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The Fits and Starts of Targeted Cancer Drug Development

This article was originally published in Start Up

Executive Summary

Despite the success of Gleevec, developing drugs that inhibit complex signaling pathways, while simultaneously trying to understand the biology around a drug's target, remains a challenge. Without biomarkers to help establish dosing and identify likely responding patients, clinical development of targeted cancer drugs will remain challenging. AstraZeneca's recent experience with Iressa bears this out. It's likely that single markers will not be sufficient to stratify patients by their tumor types; rather, patterns of gene and protein expression will be required. The technology to take these measurements is making its way from academia to industry, but the process is slow, and needs encouragement and better coordination between academia, regulators, and industry. Meanwhile, clinical trials themselves remain the best target validation tools. When all is said and done, efficacy is the best biomarker.

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In 1997, Abbott Lab's Steve Fesik showed how a complex between a survival protein and a cell death-inducing helix interacted, triggering a spate of apoptosis-oriented (programmed cell death) cancer research. Now a research team has identified a distinct and completely unforeseen site on a death protein that activates its cell-killing function, potentially kicking off a renaissance in this still challenging field.

Long-Term Risks of Shutting Down VEGF from Inside the Cell

New research shows that production of VEGF -- a master regulator of blood vessel growth -- from within a cell is an important survival mechanism used by that cell, and that shutting it down could pose long-term risks. The work raises a red flag about long-term use of VEGF-inhibiting small-molecule cancer drugs that travel inside a cell to prevent VEGF expression. It also reinforces the importance of advancing methods for direct delivery of these drugs to tumors.

Novartis Out, Merck In, a Win for Vertex's Aurora Kinase Program

Earlier this year, Vertex and Novartis reworked their 2000 deal covering R&D of drugs against kinases. The shift has already proved consequential. Vertex had yet to present a compound to Novartis: the original arrangement called for Vertex to conduct all R&D through early clinical proof of concept and the most advanced molecule, VX-680, was just at IND filing. With Novartis unwilling to decide on VX-680 before seeing clinical data, as part of the renegotiation Vertex was able to regain control of the compound then license it to Merck. For that compound, at least, Vertex got from Merck what it couldn't get from Novartis: significant value and an earlier handoff of an asset.

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