Lipocine Inc. continues to march forward with its 138-subject ambulatory blood pressure monitoring (ABPM) study in patients given the oral testosterone replacement therapy (TRT) Tlando as new discoveries roll out regarding not only the cardiovascular (CV) risk for men on TRTs but also the value of such treatments in easing depression, an idea that has been the subject of much debate.
Agenus Inc. CEO Garo Armen told BioWorld the company is "in multiple discussions right now" for more partnerships to follow the immuno-oncology (I-O) agreement with Gilead Sciences Inc. that brings $150 million at closing, which includes $120 million up front and a $30 million equity investment, and about $1.7 billion in fees and milestone payments potentially down the road.
Aduro Biotech Inc.'s research and licensing deal with Eli Lilly and Co. not only provides $12 million up front and potential milestone-related money in the amount of $620 million per product – for an unlimited number of them – but also includes a "nice modularity," as Chief Scientific Officer Andrea van Elsas put it, in the form of an option to co-fund development.
Stamford, Conn.-based Loxo Oncology Inc. and partner Bayer AG, of Leverkusen, Germany, recently scored their expected win with the accelerated clearance by the FDA for Vitrakvi (larotrectinib) to treat adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without an acquired resistance mutation.
As "one of the innate immune pathways that gets triggered post-viral infection," RIG-1 – which stands for retinoic acid inducible gene-1 – was first investigated as a way to attack bugs, Kineta Inc.'s Chief Scientific Officer Kristin Bedard told BioWorld, and Spring Bank Pharmaceuticals Inc. lately has gained attention for its RIG-1 push in hepatitis B virus (HBV).
Wall Street didn't seem much enthused about Idera Pharmaceuticals Inc.'s data from the ongoing phase II trial called Illuminate-204 testing the intratumorally delivered Toll-like receptor 9 (TLR9) agonist tilsotolimod in combination with Yervoy (ipilimumab, Bristol-Myers Squibb Co.) against melanoma, but lead investigator Adi Diab from MD Anderson Cancer Center said that "to see such a durable response for these patients really creates hope. This is clearly an effective combination."
A scrappy joint meeting of the House Subcommittee on Healthcare, Benefits, and Administrative Rules and the House Subcommittee on Government Operations featured opposing views of current science with regard to fetal tissue research in a two-hour-plus session that included Chairman Rep. Mark Meadows (R.-N. Carolina) objecting to the sale of "baby parts."
Less than two weeks after the start of a phase III trial with CPI-613 (devimistat) called Armada 2000 in relapsed or refractory acute myeloid leukemia (AML) by Rafael Pharmaceuticals Inc., the metabolic oncology space again moved forward significantly as the company launched a phase III experiment dubbed Avenger 500 to test the same compound in pancreatic cancer.
Making good on a promise detailed during its earnings call with investors last month, Voyager Therapeutics Inc. kicked off Restore-1, a phase II, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of gene therapy VY-AADC for Parkinson's disease (PD) in patients with motor fluctuations refractory to medical management.
