→ Hookipa Biotech has raised $60 million (€50 million) in an oversubscribed Series C round to help push its lead program, a vaccine for infections caused by a genus of viruses called cytomegalovirus, through Phase II clinical trials. The new round was led by an unnamed blue chip U.S. public invenstment fund, and was joined by Gilead as a strategic investor. Other new investors include HBM Partners, Hillhouse Capital, and Sirona Capital. Hookipa already had several existing investors on board including Boehringer Ingelheim’s venture arm and Takeda Ventures, which participated in the round. Other than the cytomegalovirus program (called HB-101), the Vienna-based company is also hoping to take its therapy for head and neck squamous cell carcinoma to Phase I trials. Hookipa plans to expand its tech platform into other disease areas, including prostate cancer.
→ Ionis started the day with the news that its partner Roche has exercised the option to license IONIS-HTTRx for Huntington’s disease, handing the company $IONS $45 million in cash. Roche made the decision — which makes the giant $RHHBY responsible for all development and commercial activities of the drug — in light of results from a Phase I/IIa placebo-controlled, dose escalation study. A deal years in the making, the pact with Roche dates back to 2013, when Ionis was still known as Isis. To be sure, HD is not at the top of Ionis execs’ minds, who are busy in battle with their hereditary ATTR amyloidosis blockbuster contender inotersen. But they didn’t mind touting the data from this deal-sealing study, either: “For the first time, a drug has lowered the level of the toxic disease-causing protein in the nervous system, and the drug was safe and well tolerated,” said lead investigator Sarah Tabrizi in a statement.
→ The FDA has accepted Regeneron’s application for a 12-week regimen of wet AMD drug Eylea and set a PDUFA date for August 2018. The progress puts the company in a better position to compete with Novartis’ fast-approaching Eylea rival RTH258 (brolucizumab), should the dosing schedule be approved. Novartis $NVS is largely banking on RTH258’s 12-week regimen will win over a big slice of the Wet AMD market, as Regeneron’s flagship therapy Eylea is currently an 8-week regimen. There’s a lot at stake, with Regeneron $REGN taking in $953 million in US Eylea sales in Q3 this year. The news is likely a relief for Regeneron, which has undergone two back-to-back combo trial flops with Eylea. Earlier this year, the drug in combination with nesvacumab failed to beat a solo version of Eylea. And more than a year ago, its anti-PDFG antibody rinucumab combined with Eylea failed a Phase II trial for age-related macular degeneration.
→ In another attempt to run ahead of rivals Ironwood and Synergy, Ardelyx announced today that it has out-licensed tenapanor for $12 million upfront to Shanghai-based Fosun Pharma, which has bought the exclusive rights to develop and commercialize the lead product in China. Additional milestones total up to $113 million; the agreement also covers tiered royalty payments on net sales ranging from the mid-teens to 20%. Whereas the focus is on the hotly contested field of irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia related to chronic kidney disease, Fosun has also acquired the rights to commercialize tenepanor for other indications approved in the US. The Fremont, CA-based biotech came out in October with new PhIII data that proved more impressive than the round released in May. Clearly, Fosun shared the enthusiasm of US investors. “Tenapanor’s potential as a differentiated treatment for both cardiorenal and GI diseases is impressive,” said Yifang Wu, president and CEO of Fosun’s eponymous parent company. “The data generated by Ardelyx to-date gives us confidence that tenapanor could be a leading treatment option for both therapeutic areas, offering unique advantages to patients.”
With additional reporting by Brittany Meiling.
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