CVac (short for Cancer Vaccine), is an

immunotherapeutic Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherap ...

agent that was 1st developed in

Australia Australia, officially the Commonwealth of Australia, is a country comprising mainland Australia, the mainland of the Australia (continent), Australian continent, the island of Tasmania and list of islands of Australia, numerous smaller isl ...

. CVac was developed by the

biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...

company

Prima BioMed Immutep Ltd (formerly Prima Biomed) is a biotechnology company working primarily in the field of cancer immunotherapy using the LAG3 immune control mechanism. The company was originally built on CVac, a therapeutic cancer vaccine. In late ...

(

Nasdaq The Nasdaq Stock Market (; National Association of Securities Dealers Automated Quotations) is an American stock exchange based in New York City. It is the most active stock trading venue in the U.S. by volume, and ranked second on the list ...

: PBMD) through to Phase II clinical studies between 2001 and 2015. After inconclusive clinical data in

ovarian cancer Ovarian cancer is a cancerous tumor of an ovary. It may originate from the ovary itself or more commonly from communicating nearby structures such as fallopian tubes or the inner lining of the abdomen. The ovary is made up of three different ...

2013 and 2014, Prima announced in February 2015 that it had ceased recruiting into CVAc clinical studies and was seeking commercial partners for the product.

Treatment method

CVac is an ''

ex vivo refers to biological studies involving tissues, organs, or cells maintained outside their native organism under controlled laboratory conditions. By carefully managing factors such as temperature, oxygenation, nutrient delivery, and perfusi ...

'' dendritic cell priming technology involving MFP, or mannan

fusion protein Fusion proteins or chimeric (kī-ˈmir-ik) proteins (literally, made of parts from different sources) are proteins created through the joining of two or more genes that originally coded for separate proteins. Translation of this '' fusion gene'' ...

, where a fusion protein of MUC1 and

Glutathione S-transferase Glutathione ''S''-transferases (GSTs), previously known as ligandins, are a family of eukaryote, eukaryotic and prokaryote, prokaryotic Biotransformation#Phase II reaction, phase II metabolic isozymes best known for their ability to Catalysis, ...

is coupled to oxidized polymannose. The dendritic cells are the orchestrators of the immune system. 'Priming' dendritic cells involves exposing those cells to disease antigens in order to get the immune system to properly recognise the antigen and mount an appropriate response. With CVac this takes place outside the body of the patient (''ex vivo''), with dendritic cells obtained by

leukapheresis Leukapheresis () is a laboratory procedure in which white blood cells are separated from a sample of blood. It is a specific type of apheresis, the more general term for separating out one particular constituent of blood and returning the remainde ...

. The antigen in this case is MUC1, known to be overexpressed on a variety of cancer cells and in CVac MUC1 is conjugated to the carbohydrate mannan to facilitate uptake by the dendritic cells. CVAc can be administered subcutaneously, whereas Provenge is intravenous.

Early development in Melbourne

CVac originated in the mid-1990s at the Austin Research Institute, a medical research facility then associated with Melbourne's

Austin Hospital The Austin Hospital is a public teaching hospital in Melbourne's north-eastern suburb of Heidelberg, and is administered by Austin Health, along with the Heidelberg Repatriation Hospital and the Royal Talbot Rehabilitation Centre. History The Aus ...

(and that merged with the

Burnet Institute The Burnet Institute is an Australian medical institute that combines medical research in the laboratory and the field, with public health action to address major health issues affecting disadvantaged communities in Australia, and internationall ...

in 2006). The original version of the product was developed in the laboratory of the Austin Professor Ian McKenzie in 1993. CVac therapy was originally intended to be ''in vivo'' but the Austin researchers started getting better results in ''ex vivo'' therapy.

Development by Prima BioMed

Prima BioMed was formed around 2001 to commercialise a number of Austin Research Institute projects including CVac. The company was taken public in July 2001 on the ASX in a

reverse takeover A reverse takeover (RTO), reverse merger, or reverse IPO is the acquisition of a public company by a private company so that the private company can bypass the lengthy and complex process of going public. Sometimes, conversely, the public compa ...

of a defunct mineral explorer called Prima Resources. CVac ultimately ended up as Prima BioMed's core project until Prima's acquisition of the French biotechnology company Immutep SA in 2014.

Dubai Approval

CVac was approved for use by the Dubai Health City Authority in May 2011.

Manufacturing

CVac was manufactured in

Germany Germany, officially the Federal Republic of Germany, is a country in Central Europe. It lies between the Baltic Sea and the North Sea to the north and the Alps to the south. Its sixteen States of Germany, constituent states have a total popu ...

by Fraunhofer IZI (Das Fraunhofer-Institut für Zelltherapie und Immunologie), an institute of the

Fraunhofer Society The Fraunhofer Society () is a German publicly-owned research organization with 76institutes spread throughout Germany, each focusing on different fields of applied science (as opposed to the Max Planck Society, which works primarily on Basic re ...

Leipzig Leipzig (, ; ; Upper Saxon: ; ) is the most populous city in the States of Germany, German state of Saxony. The city has a population of 628,718 inhabitants as of 2023. It is the List of cities in Germany by population, eighth-largest city in Ge ...

Saxony Saxony, officially the Free State of Saxony, is a landlocked state of Germany, bordering the states of Brandenburg, Saxony-Anhalt, Thuringia, and Bavaria, as well as the countries of Poland and the Czech Republic. Its capital is Dresden, and ...

The Fraunhofer IZI was authorized to manufacture the treatment in Europe in late 2011 after meeting criteria laid down by the German ''Arzneimittelgesetz'' (Drug Law). Prima intended that its product would be manufactured at this one central location, with patient blood being flown to Leipzig and primed dendritic cells being shipped back to the relevant trial site.

References

{{reflist, 2

External links

* http://primabiomed.com.au/ Cancer vaccines