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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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.
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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.
