
Reeling from FDA rejection, BeyondSpring axes 35% of US staffers in hopes of I/O comeback
It’s been a roller coaster few months for BeyondSpring Pharmaceuticals — and the New York-based biotech is now asking a third of its staffers to alight the train early.
BeyondSpring is chopping its US workforce by 35%, with some of those employees being assigned to subsidiaries, in a move described as “organizational streamlining” implemented to “preserve long-term sustainability.”
The low-profile biotech found itself in a sudden spotlight back in August after releasing surprisingly positive Phase III results suggesting its offbeat approach to immunotherapy could extend the overall survival of non-small cell lung cancer patients. But the skyrocketing shares came crashing down a few months later when the FDA rejected the same drug for a different indication, dashing its immediate hopes for a market entry.
Not much is exactly changing at BeyondSpring, where the plinabulin franchise will remain the core focus.
A selective immunomodulating microtubule-binding agent derived from seaweed, the drug was initially tested, in combination with a G-CSF analog, for the prevention of chemotherapy-induced neutropenia (a condition marked by dangerously low levels of certain white blood cells leading to heightened risk of infection).
With data from only one trial, though, the FDA deemed BeyondSpring’s package “not sufficiently robust to demonstrate benefit” and asked for a second well-controlled trial in its complete response letter.
The company suggested it will continue to push for a CIN approval in China and the US, while gearing up for an NDA filing of the NSCLC indication after stunning investors with what one analyst called “VERY unexpected” data.
In a Phase III trial involving 559 patients, the company reported that nearly twice as many patients were alive after two years on the drug arm than on the standard-of-care arm. And by year four, 10.6% of patients who received plinabulin plus chemo were alive, compared to none of the patients who received placebo plus chemo.
Those results drew Chinese oncology giant Jiangsu Hengrui to ink a $170 million development and commercialization pact. But as BeyondSpring released more detailed data, outside oncologists also raised questions about the magnitude of the benefit and whether it may have been driven in part by some patients in the trial receiving “substandard” care.
It’s now time to hunker down and deliver on those promises, including testing plinabulin in other I/O combos — while the other preclinical programs go on the backburner.
“This reorganization will enable BeyondSpring to reduce operating expenses and extend its cash runway,” CEO Lan Huang said in a statement.