabetes and hypercholesterolemia, so the patient also stops taking those. What BL-1020 does is attack the two main deficiencies in the patients – it blocks the dopamine and activates GABA. The preliminary results show we can achieve a much higher dosage without any of those side effects.”
But even if BL-1020 fails, the 35-person staff of BioLineRx won’t be out on the street. That’s because the company’s strategy is not to focus on one drug but instead build a large catalogue of compounds for treating a wide variety of medical conditions. Besides BL-1020, BioLineRx’s researchers are developing treatment of damaged heart tissue post-myocardial infarction, and compounds for the treatment of cancer and CNS, cardiovascular, metabolic, infectious and autoimmune diseases.
“It’s a fairly intense atmosphere,” laughs the Brooklyn-bred Laster from his office in the sleek Har Hotzvim high tech center outside Jerusalem’s Ramot neighborhood. Laster was previously involved in founding, and taking public, two Israeli biotech companies, XTL Biopharmaceuticals and Keryx Biopharmaceuticals.
Partnering with researchers, universities and biotech companies to further the commercialization of promising compounds, BioLineRx seeks to enrich the pipeline of large pharmaceutical companies seeking their next blockbuster drugs.
Where do they find the compounds? Hundreds of them are discovered in university and government labs, but few ever succeed because of the enormous cost and time investment involved in drug development.
But BioLineRx, founded in 2003, has some well-heeled names in the Israel life science arena among its founders, including Teva Pharmaceuticals Ltd., Giza Venture Capital, Pitango Venture Capital, Hadasit and the Jerusalem Development Authority.
“Our founders had tremendous foresight and courage,” Laster said. “They knew they’d have to suck it up, put out the money first, even before they knew what the projects will be or who will manage them.”
BioLineRX’s basic premise is that most biotech projects and companies don’t work, explained Laster.
“There’s a lot of ‘R’ going on here in Israel – research – but no ‘D’ – development. Occasionally there’s a big success like Teva’s multiple sclerosis drug Copaxone or [Parkinson's drug] Rasagiline, but there was a sense among the founders of BioLineRX that the whole development potential existed but was not manifesting itself as completed drugs.
“They knew that most projects wouldn’t pan out, therefore the idea was to take on five or six projects a year and hope something works. Then once you have a critical mass of projects in the pipeline and you can sell a compound every year or so, it becomes self sustaining.”
Using that mode of operation, BioLineRx has raised more than $100 million via several rounds of venture capital, government, and public funding. An initial public offering in February – the largest ever for a biotech company on the Tel Aviv exchange – netted the company over $50 million.
Since beginning operations over three years ago, BioLineRx’s staff of doctors and scientists have screened more than 800 compounds, about 600 of them Israeli. All that work has resulted in about 20 in-licensing events so far, noted Laster. Three – including BL-1020 – are in, or near, the process of clinical trials, and another two are scheduled for next year.
“We have an in-house screening system called Med Matrx which enables you to go through each drug separately – make sure you didn’t fall in love with it without due cause,” explained Laster. “Once it passes our internal screening and the Med Matrx screening, it goes to final approval before our scientific advisory board.” The board is a star-studded delegation headed by Nobel laureate in chemistry, Prof. Aaron Ciechanover.
BL-1020, licensed from Ramot at Tel Aviv University and Bar-Ilan University Research and Development Company, was one of the compounds which passed the stringent tests, and now BioLineRx has high hopes.
“We’re not saying it works better than other drugs, but we are saying that it doesn’t cause the side effects,” said Laster. “We’ll be starting Phase II studies soon on patients in Romania and Israel.”
Laster expects to see the company’s first revenue from an out-licensing agreement within two to three years. Besides BL-1020, he is particularly enthusiastic about a compound the company has licensed for cardiac deterioration prevention.
“BL-1040 is another breakthrough technology – an injectable polymer. When a patient gets a stent or coronary catheterization, BL-1040 is injected into the infarcte area via the coronary artery providing mechanical support while the heart heals and prevents cardiac deterioration. We’re starting clinical trials in a month or so.”
And, ending the conversation, Laster returns to juggling all of those eggs in all of those baskets, hoping to find that perfect omelet.