Welcome to the latest edition of our weekly EuroBiotech Report. We start this week in the U.K., where a pair of biotechs built on Big Biopharma’s pipeline pruning practices furthered their CNS drug development plans. Autifony Therapeutics, which spun out of GlaxoSmithKline ($GSK) in 2011, posted solid safety data from a Phase I schizophrenia trial, emboldening it to advance into a pair of Phase Ib studies. Nearby in Oxford, Chronos hired a pair of former Shire directors to oversee development of three programs it picked up from the same source. In Israel, BioLineRx in-licensed a nonalcoholic steatohepatitis drug that could ultimately go the other way, from biotech to Big Pharma. The asset was licensed as part of BioLineRx’s agreement with Novartis, which gives the Big Pharma a pipeline of potential prospects from Israel. Adaptimmune landed on the European Medicines Agency fast track, only to have its week soured by a FDA partial hold. PharmaMar began a Phase III small cell lung cancer trial. And more. Nick Taylor
1. Pfizer-backed GSK spinout advances schizophrenia drug following PhI success
Autifony Therapeutics is gearing up to test its schizophrenia candidate AUT00206 in a pair of Phase Ib studies. The advance of the asset, which comes one year after Pfizer Venture Investments and others bankrolled Autifony’s expansion into schizophrenia, is underpinned by safety data from a 60-person Phase I trial.
2. Novartis partner BioLineRx in-licenses NASH drug after joint evaluation
Novartis ($NVS) is set to support the development of a nonalcoholic steatohepatitis (NASH) drug by its Israeli partner BioLineRx ($BLRX). The arrangement sees BioLineRx, which Novartis works with to scout opportunities in Israel, in-license the NASH asset under its R&D framework with the Swiss Big Pharma.
3. Ex-Shire duo joins Chronos, following the path taken by three research programs
Chronos Therapeutics has hired two ex-Shire ($SHPG) directors to oversee its preclinical development programs. The appointees, who list stints at AstraZeneca ($AZN) and Merck ($MRK) on their résumés, will take responsibility for development of the three programs Chronos picked up from Shire in July.
4. Adaptimmune T-cell therapy snags PRIME status, putting it on EMA’s nascent fast track
Adaptimmune ($ADAP) has become one of the first companies to have a drug accepted into the EMA’s Priority Medicines (PRIME) regulatory initiative. The scheme, which to date has accepted 8 drugs while rejecting almost 30, is designed to ensure developers of products with the potential to address major unmet needs receive support with regulatory applications and potentially accelerated reviews.
5. PharmaMar pits small cell lung cancer hopeful against competition in PhIII trial
PharmaMar (BME:PHM) has begun a Phase III small cell lung cancer (SCLC) trial pitting PM1183 against topotecan and a three-drug chemotherapy combination. The 600-person study will assess whether the tumors of people who take PharmaMar’s RNA polymerase II inhibitor go longer without progressing than those who receive the existing therapeutic options.