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PDS Biotechnology Corporation
Biotech Specialty Pharma
500 Industrial Drive, Suite A,
Lawrenceburg,, IN 47025 USA
phone:812-537-0779
fax:812-537-1614
Symbol Private
Founded 2006
Employees
www.pdsbiotech.com
Research Sector Biotech Specialty Pharma
Summary Description
VeramuneTM nanoparticle-based therapies demonstrated to be safe and effective in treating aggressive cancers and infectious diseases. Focus markets: Oncology and Infectious diseases.
Management
Frank Bedu-Addo, PhD, President and CEO Gregory Conn,PhD, CSO
Keywords
PDS Biotechnology Corporation Indiana-based biotech VersamuneTM proprietary platform nanotechnology eradicating aggressive cancers metastatic melanoma human-papilomavirus cancers single-dose preclinical studies sub-cutaneous injection

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Updated: Aug. 30, 2011

Description
PDS Biotechnology Corporation (PDS) was founded to commercialize a new generation of safer and more potent therapeutic/curative vaccines to treat various cancers and infectious diseases. PDS owns VersamuneTM, a proprietary platform nanotechnology that has demonstrated effective eradication and prevention of aggressive cancers with single low doses of the simple and safe VersamuneTM-based products in pre-clinical studies. The ingredient of the nanoparticles is provided by Merck AG, Switzerland under an exclusive licensing and supply agreement with PDS. PDS is also partnering with the National Cancer Institute via a CRADA to complete preclinical studies and to perform human clinical trials for the company's two lead products. The simple lipid-based technology overcomes critical obstacles facing the current curative vaccine technologies, and is being utilized to develop a number of therapies to treat various cancers and infectious diseases. VersamuneTMs unique mechanism of action and successful GLP toxicology studies predict a very good safety profile in humans. The companys lead product to treat widespread cancers such as cervical cancer and head and neck cancers is planned to enter human clinical trials in 2011. PDS biotechnology was recently awarded a $1.3M contract by the National Cancer Institute to complete IND-related studies for the lead product.
Products / Services
Safe and effective treatments for cancer and infectious diseases. PDS0101 - Cervical cancer therapy, head and neck cancer therapy. Subcutaneous injection. High efficacy in treating the cancer, and superior efficacy and safety to leading competitors has been demonstrated and published in leading peer-reviewed cancer journals. Clinical trials are planned for Q4 2011. PDS0102 - Melanoma therapy. Subcutaneous injection. High efficacy in treating both localized and metastasized melanoma has been demonstrated with single dose administrations of PDS0102 in preclinical studies. PDS plans to enter human clinical trials in 2012. Veterinary Vaccines - PDS is collaborating with the veterinary vaccines division of a major multi-national pharmaceutical company to evaluate the VersamuneTM nanotechnology in veterinary vaccines.
Technology / Differentiation
The proprietary VersamuneTM based products are the first pharmaceuticals to be based on a pure active cationic lipid enantiomer. The technology overcomes the following major drawbacks associated with the current curative/therapeutic vaccine technologies: 1. LOW POTENCY: This results from inefficient uptake, processing and presentation of the disease-specific proteins or peptides (antigens) by the cells of the immune system. . VersamuneTM Solution: Upon injection, the nanoparticles containing the encapsulated disease-specific proteins are naturally taken up and internalized by the immune cells. The nanoparticles due to their composition activate the immune cells and enable efficient presentation of the disease-associated protein to the T-cells. Superior tumor regression has been demonstrated with single low doses of the VersamuneTM-based products in head-to-head studies with leading technologies in clinical trials Other complementary mechanisms have also been implicated. 2. TOXICITY: Immune stimulators (adjuvants) are utilized in therapeutic vaccines to boost the bodys immune response to treatment. A major draw-back to the adjuvants currently in development is the potential to induce severe toxic reactions in patients. VersamuneTM Solution: A unique technology which activates a cell signaling mechanism leading to activation of the immune system without the typical inflammatory responses. Safety has been demonstrated in extensive toxicology studies. 3. COMPLEXITY: In an attempt to improve immune cell uptake and potency of vaccines, complex combinations of targeting moieties, delivery systems, adjuvants and cytokines are often used. Live virus and live bacteria-based vaccines are also being developed. VersamuneTM Solution: The VersamuneTM-based vaccines due to the inherent ability to activate the immune system, and secondly, the ability of the nanoparticles to effectively deliver the protein into the immune cells results in efficient processing. This has led to the development of simple products consisting only of the nanoparticles and protein. The lipids are synthetic and biodegradable.
