The PD-(L)1xVEGF field had a roller coaster week marked by an imperfect readout and a potentially $11 billion deal. AstraZeneca and Daiichi Sankyo trotted out Enhertu's detailed data in first-line breast cancer. Regeneron signed on a GLP-1/GIP candidate from China's Hansoh Pharma. And more.
Summit Therapeutics unveiled the first global phase 3 readout from Akeso’s PD-1xVEGF bispecific ivonescimab, saying the drug reduced the risk of progression or death by 48% in previously treated EGFR-mutated nonsquamous non-small cell lung cancer. But, because the HARMONi trial did not meet the overall survival endpoint at the current analysis, the company’s stock price tanked.
But the PD-(L)1xVEGF field quickly got an injection of confidence when Bristol Myers Squibb announced a potentially $11.1 billion deal to co-develop and co-commercialize BioNTech’s PD-L1xVEGF candidate BNT327. The deal includes $1.5 billion upfront and $2 billion in unconditional anniversary payments through 2028. BioNTech got the drug recently from purchasing its then-partner, Chinese biotech Biotheus, for $800 million upfront.
AstraZeneca and Daiichi Sankyo’s Enhertu, used in combination with Roche’s Perjeta, significantly reduced the risk of progression or death by 44% versus the standard THP regimen in first-line HER2-positive breast cancer. Experts suggested that the result, from the Destiny-Breast09 trial, makes the Enhertu combo a new first-line standard treatment option, although some questions such as treatment duration remained.
3. Regeneron pens $2B pact for Hansoh's potential obesity rival to Lilly's Zepbound
Regeneron is paying China’s Hansoh Pharma $80 million upfront for ex-China rights to a GLP-1/GIP receptor agonist coded HS-20094. The deal includes up to $1.93 billion in potential milestone payments. The drug is currently undergoing a phase 2b in diabetes and a phase 3 in obesity in China.
4. Astellas aspires to strike CLDN18.2 gold again with ADC licensing deal worth up to $1.34B
Astellas has doubled down on the Claudin18.2 field by in-licensing an antibody-drug conjugate from Chinese biotech Evopoint Biosciences in a deal potentially worth up to $1.34 billion. Evopoint is testing the agent, XNW27011, in a phase 1/2 solid tumor trial covering gastric, pancreatic, colorectal, ovarian and other cancers. Astellas already has the first FDA-approved Claudin18.2 agent, Vyloy.
5. Cullinan pens $700M pact for BCMA bispecific to pair with another autoimmune T-cell engager
Cullinan Therapeutics, which is already working on a CD19 bispecific for autoimmune diseases, is getting a BCMA T-cell engager. For $20 million upfront and nearly $700 million in potential milestones, Cullinan is getting ex-China rights to Genrix Bio’s BCMAxCD3 candidate velinotamig. Last year, researchers reported a deep remission in a woman with aggressive refractory systemic lupus erythematosus who received Johnson & Johnson’s BCMA bispecific Tecvayli.
6. Kelun-Biotech raises $250M with 6M share placement (release)
After its Hong Kong IPO in 2023, China's Kelun-Biotech has raised about $250 million in a new share placement. The company sold about 5.92 million shares at HK$331.80 per share, according to a press release. Kelun said the placement was "multiple times oversubscribed" with support from various types of investors, leading the biotech to expand a previous fundraising target of $200 million. Kelun plans to use the money to fund R&D operations, regulatory interactions, manufacturing infrastructure and more.
Other News of Note:
7. Ascletis scores phase 3 win for daily acne pill, prepares push to Chinese regulators
8. ASCO: Kura, Kyowa reveal 23% remission rate behind oral leukemia drug's phase 2 win
10. Astellas organizes action week to connect patients to advocacy groups
11. Fujifilm, Coherus, ViGeneron unveil rebrands to better reflect ongoing work