The United States Food and Drug Administration (FDA) has approved the use of a cancer-treating antibody originally developed by Vancouver-based biotech company Zymeworks.
Dublin, Ireland-headquartered Jazz Pharmaceuticals announced this week that the FDA had approved use of Zihera, an antibody that treats adults living with a form of biliary-tract cancer, in the US. In 2022, Jazz Pharmaceuticals secured the commercialization rights to Ziihera for use in North America, Europe, and Japan in a deal worth $375 million USD upfront, with additional royalties based on net sales.
Zihera (generic name zanidatamab) is a non-chemotherapy treatment for patients with metastatic HER2-positive biliary tract cancer, a form of cancer that originates in the bile ducts, gallbladder, or nearby structures and has spread to other parts of the body.
In Western countries, including Canada, the incidence of this rare and deadly cancer is approximately two per 100,000 individuals. In a statement, Jazz Pharmaceuticals executive vice president, global head of research and development, and chief medical officer Rob Iannone said the metastatic form of the disease has a five-year survival rate of under five percent.
In a statement, Jazz Pharmaceuticals said the FDA approval was granted based on results from a Phase 2b trial, in which 52 percent of participants experienced significant tumour shrinkage, with benefits lasting an average of 15 months.
Ali Tehrani, co-founder and former president and CEO of Zymeworks, shared his elation over the FDA approval in a LinkedIn post this week. “Back in 2003, when I co-founded the company, this was the dream that many said was not possible,” Tehrani wrote. “Today it became reality—most importantly for patients who will benefit from it.”
RELATED: AbCellera’s antibody treatment becomes first to receive emergency FDA approval for kids under 12
Tehrani co-founded and led Zymeworks for over 18 years, taking the company through clinical validation and an $80-million CAD New York Stock Exchange debut.
A report in The Globe and Mail this week noted that Zymeworks hit a rough patch in 2022 following disappointing results from one of its flagship drugs. That same year, Tehrani departed the company and joined life sciences venture firm Amplitude Ventures, where he remains a partner.
Under subsequent CEO Kenneth Galbraith, Zymeworks thwarted a hostile takeover attempt from All Blue Capital in June 2022 by adopting a poison-pill strategy and relocating its headquarters to Delaware, as reported by Reuters.
Zymeworks’ stock, which hit a low of $4.87 USD in April 2022, has since rebounded to $14.22 USD as of press time.
Feature image courtesy Unsplash. Photo by National Cancer Institute.
The post FDA clears drug for rare and deadly GI cancer developed by Canadian firm Zymeworks first appeared on BetaKit.