Prokarium’s first Onconella therapy takes aim at early-stage non-muscle invasive bladder cancer (NMIBC). Though over 550,000 new cases of NMIBC are diagnosed globally every year, this cancer type is still typically treated with the tuberculosis vaccine, BCG. Fjallman says there are many shortcomings associated with the BCG, including high disease recurrence, long treatment schedule, considerable side effects, and low compliance. The company’s NMIBC therapy offering, Vesibax, aims to ameliorate many of these drawbacks. “Vesibax will offer a well-characterized, easy-to-manufacture, and more efficacious microbial immunotherapy,” says Fjallman. He adds that the company’s goal for Vesibax is to provide a NMIBC treatment option that will require fewer doses and will improve patient comfort and compliance.

To date, Vesibax has been successfully shown to drive anti-tumor effects in preclinical mouse bladder cancer models. The therapy is expected to enter clinical development in 2022. Though Prokarium has not made any announcements, the company is planning to expand its Onconella portfolio to address other solid tumor types.

Oncology isn’t Prokarium’s only focus. “Much of our development work underway for oncology is also applicable to infectious diseases,” says Fjallman. The company is currently in early clinical development for its enteric fever vaccine, Entervax.

Enteric fever, also known as typhoid, affects between 11-21 million people each year, resulting in as many as 160,000 deaths. The Entervax vaccine, built off the company’s infectious disease prevention platform, Vaxonella, targets the bacterial blood infection caused by Salmonella enterica serovars Typhi and the less severe paratyphoid fever caused by Salmonella Parathypi A. Unlike traditional typhoid vaccines injections, Prokarium’s vaccine is an oral prophylactic which utilizes their proprietary strains of Salmonella Typhi ZH9 as well as a novel strain modified to express S. Prathypi A antigens.

Prokarium recently announced a funding partnership with the Wellcome Trust to advance clinical studies of Entervax, with the readout expected in the first half of 2021. If successful, the oral medication could present a much simpler and more accessible typhoid vaccine option for millions of people worldwide.

Of course, no 2020 vaccine conversation would be complete without mentioning the Covid-19 pandemic. Fjallman says that the company has been approached by several parties interested in using its platform to deliver SARS-CoV2 antigens. After next year’s Entervax readout, Fjallman says the company will be open to inquiries from other pharma companies interested in developing and licensing their technology.

Interest in Prokarium’s novel therapeutics platform is high, as their Series B round firmly demonstrates. But the company is doing more than raising funds to establish its value in the immunotherapy space. The company is also building out its leadership team, starting with therapeutics development expert, Hyam Levitsky, MD. With over 30 years of immunology, oncology, and internal medicine research experience, the industry veteran will bring insights and vision to the company’s Board of Directors. Prokarium also recognizes its own internal talent. The company recently promoted Kristen Albright, PharmD, to COO and Livija Deban Ph.D., to VP of research, while Peter McGowan, FCCA, rounds out the leadership expansion as the newly appointed CFO.

With these latest investment and leadership developments along with the company’s novel vaccine and oncology platforms, Prokarium looks to be a promising pioneer in advanced immunology therapeutics.

Subscribe to my weekly synthetic biology newsletter. Thank you to Fiona Rose Mischel for additional research and reporting in this article. I’m the founder of SynBioBeta and the SynBioBeta Global Synthetic Biology Summit.