Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with Galapagos, which followed FibroGen by getting a stock bump in the back of idiopathic pulmonary fibrosis data. Galapagos framed the data as clearing it to advance into a late-stage trial, although the phase 2 study’s relatively small size and short duration mean it is a long way from showing the drug works.
Vernalis thinks its drugs work. The problem is it keeps failing to persuade the FDA to approve them. A rejection for CCP-08 made Vernalis 0-2 for the year. Orchard Therapeutics named a former PTC Therapeutics executive as its CEO. Roche offloaded the rights to IL-13 monoclonal antibody lebrikizumab in certain indications. Cancer Research UK took a stake in Biotecnol in return for supporting a phase 1 trial of a T-cell engager. And more. - Nick Taylor
1. Galapagos to take IPF drug into late-stage trial after ph2 win
Belgian biotech Galapagos has chalked up a positive phase 2a trial for its idiopathic pulmonary fibrosis drug GLPG1690, saying it halted the relentless decline in lung function normally seen in patients.
2. Back-to-back FDA rejections leave Vernalis reeling
The FDA has rejected Vernalis’ filing for approval of CCP-08. Vernalis wanted to bring CCP-08 and CCP-07 to market in time for the 2017-18 cough-cold season, but back-to-back FDA rejections have scuttled its plans.
3. Orchard Therapeutics hires ex-PTC executive Mark Rothera as new CEO
Orchard Therapeutics, a 2016 Fierce 15 winner and ultra-rare disease startup, has hired Mark Rothera as its new president and chief.
4. Roche in part-sale of mixed bag lebrikizumab to Dermira
California dermatology biotech Dermira will take on exclusive worldwide rights to IL-13 monoclonal antibody lebrikizumab from Roche, although the big pharma holds on to its rights for the medication in certain indications.
5. CRUK, Biotecnol team up for T-cell engager trial
Biotecnol has teamed up with Cancer Research UK (CRUK) to take its T-cell engager into the clinic. The agreement sees CRUK take a stake in the Anglo-Portuguese biotech in return for help testing a 5T4-CD3 bispecific antibody in patients with lung cancer and other solid tumors.