Executive Summary

CureVax is a bio-immunology pharmaceutical development company with offices in New York City and its laboratory and research facility at the SUNY Downstate Incubator in Brooklyn, New York. The Company has protected intellectual property for the synthesis, and composition of the MelVac platform, including its lead product, DC-MelVac Vaccine (US patent 7,015,205). The CureVax business plan is to fully develop the MelVac design in order to provide immunotherapeutic cures of melanoma either singly or in combination regimens. The company’s patented technology and ongoing research will yield a continuous stream of immunological breakthrough products and a continuous patent pipeline in the future.

The advantages of the CureVax MelVac and its competitive features that can potentially transform the landscape of bio-immunology cancer treatments options are as follows:

  • It is a Immunotherapeutic Vaccine with a broad repertoire of common melanoma-associated antigens
  • It has a validated adjuvant in vaccinia (cowpox) virus which has a long history of effective and safe human use as a vaccine for smallpox
  • Technology platform readily adaptable to other cancers increasing its IP pipeline
  • Technology platform readily adaptable with other combination therapies including Checkpoint Inhibitors
  • Technology platform readily adaptable to autologous vaccines, if required
  • It is a positive stimulator of the cancer specific immune response that can afford enhanced benefit to patients who have failed checkpoint inhibitors (currently 40-60% of advanced melanoma patients)
  • It has commercial scalability and readily deployable treatment availability – “common melanoma antigens provides an “off the shelf” business model.

Advanced melanoma patients with metastatic disease are the primary clinical targets for the initial testing of this immunotherapeutic vaccine. The successful use of the checkpoint inhibitors, (Ipilimumab, Pembrolizumab, Nivolumab which are anti-CTLA-4 and anti-PD-1/PDL-1 therapeutics) in many-advanced melanoma patients have afforded new hope to these patients. However, it is also understood that close to 40%-60% of the patients do not respond. Additionally, one other drawback to Checkpoint Inhibitor Therapy is that treatment can be associated with severe adverse effects and toxicity. The patented MelVac platform provides a new alternative of a positive stimulator of the patient’s own immune system against his/her own cancer. We expect the MelVac platform products, including it lead product, DC-MelVac, to be used in all patients with advanced disease irrespective of their prior treatment history.

The CureVax MelVac platform immunotherapeutic vaccine can provide clinicians with a new weapon in the armamentarium to fight cancer and bring much needed management of cancer to prolong survival and the patient’s quality of life.

The CureVax scientific team has over a century of collective experience with the President being the inventor of the proposed vaccine platform. The CureVax Research and Development Team is composed of academic clinicians and scientists with broad experience in translational clinical research, as well basic mechanistic immunologic science. Management believes this team brings tremendous value to the company in terms of further IP development. The Company expects to grow the current research and development team of academic scientists and expand into new laboratory space in the SUNY Downstate Technology Incubator located in Brooklyn, New York in the fourth Quarter 2015.

CureVax Major Developments:

  • Management and Founding Team in place.
  • Research and Scientific Team in place.
  • Forty years of immunotherapy research experience. The current Research and Scientific Team was the first research team to have completed a Randomized, Double-Blind, Multi-Centered, Pharma Produced NCI sponsored cancer immunotherapeutic trial in the US.
  • Anti-melanoma immune response have been observed with the CureVax lead product, DC-MelVac and it was associated with improved patient survival.
  • FDA clearance for initiating a Phase I clinical trial for its proprietary lead product (DC-MelVac) in place.
  • Rapid testing and establishing of an immunotherapeutic regimen in melanoma at stages where treatment options are very minimal, and no clear standard of care exists.
  • Industry observers believe the bio-immunity pharmaceutical development market is worth $3-5B
  • Management Team believes in its ability to collaborate and developclinical partnerships with pharmaceutical research and drug discovery companies to expand its pipeline and provide therapeutic combination options in the cancer space today.
  • The Phase 1 clinical trial goal is to demonstrate safety of DC-MelVac and demonstrate induction of anti-melanoma immune response in patients.
  • The Research and Scientific Team believes the completion of Phase 1 clinical testing can be accomplished within an 18 month window
  • Collaborative business opportunities with Biopharmaceutical Companies marketing Checkpoint Inhibitors exist
  • DC-MelVac platform has broad specificity to be used in all stages of melanoma patients.
  • The CureVax technology is well adapted as an off-the-shelf vaccine demonstrating that commercialization and production of DC-MelVac is a feasible business model.
  • The MelVac platform technology can be readily adapted to autologous vaccines which may be required for personalized medicine and used with Checkpoint Inhibitors.
  • The MelVac technology platform is broad and can be extended and adapted to many other cancers, such as lung and colon. CureVax has the potential to enhance future IP with expansion into the treatment of other non-melanoma cancers.
  • Multiple paths for business extensions and advancement of the companies Intellectual Properties exist.

The CureVax MelVac platform technology and its lead product, DC-MelVac, is the result of over 40 years of basic and clinical cancer research and has evolved from the development stages of cancer immunotherapy through the golden era that is just beginning to emerge in the cancer therapeutic marketplace. The basic science of the MelVac Platform has been vetted through all the steps of molecular and cellular biology, and the regulation of the immune system, so that this vaccine may be able to modulate and affect ‘cures’ in metastatic disease, the holy grail of cancer therapy.

Management believes the CureVax MelVac platform IP can be leveraged to provide new Intellectual Properties in several ways.

  • The MelVac platform can be adapted to treat different cancers by changing the composition of the cell lines used in making the oncolysates.
  • The MelVac platform’s immunostimulatory capabilities can be expanded and modulated by the construction of additional recombinant vaccinia virus vectors, each with its own IP. These patent protected vaccine vectors (including the current IL-2-recombinant virus) may be used with or without dendritic cells, doubling their IP potential.
  • The MelVac platform may be used in combination with other cutting edge therapies such as checkpoint inhibitors and small molecule inhibitors. Each of these combination therapies potentially carries its own IP.

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Further the Genomic Classification of melanoma has just recently been published by the National Cancer Institute (Reference Index # 4 Akbani et al., 2015), thereby positioning the future use of DC-MelVac with additional targeted small molecule therapies.