Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.
Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latters ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.
At the time of the hold, regulators determined that the biotech could continue dosing patients already in the studies, but couldnt add patients until after it conducted an additional in-use and compatibility study of PRS-343 with various infusion materials under specific conditions to confirm suitability of PRS-343 for administration in clinical settings.
The FDA did not cite any adverse effects and the Phase II is still on track for later this year should the hold be lifted.
Under the terms of the new agreement, Eli Lilly will supply the additional compounds and collaborate on data while Pieris prepares to initiate Phase II. Max Gelman
A combination of Opdivo and Yervoy has proven more effective than chemotherapy as a first-line treatment for a form of mesothelioma in a Phase III study of 600 patients. In the study, one of numerous, Bristol Myers Squibb is running to test whether the two forms of checkpoint inhibitors can be complementary, 40.8% of patients with unresectable malignant pleural mesothelioma who received the immunotherapy cocktail survived for two years, compared with 27% of patients on the chemotherapy arm.
Just over 30% of patients in both arms of the trial experienced grade 3 or grade 4 adverse events, but patients were twice as likely to drop out as a result in the combination arm: 15%, compared with 7.4%.
Results were presented Saturday at the International Association for the Study of Lung Cancer Virtual Presidential Symposium. Jason Mast
In a Phase III trial announced Friday, patients given Hong Kong-based Xcoverys lead ALK inhibitor responded for twice as long as patients given Pfizers Xalkori. ALK-positive non-small cell lung cancer patients given Xcoverys ensartinib had a progression-free survival time of 25.8 months, compared to 12.7 months for the patients on Xalkori. The response rate was also higher for ensartinib, 75% compared to 67%.
The results are a positive sign for Xcovery but they are not necessarily surprising: Xalkori was the first ALK-inhibitor approved in 2011, but since then, other inhibitors have come out and proven far more durable. Late last year, Takedas Alunbrig showed a similar rate of progression-free survival. Jason Mast
Just a week and a half after signing a deal with Massachusetts-based Harbour BioMed to help incubate new startups, Viva Biotech has continued its march with a new acquisition.
The Chinese company a half-incubator, half-drug discovery business announced the purchase of 80% of Langhua Pharmaceutical for about $367 million. With the acquisition, Viva expects to expand its R&D capabilities and begin offering CDMO services.
We have steady confidence towards the business prospects and potential future growth of Langhua Pharmaceutical, Viva Biotech CEO Chen (Cheney) Mao said in a statement.
Viva offers both equity for service and cash for service models to US and Chinese biopharmas looking for outsourcing services. Max Gelman