TroVax
Encyclopedia
TroVax is a cancer vaccine
being developed by Oxford BioMedica
. No cancer vaccines have been proven to cure cancer or extend life yet, but TroVax is recruiting patients for 3 human trials.
TroVax uses a tumor-associated antigen
, 5T4, with a pox virus vector
. 5T4 is found in a wide range of solid cancers and its presence is correlated with poor prognosis.
is present. Clinical development is ongoing in renal cell carcinoma
, colorectal cancer
and prostate cancer
, and is planned in breast cancer
.
Oxford BioMedica began patient recruitment in a Phase III trial in renal cell carcinoma in November 2006. The trial was halted in August 2008 as it was assessed that it would not meet its endpoint. Subsequent analysis has shown that Trovax was not effective on patients with poor blood chemistry (approx 50% of the patients) but that if patients were screened for blood chemistry it would have met its end point. Further phase II trials in different indications are ongoing to prove this proposition.
to combat Stage IV colorectal cancer. It induced an anti-tumor immune response in 94% of patients while 41% of patients showed periods of disease stabilization. The immune response induced by TroVax correlated with time to disease progression (p < 0.01) and a relationship was determined with survival
trial, the immune response induced by TroVax correlated with tumour responses (p < 0.02). 25% of patients were alive at an average follow-up time of almost two and a half years.
to combat advanced or metastatic renal cell carcinoma to 700 patients, with the primary endpoint being the rate of overall survival. There is a Special Protocol Assessment agreement with the FDA that specifies the design, conduct, analysis and endpoints of the trial.
Trovax works by targeting the 5T4 antigen—a protein that is found on 85% of solid tumors. The idea is that by targeting this protein Trovax instigates an immune response enabling the body to fight the cancer.
See the Oxford BioMedica website for more information.
. There are many aspects to this agreement including co-funding the ongoing TRIST
study and funding all other research, development, regulatory and commercialisation activities.
Cancer vaccine
The term cancer vaccine refers to a vaccine that either prevents infections with cancer-causing viruses, treats existing cancer or prevents the development of cancer in certain high risk individuals...
being developed by Oxford BioMedica
Oxford BioMedica
Oxford BioMedica is a biopharmaceutical company specializing in the development and commercialization of innovative gene-based medicines. It was established in 1995 as a spin out from Oxford University. The lead product is TroVax, a therapeutic cancer vaccine for multiple solid cancers, which is...
. No cancer vaccines have been proven to cure cancer or extend life yet, but TroVax is recruiting patients for 3 human trials.
TroVax uses a tumor-associated antigen
Antigen
An antigen is a foreign molecule that, when introduced into the body, triggers the production of an antibody by the immune system. The immune system will then kill or neutralize the antigen that is recognized as a foreign and potentially harmful invader. These invaders can be molecules such as...
, 5T4, with a pox virus vector
Viral vector
Viral vectors are a tool commonly used by molecular biologists to deliver genetic material into cells. This process can be performed inside a living organism or in cell culture . Viruses have evolved specialized molecular mechanisms to efficiently transport their genomes inside the cells they infect...
. 5T4 is found in a wide range of solid cancers and its presence is correlated with poor prognosis.
Indication
All solid tumors where the 5T4 tumor antigenTumor antigen
Tumor antigen is an antigenic substance produced in tumor cells, i.e., it triggers an immune response in the host. Tumor antigens are useful in identifying tumor cells and are potential candidates for use in cancer therapy.- Mechanism of tumor antigenesis:...
is present. Clinical development is ongoing in renal cell carcinoma
Renal cell carcinoma
Renal cell carcinoma is a kidney cancer that originates in the lining of the proximal convoluted tubule, the very small tubes in the kidney that filter the blood and remove waste products. RCC is the most common type of kidney cancer in adults, responsible for approximately 80% of cases...
, colorectal cancer
Colorectal cancer
Colorectal cancer, commonly known as bowel cancer, is a cancer caused by uncontrolled cell growth , in the colon, rectum, or vermiform appendix. Colorectal cancer is clinically distinct from anal cancer, which affects the anus....
and prostate cancer
Prostate cancer
Prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostate cancers. The cancer cells may metastasize from the prostate to other parts of the body, particularly...
, and is planned in breast cancer
Breast cancer
Breast cancer is cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with milk. Cancers originating from ducts are known as ductal carcinomas; those originating from lobules are known as lobular carcinomas...
.
