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 The leading web portal for pharmacy resources, news, education and careers September 24, 2017
Pharmacy Choice - Pharmaceutical News - Researchers Submit Patent Application, "Tumor Therapy with an Antibody for Vascular Endothelial Growth Factor and an Antibody for Human Epithelial... - September 24, 2017

Pharmacy News Article

 9/13/17 - Researchers Submit Patent Application, "Tumor Therapy with an Antibody for Vascular Endothelial Growth Factor and an Antibody for Human Epithelial...

Researchers Submit Patent Application, "Tumor Therapy with an Antibody for Vascular Endothelial Growth Factor and an Antibody for Human Epithelial Growth Factor Receptor Type 2", for Approval (USPTO 20170239353)

By a News Reporter-Staff News Editor at Biotech Week From Washington, D.C., NewsRx journalists report that a patent application by the inventors Friess, Thomas (Diessen-Dettenhofen, DE); Hasmann, Max (Muenchen, DE); Scheuer, Werner (Penzberg, DE), filed on May 10, 2017, was made available online on August 31, 2017 (see also Pharmaceutical Companies).

The patent's assignee is Hoffmann-La Roche Inc.

News editors obtained the following quote from the background information supplied by the inventors: "Angiogenesis is implicated in the pathogenesis of a variety of disorders which include solid tumors, intraocular neovascular syndromes such as proliferative retinopathies or age-related macular degeneration (AMD), rheumatoid arthritis, and psoriasis (Folkman, J., et al., J. Biol. Chem. 267 (1992) 10931-10934; Klagsbrun, M., et al., Annu. Rev. Physiol. 53 (1991) 217-239; and Garner, A, Vascular diseases, In: Pathobiology of ocular disease, A dynamic approach, (eds.) Garner and A, Klintworth, G K, 2nd Edition Marcel Dekker, New York, (1994), pp 1625-1710). In the case of solid tumors, the neovascularization allows the tumor cells to acquire a growth advantage and proliferative autonomy compared to the normal cells. Accordingly, a correlation has been observed between density of microvessels in tumor sections and patient survival in breast cancer as well as in several other tumors (Weidner, N., et al., N. Engl. J. Med. 324 (1991) 1-6; Horak, E. R., et al., Lancet 340 (1992) 1120-1124; and Macchiarini, P., et al., Lancet 340 (1992) 145-146).

"Vascular endothelial growth factor (VEGF) is involved in the regulation of normal and abnormal angiogenesis and neovascularization associated with tumors and intraocular disorders (Ferrara, N., et al., Endocr. Rev. 18 (1997) 4-25; Berkman, R. A., et al., J. Clin. Invest. 91 (1993) 153-159; Brown, L. F., et al., Human Pathol. 26 (1995) 86-91; Brown, L. F., et al., Cancer Res. 53 (1993) 4727-4735; Mattern, J., et al., Brit. J. Cancer 73 (1996) 931-934; and Dvorak, H. F., et al., Am. J. Pathol. 146 (1995) 1029-1039). Anti-VEGF neutralizing antibodies suppress the growth of a variety of human tumor cell lines in mice (Kim, K. J., et al., Nature 362 (1993) 841-844; Warren, R. S., et al., J. Clin. Invest. 95 (1995) 1789-1797; Borgstrom, P., et al., Cancer Res. 56 (1996) 4032-4039; and Melnyk, O., et al., Cancer Res. 56 (1996) 921-924). WO 94/10202, WO 98/45332, WO 2005/00900 and WO00/35956 refer to antibodies against VEGF. Humanized monoclonal antibody bevacizumab (sold under the tradename Avastin.RTM.) is an anti-VEGF antibody used in tumor therapy and is the only anti-angiogenic agent approved for treatment of cancer (WO 98/45331).

