A Phase I/II Trial of an Allogeneic Cell Based Vaccine and an Anti-Idiotypic Antibody Vaccine Approach for Metastatic Adenocarcinoma of the Colon or Rectum

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from cancer cells may make the body build an immune response to kill colorectal tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy and/or vaccine therapy in treating patients who have locally advanced or metastatic colorectal cancer.

Start Date01 Apr 2000

Sponsor / Collaborator

Onyvax Ltd.

100 Clinical Results associated with Anti-idiotype cancer vaccine 105AD7(The University of Nottingham Students' Union)

100 Translational Medicine associated with Anti-idiotype cancer vaccine 105AD7(The University of Nottingham Students' Union)

100 Patents (Medical) associated with Anti-idiotype cancer vaccine 105AD7(The University of Nottingham Students' Union)

Literatures (Medical) associated with Anti-idiotype cancer vaccine 105AD7(The University of Nottingham Students' Union)

01 Aug 2008·Clinical ImmunologyQ3 · MEDICINE

T-cell responses in osteosarcoma patients vaccinated with an anti-idiotypic antibody, 105AD7, mimicking CD55

Q3 · MEDICINE

Article

Author: I. Spendlove ; K. Pritchard-Jones ; C. Kallmeyer ; N.F.S. Watson ; L.G. Durrant ; G.J. Ullenhag

We assessed T-cell responses in young osteosarcoma patients vaccinated with 105AD7, 1-6 months after having received chemotherapy. 105AD7 is a human anti-idiotypic antibody mimicking CD55, a glycoprotein that protects from attack by complement and which is overexpressed on osteosarcoma cells. Seven out of 21 investigated patients made a IFN-gamma T-cell response against the vaccine, 105AD7 as assessed by ELISPOT. Cytokine secretion was analysed using Luminex assays and revealed TNF-alpha and GM-CSF responses not only to the vaccine but also towards the native antigen, CD55, in 5 / 14 (36%) of investigated patients. Importantly, the Luminex assay was found to be more sensitive than the more established T-cell assays (ELISPOT and proliferation assay), since responses towards the native antigen were recorded in this assay. Clinical responses and induction of immune responses to both the anti-idiotype and the native CD55 antigen support the use of CD55 as a target in cancer treatment.

15 Dec 2006·Clinical Cancer ResearchQ1 · MEDICINE

A Neoadjuvant/Adjuvant Randomized Trial of Colorectal Cancer Patients Vaccinated with an Anti-Idiotypic Antibody, 105AD7, Mimicking CD55

Q1 · MEDICINE

Article

Author: Maxwell-Armstrong, Charles ; Ullenhag, Gustav J. ; Spendlove, Ian ; Dube, Mukul ; Indar, Adrian A. ; Durrant, Lindy G. ; Scholefield, John H. ; Robins, Richard A. ; Watson, Nicholas F.S.

AbstractPurpose: To assess the tolerability and effectiveness of 105AD7 vaccination in colorectal cancer patients. 105AD7 is a human anti-idiotypic antibody mimicking CD55, a glycoprotein, which is more than expressed on colorectal cancer cells and protects them from attack by complement.Experimental Design: Colorectal cancer patients (n = 67) eligible for primary surgery were randomized to receive the anti-idiotypic antibody 105AD7±Bacillus Calmette-Guerin/alum or to no treatment (control group). The immunizations were given i.d./i.m. before surgery and continued for a period of 2 years. The patients were monitored in enzyme-linked immunospot (ELISPOT; γ-IFN), proliferation assay, and Luminex cytokine assays.Results: No serious adverse events were recorded. Of the 32 investigated immunized patients, 14 (44%) were considered to be responders in the ELISPOT assay. Induced proliferative responses were noted in 17 of 40 (43%) monitored patients. There was no correlation between the ELISPOT and proliferation assays. Luminex analyses revealed tumor necrosis factor-α and granulocyte macrophage colony-stimulating factor responses not only to the vaccine but also toward the native antigen CD55 in 9 of 13 (69%) patients.Conclusions: Immune responses to vaccination were induced in a majority of monitored patients measured by ELISPOT and proliferation assay. The lack of correlation between the ELISPOT and proliferation assays may reflect the fact that the two methods measure different T-cell responses and highlights the importance of multiple readouts in evaluating a potential cancer vaccine. Responses to both the anti-idiotype and the CD55 antigen were measurable, adding support to the use of CD55 as a target in cancer treatment.

01 Apr 2005·British Journal of CancerQ1 · MEDICINE

Immune responses to the 105AD7 human anti-idiotypic vaccine after intensive chemotherapy, for osteosarcoma

Q1 · MEDICINE

Article

Author: C Wilton ; J Whelan ; J Hale ; S Weeden ; I Spendlove ; I Lewis ; G Halbert ; L G Durrant ; B Campbell ; C Douglas ; P Alvarez ; C Pagonis ; K Pritchard-Jones

105AD7 is a human monoclonal antibody that mimics the complement regulatory protein, CD55, overexpressed by many solid tumours including osteosarcoma. This study was designed to assess the toxicity and efficacy of this vaccine in a young age group of patients within 1-6 months of myleosuppressive chemotherapy. Out of 28, 20 (71%, 95% CI 51-87%) patients showed a significant T-cell proliferation response in vitro to the 105AD7 protein but not to human IgG. Furthermore, 13 out of 22 (59%, 95% CI 36-79%) patients showed antigen-specific gammaIFN secretion (range 20-370 U/ml). Nine out of 28 (32%, 95% CI 16-52%) patients made weak antibody responses to CD55. This study showed that 105AD7 was well tolerated in younger patients with osteosarcoma. In addition, two patients with possible clinical responses were given compassionate permission to continue immunisation quarterly for 2 years. They both remain alive and disease free 5.8 and 6.5 years from original diagnosis of osteosarcoma and showed no adverse effects of repeated immunisation. In conclusion, the majority of patients showed measurable T helper responses when vaccination was commenced within a 6-month window of intensive chemotherapy with no clinically significant toxicity. Future clinical trials incorporating immune stimulation strategies should include early introduction of vaccines during the highest risk period for relapse.

100 Deals associated with Anti-idiotype cancer vaccine 105AD7(The University of Nottingham Students' Union)

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 2	-	The University of Nottingham Students' Union	-
Colorectal Cancer	Phase 2	-	National Cancer Institute	-
Prostatic Cancer	Phase 2	United States	-	-
Prostatic Cancer	Phase 2	-	Onyvax Ltd.	-
Prostatic Cancer	Phase 2	-	National Cancer Institute	-
Prostatic Cancer	Phase 2	-	Cancer Research Technology Ltd.	-
Prostatic Cancer	Phase 2	-	The University of Nottingham Students' Union	-
Sarcoma	Phase 2	-	The University of Nottingham Students' Union	-
Sarcoma	Phase 2	-	Onyvax Ltd.	-
Sarcoma	Phase 2	-	National Cancer Institute	-

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Anti-idiotype cancer vaccine 105AD7(The University of Nottingham Students' Union)

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