On August 12, 2020 The Canadian Cancer Trials Group (CCTG) reported the commencement of a phase 2 study of CFI-400945, an oral, first-in-class inhibitor of Polo-like Kinase 4 (PLK4) in combination with durvalumab, a PD-L1 checkpoint inhibitor, in patients with advanced or metastatic triple negative breast cancer (TNBC) (Press release, Treadwell Therapeutics, AUG 12, 2020, View Source [SID1234563534]). "Immunotherapy in combination with chemotherapy has shown promise in this disease; however, non-chemotherapy combinations which avoid those toxicities and may have activity in the chemorefractory setting are of particular interest," says Study Co-Chairs Dr. David Cescon, medical oncologist at Princess Margaret Cancer Centre (PMCC), and Dr. Andrew G. Robinson of the Department of Oncology, Queen’s University.

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"This is the third phase 2 clinical study sponsored by CCTG involving Treadwell Therapeutics compounds. The others included patients with breast or prostate cancer. The phase 1 clinical trial of CFI-400945 demonstrated antitumor activity, while non-clinical studies conducted at the PMCC showed activity of CFI-400945 in TNBC models, which appears to be increased in immune competent models in combination with checkpoint blockade," said Dr. Lesley Seymour, Director of CCTG’s Investigational New Drug Program and medical oncologist in the Department of Oncology at Queen’s University. The study is supported as part of the CCTG/AstraZeneca collaboration with CFI-400945 provided by Treadwell Therapeutics.

This multi-center, single-arm, open-label phase 2 trial is designed to assess the efficacy of CFI-400945 given with durvalumab in patients with treatment-resistant TNBC. The primary endpoint is objective response rate. Secondary endpoints include disease control rate, immune-related response rate, safety and tolerability, and correlative studies, including cfDNA analyses.

Initially, participating centers will include the PMCC, the Ottawa Hospital Research Institute, and Kingston Health Sciences Centre. For additional information about the study, please visit www.clinicaltrials.gov (search identifier NCT04176848).

About CFI-400945

CFI-400945 is a first-in-class, oral selective and potent inhibitor of Polo-like Kinase 4 (PLK4), which regulates centriole duplication and thus mitotic progression. PLK4 is overexpressed in a variety of solid tumors and elevated expression is associated with poor clinical outcomes. Depletion of PLK4 expression in cancer cells by RNA interference leads to mitotic defects and cell death. PLK4 was identified as a drug target based on functional screening to identify vulnerabilities of genomically unstable breast cancers.

Anti-tumor activity of CFI-400945 has been shown in mice bearing human cancer xenografts, including robust tumor growth inhibition and durable tumor regression in primary tumor xenografts from breast cancer.

On August 12, 2020 PIC Therapeutics ("PIC"), a biotechnology company focused on transforming the treatment of cancer through the selective modulation of oncogene translation, reported the appointment of Katherine Bowdish, Ph.D., as its President and Chief Executive Officer (Press release, PIC Therapeutics, AUG 12, 2020, View Source [SID1234563533]). Dr. Bowdish will also join the Board of Directors of PIC.

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Dr. Bowdish brings more than 20 years of biopharmaceutical business and scientific leadership to PIC Therapeutics. Kathy was most recently at Sanofi, where she launched and led Sanofi Sunrise, a venture investment and partnering vehicle to accelerate early stage pioneering science for patients benefit through unique relationships with leading entrepreneurs, and more recently served as Vice President and Head of R&D Strategy. Prior to her leadership roles at Sanofi, Kathy co-founded or led several early-stage life science companies focused on biological therapies. Kathy’s positions include President & CSO, Permeon Biologics; Co-founder, President & CEO, Anaphore; President, Alexion Antibody Technologies and Senior Vice President, Alexion Pharmaceuticals; and Founder, CEO & CSO, Prolifaron, prior to its acquisition by Alexion.

Kathy has served on the Boards of Directors of MyoKardia, Warp Drive Bio, Portal Instruments, Thermalin, Permeon Biologics, Anaphore and Prolifaron, and most recently served as an Observer on the DiCE Molecules Board. Kathy received her Ph.D. in molecular genetics from Columbia University College of Physicians and Surgeons, and her B.Sc. degree from the College of William and Mary.

