Eoganacht wrote: Prokarium's goal is to replace an old TB vaccine (BCG) with an old typhoid fever vaccine (engineered salmonella bacteria) as a first-line treatment (post-TURBT) for NMIBC. A 2016 pre-clinical efficacy and safety study found that
Vivotif/Ty21a was more effective and safer than
BCG in treating mice bladder tumours.
Preclinical Efficacy and Safety of the Ty21a Vaccine Strain for Intravesical Immunotherapy of Non-Muscle-Invasive Bladder Cancer Prokarium is currently running a NMIBC phase 1 trial in association with the Lausanne University Hospital.
Prokarium Signs an Exclusive Option Agreement with the Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois - CHUV) for the Treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) April 28, 2020 02:00 AM Eastern Daylight Time
LONDON--(BUSINESS WIRE)--Prokarium, a private biotechnology company, focusing on genetically engineered bacteria for the development of microbial immunotherapy and vaccines, is pleased to announce 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.
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–Gurin (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–Gurin (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.
About Prokarium
Prokarium is a venture-backed biotechnology company, focussing on genetically engineered bacteria for the development of microbial immunotherapies and vaccines. The Company’s lead vaccine candidate is Entervax™, the world’s first combination typhoid-paratyphoid vaccine to enter the clinic in collaboration with the Wellcome Trust. As of 2019, Prokarium has been investigating the use of their Salmonella platform as microbial immunotherapy for the treatment of solid tumours.
About the CHUV
The CHUV, Lausanne University Hospital, is one of the five university hospitals in Switzerland. With its 16 clinical and medico-technical departments and their numerous services, the CHUV is renowned for its academic achievements in health care, research, and teaching.
The CHUV is also a well-known center of medical education and research thanks to its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and the Swiss Federal Institute of Technology in Lausanne (EPFL). Together, these institutions form a vast campus in the Lake Geneva region. The CHUV has been recognized as one of the World’s 10 best hospitals according to the 2019 ranking of Newsweek magazine.
It is with enthusiasm, that the new Chairman of the Department of Urology, Prof Beat Roth, will pursue and support the research and studies with this novel treatment for bladder cancer.