Antibody-drug conjugates from Kelun-Biotech and Hansoh Pharma, respectively partnered with Merck & Co. and GSK, delivered positive phase 3 readouts in China. AstraZeneca reached out to its spinout Dizal Pharma for an EGFR lung cancer med. Biotechs are growing protective of their intellectual property and business intelligence. And more.
1. Kelun scores sac-TMT win in first-line NSCLC population missing from Merck’s massive phase 3 program
Kelun-Biotech reported a positive phase 3 readout for its Merck & Co.-partnered TROP2 ADC, sac-TMT, as a first-line treatment for PD-L1-negative nonsquamous non-small cell lung cancer in China. The readout offers the first, direct proof for an ADC replacing chemo in the lucrative first-line NSCLC setting and could inspire Merck to fill a gap in its global phase 3 program, analysts argued.
2. GSK sees phase 3 win for Hansoh-partnered ADC in China as validating its ‘priority asset’
Also in China, GSK’s partner Hansoh Pharma said a phase 3 study of its ris-rez, a B7-H3-targeted ADC, has hit its primary endpoint in small cell lung cancer. It marks the first positive phase 3 overall survival readout from a B7-H3 ADC. The asset, along with a B7-H4 ADC from Hansoh, are among GSK’s priority assets.
3. AstraZeneca pays up to $1.5B for EGFR lung cancer drug Zegfrovy from its spinoff Dizal
AstraZeneca has signed another China deal, this time tapping into its own spinout, Dizal Pharma. With $600 million upfront and up to $900 million in milestones, AZ is buying Dizal’s EGFR inhibitor Zegfrovy, which just reported confirmatory phase 3 data in first-line NSCLC with EGFR exon 20 insertion mutations. Dizal was formed in 2017 based on AZ’s China innovation center.
4. ‘How did they get there first?’ Biotechs forced to learn new patent tricks to protect pipelines
As competition with Chinese companies grow, U.S. biotechs have become more secretive about their research. Besides building a robust patent package, biotechs are advised to exercise caution with their public communications or use public statements to highlight lower-priority candidates to throw off competitors.
5. Insilico signs on with CDMO Bora in $2.5B AI drug discovery deal
Insilico’s Chinese partner returns for $177M pact to explore ‘mass market’ CNS indication
On a dealmaking spree, AI drug discovery outfit Insilico Medicine has teamed up with Bora Pharmaceuticals in a deal potentially worth $2.5 billion. Insilico’s proprietary Pharma.AI platform will be paired with Bora’s CDMO capabilities to enable drug innovation. Meanwhile, China Medical System has tapped Insilico’s PandaOmics in a $177 million collaboration aimed at a large central nervous system indication.
6. FDA rejects Hengrui, Elevar’s PD-1 liver cancer combo for a 3rd time
The FDA has declined to approve Hengrui Pharma and Elevar Therapeutics’ camrelizumab and rivoceranib for a third time in first-line liver cancer. While the previous two rejections cited problems at Hengrui’s camrelizumab plant, the latest complete response letter cited the plant making rivoceranib. The FDA didn’t raise any issues with clinical data.
Other News of Note:
7. Avere goes public via NextCure reverse merger, secures Hansoh IL-23 drug with $2.3B deal
8. Braveheart aims for freedom with IPO to support Hengrui-licensed cardio asset
9. FDA's latest onshoring move homes in on streamlined facility registration, foreign plant scrutiny
10. Bipartisan Senate bill seeks to build vigilance around foreign companies making drugs in US
11. Star Padcev-Keytruda combo expands bladder cancer reach with FDA approval, pressuring AstraZeneca
12. Eisai, Biogen scoop up subQ Leqembi starter dose nod (Regulatory tracker)
13. Huyabio scores with Opdivo combo in 'milestone' skin cancer trial
14. Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial