Press Releases and Announcements
March 2, 2010: PDS Biotechnology Corporation Awarded $1.28M National Cancer Institute Contract
PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company’s lead human papillomavirus (HPV)-cancer product late in 2010. This curative vaccine, which is based on PDS Biotechnology’s VersamuneTM platform nanotechnology, has demonstrated potent efficacy in curing HPV infection and HPV-related cancer in preclinical animal and human model studies. Over 400 million people are infected with the HPV virus and several common cancers are caused by the infection, including cervical, head and neck and anal cancers. No cures exist for these cancers.
The award was based on successful completion of a phase 1 SBIR contract demonstrating efficacy of the drug in human model systems, as well as recent GLP toxicology, pharmacokinetic and bio-distribution studies demonstrating an excellent safety profile and efficient uptake of the drug by the immune system. The new contract will cover over 70% of the costs required to complete the IND-enabling studies. The remaining 30% of the costs will be covered by non-federal government funds.
PDS Biotechnology’s VersamuneTM nanotechnology platform facilitates efficient uptake of disease-associated proteins and peptides by cells of the immune system and simultaneously acts a strong immune system modulator without the inflammatory side effects induced by current immune stimulators (also known as adjuvants). The result is simple, safe and cost effective drugs and vaccines that induce effective eradication of the specific cells infected with, or expressing the particular disease-related protein formulated with VersamuneTM. The company’s VersamuneTM-based melanoma product has also demonstrated high efficacy in curing melanoma, which is the most aggressive form of skin cancer, in preclinical animal studies.
PDS Biotechnology Corporation (www.pdsbiotech.com) is an Indiana-based biotechnology company applying the company’s proprietary VersamuneTM platform to the development of safe and potent immunotherapies to prevent and to treat cancer and diseases caused by infectious agents.
This project is funded in part or in whole with Federal Funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services under Contract No. HHSN261200900082C. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
October 6, 2009: PDS Biotechnology Corporation Demonstrates Pre-Clinical Safety of its Versamune™-Based HPV Product.
PDS Biotechnology Corporation today announced that the company has completed GLP toxicology studies of its lead HPV-cancer product. The studies, which included pharmacokinetic (PK) and adsorption, bio-distribution and excretion (ADE) studies in addition to the evaluation of toxicity, all demonstrated a very safe profile of the drug and PDS Biotech’s platform Versamune™ technology. No signs of toxicity were observed at the highest doses evaluated, significantly higher than the effective doses observed in preclinical studies. The studies also provided further confirmation of the technology’s mechanism of action and efficient uptake by the immune system.
Dr. Frank Bedu-Addo, PDS Biotechnology’s President and CEO, stated that this was a pivotal study in the company’s progress towards confirming the technology’s safety profile and evaluation in human clinical trials next year to treat cervical cancer. He also stated that “the high safety and efficacy that the technology has demonstrated will also enable the company to initiate discussions with prospective corporate partners to start developing the company’s infectious disease drugs which will target widespread diseases such as hepatitis, HIV, influenza and herpes.”
PDS0101 is a Versamune™-based immunotherapy drug which has demonstrated significant promise in curing HPV infection and HPV-related cancer in preclinical animal and human model studies. Cancers caused by infection with the human papilloma virus (HPV) include cervical, head and neck and anal cancers. No cures exist for these cancers. The drug is administered by subcutaneous injection.
PDS Biotechnology Corporation’s Versamune™ nanotechnology facilitates efficient uptake of disease-associated proteins and peptides by cells of the immune system and simultaneously acts as a strong immune system activator (adjuvant) without the inflammatory side effects induced by current adjuvants. The result is simple, safe and cost effective nanotechnology-based drugs and vaccines that induce effective eradication of the specific cells infected with, or expressing the particular protein formulated with Versamune™. PDS0102 has demonstrated high preclinical efficacy in curing melanoma, the most aggressive form of skin cancer. The technology is based on Merck AG’s proprietary enantiomer exclusively licensed to PDS Biotechnology for use in Versamune™.
