LipoNova GmbH

LipoNova - the cancer vaccine company!

LipoNova, a privately held company founded in 1998, focuses on the development, manufacturing and marketing of customized drugs for therapy and diagnostics. Regarding R&D we specialise in the development of biotechnologically innovative drugs in the immunotherapy of cancer. A state-of-the-art GMP manufacturing complex expanded in spring 2001 hosts our own production as well as contract manufacturing.

Scientific cooperation with leading German and European university clinics and uro-oncological competence centers is well established.

Clinical Trials

LipoNova has conducted an extensive (55 study centers, 558 patients), prospective, randomised and controlled multicenter phase-III trial to the efficacy of adjuvant immunotherapy of the renal cell carcinoma with individual tumor vaccine versus the treatment of single tumor nephrectomy. The trial is closed, the results of the interim analysis have been highly lauded at national and international uro- and oncological meetings throughout 2002. The abstract featuring these results was honoured with a Merit Award at the ASCO, 2002, meeting. The results of the final report of this study will be published in autumn 2003. Other clinical studies in various oncological indications have already started or are in advanced initiation stages.

On September 11th, 2002 the COMP adopted a positive opinion on LipoNova´s application for Orphan Medicinal Product Designation. The European Commission followed this designation on October, 21st, by granting a favourable decision on aTL being an Orphan Medicinal Product for the orphan indication: treatment of renal cell carcinoma. aTL is entered into the Community Register of Orphan Medicinal Products under the number EU/3/02/116. Based on reception of orphan-drug-status and the results of the clinical phase-III trial, LipoNova is currently entering the procedure of application for centralized marketing authorisation in the European Community. The company expects to receive marketing authorisation in 2004.

Vision

For the individual patient the tumor excised "today" could prove "tomorrow´s" medication. It is our vision to provide every tumor patient with an innovative and individual therapy. Under GMP standards we offer the storage of surgically excised tumor tissue.

LipoNova is one of the sponsors of the PA.T.H. - patients tumorbank of hope - Foundation with LipoNova´s Managing Director, Dr. Claudia Ulbrich, as one of the chairpersons of the foundation. LipoNova and PA.T.H. cooperate in the storage of tumor tissue in LipoNova´s own tumorbank. The pricing model for this cryo-asservation provides every person affected with a chance to future treatment.

Logistics

Delivering customized drugs containing viable cells to the applying physician is restricted by a very limited time schedule. By cooperating with an internationally operating logistics partner LipoNova has established and validated a logistics model guaranteeing our tumor vaccines to arrive in prime condition at the applying physician.

Business model

Even in the earliest stages of our company´s history we have understood the necessity for a life science company to diversify. We offer our partners a wholesome concept: R&D with the most solid background, standardised and validated manufacturing procedures and an open mind for new projects give us a head start into the new era of biotechnology.