Scroll through AstraZeneca’s pipeline of new drug candidates in development and there remains one glaring omission. The Big Pharma that brought one of the world’s most widely used COVID-19 shots to market doesn’t have any more vaccines in development and only has a single new immune therapy in the clinic.
Perhaps it’s not surprising, considering the controversy and political point-scoring that AstraZeneca’s adenovirus-based shot Vaxzevria seemed to attract. So, after making a big splash, has the company decided to leave the vaccines market behind? And is there any truth to past rumors of AstraZeneca considering listing its vaccines and immune therapies business as a separate entity?
When asked these questions by Fierce Biotech at a media event to unveil the Big Pharma’s fourth-quarter earnings, CEO Pascal Soriot wasn’t keen to stray beyond a “general comment on vaccines.”
After entering the vaccine arena during the pandemic, the company “learned a lot and we decided that we want to try and come up with follow-on options,” Soriot explained.
The most prominent of those options was COVID-19 antibody Evusheld, which saw its emergency use authorization nixed by the FDA last month in the face of waning effectiveness against circulating SARS-CoV-2 variants. With Beyfortus approved for respiratory syncytial virus (RSV) in November, the only immune therapy AstraZeneca still has in the works is AZD3152, a late-stage monoclonal antibody for COVID-19 that the company plans to file for approval in the second half of this year.
Licensed from RQ Biotechnology last year, the hope is that AZD3152, when combined with cilgavimab—one of the components of Evusheld—can provide protection for immunocompromised patients against the COVID-19 variants that are proving resistant to the approved therapy.
“Whether we succeed or not, we don't know because that's the name of our industry,” said Soriot. “We try and sometimes we succeed. In the last 10 years, we've succeeded more than we have failed, so hopefully the same applies to vaccine and immune therapies.
“But I cannot guarantee it will be successful, of course,” the CEO added. “The only thing we can guarantee is we'll give it our best shot.”
Answering the same question from Fierce Biotech, Iskra Reic, executive vice president for vaccines and immune therapies, was more bullish on the plans for AZD3152.
“We are working hard to accelerate the new 3152 monoclonal antibody and we feel very confident that we will be able to deliver that antibody to the patients in need in the second half of this year,” Reic said. “[We] feel comfortable, frankly, because the profile of the new monoclonal antibody demonstrates strong, high neutralization activity against all variants.”
Outlining the strategy for her business segment, Reic added that the idea is to “look not only at the vaccine but also to the monoclonal antibodies because we do see a complementary approach between developing the new or next generation vaccines for all…and then the antibodies for those who cannot develop the immune response with the vaccination.”
“In that sense, we are still looking into COVID but also beyond COVID in the viral pathogens where there is an unmet need, for example, like flu or RSV," Reic said.
A worthy aim, but with a developmental pipeline that could be entirely empty by the end of the year should AZD3152 receive its approval on time, it remains unclear where AstraZeneca’s vaccine and immune therapy strategy goes next.