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THE UNBRIDLED OPTIMISM THAT SURROUNDED MONOCLONAL ANTIBODIES
in the 1980s was infectious, You had to be the world’s toughest cynic not ta be
dazzled. Got cancer? No problem. Like heat-seeking missiles, monoclonal antibodies
tipped with poisons or radioactive isotopes would home in on malignant cells and
deliver their deadly payloads, wiping out cancer while leaving normal cells intact.
How abort an jatcerious disease? All
‘would be well, Monnaclonals would sue-
round searaucing viruses ard bocteria
Hike goombaks From Cony Soprano’s
snuscling therm isto secluded by-
ways where killer cells of the immare
system would make chem en offer they
soul's reise,
Tr only chings had been so imp
Monoclonal antibodies are highly pure
popuarions of immune system proteins
that attack specificmolecularrarge, Une
runerely, peaple who roccived ial
of tie tarly therapeusic monostonal
iver showed « predilection for these
early monoclonals, sopping them up be-
forethey could targer their quarries, Cline
ical cizls failed, Stocks plunged. Millions
ofdollars were lost. Anda generation of
scientists sad biotechnolegy business-
veloped the skepricism shared
only by the once bumed, ewice sky.
Luckily, some of those individuals
soldiered on despite the bad news and
found ways to overcome the failings af
the early sersions of the drags. Now
many are hoping chat 2001 will be che
Year o! the Monoelonals, when thei per-
sererance wil pay of in she form of lots
of elfective mozoclonal anaibody-besed
hugs approved o- under evaluation by
the U.S, Food and Doug Administarion,
Ant:
s+ Anritogies erelarge, Y-shaped molecules that cel of the immune system called
3 lymphcoyses prosiuce tefight invaders, Menacional antibodies ate made by
108, orclonas, ofono single 8 lmphazyte, ethey atteckonly ene
people
al entibadies nowon thernarker, ts do everything fom
preventing organ-traneplantrejactian to treating cancer, Thies nuie are waiting
in the wings or Food and Crvg Administration agpraval
5 Athough monocional antibaties ere usually preduced ay mammalian ceils called
hypridemas, ssienticre are warking toderive them fram the milkf genetically
engineered anyma's ane from transgente plants.
2159 called MAbs~are cheaperan faster to ready for
rraldrugs, hich are maze cf small inerganic moieeales:
20 sp evnieic avenican
“Antibodies will be surging ahead,” says
Franklin M. Berger, 2 biorech analyst
with JP Morgan Secucicies. He predicts
hat soon there will be so many mono
clonal antibodies aviting approval ly
the FDA thet they will cause a borteacck
inthe review process.
“Ten monoclonals have reached the
marker, and three awaieFDS approval =
clading the first two char would
equipped 10 deliver a dove of radiation
[sce table o7 page 35). Another 100 or
more antibodies are being tested in hu
‘mans, having already shown promise in
tests iovelving enimals,
Bur this summer the FDA senca mes-
sage that could slewethe monoclonal jug
gorau. In July the agency tld Genen-
tech, located in Somth San Francisc
Calif, that ir would have to prosent ad