Company Analysis - Pfizer
A PMED pipeline
PowderMed was founded in May 2004 by the current CEO, Dr Clive Dix, and is an immunotherapeutic company based in Oxford, the UK, developing DNA-based vaccines for chronic viral diseases and cancer. It aims to transform the vaccine market by changing the way that vaccines are manufactured. The 50 year old method of vaccine production in eggs is successful, however, it is a time-consuming process and does not permit quick adaptation for emerging strains such as the publicized H5N1 influenza strain.
Particle Mediated Epidermal Delivery technology, known as PMED™, is a needle-free method of administering vaccines that requires minimal medical training and may allow for self administration. The PMED system involves the precipitation of DNA onto microscopic gold particles that are then propelled by helium gas into the epidermis. The DNA-coated gold particles are delivered into the antigen-presenting cells (APCs) of the epidermis (Figure 1), and once inside the nuclei of the APCs, the DNA elutes off the gold and becomes transcriptionally active, producing encoded protein. This protein is then presented by the APCs to the lymphocytes to induce a T-cell-mediated immune response.
As well as being a method that could incorporate DNA of new and emerging strains of viruses, the PMED technology also has the advantages of using 1,000 times less DNA than needle/injected vaccines - reducing cost per dose - and provides vaccines that are stable at room temperature.
Table 1 displays PowderMed's products in development: vaccines for AIDS; chronic hepatitis-B virus (HBV); human papillomavirus (HPV) for genital warts; herpes simplex virus for genital herpes; pandemic and avian influenza; and gene therapies for allergy/asthma and lung cancer.
Its lead product is a vaccine for the prophylaxis of pandemic influenza, which demonstrated safety, was immunogenic and attained seroprotective levels of antibodies in clinical trials. A trivalent version of the vaccine is in a UK Phase I trial in over 100 healthy volunteers to assess safety and tolerability, with completion expected in May 2007.
One of only seven vaccines in clinical trials for the prevention of avian influenza, PowderMed's H5N1 vaccine contains the H5 Vietnam gene cassette. A Phase I trial was initiated in the UK in August and will be completed in 2007.
Next year is also a salient year for other products in PowderMed's pipeline, with results of an Asian and US Phase I trial expected to be available for its chronic HBV vaccine and initiation of Phase I trials for its preclinical HPV candidate.
PowderMed has already demonstrated the integrity of its technology via the partnering or two clinical-stage products. It is collaborating with fellow UK Company GlaxoSmithKline in the development of an AIDS vaccine and with the Ludwig Institute for Cancer Research for a therapeutic DNA vaccine for NY-ESO-1-positive lung cancer.
