Intezyne Technologies Inc. should find itself “on an IPO trajectory for late 2018 or early 2019,” its chief financial officer (CFO), Russell McAllister, told BioWorld Today, “coinciding with potential licensing deals for both” lead candidates owned by the Tampa, Fla.-based company.
With clinical news pouring from pharma giants matching up the indoleamine 2,3-dioxygenase 1 (IDO1) blocker mechanism with PD-1 immune checkpoint inhibitors, Newlink Genetics Corp.'s interim results from NLG2103 – a phase II study evaluating its IDO pathway blocker indoximod as a combo candidate in advanced melanoma – seemed to take a back seat.
As Johnson & Johnson (J&J) tied the bow on its all-cash tender offer takeover of Actelion Ltd. to gain an impressive franchise in pulmonary arterial hypertension (PAH), an expected decision grew near on the device portion of United Therapeutics Corp.’s drug-device combo Remosynch – an implantable pump system for delivery of the PAH drug Remodulin (treprostinil).
Tango Therapeutics Inc. expects clinical proof of concept "within a five-year time frame," interim CEO Barbara Weber told BioWorld Today, as the company takes to the floor with a $55 million series A round from Third Rock Ventures LLC, where she is a venture partner.
A long half-life, high bioavailability and no food affect – plus the prospect for add-back hormone therapy or not – may distinguish Geneva-based Obseva SA's gonadotropin-releasing hormone (GnRH) therapy for uterine fibroids (UF) and endometriosis, CEO Ernest Loumaye told BioWorld Today. "The beauty of this class is its capacity to suppress estradiol in a dose-dependent manner," he said. "Where we are different is in the pharmacokinetic [PK] profile of OBE2109 and how we are developing it."
Genentech is "bucking a trend" by charging less for its multiple sclerosis (MS) drug despite at least equal efficacy to others and improved safety, neurologist Michael Racke told BioWorld Today, talking about the approval by the FDA for Ocrevus (ocrelizumab) as the first and only disease-modifying drug for relapsing as well as primary progressive MS, the two forms most prevalent among patients at the time of diagnosis.
Lack of a dose response across the three levels of drug tested in part A of the phase II/III turned out to be no big deal for Cara Therapeutics Inc., which scored positive top-line results from its 174-patient experiment showing that intravenous CR845 hit statistical significance on primary and secondary endpoints for efficacy (reduced itching and improved quality of life, respectively) in patients with uremic pruritus (UP).
Less than two years after Merrimack Pharmaceuticals Inc. won approval of Onivyde (irinotecan liposome injection) for second-line pancreatic cancer, pundits are weighing Paris-based Erytech Pharma SA's odds with eryaspase (Graspa), which has landed solid phase IIb results in the same indication: a 43 percent reduction in death risk.
The FDA gave its accelerated nod to PD-1/PD-L1-targeting Bavencio (avelumab) to EMD Serono Inc., of Rockland, Mass. – the biopharmaceutical arm of Darmstadt, Germany-based Merck KGaA – for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy.