It’s not often that a biotechnology incubator becomes its own commercial-stage drug company, but that is the story of Israel-based BioLineRx, which received FDA approval for its first therapeutic in 2023.

Founded two decades earlier in 2003, BioLineRx was one of the early examples of a regional biotechnology incubator formed to help further diversify a country’s economy. Initially supported by the Israeli government, a global pharmaceutical company, and several life-science focused venture capital funds, BioLineRx’s mission was to transition university discoveries into therapeutic potential.

Through its first six years, the young incubator did just that. BioLineRx advanced multiple programs based on academic research across a range of therapeutic areas and was able to successfully out-license some of its de-risked programs.

Like other regional incubators, BioLineRx’s operating model was to in-license an asset and use its development expertise to establish therapeutic clinical proof-of-concept, at which point they would seek to partner with a pharmaceutical company to conduct larger, pivotal trials and ultimately commercialize the therapy post-approval. As part of this strategy, BioLineRx would earn revenues from development, regulatory and commercial milestones, as well as royalties on future sales.

Yet, the unpredictability inherent in drug development, and more stringent partnering requirements, ultimately put pressure on BioLineRx’s incubator operating model. The timing to out-license events was difficult to predict, and pharmaceutical companies established more stringent requirements for bringing in an asset, including randomized data, thus requiring more expensive Phase 2b trials. So, in 2010, BioLineRx took a hard look at its strategy.

Many of the challenges BioLineRx faced are familiar to biopharmaceutical leaders: Invest too many resources in too many products, and you may deplete your funding before bringing even one product to market. Fail to invest sufficient resources into promising therapies, and you may never discover their potential. 

Here’s how BioLineRx effectively focused to create a promising pipeline – and how you can too: 

Thoughtfully consider input

The process of bringing a new drug to market always involves relationships with scientists, manufacturers, regulators and investors. Use the feedback you receive from these collaborators to direct your efforts and resources. 

“If you looked at our pipeline in 2008, you would have found 15 to 20 assets, almost all of them pre-clinical and across multiple disease states,” says Philip Serlin, who became BioLineRx’s Chief Financial and Operating Officer in 2009, and its Chief Executive Officer in 2016.

When company leaders considered transitioning from an incubator model to a publicly traded biotech company, they learned that investors were not interested in such a diverse pipeline of early-stage assets. 

“Investors felt it was very important to focus,” says Serlin. “They preferred companies with expertise in a dedicated therapeutic area and assets in more advanced stages of development.” 

Review your goals and strategy

In response, BioLineRx hired a consulting firm to help the company “review the principles upon which BioLineRx was founded,” Serlin says. “Every couple of years, it’s a good idea to see whether your vision or strategy still makes sense.” 

Although BioLineRx had deliberately nurtured a broad pipeline to reduce risk, company leaders decided to pivot. The business divested all pre-clinical assets and focused exclusively on hematology and oncology. Eventually, BioLineRx selected a lead asset, a next generation CXCR4 inhibitor that held promise in both hematopoietic stem cell mobilization and in cancer immunotherapy. 

“We were looking for a clinical stage asset and this one was Phase 2 ready; it already had Phase 1 safety data,” Serlin says. BioLineRx also wanted an asset they could retain control of for as long as possible, and     the company’s primary candidate fit the bill. 

The company progressed clinical development, investigating the drug’s impact first in stem cell mobilization for autologous stem cell transplantation in multiple myeloma. The goal was to mature the asset and ultimately seek a commercial partner in this indication.

As the company got closer to regulatory submission, it began examining commercialization opportunities. The company spent a year conducting a full market analysis, and later hired an experienced commercial leader to complete the evaluation.

“From this work it became clear that for this specific indication, and in the U.S., it made more sense for us to commercialize on our own,” says Serlin.

“There are only about 200 bone marrow transplantation centers in the U.S., and the top 80 of them perform over 85% of all bone marrow transplantations,” Serlin says. “We realized this was a custom-made indication for a small company to launch on its own and thus made the decision to do so.” 

“While it meant a change in strategy, ultimately, we found that the economics of commercializing on our own in the U.S. were advantageous, and we could ensure a high-level of commitment by our appropriately sized, dedicated sales force,” says Serlin. “When you partner, you lose that control and potentially risk changes in a partner’s priorities, strategy and commitment.”

Persist where there is promise

Twelve years after going public on NASDAQ, BioLineRx received FDA approval of its lead asset for mobilization of hematopoietic stem cells for autologous stem cell transplant in patients with multiple myeloma, and the company remains committed to exploring the full potential of this drug, which shows promise in pancreatic cancer, sickle cell disease and other solid tumors.

“We feel like our best path is to continue our investment in our lead molecule,” Serlin says. “There are still indications that make sense to us.” 

The company and its collaborators are moving forward with two randomized Phase 2b studies evaluating its lead agent in combination with PD-1 inhibitors in patients with pancreatic cancer. The combination potential in pancreatic cancer, as well as other solid tumors, could have significantly larger market potential. 

BioLineRx is also partnering with researchers to evaluate its lead agent as a stem cell mobilizer for patients with sickle cell disease who are seeking gene therapy.

“Of all the thousands of molecules that are developed across the globe every year, only a few dozen branded drugs are approved each year,” says Serlin. “We are proud of our journey and are very pleased to see the continued development of biotechnology companies in the region.  But what is more important, we are excited to be supporting patients and their families.”

That is directed persistence in action. By thoughtfully focusing efforts, reviewing goals and strategies, letting go of less promising initiatives, and persisting where promise shines brightest, biopharmaceutical companies can find success.