As Legend Biotech became profitable, the company is navigating the next phase of growth for its flagship CAR-T therapy, Carvykti. Taiho Pharmaceutical and Cullinan Therapeutics' EGFR candidate delivered a phase 3 win. WuXi AppTec won a preliminary injunction against the Defense Department's black list designation. And more.
1. Legend interim CEO talks rising competition as Carvykti maker posts first profit
Legend Biotech has posted its first profitable quarter, recording $63 million in adjusted net income for the three months ended in June. The company’s interim CEO Alan Bash talked to Fierce about its continued effort to expand Carvykti, including navigating its partnership with Johnson & Johnson amid rising threats from the Big Pharma’s bispecifics.
2. Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal
Taiho Pharmaceutical and Cullinan Therapeutics’ EGFR inhibitor zipalertinib, used in combination with chemotherapy, just delivered a positive phase 3 in first-line, EGFR exon 20-mutated non-small cell lung cancer. The partners plan to seek FDA approval, teeing up potential competition with J&J’s bispecific Rybrevant and AstraZeneca’s soon-to-be-bought Zegfrovy.
3. WuXi AppTec scores temporary win amid fight over DOD's Chinese military company brand
A federal judge in Washington D.C., granted WuXi AppTec a preliminary injunction, temporarily preventing the Department of Defense from deeming the contract research and manufacturing service provider a 1260H company with alleged ties to the Chinese military. The judge said WuXi made a reasonable case that the Defense Department acted in an “arbitrary and capricious” manner.
4. Akeso's ivonescimab wins landmark first-line NSCLC nod in China (Regulatory tracker)
Chinese authorities approved Akeso’s PD-1xVEGF bispecific, ivonescimab, in combination with chemotherapy, for the treatment of first-line squamous non-small cell lung cancer. In the same setting, AbbVie just registered a global phase 3 study for its PD-1xVEGF candidate, ABBV-1480, which it licensed from China’s RemeGen.
Other News of Note:
5. Senate version of BINSA introduced by bipartisan lawmakers (release)
6. Daiichi Sankyo taps Innovent to market AML drug Vanflyta in China (release)
7. WuXi Biologics to buy CDMO assets from Transcenta in $26M deal (release, PDF)