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Genta's Clinical Quest

Executive Summary

In one of the biggest late-stage biotech licensing deals ever, Genta has given Aventis worldwide rights to Genasense. The antisense compound targets Bcl-2, a protein now known to protect cancer cells from death messages. The firms are betting that giving patients this compound in combination with conventional therapies will kill cancer more effectively. The potential is high, but risk remains. Bcl-2 is unproven as a target, and designing clinical trials for two agents is not straightforward. Emerging from a troubled past, Genta initially decided to take the compound to market in the US all on its own. It focused on helping desperately ill patients in small disease indications. Eventually, as encouraging data accumulated, the small firm realized it would be better off partnering. The focused indications that Genta chose, and the way it pursued them, made strategic sense for it-but Aventis aspires to develop the drug against major cancer cancers. The large firm can afford to think bigger: it has more money and resources and the benefit of coming in after Genta laid the groundwork. Both companies are being guided by theories and observations, fully aware that such things mean little to regulators who demand clinical evidence. As befits their respective size and scope, the firms have different approaches to managing the risks of novelty.

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Can-Fite BioPharma Ltd.

Israeli start-up Can-Fite is developing small-molecule agonists of the adenosine A3 receptor, having come to its lead compound (in-licensed from the NIH) in the course of investigating why cancer never metastasizes to muscle tissue. The firm says mechanistic studies indicate that its lead compound could also treat inflammatory conditions like rheumatoid arthritis.

Antibiotics: Start-Ups Ply Novel Targets and Technologies

Microbial drug resistance is a real and growing problem, but drugmakers face disincentives: a plethora of products already on the market, the difficulty of differentiating drugs, and the habit of reserving truly new drugs for emergencies. Big Pharmas are backing out, creating opportunities for small companies who feel they can play successfully. But lack of interest from large partners means biotechs can't access the assets those firms hold, so many start-ups are pairing up with peers. Some firms are building businesses around an abundance of targets derived through genomics. But others are deliberately avoiding working with novel genetic code and instead studying whole cells and physiological changes in organisms. Many firms are addressing the lack of chemical diversity against targets. Some of these are pursuing diversity through natural products like marine microbes, insisting they'll fare better than earlier firms did, in part because of technological advances. Others are trying to create diversity synthetically, by taking structural approaches to understanding targets new and old, as well as compounds. Crystallography, in silico libraries, computational models and mass spectroscopy are key tools in iterative development processes that remain unproven in the anti-infectives field. Some firms are seeking to minimize the risks of novelty, by putting their efforts into developing new versions of antibiotics that worked well before resistance grew. No matter what technological approach start-ups take to developing antibiotics, all face similar challenges external to themselves-primarily in regulatory affairs and funding, but also in hunting Big Pharma partnerships.

Testing Drugs Against New Targets: Like Playing Blind Man's Bluff?

As companies move into development of drugs against novel targets, including a host of genomically derived drugs, they are assuming a new kind of target risk. The heightened risk exists largely because the targets revealed by genomics techniques for the most part have not been validated by linking them empirically to the initiation or maintenance of a disease state, nor through the use of biomarkers during clinical development. Stumbles in the pursuit of drugs against EGFR are symptomatic of this new pharma industry problem. In this context, the cancer drugs Herceptin and Gleevec, widely touted as the first examples of rapidly developed, rationally designed molecular medicines, will prove to be much more the exception than the rule. And importantly, the emerging pattern of EGFR drug development suggests that pursuit of novel targets will do little to ameliorate the industry's R&D productivity problem.

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