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Kowalski M.,Viventia Biotechnologies Inc. | Guindon J.,Viventia Biotechnologies Inc. | Brazas L.,Viventia Biotechnologies Inc. | Moore C.,Viventia Biotechnologies Inc. | And 4 more authors.
Journal of Urology | Year: 2012

Purpose: A phase II study was performed to assess the efficacy and tolerability of intravesical oportuzumab monatox in patients with urothelial carcinoma in situ of the bladder. Bacillus Calmette-Guérin treatment had previously failed in all patients. Materials and Methods: A total of 46 patients received 1 induction cycle of 6 (cohort 1) or 12 (cohort 2) weekly intravesical oportuzumab monatox (VB4-845) instillations of 30 mg, followed by up to 3 maintenance cycles of 3 weekly administrations every 3 months. Results: A complete response to oportuzumab monatox was seen in 9 of 22 patients (41%) in cohort 1 and 9 of 23 (39%) in cohort 2 at the 3-month evaluation. A total of 20 patients (44%) achieved a complete response. Two other patients without carcinoma in situ who achieved a complete response were not included in the study due to the development of noninvasive papillary (Ta) disease. Median time to recurrence in patients who achieved a complete response was 274 and 408 days in cohorts 1 and 2, respectively. Overall 7 patients (16%) remained disease-free. Post-study assessment demonstrated that these patients were still disease-free at last followup (18 to 25 months). The most common adverse events were mild to moderate reversible bladder symptoms. Conclusions: Oportuzumab monatox was effective and well tolerated in patients with bacillus Calmette-Guérin refractory carcinoma in situ of the bladder. These results demonstrate the clinical benefit of oportuzumab monatox and support its continued development for the second line treatment of nonmuscle invasive bladder cancer. © 2012 American Urological Association Education and Research, Inc.


Trademark
Viventia Biotechnologies Inc. and Viventia Biotech Inc. | Date: 2011-11-03

Biotechnology preparations for commercial purposes, namely, recominant-generated antibodies and recominant fragments thereof for commercial purposes; biopharmaceutical and biotechnology products; diagnostic preparations for laboratory and medical research purposes; nucleic acids for laboratory use; biological tissue, namely, stem cells for scientific and medical research use; protein arrays for scientific and medical research; biochemicals, namely, monoclonal antibodies for in vitro scientific or research use; diagnostic preparations for scientific use, namely, monoclonal antibodies, human antibodies, immune toxins; proteins for clinical or medical laboratory use. Biopharmaceutical preparations and biotechnology preparations for medical purposes for the treatment of malignant and benign tumors; cancer; immune diseases, including autoimmune, inflammatory diseases, infectious diseases and vascular diseases; synthetic polypeptides for biopharmaceutical purposes; vaccines; diagnostic preparations for medical purposes; diagnostic preparations for medical purposes, namely, monoclonal antibodies, human antibodies, immune toxins; toxin proteins, and proteins for clinical or medical laboratory use. Medical and scientific research and development services, namely, preparation and development of proteins and in vitro generated recombinant antibodies and proteins, and fragments thereof; product development services for others in the field of medical and scientific research and development; medical laboratory services, namely, preparation and screening of libraries of proteins and antibodies, libraries of cells producing antibodies and proteins, and libraries of vector coding for antibodies and proteins.


Trademark
Viventia Biotechnologies Inc. and Viventia Biotech Inc. | Date: 2012-08-07

Biotechnology preparations for commercial purposes, namely, for use in the manufacture of biopharmaceutical and biotechnology products; diagnostic preparations for laboratory and/or medical research purposes; nucleic acids for laboratory use; biological tissue, namely, stem cells for scientific and medical research use; protein arrays for scientific and medical research; biochemicals, namely, monoclonal antibodies for in vitro scientific or research use. Biopharmaceutical preparations and biotechnology preparations for medical purposes for the treatment of malignant and/or benign tumors; cancer; immune diseases, including autoimmune, inflammatory diseases, infectious diseases and vascular diseases; synthetic polypeptides for biopharmaceutical purposes; vaccines; diagnostic preparations for medical purposes; diagnostic preparations, namely, monoclonal antibodies, human antibodies, immune toxins; toxin proteins, and proteins for clinical or medical laboratory use. Medical and scientific research and development services, namely, preparation and development of proteins and preparation and development services, namely, preparation and development of proteins and preparation and development of in vitro generated recombinant antibodies and proteins, and fragments thereof; product development services for others; preparation and screening of libraries of proteins and antibodies, libraries of cells producing antibodies and proteins, and libraries of vector coding for antibodies and proteins.


Entwistle J.,Viventia Biotechnologies Inc. | Brown J.G.,Viventia Biotechnologies Inc. | Chooniedass S.,Viventia Biotechnologies Inc. | Cizeau J.,Viventia Biotechnologies Inc. | MacDonald G.C.,Viventia Biotechnologies Inc.
Cancer Biotherapy and Radiopharmaceuticals | Year: 2012

VB6-845 is a recombinant immunotoxin comprised of deBouganin (a de-immunized plant toxin) genetically linked to an epithelial cell adhesion molecule (EpCAM)-targeting humanized Fab fragment (4D5MOCB). EpCAM is highly expressed on a wide range of epithelial tumors but has limited expression on most normal epithelia and therefore represents an excellent target for immunotherapy. A comprehensive preclinical evaluation was performed to determine the safety and suitability of VB6-845 as a systemically administered drug for the treatment of solid tumors. Efficacy studies in mice demonstrated that VB6-845 specifically and potently targeted EpCAM-positive tumors. In a dose-ranging study in Sprague-Dawley rats, single doses of VB6-845 were well-tolerated resulting in a no-observable adverse effect level (NOAEL) of 100 mg/kg whereas repeated doses of VB6-845 resulted in vascular leak-associated symptoms particularly at higher dose levels. However, much higher doses in Cynomolgus monkeys were well-tolerated when given as a 3-hour infusion mimicking the intended route of administration in the clinic. In addition, VB6-845 proved to be minimally immunogenic in monkeys. The toxicological data obtained in Cynomolgus monkeys indicated an excellent safety profile with a NOAEL value of 30 mg/kg (equivalent to a 10 mg/kg dose in humans). These results are supportive of an exploratory Phase I trial. © Mary Ann Liebert, Inc.


