NCCN Oncology Research Program and Puma Biotechnology, Inc. Collaborate to Research on Neratinib in Various Cancers

National Comprehensive Cancer Network | October 16, 2020

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to evaluate neratinib, a type of tyrosine kinase inhibitor (TKI) that works as a dual inhibitor of the epidermal growth factor receptor 1 (EGFR) and human epidermal growth factor receptor 2 (HER2). The research funding is supported by a $2-million grant from Puma Biotechnology, Inc. Projects may include pre-clinical, translational and clinical trials. They will focus on treatment of: Pediatric tumors(including neurofibromatosis Type 2 and progressive Vestibular Schwannoma). Early-stage and metastatic breast cancer, including those with HER2+ brain metastases. Other HER2-amplified tumors. EGFR-mutated glioblastoma multiforme. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team.

Spotlight

Biological processes arise from nature’s inherent complexity, and they involve many components connected with positive and negative feedback, sometimes with redundant circuitry, sometimes with differential pathways in different individuals, sometimes with blurry, and conditional and variable connectivity patterns. In consequence, an intuitive understanding of their dynamics is hard to obtain.

Spotlight

Biological processes arise from nature’s inherent complexity, and they involve many components connected with positive and negative feedback, sometimes with redundant circuitry, sometimes with differential pathways in different individuals, sometimes with blurry, and conditional and variable connectivity patterns. In consequence, an intuitive understanding of their dynamics is hard to obtain.

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CELL AND GENE THERAPY

Terumo Blood and Cell Technologies to Collaborate with CSL Plasma on U.S. FDA Clearance of Plasma Collection Technology

CSL Plasma | March 11, 2022

CSL Plasma, a division of global biotherapeutics pioneer CSL Behring, announced the Rika Plasma Donation System created by Terumo Blood and Cell Technologies, a medical technology company based in Lakewood, Colorado, has received regulatory approval. The new plasmapheresis system is expected to provide technologies to support a safe, efficient, and better experience for plasma donors and an improved experience for CSL Plasma personnel, according to Terumo Blood and Cell Technologies. Additional characteristics of the new Rika system, according to CSL Plasma, will allow for the collection of more plasma in less time, hence improving quality and safety and, in turn, better serving patients who rely on plasma-based therapies. These advantages include: On average, Rika completes one plasma collection in 35 minutes or less: Compared to previous average CSL Plasma donation timings, this might mean a nearly 30% reduction in donor donation time. It assures that no more than 200 milliliters of blood are ever removed from the donor's body. This is believed to make the donor more comfortable during the donation process and lessen the risk of red cell loss deferral. It has a sophisticated user interface that helps CSL Plasma front-line personnel operate the equipment. This milestone helps bring to life how we demonstrate innovation, collaboration, and patient-focus, part of the CSL Values that underpin our commitment to manufacturing and delivering life-saving and life-extending medicines around the world, We continue to evolve as a leading biotechnology company, investing in our core plasma business. Continued innovation that benefits our employees and plasma donors speak to how we are driven by our promise to save and improve lives around the world." CSL Chief Operating Officer Paul McKenzie. CSL Plasma will begin installing the new technology at locations in the Denver, Colorado, area in the following months. There is a critical and ongoing need for human plasma to produce life-saving medicines for people with serious and rare diseases, CSL Plasma's decision to work with Terumo Blood and Cell Technologies is consistent with our business goals to improve the donor and employee experience through innovation and remain the plasma donation center of choice. We look forward to rolling out this new technology." CSL Plasma General Manager Michelle Meyer.

