Roivant takes aim at resistant infections with $667.5M Intron deal

S. aureus infection
Roivant says it will form a new company to take the program forward. (CDC/Matthew Arduino/Janice Haney Carr)

Fresh from a $200 million fundraising that pushed its valuation above $7 billion, Roivant Sciences has spent more money on its R&D portfolio, licensing a midstage drug for resistant bacteria from South Korea’s Intron Biotechnology.

Vivek Ramaswamy’s fast-growing biotech group is paying $10 million upfront for rights to SAL200 (Tonabacase), a biologic it says is based on an enzyme (endolysin) derived from a bacteriophage—a virus that infects bacteria—that acts by breaking down bacterial cell walls.

The mechanism is unlike that of any current antibiotic class and, according to Intron, could develop into a new approach to the big problem of antimicrobial resistance in bacterial pathogens, including superbugs like MRSA and other staphylococcal infections, because it doesn’t involve the use of inhibitors that can induce the development of resistance mutations.

WEBINAR

Webinar: Meet the Challenge of Complex Protein Expression

As market demand continues to rise for more potent and effective therapeutics, biologic pipelines are evolving from standard antibody formats to next-generation biologics (NGBs). In this webinar we will discuss and demonstrate application through case studies, two significant enhancements to Lonza’s GS Xceed® expression system to help address the challenges of NGBs.

Roivant has pledged $657.5 million in milestones for the program, plus royalties on sales, and has taken an option on some of Intron’s earlier-stage programs as well. That includes endolysin projects against Gram-positive bacteria, including problem pathogens such as vancomycin-resistant enterococci and resistant strains of tuberculosis, which could add another $45 million apiece to the deal, and Intron’s Gram-negative program.

Following its usual pattern, the Swiss umbrella group plans to set up a new subsidiary to handle development and commercialization of the endolysin candidates, although it hasn’t yet revealed a name for the unit. It already has 12 companies grouped around therapeutic categories and a healthcare data unit, but until now its only presence in anti-infectives has been in hepatitis B with Arbutus and Sinovant’s lefamulin for community-acquired bacterial pneumonia.

“The development of novel anti-infective therapies is one of the greatest needs of our time,” said Roivant President Mayukh Sukhatme, M.D., during a signing ceremony for the deal with Intron’s CEO Kyung Won Yoon. “We hope to maximize the impact of SAL200 on public health through innovative approaches to both development and commercialization.”

In a phase 1 clinical trial carried out in Korea, single intravenous doses of SAL200 were shown to be safe and tolerable, and Intron has now advanced the program into a multidose phase 1 trial as well as a phase 2a study in patients with Staphylococcus aureus infections in the blood. Roivant says it plans to start its own phase 2 trials next year.

Every year, more than 2 million Americans contract antibiotic-resistant infections and 23,000 people die from them, according to CDC estimates.

Suggested Articles

J&J’s Ethicon unit received an FDA clearance for its Vistaseal applicators that spray a biologic sealant from Grifols to help stem surgical bleeding.

Gilead Sciences is paying Nurix $45 million upfront in a deal that could reach $2.3 billion in value if all milestones are met and royalties realized.

Bio-Techne’s urine test has received a breakthrough device designation from the FDA for ruling out unnecessary tissue biopsies.