The study, sponsored by Daiichi, is expected to begin 1Q18 in the U.S. and Europe.
Jazz Pharma, ImmunoGen
Jazz Pharmaceuticals and ImmunoGen
have entered into a collaboration and option agreement that gives Jazz exclusive,
worldwide rights to opt into development
and commercialization of two early-stage,
hematology-related antibody-drug conjugate (ADC) programs, as well as an additional program to be designated during
the term of the agreement. The programs
covered under the agreement include
IMGN779, a CD33-targeted ADC for
the treatment of acute myeloid leukemia
(AML) in Phase 1 testing, and IMGN632,
a CD123-targeted ADC for hematologi-cal malignancies expected to enter clinical
testing before the end of the year.
ImmunoGen will be responsible for
the development of the three ADC programs prior to any potential opt-in by
Jazz. Following any opt-in, Jazz would be
responsible for any further development
as well as for potential regulatory submissions and commercialization.
Jazz will pay ImmunoGen $75 million
upfront and then as much as $100 million
in development funding over seven years
to support the three ADC programs.
“We are pleased to enter into this
collaboration with ImmunoGen, a well-
known leader in the field of ADC tech-
nology, with demonstrated success in
creating ADC molecules, including the
only FDA-approved ADC product to treat
metastatic breast cancer,” said Bruce Co-
zadd, chairman and chief executive officer,
Jazz Pharmaceuticals. “This investment
supports our long-term commitment to
expand our hematology/oncology portfo-
lio with the potential addition of multiple
innovative antibody drug conjugates.”
Mark Enyedy, president and chief ex-
ecutive officer, ImmunoGen, said, “This
strategic partnership with Jazz significantly
advances our goal of accelerating the de-
velopment of our early-stage novel ADC
assets. This deal joins us with a global part-
ner, provides us with substantial funding
to support these programs, and preserves
the right to co-commercialize one of these
assets. Jazz has demonstrated the ability to
bring innovative compounds to patients
and will make an ideal partner to help de-
velop and commercialize our novel ADC
assets targeting AML, and more broadly, in
the area of hematology/oncology.”
MilliporeSigma has entered a collaboration with Angiex, Inc. to support the
development of Angiex’s lead oncology
antibody drug candidate for clinical use.
Angiex is developing TM4SF1 as a potential therapy for cancer against a vascular target.
This collaboration is the first project
to be undertaken at MilliporeSigma’s new
bio-development center in Burlington,
MA, which will open in October 2017.
MilliporeSigma will provide access to process development tools, education programs and training.
“Companies benefit from our exper-
tise and experience in developing GMP
manufacturing processes for early clinical
development programs,” said Udit Batra,
chief executive officer, MilliporeSigma.
“With an end-to-end approach, Milli-
poreSigma can facilitate and accelerate
scaling and technical transfer for compa-
nies like Angiex.”
Angiex chief executive officer, Dr. Paul
Jaminet, said, “Through this collaboration,
Angiex hopes to accelerate our path to the
clinic. We appreciate MilliporeSigma’s ex-
pertise in bringing to cancer patients an
innovative treatment capable of address-
ing the most dangerous solid tumors.”
Champions Oncology, AstraZeneca
Champions Oncology has entered a collaboration with AstraZeneca to develop
novel cohorts of PDX models. These models will be used in AstraZeneca’s oncology
R&D programs in breast and lung cancer,
in addition to being added to Champions’
existing TumorGraft bank for translational
oncology research for academic and industry customers. Champions’ global network of collaborating sites will be leveraged to support this multi-year initiative.
These novel models will expand Champions’ bank of estrogen-receptor-positive
(ER+) metastatic breast cancer and epidermal growth factor receptor (EGFR) mutant
non-small cell lung cancer PDX models.
Both cohorts will focus on the metastatic,
previously treated setting and will enable a
better understanding of mechanisms of resistance, providing a critical platform to optimize drug development in these settings.
Full clinical and molecular annotation will
be available to enable model selection for
testing innovative therapies, investigating
new and existing pathways, and identification of biomarkers.
“This collaboration with Champions
is allowing us to develop and characterize
tumor models representing the drug refractory and drug resistant state, a surprisingly underserved space in cancer biology
and drug development with most current
cell line and PDX models being derived
from diagnostic untreated patient samples,” said Steve Fawell, vice president and
head of oncology science, AstraZeneca.
Angela Davies, chief medical officer,
Champions, said, “We are excited to be
partnering with AstraZeneca to support
their translational oncology needs. This
collaboration represents another dimension in our capabilities to deliver a specific
cohort of PDX models to clients to support
drug development portfolios in key areas.
These unique models reflect current standard of care and are not widely available.
These new models continue to be a valuable and cost-effective tool for the pharmaceutical industry in their preclinical and
clinical drug development research.”
Daiichi Sankyo, Charleston Labs
Daiichi Sankyo Co., Ltd. has elected to
terminate its 2014 development and commercialization agreement with Charleston
Laboratories, forgoing further development of Charleston’s hydrocodone products, including CL- 108 (hydrocodone,
acetaminophen, promethazine) and will
be returning all rights to those products to
“During a recent portfolio and U.S.
market review, Daiichi Sankyo made the
strategic decision to refocus our commercial efforts on our current product line in
the U.S. pain franchise as well as other
molecules in our pipeline,”said Ken Keller,
president, Administrative and Commercial, Daiichi Sankyo, Inc.“We would like to
thank Charleston Laboratories for its partnership and commitment to patients suffering with acute pain and opioid-induced
nausea and vomiting. Daiichi Sankyo
remains dedicated to bringing innovative
medicines to patients and will continue to
explore future opportunities that support
our corporate strategy to expand our business and achieve long-term growth.” CP