Market / Customers
PDS0101 - Indications: Human Papillomavirus (HPV) related infection & cancers, e.g. cervical cancer & head and neck cancer. HPV is the most prevalent sexually transmitted agent worldwide. Over 400 million are infected. No cures exist, with existing products such as Gardasil useful only for prophylaxis prior to infection. Cervical cancer is a leading cause of female mortality worldwide. Head and neck cancers are the sixth most common cancer. Published expert studies suggest no decrease in the HPV market size over the next 20-30 years due to the prevalence of the infection and the long duration of disease progression. PDS0102 Indications: Melanoma, the most deadly form of skin cancer. The NIH estimates the lifetime risk in the US to be 1 in 55 males and 1 in 82 females. The veterinary vaccines market is expected to reach $5.1b by 2012. PDS is collaborating with a leading pharmaceutical company to evaluate VersamuneTM-based veterinary vaccines and could consider licensing agreements to generate early revenues. Pipeline VersamuneTM-based pipeline products will focus on the $47.7b cancer market and the $18b infectious disease market & applications.
Competitors / Substitutes / Alternatives
Advances in curative vaccine research suggest that this class of therapies provide great potential to successfully treat cancer and various infectious diseases. As a result of an improved understanding of the immune system and the potential of these therapies, a number of pharmaceutical companies are actively developing therapeutic vaccines. The first therapeutic vaccine was approved by the FDA in May 2010 to treat advanced prostate cancer. PDS Biotechnology's advantage over the current technologies is described in the Technology Differentiation Section.
Strategy
PDS is collaborating with experts in the field of cancer vaccines at the NIH/ National Cancer Institute to maximize potential for clinical success of the company's products. PDS expects to generate an early revenue stream prior to commercialization of the company's products via strategic technology licenisng and partnerships. Complete development of PDS0101 clinical formulation (Q2/2011). Start phase I human clinical trials for HPV-related cancer (Q4/2011). Corporate partnerships to co-develop products (2012/2013). Generate revenue by strategic technology out-licensing (2012/13). Initiate sales of the company's proprietary products (2016/17).
Funding
PDS is raising a Series A round of capital to support phase I human clinical trials for the company's lead product. The funds will cover clinical manufacturing and operational costs. A CRADA has been finalized with the NIH / National Cancer Institute (NCI) cancer vaccine division to collaborate through the final preclinical studies and to fund the phase PDS0101 and PDS0102. PDS Biotechnology has to date accepted approx. $6M in funding. About 80% of the funding has been obtained via non-dilutive sources such as the NIH's National Cancer Institute and the Indiana Economic Development Corporation.
Status
PDS Biotechnology is a privately funded company. The company's lead patent was issued in December 2007 and additional patents have been submitted. The company has close collaborations with the National Cancer Institute and an exclusive licensing agreement and partnership with Merck Cie in Europe. Safety of the technology was demonstrated in recent toxicology studies. Lead product: PDS0101 - late preclinical development of treatments for HPV infection, cervical cancer, head and neck cancers. Clinical studies anticipated to start Q4/2011 PDS0102 - preclinical development of treatments for metastatic melanoma. Clinical studies anticipated to start Q4/2012 PDS is collaborating with a multi-national Pharmaceutical company to apply the nanotechnology to veterinary vacines. Additional infectious disease and oncology pipeline products to be determined early 2012.