Seat­tle Ge­net­ics may beat Roche Hold­ing AG in can­cer ther­apy

The Pak Banker - - Company& -

SAN FRAN­CISCO: Seat­tle Ge­net­ics Inc. and Takeda Phar­ma­ceu­ti­cal Co. may beat Roche Hold­ing AG in de­vel­op­ing a new type of com­bi­na­tion can­cer ther­apy that's less toxic than stan­dard treat­ments.

The prod­uct, SGN-35, uses an an­ti­body that rec­og­nizes and con­nects to re­cep­tors found only on the sur­face of ma­lig­nant cells. Once there, the ther­apy re­leases a pow­er­ful chem­i­cal called au­ris­tatin that kills can­cer cells by stop­ping them from di­vid­ing. By keep­ing that drug out of the blood­stream and away from healthy tis­sue, the treat­ment avoids the side ef­fects of stan­dard chemo­ther­apy.

Two stud­ies on SGN-35's use in lym­phoma, to be re­ported at a med­i­cal meet­ing next week, may al­low Osaka, Ja­pan-based Takeda and Seat­tle Ge­net­ics, of Bothell, Washington, to win U.S. clear­ance a year be­fore Roche's sim­i­lar ther­apy, called T-DM1. If ap­proved, SGN-35 may gen­er­ate $420 mil­lion in an­nual rev­enue by 2015, said Ja­son Kantor, an an­a­lyst at RBC Cap­i­tal Mar­kets.

The two drugs "are the tip of an ice­berg," said Kantor, who is based in San Fran­cisco, in a tele­phone in­ter­view. "Once one of these drugs proves it­self clin­i­cally and is ap­proved, we're go­ing to see many more over the next three to five years. And they will have a mean­ing­ful im­pact on can­cer treat­ment."

Seat­tle Ge­net­ics, which has no mar­keted prod­ucts, plans to ap­ply to the U.S. Food and Drug Ad­min­is­tra­tion for con­di­tional ap­proval of SGN35 in the first half of 2011, said Chair­man and Chief Ex­ec­u­tive Of­fi­cer Clay Sie­gall. That process would al­low the drug to be used while the com­pany con­ducts con­fir­ma­tory stud­ies. If the agency agrees, SGN-35 may be in doc­tors' hands by the end of 2011, Sie­gall said in an in­ter­view.

In Au­gust, the FDA de­clined a request by Basel, Switzer­land-based Roche, the world's biggest maker of can­cer drugs, and its part­ner, Waltham, Mas­sachusetts­based Im­muno­gen Inc., to ap­prove T-DM1, a souped-up ver­sion of its breast can­cer ther­apy Her­ceptin, on an ac­cel­er­ated ba­sis. The agency said the ap­pli­ca­tion didn't meet the cri­te­ria be­cause other ther­a­pies for breast can­cer are avail­able to pa­tients, ac­cord­ing to Roche.

Roche may file a new ap­pli­ca­tion in 2012, Krysta Pel­le­grino, a spokes­woman for Roche's Ge­nen­tech unit, based in South San Fran­cisco, Cal­i­for­nia, said in an e-mail.

Seat­tle Ge­net­ics fell 7 cents to $15.10 in Nas­daq Stock Mar­ket trad­ing yes­ter­day. The shares have surged 63 per­cent in 12 months, and have risen 24 per­cent since pre­lim­i­nary re­sults on the lym­phoma stud­ies were an­nounced be­fore the start of trad­ing on Sept. 27.

Those ini­tial re­sults showed the drug was "very po­tent" and pro­vide the ba­sis for Seat­tle Ge­net­ics to seek U.S. clear­ance, Kantor said. While ap­proval would come first for pa­tients who weren't cured by other ther­a­pies, the drug even­tu­ally may gain wider use if it proves it­self as a first-line treat­ment, he said.

