The Children’s Cancer Therapy Development Institute (cc-TDI) is collaborating with Champions Oncology (NASDAQ: CSBR) and The Jackson Laboratory (JAX) to provide end-to-end bioinformatics, lab-based and xenograft solutions for pediatric preclinical study packages.
The Jackson Laboratory, cc-TDI and Champions Oncology, share the same goal as every parent, scientist, and clinical investigator: to get the right drug to treat the specific type of pediatric cancer, ultimately improving outcomes.
As a result of the RACE for Children Act (Research to Accelerate Cures and Equity for Children Act) any targeted cancer drug in development will now be developed for both adults and children. The goal of this legislative requirement is to balance the scales as adult cancer averages twelve or more drugs earning FDA approval each year, yet pediatric cancer has only received eight FDA approvals since 1978.
By working with The Jackson Laboratory and Champions Oncology, cc-TDI is able to bring their domain expertise to offer turnkey preclinical studies that are required of Phase 2 adult oncology drugs that will move to phase 3 clinical trials. Despite RACE Act legislation, many pharmaceutical companies will not have resources to attribute to pediatric cancer-specific basic science and translational (preclinical/animal model) R&D. The turnkey services offered by this consortium will create a virtual pediatric cancer research and development group for any pharmaceutical company seeking compliance and/or opportunities for childhood cancer drug development. These pediatric preclinical study plan packages span bioinformatics from in vitro to in vivo studies.
“Knowing that the industry-wide need for pediatric study plans will be high, Champions Oncology, The Jackson Laboratory and cc-TDI are committed to helping pharmaceutical companies select the drugs with greatest promise for further pediatric study, or to rule out drugs without appreciable pediatric indications (thereby increasing the availability of new agents to children with cancer via clinical trials),” said Charles Keller, M.D., scientific director of cc-TDI.
Ronnie Morris, M.D., CEO of Champions Oncology remarked, “We appreciate that the decision to take an oncology drug from phase II to phase III trials is often done leaving as little as six months to determine what pediatric cancer might apply (with respect to RACE Act guidelines). By utilizing our unique tumor bank with many pediatric cancer models, we can facilitate preclinical studies in an accelerated and time-efficient manner.”
“JAX is a pioneer in genetics and mouse model development. We maintain the world’s largest and diverse collection of mouse models that better represent the genetic and biological complexity of human disease,” said James Keck, Ph.D., senior director of Innovation and Product Development, The Jackson Laboratory. “Our mission is to support the scientific community by providing these tools and leverage our 90 years of expertise to design and perform preclinical studies. We are thrilled to work with The Children’s Cancer Therapy Development Institute as we have a longstanding commitment to pediatric cancer research, and the pediatric, adolescent, and young adult mouse models that we have developed are well-suited to the preclinical studies now required by the RACE for Children Act.”
Champions Oncology (www.ChampionsOncology.com) (NASDAQ: CSBR) is a leading global oncology pharmacology services provider. US-based, we utilize our experience in clinically relevant models of cancer and assist biopharmaceutical companies of all sizes across all stages of drug development. Our mission is to provide translational solutions that enable the assessment of drug effectiveness and identification of relevant patient populations to target in human clinical trials. With an extensive and well-characterized Patient Derived Xenograft bank across a wide range of indications, Champions is well positioned to run proof-of-concept, indication expansion and clinical trial simulation studies. Models are available with patient clinical data, including patient treatment and response information, in addition to Whole Exome and RNA Sequencing data. Standard of care responses have also been generated in vivo for a large number of models. These models include more than 150 pediatric, adolescent and young adult patient-derived xenografts models representing leukemias (ALL, AML), brain tumors (malignant glioma, ETANTR/EMTR), hepatoblastoma, teratoma/malignant germ cell tumor and sarcoma (osteosarcoma, rhabdomyosarcoma, synovial sarcoma, spindle cell sarcoma, Ewing sarcoma, DSRCT, UPS, fibrosarcoma, MPNST, chordoma, myoepithelioma, liposarcoma and salivary carcinoma.