Technical design
TroVax is a proprietary tumor-associated antigen, 5T4, delivered by the pox virus vector, modified vaccinia virus Ankara (MVA).Clinical status
Over 150 patients have been treated with collectively over 500 doses of TroVax in clinical trials. TroVax has been safe and tolerable, with no serious adverse effects. TroVax has induced an anti-tumor immune response to the 5T4 tumor antigen in over 95% of evaluable patients. The strongest immune responders have also tended to show the greatest clinical benefit.Oxford BioMedica began patient recruitment in a Phase III trial in renal cell carcinoma in November 2006. The trial was halted in August 2008 as it was assessed that it would not meet its endpoint. Subsequent analysis has shown that Trovax was not effective on patients with poor blood chemistry (approx 50% of the patients) but that if patients were screened for blood chemistry it would have met its end point. Further phase II trials in different indications are ongoing to prove this proposition.
Colorectal cancer
TroVax was administered as a single agent post chemotherapyChemotherapy
Chemotherapy is the treatment of cancer with an antineoplastic drug or with a combination of such drugs into a standardized treatment regimen....
to combat Stage IV colorectal cancer. It induced an anti-tumor immune response in 94% of patients while 41% of patients showed periods of disease stabilization. The immune response induced by TroVax correlated with time to disease progression (p < 0.01) and a relationship was determined with survival
Colorectal cancer (two trials)
TroVax was administered alongside first-line chemotherapy to combat Stage IV colorectal cancer. It induced an anti-tumor immune response in all patients while 95% of patients showed disease stabilization and 17% of patients showed complete tumor responses. In the TroVax plus FOLFOXFOLFOX
FOLFOX is a chemotherapy regimen for treatment of colorectal cancer, made up of the drugs* FOL– Folinic acid * F – Fluorouracil * OX – Oxaliplatin - FOLFOX4 :...
trial, the immune response induced by TroVax correlated with tumour responses (p < 0.02). 25% of patients were alive at an average follow-up time of almost two and a half years.
Colorectal cancer
TroVax is administered as an adjuvant to surgery to combat Stage IV colorectal cancer with operable liver metastases. It induced an anti-tumor immune response in 95% of patients while 56% of patients remained disease-free at a median follow-up of nine months.Renal cell carcinoma (four trials)
Trovax is administered alongside interleukin-2 or interferon-alpha to combat advanced or metastatic renal cell carcinoma. It has induced an anti-tumor immune response in 88% of patients while several patients have shown partial tumor responses.Prostate cancer
Trovax is administered either as a single agent or in combinations with GM-CSF to combat hormone-refractory prostate cancer. It has mounted an immune response in 85% of patients. Further data will be announced in November 2006.Renal cell carcinoma
Trovax is administered in combinations with interleukin-2, interferon-alpha, sunitinibSunitinib
Sunitinib is an oral, small-molecule, multi-targeted receptor tyrosine kinase inhibitor that was approved by the FDA for the treatment of renal cell carcinoma and imatinib-resistant gastrointestinal stromal tumor on January 26, 2006...
to combat advanced or metastatic renal cell carcinoma to 700 patients, with the primary endpoint being the rate of overall survival. There is a Special Protocol Assessment agreement with the FDA that specifies the design, conduct, analysis and endpoints of the trial.
Trovax works by targeting the 5T4 antigen—a protein that is found on 85% of solid tumors. The idea is that by targeting this protein Trovax instigates an immune response enabling the body to fight the cancer.
See the Oxford BioMedica website for more information.
Breast Cancer
TroVax will be administered after standard chemotherapy to combat Stage III/IV breast cancer to 120 patients, with the key endpoint being progression-free survival compared to historical controls. The United States clinical trial consortium, Southwest Oncology Group has received FDA clearance to start the trial with sponsorship from the United States National Cancer Institute and is expected to begin by end 2006.Colorectal cancer
TroVax will be administered with adjuvant chemotherapy to combat Stage II/III colorectal cancer to approximately 3000 patients, with the primary endpoint of overall and disease-free survival at three years. Clinical trial network, QUASAR, is seeking funds for the proposed trial through appropriate agenciesCommercialisation Strategy
Oxford BioMedica entered a global development and commercialisation agreement for TroVax in March 2007 with sanofi-aventisSanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
. There are many aspects to this agreement including co-funding the ongoing TRIST
Trist
Trist may refer to:*David Trist , a New Zealand cricketer*Eric Trist , a British scientist*Nicholas Trist , an American diplomat...
study and funding all other research, development, regulatory and commercialisation activities.
External links
- TroVax info on OxfordBioMedica
- Vaccine for kidney and bowel cancers tested - Daily MailDaily MailThe Daily Mail is a British daily middle-market tabloid newspaper owned by the Daily Mail and General Trust. First published in 1896 by Lord Northcliffe, it is the United Kingdom's second biggest-selling daily newspaper after The Sun. Its sister paper The Mail on Sunday was launched in 1982...
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