The new com­bi­na­tion drugs have three key com­po­nents: an an­ti­body, a can­cerkilling drug, and a Vel­cro-like sub­stance known as a linker that holds the two tightly to­gether so they don't sep­a­rate in the blood­stream. Af­ter the an­ti­body finds and binds to its tar­get, the linker loosens its grip and dumps the drug in the cell, where it attacks from within.

Be­cause the med­i­ca­tions de­liver their chem­i­cal pay­loads only to the tu­mor, they can be given at high doses and still avoid the side ef­fects that can make chemo­ther­apy mis­er­able for many pa­tients, said Hope Rugo, a breast can­cer spe­cial­ist at the Uni­ver­sity of Cal­i­for­nia, San Fran­cisco.

"If this ap­proach pans out, it could bring a real change in the way we think about de­liv­er­ing treat­ment," Rugo said in a tele­phone in­ter­view. "It's a per­fect sce­nario for how you could kill can­cer and not cause so much sys­temic tox­i­c­ity."

An­drei Shus­tov, a blood can­cer spe­cial­ist at the Uni­ver­sity of Washington in Seat­tle, led a trial of pa­tients who had re­lapsed af­ter be­ing treated for anaplas­tic large cell lym­phoma, a rare and ag­gres­sive type of t-cell lym­phoma. Lym­phomas at­tack the lym­phatic sys­tem, part of the body's dis­ease-fight­ing sys­tem.

Shus­tov and his col­leagues gave as many as 16 rounds of SGN-35 to 58 pa­tients. In the first group of 30, 57 per­cent had a com­plete re­sponse, mean­ing their can­cer was un­de­tectable, and 30 per­cent had les can­cer in their sys­tem.

"In treat­ing t-cell lym­phomas for the past five years, I have never seen ac­tiv­ity even ap­proach­ing the ef­fi­cacy of SGN-35," Shus­tov said. "I be­lieve this is a ma­jor break­through in t-cell lym­phoma ther­apy."

Among the pa­tients was a 19-year-old woman who'd been told she was likely to die. She's now in re­mis­sion, Shus­tov said. He will present de­tailed re­sults on all 58 pa­tients at the an­nual meet­ing of the Amer­i­can So­ci­ety of Hema­tol­ogy, be­gin­ning Dec. 4 in Or­lando, Florida.

SGN-35 also was tested in 102 pa­tients with a more com­mon con­di­tion called Hodgkin's lym­phoma. While Hodgkin's is of­ten cur­able, the peo­ple in the study were drawn from the 15 per­cent of pa­tients who didn't im­prove on chemo­ther­apy and had poor prospects for sur­vival.

Ini­tial re­sults of the trial, which also will be pre­sented at the hema­tol­ogy meet­ing, showed that the tu­mors shrank in 97 per­cent of pa­tients, and symp­toms dis­ap­peared in 83 per­cent.

"This is un­heard of for a sin­gle drug," said Robert Chen, the study's lead re­searcher. "Within a week you could see some pa­tients get bet­ter." With SGN-35, "you're go­ing to see more cures and you're go­ing to buy a lot more time for pa­tients who pre­vi­ously were des­tined for hospice."

Chen is an as­sis­tant pro­fes­sor at the City of Hope, a non­profit can­cer cen­ter in Duarte, Cal­i­for­nia, and a con­sul­tant for Seat­tle Ge­net­ics.

Seat­tle Ge­net­ics and other part­ners are also test­ing dif­fer­ent an­ti­body-drug com­bi­na­tions for treat­ing can­cers of the kid­ney, prostate, pan­creas and other or­gans. The al­lies in­clude Roche's Ge­nen­tech unit; Bayer AG of Lev­erkusen, Ger­many; Celldex Ther­a­peu­tics Inc. of Need­ham, Mas­sachusetts; Dai­ichi Sankyo Co. of Tokyo; Glax­oSmithK­line Plc of London; As­traZeneca Plc of London, and Astel­las Pharma Inc. of Tokyo. -Bloomberg

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