PDS Biotechnology Corporation (www.pdsbiotech.com) is an Indiana-based biotechnology company applying the company’s proprietary platform Versamune™ nanotechnology to the development of safe and potent immunotherapies to prevent and to treat cancer and diseases caused by infectious agents.
Under its Prime Contract (HHSN261200800001E) with the National Cancer Institute, SAIC-Frederick, Inc. awarded a $366,400 subcontract to PDS Biotechnology, which covered 46% of the study costs, with the remaining 54% funded by the Indiana Economic Development Corporation’s 21st Century Fund, and private investments.
The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
May 18, 2009: BIOTECHNOLOGY COMPANY SELECTS LAWRENCEBURG LOCATION
PDS Biotechnology Corporation, a medical research company, has been working with several entities in Lawrenceburg concerning the possibility of locating the company in Lawrenceburg, Indiana. The company has now made a decision and reached an agreement to locate the company in Lawrenceburg effective immediately. This establishment of a major Biotechnology Medical Research Company moving to Lawrenceburg is the culmination of a cooperative effort which included Dearborn County Economic Development, the State of Indiana Economic Development, the City of Lawrenceburg, and Ivy Tech Community College working with PDS. The efforts to bring the company to Lawrenceburg had been underway in recent weeks and the agreement was signed last week.
The PDS Biotechnology Corporation was founded by an experienced drug development team to commercialize vaccines to cure and also to prevent cancer and infectious diseases in large markets with the unmet needs. PDS owns Versamune, a platform nanotechnology that overcomes the obstacles associated with competing technologies and enables the development of safe, simple, cost effective and potent vaccines to treat cancer and infection diseases. The company’s first Versamujne based product, Versamune-HPV is being developed to treat currently untreatable cancers caused by infection with the human papillomavirus (HPV), such as cervical cancer, head and neck cancer and anal cancer. In January 2009, the Indiana Economic Development Corporation (IEDC) through its 21st Century Fund awarded PDS $2.0 million grant to complete pre-clinical development of Versamune-HPV. The grant award required PDS relocate to the State of Indiana by June, 2009. PDS proceeded with the process of researching Indiana sites and identifying a suitable place to locate, as the company intends to reside and grow long-term in Indiana. PDS expects to grow approximately 100, and possibly more, employees which will consist of high paying jobs to highly skilled employees with a wide range of college degrees up to and including the Doctorate. Two key stages of growth are anticipated: 1) 2011-2012 upon completion of human safety studies leading to successful licensing of the technology and information of corporate partnerships with larger pharmaceutical companies. 2) 2016-2017 upon successful commercialization of the company’s lead product Versamune-HPV.
The City of Lawrenceburg, Ivy Tech Community College, Dearborn County Economic Development, and the State of Indiana are extremely pleased to have a major medical research company select the Lawrenceburg location for the PDS Biotechnology Company. Discussions were held over recent weeks directly with PDS officials Mr. Frank K. Bedu-Addo, Ph.D., PDS President and CEO, and Gregory L. Conn, Ph.D., the PDS company Chief Scientific Officer. Local officials involved in the process and working to bring this together include Lawrenceburg Mayor Bill Cunningham, Chancellor Jim Helms of Ivy Tech Community College and Chairman of the Dearborn Economic Development Board, City Manager Tom Steidel, Dearborn Economic Development Director Mike Rozow, and Doug Moorman of Cincinnati USA Partnership; also support from Ivy Tech Community College President Tom Snyder and Susan Brooks, Ivy Tech statewide Legal Counsel and head of the college Workforce and Economic Development.
