BerGenBio narrows R&D to focus on NSCLC and Covid-19; Oral SERDs see another setback as G1 drops program
BerGenBio said it will prioritize its pipeline to focus on first-line non-small cell lung cancer and Covid-19 with its lead drug bemcentinib. That means work in acute myeloid leukemia, MDS and ovarian cancer has been put on pause.
The company said the narrowed R&D work provides the “optimal path towards translating BerGenBio’s strong scientific foundation” and the shift comes a month after the biotech named former IQVIA VP of oncology Cristina Oliva as its CMO.
“As a small biotech company, there’s only so much we can efficiently do at the same time,” CEO Martin Olin said on an investor call.
Bemcentinib has FDA fast track designation in the first-line NSCLC indication and the company thinks there’s “potential for an accelerated approval pathway in this indication,” Olin said on the Wednesday morning call.
In Covid-19, the drug met the primary goal in a Phase II study when combined with standard of care, including Gilead’s remdesivir, the company said last month. The drug is being added to a pan-European platform Covid-19 study, as well, dubbed EU-SolidAct.
“We were also able to prevent patients to progress to non invasive ventilation or high flow nasal oxygen and we were able to discharge the patients much sooner from the hospital than standard of care,” Olin said of the trial, which took place in India and South Africa.
“If we are able to repeat the data, we believe that it could be an opportunity to have an expedited regulatory process with the agencies for a potential approval,” Olin said, referring to emergency use nods.
Olin said the company is scaling up manufacturing capabilities to “hopefully allow us to engage in a discussion with the authorities about a potential launch post-Phase IIb study, if successful.” BerGenBio is in partnership discussions on its assets, Olin said. — Kyle LaHucik
G1 Therapeutics drops an oral SERD program
G1 Therapeutics is saying farewell to a pipeline program.
Researchers will discontinue development for its experimental oral SERD drug rintodestrant, the North Carolina biotech announced in Wednesday’s first-quarter earnings report. G1 decided to end the program after reviewing partnership options and recent data. The intellectual property will be returned to the University of Illinois-Chicago.
According to the company, the oral SERD space proved “highly competitive,” suggesting there weren’t any partners who wanted to take on the challenge.
It’s been a tough time for oral SERDs recently following big setbacks from Roche and Sanofi. Two weeks ago, Roche investigators flagged a failure on the primary endpoint for progress-free survival among ER-positive, HER2-negative patients in a Phase II study. And in March, a top Sanofi prospect flunked a major test in breast cancer. — Max Gelman