BioNTech nabs up to $90M for mpox vaccine as it begins PhI/II trial behind Moderna’s lead

Building on its infectious disease work in Covid-19, malaria and tuberculosis, BioNTech is now rolling out a Phase I/II test of a jab to protect against the mpox virus, which caused international concern in the summer of 2022 but has since waned.

Like its Covid-19 vaccine counterpart Moderna, the German biotech is hoping to create an mRNA-based vaccine for mpox, which can lead to irritable skin lesions, rashes and painful swelling of the lymph nodes.

BioNTech is partnering with the Coalition for Epidemic Preparedness Innovations (CEPI), which will provide up to $90 million to help the biotech develop vaccine candidates, the duo said Monday morning. The company is starting a 196-person Phase I/II trial to test multiple doses of two candidates, known as BNT166a and BNT166c.

“Mpox can cause severe complications, particularly in children and pregnant women as well as in immunocompromised individuals,” BioNTech co-founder and CEO Uğur Şahin said in a statement. “The global outbreak, which was declared a public health emergency of international concern, underlines the need for a highly effective, well-tolerated and accessible mpox vaccine.”

While a vaccine exists — the FDA approved Bavarian Nordic’s two-dose shot, known as Jynneos, for mpox and smallpox infections in 2019 — there have been calls for additional protective measures against the virus. The outbreak has led to 50 deaths stateside out of 30,767 cases, as of an Aug. 23 update from the Centers for Disease Control and Prevention (CDC).

About 1.26 million doses of mpox vaccines have been administered in the US as of last month, per a CDC tracker. During a vaccine supply crunch in the early days of the outbreak, organizations and governments also considered the potential of Emergent’s ACAM2000, which was approved for smallpox but not mpox. But HHS said the shot had “significant side effects” and was not recommended for most people.

BioNTech and Moderna are hoping to apply the mRNA revolution to mpox, with BioNTech’s shot going after surface antigens that it hopes will thwart virus replication and chances of infection. Şahin said the program began in May 2022, when the mpox outbreak, then known as monkeypox, became international news.

Moderna started a Phase I/II trial of its candidate mRNA-1769 last month, but CEO Stéphane Bancel has previously signaled the company might not move into Phase III if there’s a “product equivalent on the market and the outbreak is finished,” he told Fierce Biotech. The mpox work also wasn’t included in Moderna’s R&D presentation last week, during which it outlined a bevy of plans for 50 clinical candidates in five years.

Richard Hatchett

By lining up with CEPI, BioNTech is contributing to the 100 Days Mission, an ambitious plan to boost vaccine development against potential pandemic threats in less than four months.

“Our work on mpox could broaden the portfolio of vaccines available against this potentially deadly disease,” CEPI chief executive Richard Hatchett said, “while building our understanding of how mRNA technology performs against Orthopoxviruses, a family of viruses that have long afflicted humankind and remain an ongoing threat today.”

Other drugmakers are also looking at the potential for antibody treatments for mpox. The Department of Defense is paying up to $74 million to Just-Evotec Biologics to create antibodies for orthopoxviruses, which includes mpox, chickenpox and smallpox. Last year, the AIDS Clinical Trials Group started a Phase III trial of tecovirimat, an FDA-approved smallpox antiviral that has been used during the mpox outbreak.

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