PDS President Frank K. Bedu-Addo, Ivy Tech Chancellor Jim Helms, and Ivy Tech President Tom Snyder all signed the lease agreement last week. The PDS Company is currently moving into the Ivy Tech facility at the Lakefront Campus location on Industrial Drive, Lawrenceburg. The Lawrenceburg people involved have expressed excitement and are extremely pleased to have a company of this caliber locate in the City of Lawrenceburg, as well as the securing excellent jobs for the area; and a company which can contribute greatly to the benefit of Dearborn County, the State of Indiana, and the entire area. Ivy Tech will also have the opportunity for student internships with the company. PDS President and CEO expressed that they appreciate all of the assistance in making their relocation to Lawrenceburg a smooth one and that PDS looks forward to being an integral part of the Lawrenceburg community. Chancellor Helms basically sees this as the beginning of an era of the Ivy Tech facility becoming a medical research incubator and leading to many great opportunities for all concerned, as well as possible new degree programs to compliment PDS and the Biotech industry in the future.
February 24, 2009: PDS Biotechnology Corporation Finalizes Commercial Licensing Agreement with Merck Eprova AG to Utilize Merck Eprova’s Enantiomers of DOTAP Chloride in Immunotherapies
PDS Biotechnology today announced that the company has obtained an exclusive license from Merck Eprova AG to utilize Merck Eprova’s proprietary chiral lipid DOTAP Chloride in Versamune™–HPV and other products in development based on the Versamune™ technology. The use of enantiomerically pure DOTAP Chloride shows enhanced adjuvant activity compared to the racemate. Merck Eprova AG will be providing enantiomerically pure DOTAP Chloride manufactured under cGMP for use in clinical and commercial drug products developed with PDS Biotechnology’s Versamune™ nanoparticle technology. PDS Biotechnology will own the intellectual property rights to products incorporating the chiral DOTAP lipids for immunotherapeutic applications.
Versamune™–HPV is an immunotherapy drug which has demonstrated significant promise in curing HPV infection and HPV-related cancer in preclinical animal and human model studies. Cancers caused by infection with the human papilloma virus (HPV) include cervical, head and neck and anal cancers. No cures exist for these cancers. Based on promising in vivo and in vitro efficacy data, PDS Biotechnology has been awarded grants by the US National Institutes of Health/National Cancer Institute to develop Versamune™–HPV and Versamune™–Melanoma. Versamune™–Melanoma is being developed to treat melanoma, which is the most aggressive form of skin cancer.
PDS Biotechnology’s Versamune™ nanotechnology facilitates the uptake of disease-associated protein and peptide antigens by the antigen-presenting cells of the immune system. Simultaneously it acts as a strong immune system activator (adjuvant) without the inflammatory side effects induced by current adjuvants. The result is simple, safe and cost effective nanotechnology-based drugs and vaccines that induce effective eradication of the specific cells infected with, or expressing the particular protein formulated with Versamune™.
PDS Biotechnology Corporation (www.pdsbiotech.com) is an Indiana-based biotechnology company applying the company’s proprietary Versamune™ nanotechnology drug platform technology to the development of safe and potent immunotherapies to prevent and to treat cancer and diseases caused by infectious agents.
Merck Eprova AG (www.merckeprova.com), located in Schaffhausen, Switzerland, is a wholly owned subsidiary of Merck KGaA located in Darmstadt, Germany. Merck Eprova AG specializes in the development and production of cGMP grade, highly purified and characterized Drug Delivery Compounds such as cationic lipids, PEGs, PEG-lipids, and phospholipids. In addition Merck Eprova AG is a centre of excellence for reduced folates in the pharmaceutical and nutritional field and the world’s leading supplier of reduced folates.
January 19, 2009 - Biotechnology Company to Relocate Its Cincinnati Operations to Indiana
INDIANAPOLIS (Jan. 19, 2009) – PDS Biotechnology Corporation, a developer of disease-destroying nanotechnology, announced today it will relocate its Cincinnati headquarters and laboratory here with the help of a $2 million grant from the state’s 21st Century Research and Technology fund.
The biopharmaceutical company, which will locate its operations at a yet-to-be announced site in the capitol city, will bring to Indiana its Versamune™ platform technology that allows scientists to deliver targeted nanoparticles to the body’s immune system and then stimulate the immune system to destroy infections and cancers.
