After a phase 2 fail in COVID-19 last year, BerGenBio is shifting its business strategy to focus on, well, still COVID-19.
The Norwegian biotech unveiled a business strategy update Wednesday that explained a new—or renewed—focus on COVID-19 and non-small cell lung cancer for lead candidate, bemcentinib.
So far, BerGenBio has had mixed success with the AXL inhibitor in both those indications. The drug is also being tested in acute myeloid leukemia.
Moving forward, the focus will be on COVID-19 and first-line NSCLC, while the AML and second-line NSCLC indications will be deprioritized. BerGenBio will also put the development of anti-AXL function-blocking monoclonal antibody, tilvestamab, on the back burner.
"As a small biotech company, there's only so much we can efficiently do at the same time," CEO Martin Olin said during an investor call Wednesday. The company, therefore, underwent what he called "a quite coherent and impressive review" of the data collected so far across its candidates and decided to make some changes.
Underpinning the changes is a desire to get bemcentinib to patients as fast as possible, and the COVID and first-line lung cancer indications seem to be the way to do that.
Attacking first-line NSCLC would be a reversal from the typical biotech playbook, considering companies tend to go after later-line cancers and work their way up as a quick way to assess a drug's potential and get to the market as fast as possible. But the FDA's Richard Pazdur, director of the Oncology Center of Excellence, recently signaled interest in flipping the script to get newer treatments used for earlier cancers.
As for the AML and second-line indications for bemcentinib and tilvestamab, which was in early testing, Olin referred to the status of these programs as deprioritized, not discontinued.
"That does not mean that we don't believe in these indications," the CEO said, noting it's purely a matter of focusing on those indications that provide the most potential to get those drugs on the market.
The strategy shift comes about a week after BerGenBio showcased a sub-protocol analysis from a phase 2 COVID-19 study called ACCORD2 that linked bemcentinib to a clinical response in about 90% of patients. The response was defined as a two-point improvement on a WHO scale or discharge from hospital. Patients on bemcentinib had a response after a median of seven days.
This readout followed a miss last year in the phase 2 BGBC020 trial in a similar group of patients, when the therapy failed on the primary endpoint of accelerating the time to sustained clinical improvement over standard of care.
BerGenBio nevertheless pointed to a subgroup of the trial in an effort to flip the negative results into a positive—a familiar play from small biotechs trying to make an entry into the COVID-19 therapeutics market.
Under the new strategy, BerGenBio’s COVID-19 work will focus on confirming the results of the sub-analysis from the ACCORD2 trial. The company will have the opportunity to do that through the EUSolidAct platform trial, which is being conducted by Oslo University Hospital, Norway.
If the confirmation is secured, BerGenBio believes it will have evidence to support an emergency use authorization request.
In NSCLC, the company will keep working towards a collection of studies in patients with certain mutations.