On April 28, 2020 Prokarium, a private biotechnology company, focusing on genetically engineered bacteria for the development of microbial immunotherapy and vaccines, reported that it has signed an exclusive, worldwide Option Agreement with the Lausanne University Hospital – CHUV, a Switzerland-based research hospital, to acquire a license to cover the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) patients with intravesical instillations of Salmonella (Press release, Prokarium, APR 28, 2020, View Source [SID1234556709]).
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Prokarium is investigating the use of engineered bacteria for the development of microbial immunotherapy for solid tumours. Their first oncology indication in preclinical development is NMIBC, which accounts for 400,000 new cases yearly worldwide and is currently lacking innovative treatments. Prokarium aims to disrupt the market with their engineered Salmonella that acts by boosting the natural anti-tumour immune response as well as through direct tumour killing.
"The standard of care of NMIBC is surgical removal of the tumour followed by up to 27 intravesical instillations of Bacillus Calmette–Guérin (BCG), which, despite the initial high response rate, has a 40-80% recurrence rate within 5 years" said Ted Fjallman, Ph.D, Chief Executive Officer, Prokarium. "Additionally, there is a significant worldwide shortage of BCG and many oncology patients are not able to receive their treatments."
Prokarium started a collaboration with a team at the Department of Urology of CHUV, led by Dr. Denise Nardelli-Haefliger, in 2019. The group, with Prof. Patrice Jichlinski and Dr. Ilaria Lucca, is running a Phase I trial in NMIBC patients investigating the intravesical administration of Salmonella Typhi Ty21a. Prokarium is working with this medical team to generate an adequate preclinical data package to file an IND.
"We are happy that thanks to the partnership with Prokarium, the results of our long-lasting immunotherapeutic research will soon be developed to benefit NMIBC patients" said the inventors Sonia Domingos-Pereira, Patrice Jichlinski and Denise Nardelli-Haefliger.
About NMIBC
Bladder cancer represents 5% of all new cancer cases in the US and accounts for 550,000 new cases yearly worldwide. The clinical staging is determined by the depth of invasion into the bladder wall and more than 70% of cases are diagnosed at an early stage, also known as Non-Muscle Invasive Bladder Cancer (NMIBC). Despite the early diagnosis, the only approved therapies are Bacillus Calmette–Guérin (BCG), which often faces shortages, and chemotherapy, both delivered intravesically. Because of its high incidence and the low number of treatment options, a huge unmet medical need remains in NMIBC.