Astellas' first-in-class CLDN18.2 drug Vyloy has cleared the FDA. After a positive phase 3 readout, Otsuka is targeting an accelerated approval filing for a kidney disease candidate. Samsung Biologics has signed its largest contract from a single customer to date.
1. Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy
After a prior rejection, Astellas has picked up an FDA approval for its first-in-class drug Vyloy, used in combination with chemo, as a first-line treatment for HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. CLDN18.2 has become an increasingly crowded field with its fair share of R&D setbacks.
2. Otsuka's kidney disease drug improves UPCR levels in phase 3 trial
A phase 3 trial of Otsuka’s sibeprenlimab in immunoglobulin A nephropathy (IgAN) has met its primary endpoint, showing in an interim analysis that the anti-APRIL drug significantly reduced urine protein levels compared with placebo after nine months of treatment. Otsuka plans to talk with the FDA about a potential submission for an accelerated approval while the trial continues to evaluate kidney function.
3. CDMO Samsung Biologics bags $1.2B production contract, bringing total 2024 deal value to $3.3B-plus
Samsung Biologics has secured a $1.2 billion contract with an unnamed Asia-based pharma company. The deal is the largest with a single client in the Korean CDMO’s history. The contract, which will run through December 2037, brings the total value of Samsung Bio's new contracts this year to $3.3 billion.
4. BioNTech-OncoC4 phase 3 cancer trial under partial hold after varying results reported
The FDA has put a partial hold on a phase 3 of BioNTech and OncoC4’s CTLA-4 inhibitor gotistobart. The trial, coded PRESERVE-003, is testing the drug in non-small cell lung cancer. The hold is due to “varying results between the squamous and non-squamous” patient populations, according to BioNTech. The partners have voluntarily paused enrollment of new patients.
5. Takeda details another round of layoffs in Massachusetts as restructuring drive rolls on
As part of a broader restructuring unveiled in May, Takeda said in a notice to Massachusetts that it will lay off 79 employees across two sites. The final number of employees affected will depend on potential “redeployment opportunities,” according to a detailed filing cited by the Boston Business Journal.
6. Amid geopolitical tensions, Legend sheds GenScript as its majority shareholder
GenScript Biotech no longer considers itself the majority shareholder of Legend Biotech and is working to separate the cell therapy specialist from its financial reports. The change comes after Legend removed “discretionary proxy" voting, which previously allowed Genscript to exercise more than 50% of Legend's voting rights. Legend said the move was not triggered by the BIOSECURE Act nor U.S.-China geopolitical tensions.
Other News of Note
7. Hengrui is said to weigh second listing in Hong Kong (Bloomberg)
8. Regulatory Tracker: FDA accepts Elevar resubmission for Hengrui liver cancer combo
9. Zai Lab shares jump on early DLL3 ADC data in lung cancer (release)
10. Minghui’s thyroid eye disease drug slashes eye bulging in midstage trial