HACKENSACK, N.J., June 18, 2018 /PRNewswire/ -- Champions
Oncology, Inc. (Nasdaq: CSBR), engaged in the development of
advanced technology solutions and services to personalize the
development and use of oncology drugs, today announced that they
have partnered with NSABP Foundation, Inc. (formerly National
Surgical Adjuvant Breast and Bowel Project) and Puma Biotechnology,
Inc. (Nasdaq: PBYI) to develop patient derived xenograft (PDX)
models in two multi-center co-clinical PDX trials.
The first trial, NSABP FB10 is a phase II study evaluating the
combination of trastuzumab emtansine (T-DM1) with neratinib in
women with metastatic HER2-positive breast
cancer (NCT02236000) and is currently enrolling patients. All
patients in this study will have had prior trastuzumab, pertuzumab
and taxane. The second trial, NSABP FC11 is a phase II study
evaluating the combination of neratinib plus trastuzumab or
neratinib plus cetuximab in patients with "quadruple wild-type"
(KRAS, NRAS, BRAF PIK3CA wild-type) metastatic colorectal cancer
based on HER2 status: amplified, non-amplified (wild-type) or
mutated (NCT03457896). The first patient is expected in June
2018. NSABP Foundation initiated a "live tissue repository"
which has accrued 3000 tissue samples. Molecular profiling of these
samples will locate potential eligible patients already at NSABP
sites, in addition to patients identified with molecular profiling
performed at a CLIA lab, who meet eligibility criteria. The PDX
models developed from patients enrolling on these studies will make
it possible to test individual drugs and novel combinations as well
as investigate mechanisms of sensitivity and resistance.
Joan Goldberg, Chief Executive
Officer of NSABP, said, "The NSABP
Foundation is delighted to be collaborating with Champions Oncology
and Puma Biotechnology on these two important trials which offer
promising treatment to patients with advanced disease and, at the
same time, by incorporating PDX models, study the molecular
pathways to determine why some tumors are more responsive to
treatment than others."
"This collaboration with Puma Biotechnology, Champions and NSABP
will deepen our understanding of the sensitivity and resistance of
neratinib in metastatic breast and colon cancers, and may help us
further design optimal therapeutic approaches for patients," said Alshad S. Lalani, PhD, Vice President of
Translational Medicine at Puma Biotechnology, Inc.
Angela Davies, MD, Chief Medical
Officer at Champions Oncology,
said, "We are really pleased to be collaborating with a leading
oncology research group, NSABP Foundation, and Puma Biotechnology
to advance research in HER2 positive cancers." Dr. Davies further
added, "Developing PDX models from patients enrolling on these
clinical trials will provide an in vivo translational
research tool that may afford a much deeper understanding of tumor
response and resistance. PDX models can be used to simultaneously
evaluate the efficacy of different drug or drug combinations and to
compare the detailed molecular characterization between tumors of
clinical responders and non-responders, allowing for real-time
screening for biomarkers to further refine the drug development
strategy."
About Champions Oncology, Inc.
Champions Oncology,
Inc. is engaged in the development of advanced technology solutions
and services to personalize the development and use of oncology
drugs. The Company's TumorGraft technology platform is a novel
approach to personalizing cancer care based upon the implantation
of primary human tumors in immune deficient mice followed by
propagation of the resulting engraftments, or TumorGrafts, in a
manner that preserves the biological characteristics of the
original human tumor in order to determine the efficacy of a
treatment regimen. The Company uses this technology in
conjunction with related services to offer solutions for two
customer groups: Personalized Oncology Solutions, in which
results help guide the development of personalized treatment plans,
and Translational Oncology Solutions, in which pharmaceutical and
biotechnology companies seeking personalized approaches to drug
development can lower the cost and increase the speed of developing
new drugs. TumorGrafts are procured through agreements with a
number of institutions in the U.S. and overseas as well as through
Champions' Personalized Oncology Solutions business. For more
information, please visit www.championsoncology.com.
About Puma Biotechnology, Inc.
Puma Biotechnology,
Inc. is a biopharmaceutical company with a focus on the development
and commercialization of innovative products to enhance cancer
care. The Company in-licenses the global development and
commercialization rights to three drug candidates — PB272
(neratinib, oral), PB272 (neratinib, intravenous) and PB357.
Neratinib, oral was approved by the U.S. Food and Drug
Administration in July 2017 for the
extended adjuvant treatment of adult patients with early stage
HER2-overexpressed/amplified breast cancer, following adjuvant
trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib)
tablets. NERLYNX is a registered trademark of Puma Biotechnology,
Inc. Further information about Puma Biotechnology can be found at
www.pumabiotechnology.com.
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SOURCE Champions Oncology, Inc.