Sorrento Therapeutics ($SRNE), at work on a nanoparticle successor to the blockbuster cancer drug Abraxane, said its candidate is coming through in an ongoing Phase III trial. And while the biotech declined to get into specific details, the whiff of success sent its shares up more than 10% on Monday.
The drug, Cynviloq, is in the midst of a Phase III study in breast and lung cancers with a goal of demonstrating bioequivalence to Abraxane, a Celgene ($CELG) product that uses the protein albumin to deliver a targeted blast of the cancer-killing chemical paclitaxel. Looking at pharmacokinetic results, data analysis "suggests" Cynviloq is hitting the mark on bioequivalence, Sorrento said. And, on the safety side, the drug has charted a profile similar to Abraxane, according to the company.
And, beyond that, Sorrento is keeping the results to itself. The biotech made its announcement in a news release with fewer than 100 words of news, none of which disclosed granular data or when the company plans to present full data from the study.
Sorrento is bullish that success in a single bioequivalence trial could be enough to convince the FDA to approve Cynviloq through its 505(b)(2) pathway, which would allow the company to use old Abraxane data in its application. And investors are in on the idea, bidding up Sorrento's shares despite the absence of details.
|NantWorks founder Patrick Soon-Shiong|
Headquartered in San Diego, Sorrento has been steadily raising its profile in oncology over the past year with the help of billionaire physician and entrepreneur Patrick Soon-Shiong--who, as it happens, invented Abraxane. Soon-Shiong's NantWorks family of startups has inked a series of equity and R&D deals with Sorrento, launching a $20 million joint venture devoted to immuno-oncology and paying $110 million for the rights to some anticancer candidates.
The company, also developing a nonopiate pain drug, has watched its share value nearly triple since November.
- read the statement
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