"HER2 is a member of the human epidermal growth factor receptor family and possesses protein kinase activity in its cytoplasmic domain. HER2 is over-expressed in tumor cells and is correlated with poor prognosis and survival. HER2 is therefore a valuable target of breast cancer therapy. Antibodies against HER2 are known from Takai, N., et al., Cancer 104 (2005) 2701-2708; Yeon, C. H., et al., Invest. New Drugs 23 (2005) 391-409; Wong, W. M., et al., Cancer Pract. 7 (1999) 48-50; Albanell, J., et al., Drugs Today (Barc). 35 (1999) 931-46.

"Trastuzumab (sold under the tradename Herceptin.RTM.is a recombinant humanized anti-HER2 monoclonal antibody used for the treatment of HER2 over-expressed/HER2 gene amplified metastatic breast cancer. Preclinical studies demonstrated that the antibody has anti-tumor activity in vivo and in vitro. Moreover, additive or synergistic enhancement of anti-tumor activity of trastuzumab was observed in combination with various anti-tumor agents in mouse models. In clinical studies, extension of survival was observed in HER2 overexpressing metastatic breast cancer patients.

"According to WO 98/45331, the effectiveness of an anti-VEGF antibody in preventing or treating disease may be improved by administering the antibody serially or in combination with another agent that is effective for those purposes, such as an antibody capable of binding to HER2 receptor. WO 2005/012531 describes antibodies that may be combined with an anti-VEGF antibody (e.g. Avastin.RTM.) and/or anti-ErbB antibodies (e.g. Herceptin.RTM.) in the treatment of colorectal cancer, metastatic breast cancer and kidney cancer. According to WO 2005/063816, anti-VEGF antibodies may be combined with anti-ErbB antibodies in a treatment of metastatic breast cancer. WO 2005/00090 and WO 2003/077841 also disclose the combination of anti-VEGF antibodies with anti-ErbB2 antibodies for tumor therapy.

"Clinical oncologists are in agreement that the failure of cancer treatment is not necessarily caused by the growth of the primary tumor, which is generally dealt with using surgery, but rather by the metastatic spread into different organs. The regression of primary tumors by different cytotoxic drugs is not always indicative for anti-metastatic activity per se. On the contrary, enhanced metastasis has been observed in response to several anti-cancer drugs (Geldof, A. A., et al., Anticancer Res. 8 (1988) 1335-1339; Murphy, S. B., J. Clin. Oncol. 11 (1993) 199-201; and De Larco, J. E., et al., Cancer Res. 61 (2001) 2857-2861). Clearly there exists a need to develop treatment therapies that target not only the primary tumor, but also suppress metastasis."

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors' summary information for this patent application: "The invention comprises the use of an anti-HER2 antibody and an anti-VEGF antibody for the manufacture of a medicament for treating a breast cancer disease in a patient who has failed prior cancer therapy with an anti-VEGF antibody, comprising administering to the patient a therapeutically effective amount of an anti-HER2 antibody and an anti-VEGF antibody.

"In a preferred embodiment, the invention comprises the use of trastuzumab and bevacizumab for the manufacture of a medicament for treating a breast cancer disease characterized by an overexpression of the HER2 receptor protein in a patient who has failed prior therapy with an anti-VEGF antibody such as bevacizumab, comprising administering to the patient a therapeutically effective amount of trastuzumab and bevacizumab.

"The invention further comprises a method of treating a breast cancer disease in a patient who has failed prior therapy with an anti-VEGF antibody, comprising administering to the patient a therapeutically effective amount of an anti-HER2 antibody while continuing said anti-VEGF antibody therapy.

"The invention further comprises a method of treating a breast cancer disease, in a patient who has failed prior therapy with an anti-VEGF antibody, comprising administering to the patient a therapeutically effective amount of trastuzumab while continuing bevacizumab therapy, wherein the breast cancer disease is characterized by an overexpression of the HER2 receptor protein.

"The invention further comprises a method for increasing the duration of survival of a patient having breast cancer disease who has failed prior therapy with an anti-VEGF antibody, comprising administering to the patient effective amounts of an anti-VEGF antibody and an anti-HER2 antibody, whereby the co-administration of the anti-VEGF antibody and the anti-HER2 antibody effectively increases the duration of survival.