Premsukh A.,Viventia Biotechnologies Inc. | Lavoie J.M.,Viventia Biotechnologies Inc. | Cizeau J.,Viventia Biotechnologies Inc. | Entwistle J.,Viventia Biotechnologies Inc. | MacDonald G.C.,Viventia Biotechnologies Inc.
Protein Expression and Purification | Year: 2011

VB4-845 is a recombinant immunotoxin comprised of an anti-epithelial cell adhesion molecule (EpCAM) scFv fused to a truncated form of the bacterial toxin, Pseudomonas exotoxin A. VB4-845, purified from TB fed-batch fermentation, showed clinical efficacy when administered locally to treat non-muscle invasive bladder cancer (NMIBC) and squamous cell carcinomas of the head and neck (SCCHN). Here, we describe the implementation of an Escherichia coli high cell density (HCD) cultivation and purification process for VB4-845. HCD cultivation was a prerequisite for achieving higher yields necessary for Phase III clinical trials and commercialization. Using this process, the VB4-845 titer in the supernatant was increased by 30-fold over the original TB fed-batch cultivation. To obtain clinical grade material, a process involving a five-step column purification procedure was implemented and led to an overall recovery of ∼40%. VB4-845 purity of >97% was achieved after the first three columns following the removal of low-molecular weight product-related impurities and aggregates. Endotoxins were effectively separated from VB4-845 on the Q-columns and by washing the Ni-column with a detergent buffer while host cell proteins were removed using ceramic hydroxyapatite. Comparability studies demonstrated that the purified product from the Phase III process was identical to the Phase II reference standard produced using TB fed-batch fermentation. © 2011 Elsevier Inc. All rights reserved.


Cizeau J.,Viventia Biotechnologies Inc. | Torres M.G.P.,Viventia Biotechnologies Inc. | Cowling S.G.,Viventia Biotechnologies Inc. | Stibbard S.,Viventia Biotechnologies Inc. | And 3 more authors.
Journal of Biomolecular Screening | Year: 2011

Antibody-based therapeutics play a vital role in the treatment of certain cancers; however, despite commercial success, various strategies are being pursued to increase their potency and hence improve patient outcomes. The use of antibodies to deliver a cytotoxic payload offers a promising alternative for more efficacious therapies. Immunotoxins are composed of an internalizing antibody fragment linked to a bacterial or plant toxin. Once internalized, the payload, such as Pseudomonas exotoxin A (PE), blocks protein synthesis and induces apoptosis. Typically, immunotoxins are developed by first isolating a tumor-specific antibody, which is then either chemically linked to a toxin or reengineered as a fusion protein. Here, the authors describe the development of Fusogenics, an immunotoxin-based screening method that selects internalizing tumor-specific antibodies using a functional assay. Selected immune library clones were characterized and shown to be selective against normal tissues and specific to tumor tissues. In summary, the Fusogenics immunotoxin platform represents a unique, single-step selection approach combining specificity and functionality to isolate novel internalizing tumor-specific antibody fragments with potential for direct clinical application in the treatment of cancer. © 2011 Society for Laboratory Automation and Screening.


Patent
Viventia Biotechnologies Inc. | Date: 2013-01-17

The present invention provides the amino acid and nucleic acid sequences of heavy chain and light chain complementarity determining regions of a tumor specific antibody. In addition, the invention provides tumor-specific antibodies and immunoconjugates comprising the tumor-specific antibody attached to a toxin or label, and methods and uses thereof. The invention also relates to diagnostic methods and kits using the tumor-specific antibodies of the invention.


Patent
Viventia Biotechnologies Inc. | Date: 2011-04-26

The present invention provides a novel cancer-associated antigen that can be used in the treatment and diagnosis of cancer. Further, the invention provides amino acid and nucleic acid sequence of the novel antigen, binding proteins, and immunoconjugates. The invention also relates to diagnostic and therapeutic methods and kits.


Patent
Viventia Biotechnologies Inc. | Date: 2011-11-16

The present invention provides the amino acid and nucleic acid sequences of heavy chain and light chain complementarity determining regions of a cancer specific antibody. In addition, the invention provides cancer specific antibodies and immunoconjugates comprising the cancer specific antibody attached to a toxin or label, and methods and uses thereof. The invention also relates to diagnostic methods and kits using the cancer specific antibodies of the invention. Further, the invention provides a novel cancer-associated antigen and its uses thereof.


Patent
Viventia Biotechnologies Inc. | Date: 2013-01-25

The present invention provides a novel cancer-associated antigen that can be used in the treatment and diagnosis of cancer. Further, the invention provides amino acid and nucleic acid sequence of the novel antigen, binding proteins, and immunoconjugates. The invention also relates to diagnostic and therapeutic methods and kits.

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