It may have made its name—and fortune—with a COVID shot, but mRNA pioneer BioNTech is thinking bigger for 2023, with up to five trials for infectious disease vaccines set to enter the clinic.
The German-based biotech has a list of first-in-human trials for mRNA vaccines ready to go in the coming months, including BNT163 for herpes simplex virus type 2 (HSV-2). A vaccine for shingles is also expected this year, in collaboration with long-term partner Pfizer, and is likely to be followed by a malaria vaccine dubbed BNT165, which will enter trial participants’ arms either this year or in early 2023.
The opening months of 2023 should also see the first patient receive BNT164, a vaccine for tuberculosis, the company said in its third-quarter earnings results. The accelerating infectious disease pipeline update comes a week after BioNTech began a phase 1 trial of an mRNA-based combination vaccine for influenza and COVID-19.
Those ambitious plans will increase the competition between BioNTech and Moderna, which unveiled its own mRNA vaccine candidates for HSV-2 and shingles this year. While the U.S. biotech has yet to announce a potential tuberculosis vaccine, the bacterial infection is one of the global health priorities highlighted in Moderna's collaboration with nonprofit scientific research organization IAVI in April.
Meanwhile, BioNTech’s oncology pipeline is already well underway. The company has 19 candidates across a total of 24 clinical trials, including CAR-T cell therapy candidate BNT211. The furthest developed are phase 2 trials of melanoma vaccine BNT111 and BNT113 for HPV16-positive cancers—which both use the biotech’s FixVac platform—plus a pancreatic cancer hopeful called autogene cevumeran and the bispecific antibody immune checkpoint modulator BNT311.
There is one final cancer readout to come this year in the form of the BNT312 combination therapy in patients with advanced solid tumors, which will be presented at the ESMO immuno-oncology annual congress in December. For next year, the company is already eyeing up to 10 trial readouts from its oncology arsenal.
“The next chapter of BioNTech’s evolution is becoming tangible; we continue to expand our COVID-19 vaccine and infectious disease portfolio and advance our oncology pipeline,” BioNTech CEO Ugur Sahin, M.D., said in the release.
R&D expenses at the company topped 1 billion euros ($997.7 million) for the first nine months of the year. It marked a significant increase on the 677.7 million euros ($676.1 million) spent for the same period in 2022, which the company attributed to “increased headcount and higher expenses in the context of the share-based payments.” Still, with cash and equivalents totaling 13.4 billion euros ($13.4 billion) as of the end of September, the company shouldn’t have a problem funding its R&D growth.