Movement in cancer vaccine development plus breaking antidepressant research

DailyUpdates 12th May, 2006 (click here for entire bulletin): Today appears to be cancer vaccine day with two important announements being made. First off, Genitope Corporation announce the initiation of an ealry phase clinical trial of their MyVax idiotype immunotherapy; this was followed by an announcement by Biovest reporting that fast track status had been awarded to their phase 3 candidate, BiovaxID. This follows in the footsteps of the company's announcement that the FDA had approved sale of AutovaxID, enabling technology that should facilitate the use of candidates such as BiovaxID. In addition we highlight a study that will hopefully speed the development of novel antidepressants.

Study opens the way for rapid identification of MAO-A inhibitors as candidate antidepressants: With the global antidepressant market valued at $16.6 billion in 2002, drugs for the treatment of depression have historically provided huge returns on investment. However, several of the leading brands are expecting patent expiries over the next five years (see The World Market for Antidepressants 2006). New strategies are needed to prevent a decline in the antidepressant market. Somerset Pharmaceuticals have adopted a novel strategy having recently (Feb 2006) won the FDA approval of EMSAM, a patch formulation of Selegiline. This monoamine oxidase (MAO) inhibitor was initially approved in capsule form for use in Parkinson's Disease. The once a day patch works by delivering selegiline through the skin. The pharmacokinetic advantage of this mode of administration reduces the risk of hypertensive crisis experienced with currently employed oral irreversible MAO inhibitors due to the inhibition of MAO-A mediated tyramine catabolism. An alternative to improving the pharmacokinetics of irreversible inhibitors is the development of reversible ones. These agents are displaced from the MAO active site by tyramine thereby minimizing the risk of hypertension. Today’s featured study reports on the use of in silico modeling to predict MAO-A inhibitors. The findings were validate using an in vitro assay and it is hoped that this study can now be exploited to rapidly identify candidate antidepressants.

Biovest announce fast track status of cancer vaccine: Given an enhanced understanding of the biological basis for oncogenesis and the benefit of immunotherapy approaches such as Genentech/Roche's Rituxan, it is no surprise that targeted treatments and immunotherapy dominate the pipeline of emerging treatments for hematological malignancy (see Pipeline Insight: Hematological malignancies). Cancer vaccines represent a major class designed to complement current treatment approaches, rather than serve as a replacement. The majority of the cancer vaccine pipeline constitutes off-the-shelf vaccines rather than personalized or cell-based formulations. Although the former are capable of mass manufacture, the latter have shown greater clinical benefit, but encompass a more complex and expensive formulation. It is unclear which class will reach the market first (see Cancer Vaccines and Cell Therapies). Yesterday's announcement by Biovest may help to decide who will win the race. In their press release Biovest reported that they have been granted Fast Track status for BiovaxID, the Company's personalized biologic therapeutic for follicular non-Hodgkin's lymphoma. The targeted anti-cancer immunotherapy, now undergoing pivotal Phase 3 clinical trials at over 20 major medical centers throughout the US, showed extremely positive Phase 2 results (click here for data). This announcement should be read in the context of another release from Biovest highlighted yesterday reporting that the FDA had approved the sale of AutovaxID, the first and only instrument to enable the cost-effective and scalable production of cells or cell-derived products for personalized medicine applications.(click here).