"The invention further comprises a method for increasing the progression free survival of a patient having breast cancer disease who has failed prior therapy with an anti-VEGF antibody, comprising administering to the patient effective amounts of an anti-VEGF antibody and an anti-HER2 antibody, whereby the co-administration of the anti-VEGF antibody and the anti-HER2 antibody effectively increases the duration of progression free survival.

"The invention further comprises a method for treating a group of patients, having breast cancer disease and having failed prior therapy with an anti-VEGF antibody, comprising administering to the patient effective amounts of an anti-VEGF antibody and an anti-HER2 antibody, whereby the co-administration of the anti-VEGF antibody and the anti-HER2 antibody effectively increases the response rate in the group of patients.

"The invention further comprises a method for increasing the duration of response of a patient having breast cancer disease who has failed prior therapy with an anti-VEGF antibody, comprising administering to the patient effective amounts of an anti-VEGF antibody and an anti-HER2 antibody, whereby the co-administration of the anti-VEGF antibody and the anti-HER2 antibody effectively increases the duration of response.

"The invention further comprises a method of treating a patient having breast cancer disease who has failed prior therapy with an anti-VEGF antibody, comprising administering to the patient effective amounts of an anti-VEGF antibody and an anti-HER2 antibody, whereby the co-administration of the anti-VEGF antibody and the anti-HER2 antibody results in statistically significant and clinically meaningful improvement of the treated patient as measured by the duration of survival, progression free survival, response rate or duration of response.

"This invention further comprises a method for reducing metastasis in a patient having breast cancer disease who has failed prior therapy with an anti-VEGF antibody, comprising administering to the patient effective amounts of an anti-VEGF antibody and an anti-HER2 antibody, whereby the co-administration of the anti-VEGF antibody and the anti-HER2 antibody effectively reduces metastasis.

"The invention further comprises a method for treating a group of patients, having breast cancer disease and having failed prior therapy, with an anti-VEGF antibody, comprising administering to the patient effective amounts of an anti-VEGF antibody and an anti-HER2 antibody, whereby the co-administration of the anti-VEGF antibody and the anti-HER2 antibody effectively reduces metastasis in the group of patients.

"The invention provides an article of manufacture (e.g., pharmaceutical kit) comprising one or more containers, and preferably at least two containers, a pharmaceutical composition within a first container comprising an anti-VEGF antibody, a pharmaceutical composition within a second container comprising an anti-HER2 antibody and a package insert instructing the user of the composition to administer to a patient, having breast cancer disease who has failed prior therapy with an anti-VEGF antibody, the anti-VEGF antibody within said first container and an anti-HER2 antibody within said second container.

"The invention further provides for a pharmaceutical composition comprising an anti-HER2 antibody and an anti-VEGF antibody useful in the treatment of breast cancer disease in a patient which has failed prior therapy with an anti-VEGF antibody. Preferably the anti-HER2 antibody is trastuzumab. Also preferably the anti-VEGF antibody is bevacizumab."

For additional information on this patent application, see: Friess, Thomas; Hasmann, Max; Scheuer, Werner. Tumor Therapy with an Antibody for Vascular Endothelial Growth Factor and an Antibody for Human Epithelial Growth Factor Receptor Type 2. Filed May 10, 2017 and posted August 31, 2017. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220170239353%22.PGNR.&OS=DN/20170239353&RS=DN/20170239353

Keywords for this news article include: Antineoplastic Monoclonal Antibodies, Biotechnology, Pharmaceutical Companies, Oncology, Immunology, Bevacizumab, Trastuzumab, Angiogenesis, Therapeutics, Breast Cancer, Blood Proteins, Cancer Therapy, Women's Health, HER2 Inhibitors, Immunoglobulins, Medical Devices, Protein Kinases, Membrane Proteins, Peptide Receptors.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC



(c) 2017 NewsRx LLC

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