AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. Takeda won FDA approval for the Hutchmed-developed colorectal cancer drug Fruzaqla. BioNTech bought a PD-L1xVEGF bispecific antibody from Chinese biotech Biotheus. And more.
1. AstraZeneca pays $185M upfront to reenter oral obesity gold rush, drops phase 2 sickle cell drug
After terminating an internal GLP-1 program this summer, AstraZeneca has agreed to pay Eccogene $185 million for the Chinese biotech’s early-phase, once-daily oral GLP-1 agonist. Up to $1.8 billion in future milestones are also up for grabs. The candidate, coded ECC5004, also holds potential to be combined with other AstraZeneca drugs such as Farxiga and baxdrostat, CEO Pascal Soriot said.
The FDA has approved fruquintinib under the brand name Fruzaqla as a third-line treatment for metastatic colorectal cancer. Takeda licensed ex-China rights to the VEGFR inhibitor from Hutchmed in January. The drug will compete against Taiho and Servier’s Lonsurf, which recently got the FDA’s nod for use alongside bevacizumab in the same setting.
3. BioNTech adds bispecific candidate, mRNA delivery startup as cancer work takes center stage
BioNTech has partnered with yet another Chinese biotech. The German company paid $55 million upfront and agreed to more than $1 billion in potential milestone payments to get ex-China rights for a bispecific antibody by Biotheus. Coded PM8002, the drug targets PD-L1 and VEGF, and it’s being tested in China as both a monotherapy and a combination treatment in patients with solid tumors.
4. BMS snags another ADC with modest $100M Orum deal
Bristol Myers Squibb has paid $100 million upfront to acquire an anti-CD33 antibody-drug conjugate from Korean biotech Orum Therapeutics. The deal value could swell to $180 million if milestone payments are included. The drug, coded ORM-6151, carries a protein degrader as the payload. It has been cleared for phase 1 testing in acute myeloid leukemia or high-risk myelodysplastic syndromes.
5. WuXi XDC eyes $470.5M IPO to fuel manufacturing expansions at home and abroad
As antibody-drug conjugates continue to gain momentum, WuXi Biologics’ bioconjugation spinoff WuXi XDC is plotting a $470 million IPO on the Hong Kong Stock Exchange this month. The WuXi subsidiary plans to use the money to beef up its production facilities in Singapore and the Chinese city of Wuxi.
6. Astellas touts 2-year results for $5.9B GA drug Izervay as it amps up Apellis rivalry
Astellas and Apellis were locked in a geographic atrophy (GA) data face-off. Two-year data from the GATHER2 trial showed Astellas’ Izervay, when dosed every month, beat placebo with a significant year-over-year reduction of 14% in the mean rate of GA lesion growth. By comparison, Apellis’ Syfovre reduced general GA lesion growth by 35% compared with placebo when given monthly for three years.
7. Akeso claims overall survival win for bispecific in patients with severe gastric cancer
Akeso said its PD-1xCTLA-4 bispecific antibody, cadonilimab, used in combination with chemo, beat chemo alone at extending the lives of patients with newly diagnosed advanced gastric cancer or gastroesophageal junction adenocarcinoma. The overall survival win came from an interim analysis of a China phase 3 trial dubbed AK104-302. In the U.S., Bristol Myers Squibb’s Opdivo is approved alongside chemo in first-line stomach cancer, and Merck’s Keytruda is awaiting an FDA decision there.
8. J&J books manufacturing space at Fujifilm Diosynth's upcoming mega-plant in North Carolina
Johnson & Johnson has booked a large-scale manufacturing suite at Fujifilm Diosynth’s upcoming plant in Holly Springs, North Carolina. The plant was first unveiled in 2021 with a $2 billion investment, and it’s expected to be fully operational in 2025. The biologics plant will help J&J produce both clinical and commercial products.
Other News of Note
9. Daiichi press release found to discredit pharma on safety grounds, prompting scolding from UK body
10. Senti, Celest take liver cancer cell therapy to China in $156M biobucks deal
11. FDA slams Natco Pharma with Form 483 over sanitary, quality control problems
12. Otsuka dives in with Olympic swimming gold medalist Missy Franklin for rare kidney disease campaign