Back on track with topsalysin in prostate cancer (PC) after a patient died in the phase IIb trial, Sophiris Bio Inc. is taking aim at a pivotal push to verify encouraging data that have turned up so far. CEO Randall Woods told BioWorld that "most people didn't believe the drug was related to the death of the patient, but unlike in the legal system, where you're innocent until proven guilty, in this case you're guilty until you can prove otherwise."
CSL Ltd.'s vaccine business Seqirus expects to roll out real-world findings "in the next few months" that will help show whether and to what degree the cell-based approach to making influenza vaccines is better than the egg-based, said Gordon Naylor, Seqirus' president.
The long quest for a universal influenza vaccine may soon bear fruit, David Greenberg, associate vice president and regional medical head in North America for Sanofi Pasteur, told BioWorld. "We're moving in the right direction," he said, adding that "it's been tough from a research perspective," though his group – the vaccine division of Paris-based Sanofi SA – has been working internally and with collaborators that include the University of Georgia and others. "Progress is definitely being made toward a vaccine that would provide broader protection. I think it's likely that a candidate vaccine would be going into clinical trials in the next year or two. The testing at least is not a decade away, the way we used to talk about it some years ago."
Rakuten Aspyrian Inc.'s $150 million from its series C round will fuel a near-term phase III trial and more with ASP-1929, a light-activated antibody drug conjugate (ADC), CEO Miguel Garcia-Guzman told BioWorld. "Probably by mid-next year, we'll be running ASP-1929 in head and neck cancer plus three additional [oncology] indications," he said, adding that the new capital "will not be able to finance everything toward the market," and the ambitious firm will seek more as needed.
A little over one year after European regulators gave their nod, regulators in the U.S. cleared for marketing Milan-based Dompé farmaceutici SpA's Oxervate (cenegermin) eye drops for neurotrophic keratitis.
Ahead of June's American Society of Clinical Oncology (ASCO) meeting in Chicago, an abstract related to the data to be unveiled by Jounce Therapeutics Inc. so alarmed Wall Street that the company's shares lost 35 percent of their value, and the situation worsened when the data rolled out. But there may be cause to maintain hope for JTX-2011, the agonist of inducible T-cell co-stimulator (ICOS), a protein on the surface of certain T cells that Jounce believes can stimulate an immune response against solid tumors.
Chemocentryx Inc. recently hit an important milestone with the finish of enrollment in the Advocate phase III trial testing avacopan in anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), and that's where many investor eyes are focused.
Even with continued jostling inside the larger immuno-oncology space, the oncolytic virus (OV) approach may be more firmly staking its claim to drug-developer interest. Already this year, Johnson & Johnson inked a potentially massive deal to take over Benevir Biopharm Inc. The arrangement disclosed in early May brought the latter $140 million up front and up to $900 million in milestone payments. Rockville, Md.-based Benevir boasts a platform called T-Stealth, designed to engineer OVs to infect and destroy cancer cells.