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Jan 6, 2020
Drug developers take fresh aim at 'guided-missile' cancer drugs
FRANKFURT/ZURICH
(Reuters) - Dozens of drugmakers are conducting human trials for a
record 89 therapies that pair antibodies with toxic agents to fight
cancer, evidence of renewed confidence in an approach that has long
fallen short of its promise, an analysis compiled for Reuters shows.
FILE
PHOTO: A scientist studies cancer cells inside white blood cells
through a microscope at the GlaxoSmithKline (GSK) research centre in
Stevenage, Britain November 26, 2019. REUTERS/Peter Nicholls
These
antibody-drug conjugates, or ADCs, from companies including AztraZeneca
and GlaxoSmithKline, are described by researchers as “guided missiles”
packing a powerful anti-cancer punch.
They are engineered to zero
in on tumors and then release cytotoxins that deliver up to 10,000
times the potency of standard chemotherapy, while minimizing damage to
healthy tissue.
The approach has for decades been a major
biotech industry focus. Many experimental ADCs, however, failed due to
the complexity of pairing the right antibody with the appropriate toxic
agent. Some were abandoned as too weak; others were too harmful.
From 2000 to 2018, only five ADCs won approval. Just one, Roche’s (ROG.S)
Kadcyla, approved in 2013 for breast cancer, has surpassed $1 billion
in annual sales after data last year showed it boosted disease-free
survival for some patients compared with the standard treatment, Roche’s
Herceptin.
Over time, however, scientists devised better ways to
connect payloads and antibodies and more precisely reach tumors. There
is a growing understanding, too, of how to design ADCs to kill even
surrounding cancer cells that previously evaded destruction.
“What
we’re seeing now are the benefits of the science becoming mature,” said
ADC pioneer Chris Martin, CEO of Switzerland’s ADC Therapeutics ADCT.N.
“It took at least a decade, probably more like 15 years, to really
begin to turn the art into a science.”
In 2019, U.S. regulators
approved three ADCs, the most ever in a single year, as last-ditch
treatments based on studies showing they helped patients whose survival
outlook was bleak.
They include AstraZeneca’s (AZN.L) and Daiichi Sankyo’s (4568.T)
breast cancer drug, Enhertu, which was shown to help patients who had
failed numerous previous treatments survive a median of more than 16
months before their disease worsened.
Astellas’ (4503.T) and Seattle Genetics’ (SGEN.O)
bladder cancer drug, Padcev, also received expedited approval in
December, based on evidence that 44% of patients who had failed
immunotherapy showed improvement, and in some cases, no evidence of
cancer, when they were assessed after treatment.
Roche’s (ROG.S)
Polivy was green-lighted against lymphoma in June after producing
complete response rates, with no signs of disease, in 40% of patients
when combined with two other therapies.
NEW RECORD
While
all three drugs must prove their mettle in further studies, the
industry is growing optimistic that ADCs’ time may have arrived.
The
number of ADC drug candidates is at unprecedented levels, according to
data from consultancy Beacon Targeted Therapies compiled for Reuters,
based on a review of companies’ pipelines. Dozens more ADC prospects are
in pre-clinical review.
London-based Beacon advises drugmakers
on targeted therapies, helping them decide whether to pursue prospective
drugs or redirect efforts, based on industry trends.
Current ADC projects include GlaxoSmithKline (GSK.L) testing its belantamab mafodotin against multiple myeloma.
ADC
Therapeutics, part-owned by private equity firm Auven Therapeutics, has
several studies on experimental drugs, including with Danish partner
Genmab (GMAB.CO), on blood cancers and solid tumors.
U.S. biotech Immunomedics’ (IMMU.O)
market capitalization gained more than 60% to $4.3 billion in the last
six months, ahead of the U.S. Food and Drug Administration’s
late-December decision to review its ADC against triple-negative breast
cancer, which is hard to treat and has poor prognosis.
Massachusetts-based ImmunoGen (IMGN.O),
hit by past trial failures, got a lift in December for its ADC against
ovarian cancer when the FDA indicated it may become a candidate for
accelerated approval.
The surge in ADC investment has been
fueled, in part, by improvements in the so-called “linker” technology
that binds the antibody to its cancer-killing toxins, keeping them
stable in the circulatory system until the poison can be unleashed on
the targeted tumour.
ADCs are generally delivered via repeated infusions, similar to chemotherapy.
“There
is a revival again because there is a new generation of molecules in
which the linker is more efficient,” Giuseppe Curigliano, clinical
director of early drug development at Milan’s European Institute of
Oncology, told Reuters.
BETTING ON GROWTH
This optimism has contract manufacturers like Merck KGaA (MRCG.DE) and Lonza (LONN.S) ramping up facilities, in hopes drugmakers will farm out complex ADC production.
Merck
expects the overall ADC market to grow by more than 20% in coming
years, boosting its business, which includes manufacturing of monoclonal
antibodies, linkers and cytotoxic agents.
Rival Lonza, which
helps make Roche’s two ADCs and sees annual 9% growth for the so-called
bioconjugates market, is investing millions of dollars in its Swiss
site, where it produces ADCs for other drugmakers.
“What we see
over time at Lonza is a good request for capacity,” said Iwan
Bertholjotti, Lonza’s bioconjugate commercial development head. “That’s a
good sign that the market is booming.”
GRAPHIC: Global ADC clinical pipeline here GRAPHIC: ADC clinical development here
Still, enthusiasm is not universal.
AbbVie (ABBV.N)
in August abandoned its ADC candidate Rova-T after flunking a lung
cancer trial and wrote off most of the $5.8 billion it paid for the
drug’s developer, Stemcentrx, in 2016.
Roche, which helped
pioneer ADCs with Kadcyla and Polivy, has also backed off. In 2013, the
Basel-based company had about a dozen experimental ADCs. Today, only one
remains, and it is being developed for Staph infections, not cancer.
“We
have shifted our technology priorities,” Roche CEO Severin Schwan told
Reuters. “Maybe others will be luckier, but we failed to master the
complexity.”
AstraZeneca aims to do just that.
In March,
the Cambridge, England-based drugmaker struck a $7 billion deal with
Japan’s Daiichi Sankyo for rights to Enhertu, getting $1.35 billion
up-front, and more if it challenges Roche drugs’ dominance in breast
cancer.
Some industry analysts see Enhertu sales eventually reaching up to $7 billion annually.
“Our
plan is to expand the number of studies in different tumor types,” said
Gilles Gallant, head of oncology R&D at Daiichi Sankyo. “This agent
has potential.”
Reporting by Ludwig Burger in Frankfurt and John Miller in Zurich; Editing by Michele Gershberg and Dan Grebler
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