Discussion of Intellectual Property:

The MelVac Patent:
United States Patent #7,015,205 B1 Wallack et al.

Date of Patent Publication: March 21, 2006

Patent number US 7,015,205 B1, “Melanoma vaccine and methods of making and using the same” is broadly written, providing CureVax with the opportunity to expand the intellectual property rights of the MelVac platform. This affords the Company the platform upon which to significantly increase the product pipeline and revenue stream.

  1. In its simplest form described in the patent, The MelVac platform contains:
    A vaccinia virus (VV) that was genetically engineered to contain the IL-2 gene, so that the recombinant virus (rVV-IL2) produces the IL-2 protein, which promotes T cell proliferation.
  2. Antigens from 5 melanoma cell lines (Mel-2, Mel-3, Mel 4, Mel 6, Mel-9) that were infected with rVV-IL2 – an “oncolysate.”
  3. Dendritic cells from the melanoma patient as a delivery agent for the oncolysate.
  4. The above three components constitute the lead product, DC-MelVac vaccine for melanoma.

As the patent is written, each of the above items is expanded to include additional components that broaden the coverage of the MelVac platform. Specifically,

  1. The recombinant vaccinia virus can include other cytokines and growth factors – “The present invention contemplates that the vaccinia virus can include genes encoding cytokines and hematopoietic growth factors such as FLT-3 or FLT-3/FLK-2 ligand, GM-CSF, G-CSF, IL-2, IL-3, IL-4, IL-6, IL-7, IL-12, IL-15, IL-18, stem cell factor, various interferons, or a combination thereof.”
  2. The recombinant vaccinia virus can include melanoma-associated antigens – “The present invention also contemplates the use of recombinant vaccinia virus encoding melanoma immunogens such as MAGE-l, MAGE-3, BAGE, GAGE, PRAME and NYESO-l antigens; melanocyte differentiation antigens such as tyrosinase, Melan-A/MART-l, gp100, TRP-l and TRP-Z; mutated or aberrantly expressed antigens such MUM-1, CDK4, beta-catenin, gp100-in 4, p. 15 and N-acetylglucosaminyltransferase; and other suitable antigens like B7-1,TA-90, lysosome-associated membrane protein (LAMP),melanocyte-stimulating hormone receptor (MCIR), p90 calnexin, and other antigens known in the art.”
  3. The oncolysate can be derived from many different cell lines, as well as the patient’s own cancer cells (autologous) –”…other melanoma cell lines can be used. Such cell lines can be established de novo from tumor biopsies of melanoma patients or can be selected from already existing sources.”
  4. The DC-MelVac platform can be used in many different cancers – “the principles disclosed are equally applicable to a variety of other malignant tumors including but not limited to squamous cell carcinoma, lung cancers, breast cancers, head and neck carcinomas, thyroid carcinomas, soft tissue sarcomas, bone sarcomas, testicular cancers, prostatic cancers, ovarian cancers, bladder cancers, other types of skin cancers, brain cancers, angiosarcomas, mast cell tumors, primary hepatic cancers, pancreatic cancers, gastrointestinal cancers, renal cell carcinomas, lymphomas, and hematopoietic neoplasias.”

The Management Team believes the patented Intellectual Property, in its broadest form, covers the use of a recombinant vaccinia virus containing almost any recombinant gene, for the preparation of an oncolysate from any cell line, including the patient’s own cancer cells, for the treatment of any cancer.

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The Management, Research and Scientific Team are closely monitoring other developmental research that incorporates use of the patent for collaborative opportunities.