Protocols

AstraZeneca pushes back OS readout on MYSTIC to H2; Anthera shares obliterated in repeat PhIII flop

→ The much-anticipated overall survival data of AstraZeneca’s $AZN pivotal lung cancer trial will be delivered later than expected, the UK drugmaker announced this morning. Investors will now have to wait until the second half of 2018 for the final analysis of Imfinzi’s impact on OS, instead of the first half. The results from the MYSTIC trial remains a major catalyst after the checkpoint inhibitor failed to meet the primary endpoint of progression-free survival (PFS), sending a shock wave to AstraZeneca’s stock prices last July. The trial tests Imfinzi both as a monotherapy and in combination with tremelimumab against chemotherapy in first-line non-small cell lung cancer, an all-important arena in the battle for checkpoint drug dominance.

If at first you don’t succeed in biotech, maybe you should just cut your losses and move on. That lesson may be top of mind today for Anthera $ANTH after researchers reported that its lead drug Sollpura failed a repeat Phase III study for cases of exocrine pancreatic insufficiency caused by cystic fibrosis. The biotech had already felt the sting of investor dissatisfaction when an earlier Phase III also failed. This time scientists had hoped that more agressive dosing would fix the problem. It didn’t. Anthera’s shares were eviscerated, dropping 82% and leaving the stock deep in penny stock territory.

Malvern, PA-based Realm Therapeutics says that their Phase II study of a new therapy for allergic conjunctivitis failed, forcing the biotech to dump the drug. PR013 was a topical ophthalmic solution. Realm’s shares (AIM: $RLM) took a dive on the news.

→  Oxford University spinout OxSyBio stepped out today with a £10 million ($13.9 million) Series A round, joining the increasingly crowded space of “tissue bioprinting” startups. This one is developing a 3D printer technology that can print biological materials, with the ultimate goal of making therapeutic tissues for patients. This is not unlike the goals of San Diego’s more mature Organovo, or the relative newcomer StemoniX. OxSyBio was founded back in 2014 on research conducted in the lab of Professor Hagan Bayley, the founding academic behind Oxford Nanopore Technologies. The new financing round was led by Woodford Investment Management alongside new and existing backers, according to a company statement.


With additional reporting by Brittany Meiling and Amber Tong.


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