Moderna won't advance US-backed Zika vaccine without more outside funding

2024-03-15

疫苗临床2期临床3期临床1期信使RNA

Moderna won't advance US-backed Zika vaccine without more outside funding

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来源: FierceBiotech

Work on the vaccine dates back to at least 2016, when Moderna announced that BARDA was providing $8 million to finance a phase 1 toxicology study.

Moderna does not plan to advance a midstage Zika vaccine without additional outside cash, despite receiving U.S. funding thus far, according to a regulatory disclosure.

The news, tucked into Moderna’s annual report released Friday, throws cold water on the most mature vaccine in Moderna’s public health pipeline. The company is also working on vaccines for mpox and Niphah under the public health umbrella, both of which are in phase 1 studies.

The Flagship biotech’s Zika vaccine, mRNA-1893, is currently in a phase 2 study that’s fully enrolled some 800 patients in the mainland U.S. and Puerto Rico. The primary completion date is late July 2024, according the study’s clinical trial record.

Work on the vaccine dates back to at least 2016 when Moderna announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) was providing $8 million to finance a phase 1 toxicology study. BARDA also offered $117 million for future phase 2 and phase 3 studies, plus large-scale manufacturing.

When Moderna finalized plans for an mRNA manufacturing site in Kenya last year, CEO Stéphane Bancel specifically mentioned the potential to develop vaccines for "persistent infectious diseases like HIV and outbreak threats such as Zika and Ebola," according to a release.

Moderna's Hamilton Bennett, who serves as senior director of Vaccine Access and Partnership, mentioned the vaccine as being a key part of the company's global health portfolio in a December 2023 ESG Day. At that time, she noted that partnerships would be key to the global health portfolio.

"The value in mRNA access is that the exploratory research that our academic collaborators are conducting is taking place on a platform and a platform that is built an early development engine, an engine that can accelerate products not only into the clinic but to licensure," Bennett said. "It's this kind of collaborative model for innovative research and the type of bold approach that Moderna is willing to take in our mission to advance the greatest impact on public health."

Spokespeople for BARDA and Moderna did not immediately respond to requests for comment on the decision and on how much money had been awarded thus far.

This is the latest example of Moderna reallocating resources as it tries to stave off evaporating COVID vaccine sales with near-term launches. The company recently confirmed that some employees would be laid off after reducing its COVID manufacturing investments. Executives described 2023 as a pivot year after the commercial COVID market shaped up and demand dwindled.

Now, Moderna is looking elsewhere to resuscitate revenue and investor excitement. First and foremost is the company’s respiratory syncytial virus vaccine, slated for a decision by the FDA in May. If approved, it would join the likes of GSK and Pfizer in the older adult population. Moderna also expects interim phase 3 data on its cytomegalovirus vaccine this year. A phase 3 trial is underway testing Moderna’s individualized neoantigen therapy plus Keytruda in patients with high-risk melanoma.

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