DUBLIN – For too many cancer patients, therapy still means no more than prolonging the inevitable. Cancer drug developers are proud to trot out numbers detailing objective response rates to novel drug candidates, along with progression-free survival and overall survival data. They're not shy about charging high prices for their product offerings either. But the grim reality is that five-year survival rates for many cancers – including lung, liver and esophageal – are still well below 50 percent, even if cancer death rates continue to decline in the U.S. and other high-income countries.
DUBLIN – Autolus Ltd. closed an $80 million series C round, the largest private equity deal in European biotech this year, to progress its clinical pipeline of autologous chimeric antigen receptor (CAR) T-cell therapies in hematological malignancies. The London-based immuno-oncology firm also plans to allocate some of the cash to its preclinical pipeline of therapies that address solid tumor indications.
DUBLIN – Paris-based anti-infectives developer Da Volterra SA is planning a phase II trial of its lead product, DAV-132, in Europe in the coming months and is also looking to open an IND in the U.S. shortly.
DUBLIN – Bone Therapeutics SA is calling an early halt to a phase I/IIa trial of its Allob allogeneic cell therapy in patients with slow-to-heal bone fractures following an interim analysis that showed the therapy exceeded expectations.
DUBLIN – Shares in Thrombogenics NV rose 16 percent Monday on news that the Alcon unit of Novartis AG was handing back ex-U.S. rights to Jetrea (ocriplasmin), while also providing a cash payment of €53.7 million (US$64.2 million) and an equity investment of €10 million to the Leuven, Belgium-based biotech.
DUBLIN – Bavarian Nordic A/S lost half its market value Friday when an interim analysis showed that a phase III trial of its cancer vaccine, Prostvac (rilimogene galvacirepvec/rilimogene glafolivec), was not going to deliver a good result. The trial's independent data monitoring committee recommended that the study in patients with metastatic castration-resistant prostate cancer be stopped for futility.
DUBLIN – Proqr Therapeutics NV has spun out a startup firm, Amylon Therapeutics NV, to take forward an RNA-based drug development program focused on rare beta-amyloid-related disorders. The new company has raised an undisclosed level of seed funding from a group of institutional and private investors and has appointed Thomas de Vlaam, formerly therapeutic area lead for CNS indications at Proqr, as CEO.
DUBLIN – Advicenne SA plans to seek European approval in the second half of next year for ADV-7103 for treating distal renal tubular acidosis on the back of data from an open-label phase III trial, in which the drug attained its primary endpoint, demonstrating its noninferiority vs. the standard of care.
DUBLIN – Merck & Co. Inc. is paying €115 million (US$137 million) up front and up to €349 million more in milestones to acquire Rigontec GmbH, which is developing an RNA-based immuno-oncology therapy, based on turning on the retinoic acid-inducible gene I (RIG-I) innate immune pathway to achieve an antitumor effect.