In an exclusive interview with The Fly, BeyondSpring (BYSI) CEO Lan Huang talked about the company's lead candidate, its ongoing clinical trials, upcoming events, potential U.S.-China trade implications, and much more. Here are some highlights:
PLINABULIN IN CIN: Plinabulin, a marine-derived small-molecule, is BeyondSpring's lead asset and is currently in late-stage clinical development as an anticancer therapy in non-small lung cancer, or NSCLC, and for the prevention of chemotherapy-induced neutropenia, or CIN. Commenting on the latter, Huang told The Fly that the "we have shown last year that in combination with neulasta or pegfilgrastim we could improve the care not only in the bone pain but also reduce the chemotherapy induced severe neutropenia so that patients can stay on chemo and prolong their life." "If this plays out in the Phase 3 trial, then Plinabulin in combination with pegfilgrastim or other G-CSF will be a very important standard of care for the future in CIN," she added.
PLINABULIN IN NSCLC: Noting that the company has finished the first interim look of Phase 3 of Plinabulin/docetaxel in NSCLC, Huang believes the study is "going forward really nicely." "In the first interim look, the DSMB also reviewed our data not only on the safety but also on efficacy and there's no resizing of the patients," the executive said, adding that BeyondSpring is expecting a second look "probably by the end of this year or next year."
UPCOMING MILESTONES: Looking out over the next 12 months, BeyondSpring's CEO expects several important events to take place, including an NDA filing in China by the end of the year. Additionally, Huang noted that BeyondSpring is planning to apply for NDA in the U.S. for the CIN indication. The second look of the Phase 3 NSCLC and data presentation at upcoming conferences, as well as potential partnerships, were also highlighted as among important upcoming milestones.
UNDERSTANDING PLINABULIN: Highlighting that Plinabulin is still not very well known, BeyondSpring's CEO pointed out that "people feel like chemotherapy is probably going to go away" with Immuno-Oncology, or IO, therapy coming to the field, but "actually it’s not." "Recent publications show that from now to 2040, chemotherapy is actually going to increase," Huang argued, adding that as chemo is used more, "there will be more CIN," which will be "good for Plinabulin."
U.S.-CHINA TRADE RELATIONSHIP: As U.S.-China trade talks continue, BeyondSpring’s Huang told The Fly the company is not worried about any potential tax. "We have already our strategies of making the drugs domestically in China for the domestic approval," the executive said. Furthermore, Huang noted that the Chinese government has also recently announced a rule "saying that there's no tax for innovative oncology drug shipment into China."
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. A more detailed version of this interview to follow.
For more on BeyondSpring’s trial in CIN click here.
For more on BeyondSpring’s trial in NSCLC click here.
For more on BeyondSpring’s upcoming events click here.
For more on Plinabulin click here.
For more on any potential implications from the U.S.-China trade situation click here.