“The 21st Century Fund provides critical seed capital to emerging high-growth companies such as PDS Biotechnology that are necessary to ensure our state's economic growth,” said Governor Mitch Daniels.
PDS Biotech’s technology, which has already garnered financial support from the U.S. National Cancer Institute, will first appear in a therapy the company is developing aimed at combating currently incurable cancers associated with the human papilloma virus (HPV). Toxicology studies are underway now for the cancer-combating technology, and company officials plan to begin clinical trials in the next 18 months.
“This is a very exciting time for the company. The Versamune™ technology has demonstrated the potential to overcome the key efficacy and safety obstacles associated with other leading technologies. PDS Biotechnology chose to locate the company in Indiana over other competing states based on several important factors including the presence of top rated universities, a world-class nanotechnology center, and the solid and rapidly growing biotechnology infrastructure,” said Dr. Frank Bedu-Addo, president and chief executive officer of PDS Biotechnology Corporation.
The development of the therapy represents a breakthrough for treating HPV-related cancers. The virus is the most prevalent sexually transmitted agent worldwide and is present in nearly all cases of cervical cancer - the second leading cause of death in women worldwide.
The news of PDS relocating to Indiana comes less than three months after it was announced that the Maryland-based U.S. National Cancer Institute’s Nanotechnology Characterization Lab (NCL) is collaborating with the firm to complete preclinical development of its HPV-cancer combating therapy. The NCL, a collaboration between the U.S. National Cancer Institute, the U.S. Food and Drug Administration and the National Institute of Standards and Technologies, will assist PDS Biotechnology in performing selected physical, chemical and biological studies to help speed the technology through regulatory submissions with the FDA.
PDS Biotech is one of 63 businesses awarded a 21st Century Fund grant since January 2006. During that time, the fund has invested more than $82 million in high-tech Indiana entrepreneurial companies that collectively have the potential to create thousands of new jobs.
Press release, PR News wire - November 4, 2008
PDS Biotechnology today announced that the company has been selected as a collaborator of the US National Cancer Institute’s Nanotechnology Characterization Lab (NCL) to complete preclinical development of Versamune™–HPV prior to filing of the Investigational New Drug Application. The NCL will perform selected physical, chemical and biological studies on behalf of PDS Biotechnology Corporation at its facilities at the National Cancer Institute (NCI) in Frederick, Maryland. Dr. Frank Bedu-Addo, President of PDS Biotechnology stated that “PDS Biotechnology Corporation’s partnership with the NCL provides significant value to the company. The invaluable expertise of the NCL’s scientists will provide the company with additional expert resources and technologies, and will facilitate rapid development of the product”.
Versamune™–HPV is an immunotherapy drug which has demonstrated significant promise in curing HPV infection and HPV-related cancer in preclinical animal and human model studies. Cancers caused by infection with the human papilloma virus (HPV) include cervical, head and neck and anal cancers. No cures exist for these cancers. Based on promising in vivo and in vitro efficacy data, PDS Biotechnology Corporation was awarded in August 2008, a phase I SBIR grant by the US National Institutes of Health/National Cancer Institute to develop Versamune™–Melanoma to treat melanoma, which is the most aggressive form of skin cancer.
PDS Biotechnology Corporation’s Versamune™ technology facilitates the uptake of disease-associated protein and peptide antigens by the antigen-presenting cells of the immune system and simultaneously acts a strong adjuvant without the inflammatory side effects induced by current adjuvants. The result is simple, safe and cost effective drugs and vaccines that induce effective eradication of the specific cells infected with, or expressing the particular protein formulated with Versamune™.
PDS Biotechnology Corporation is a Cincinnati, Ohio-based biotechnology company applying the company’s proprietary Versamune™ nanoparticle platform technology to the development of safe and potent immunotherapies to prevent and to treat cancer and diseases caused by infectious agents.
The NCL is a formal collaboration between the US National Cancer Institute, the US Food and Drug Administration (FDA) and the National Institute of Standards and Technologies (NIST) to rapidly advance promising cancer nanotechnologies through regulatory submissions with the FDA.
