Synthetic completes transformation with new name and cancer-killing virus focus

Just over a year ago, as Synthetic Biologics struggled to find cash for its C. difficile candidate, the team decided it was time for a reinvention. They’ve since snapped up an oncolytic virus player and shifted the focus to cancer — and on Wednesday, they completed the final stage of transformation.

Synthetic changed its name to Theriva Biologics, a mashup of the words “therapeutics,” “intravenous,” and “virus” or “adenovirus,” the company announced. Gone is the old orange logo, replaced by a “refreshing” and “calm” blue and green color scheme, CEO and CFO Steven Shallcross told Endpoints News.

“It’s always been a vision of mine that we try to find a technology that not only was at the forefront, specifically in oncology, but that could utilize our team and combine that with another team,” he said.

The new look represents Theriva’s change from a microbiome-focused company to an oncology player, with plans to launch a Phase III trial in pancreatic cancer later this year. The team is deploying oncolytic viruses, which continue to attract investors due to their potential to selectively replicate in cancer cells and kill them.

VCN was “totally under the radar” before Synthetic scooped it up for less than $10 million upfront earlier this year, Shallcross said. The company’s lead candidate, VCN-01, has been dosed in a variety of cancers in early-stage trials, including pancreatic, retinoblastoma, colorectal cancer, and head and neck squamous cell carcinoma (HNSCC).

While Amgen’s Imlygic is the only oncolytic virus product approved by both the FDA and EMA, a suite of rivals is pursuing similar approaches, including Replimune, which recently took out a $200 million loan, and Vyriad, which scored a Series B extension earlier this year, among others.

One of the ways VCN-01 sets itself apart is that it selectively expresses hyaluronidase PH20, which degrades tumor stromal hyaluronic acid, a substance that helps tumors evade the immune system.

Preview

来源: Endpts

Manel Cascalló

The logo, which looks like a box opening, is symbolic of a tumor unraveling, according to former VCN CEO Manel Cascalló, who’s since been appointed as general director of Theriva Biologics’ European subsidiary.

The team is also still working on its mid-stage ribaxamase in acute graft-versus-host disease (aGVHD), though that’s no longer the top priority, Shallcross said.

The FDA yanked ribaxamase’s breakthrough designation back in 2018 over safety concerns, though Shallcross said those issues were resolved “way back when we reached agreement with the FDA on a Phase III program as a preventative for C. difficile.” That study never took off due to high cost, and Theriva has since decided to change course to aGVHD, a “more manageable indication.”

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