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MEDTECH

CellCarta expands its biomarker capabilities for clinical trials by adding Olink technology to its global services

CellCarta | September 01, 2021

CellCarta and Olink Proteomics AB announced today a strategic collaboration to offer Olink® Target 96 & Target 48 to pharmaceutical and biotech customers, advancing targeted protein biomarker quantification in clinical studies. CellCarta is a global leader in precision medicine and with more than 20 years of experience in mass spectrometry the company continues to invest in the field of proteomic biomarkers to better understand diseases and support therapeutic development projects. With the acquisition of the first Olink® Signature Q100 instruments and the collaborative support of Olink, CellCarta becomes the first global clinical CRO to offer the technology. "Complementing our mass spectrometry platforms with the Proximity Extension Assay (PEA) technology from Olink will allow us to support our clients with comprehensive proteomic services for their clinical studies. As the translational medicine community is turning to multi-omic analysis to address challenging questions in therapeutic development, we see Olink coupling with our other platforms (immune monitoring, histopathology, genomics) to create additional value for our clients." said Nick Wright, President and Global COO of CellCarta. The Olink platform offers an unmatched high-multiplex technique to quantify protein biomarkers using minimal clinical sample volume, with exceptional sensitivity and specificity, while covering a broad dynamic range. Differing from other multiplex protein detection platforms, Olink's PEA technology provides high specificity by avoiding cross-reactivity binding or interference at signal readout with its dual recognition approach with matched pairs of antibodies labeled with complementary DNA oligos. Olink fills the need for a robust technology that elevates clinical proteomics and is a must in a field driven by low abundant biomarkers, such as immuno-oncology. Through this collaboration, CellCarta will bring the Q100 platform into its CAP/CLIA laboratories to address the need for proteomic biomarkers for clinical trials and support multi-omics analysis with its CellEngineTM software. CellCarta's global footprint, with sites in the US, Canada, Belgium, Australia, and China, will allow for rapid deployment of the platform and support clients in their global clinical programs. "We are excited to enter this strategic collaboration with CellCarta to broaden the access to our protein biomarker solutions. CellCarta is well positioned in the pharma services market as a leading specialty CRO and is a logical choice for this collaboration to elevate the analysis of proteomic biomarkers in clinical trials specimens. Enabling proteomic analysis along with other key technologies in clinical biomarker programs will increase their value and achieve insights which only true multi-omic analyses can provide", said Jon Heimer, CEO of Olink Proteomics. About Olink Olink Holding AB (publ) (Nasdaq: OLK) is a company dedicated to accelerating proteomics together with the scientific community, across multiple disease areas to enable new discoveries and improve the lives of patients. Olink provides a platform of products and services which are deployed across major biopharmaceutical companies and leading clinical and academic institutions to deepen the understanding of real-time human biology and drive 21st century healthcare through actionable and impactful science. The company was founded in 2016 and is well established across Europe, North America and Asia. Olink is headquartered in Uppsala, Sweden About CellCarta CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with 10 facilities located in Canada, USA, Belgium, Australia, and China.

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MEDICAL

TrialSpark, Committs to Improve Speed, Quality, and Innovation of Clinical Trials, Announces Collaboration with Aditum Bio

TrialSpark | December 21, 2020

TrialSpark, a tech-enabled drug development accomplice focused on improving the speed, quality, and innovation of clinical trials, officially announces a collaboration with Aditum Bio, a San Francisco-based venture endeavor firm engaged with respect to getting and creating biotechnology resources that will benefit patients. Anteris Bio in-licensed ANT-401 from vTv Therapeutics, to be studied in CKD and across multiple etiologies of renal diseases. As Aditum Bio's drug development partner, TrialSpark will support Anteris Bio utilizing its imaginative, tech-enabled clinical development model. Aditum Bio, helped to establish by previous Novartis executives Joe Jimenez and Dr. Mark Fishman, is adopting another strategy to healthcare. Aditum Bio's central goal is to give huge patient populaces admittance to medicines which in any case may not be created. To improve access for patients and speed these drugs to market, Aditum Bio makes an individual "spin-out" organization to actualize Phase I and Phase II clinical preliminaries in partnership with TrialSpark. The "spin-out" has a lean, devoted group of supervisors that can drive quickened preliminary timetables and creative preliminary plans, utilizing TrialSpark's clinical trial platform and services.

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