"We are thrilled to have Dr. Bowdish joining PIC as CEO. Her proven strategic leadership and investment experience will be vital to realizing the full potential of PIC’s scientific platform as it advances PIC’s drug candidates toward human clinical studies," stated PIC Therapeutics’ Executive Chairman, Alan Walts. "Kathy additionally has deep experience in developing the kind of innovative strategic partnerships that will be a critical part of PIC’s success."

"The promise of addressing broad-based genomic anomalies in cancer through modulating translation of oncogene RNA provides a unique opportunity to create impactful new therapies for patients with cancer," said Dr. Bowdish. "I am excited to be joining the PIC Therapeutics team and look forward to leading the company as we advance drug candidates through remaining preclinical and translational studies, and into the clinic for patients in need."

On August 12, 2020 NOXXON Pharma N.V. (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that its poster titled "Phase 1/2 study with CXCL12 inhibitor NOX-A12 and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer" has been selected for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, NOXXON, AUG 12, 2020, View Source [SID1234563532]). The ESMO (Free ESMO Whitepaper) Virtual Congress with accompanying satellite programs will be held between September 14 and October 18, 2020.

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The presentation will be available on the ESMO (Free ESMO Whitepaper) website in the On-Demand E-Poster Display section and on the NOXXON website as of Thursday, September 17, 2020. The abstract will be published online via the ESMO (Free ESMO Whitepaper) website on Monday, September 14, 2020.

On August 12, 2020 GeneCentric Therapeutics reported it has entered into a research collaboration with Janssen Research & Development, LLC (Janssen) around RNA-based drug response biomarkers for non-muscle invasive bladder cancer (NMIBC) (Press release, GeneCentric Therapeutics, AUG 12, 2020, View Source [SID1234563531]). The research will involve the application of GeneCentric’s advanced RNA-based molecular profiling platform to elucidate potential signatures of disease progression and drug response to standard of care therapy, including the role of genomic alterations in the fibroblast growth factor receptor (FGFR). Financial terms were not disclosed.

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While cancer subtypes identified in the setting of metastatic urothelial carcinoma (mUC) have been associated with disease risk and potential therapeutic response, there is a paucity of such characterization in the area of NMIBC to potentially inform clinical decision making. The application of GeneCentric’s RNA-based gene-expression signatures have potential to identify relevant NMIBC subtypes and markers of response to potential therapeutic options. FGFR genomic alterations are among the more common tumor mutations in these patients.

"We look forward to continued deployment of our suite of RNA-based genomics analysis solutions in this collaboration as we explore the potential role of FGFR in NMIBC," said Dr. Mike Milburn, President and CEO of GeneCentric Therapeutics. "This study comes on the heels of the retrospective analysis of mUC patients that were presented earlier this year at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium."

Specifically, the research collaboration aims to deepen tumor genomic and immune microenvironment insights in the setting NMIBC patients utilizing GeneCentric’s RNA-based tumor bioinformatics technology, including the Bladder Cancer Subtype Profiler (BCSP), pan-cancer diagnostics, cancer antigen discovery, immunogenomic biomarkers, and prototype FGFR activation gene signatures.

On August 12, 2020 Akoya Biosciences, Inc., The Spatial Biology Company, reported the application of the CODEX platform to a recent Cell publication titled "Coordinated Cellular Neighborhoods Orchestrate Antitumoral Immunity at the Colorectal Cancer Invasive Front (Press release, Akoya Biosciences, AUG 12, 2020, View Source [SID1234563530])." The paper was published online in early August (Schürch et al* from the laboratory of Professor Garry Nolan, Ph.D., Stanford University).

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In a seminal approach to studying the spatial biology of colorectal cancer, the authors have established a robust analytical framework to analyze highly multiplexed imaging data and, in doing so, discovered unique spatial relationships between "neighborhoods" of cells in the tumor microenvironment. Understanding the interactions between these cellular aggregates and their impact on antitumor immunity could advance our understanding of tumor progression and immunotherapy response.

The research team at Stanford and the University of Bern used the CODEX system for deep profiling of FFPE tissues from 35 advanced-stage colorectal cancer patients with more than 50 protein markers simultaneously, and at single cell resolution. As a result, the team discovered nine distinct cellular neighborhoods, each uniquely composed of certain immune and cancer cell types. These cellular neighborhoods were found to interact with one another in a manner that correlated with disease progression and prognosis.

Most recent studies have focused on the network of interactions between different cell types and their spatial context. This study places an emphasis on analyzing tissue biology at two different levels, the interacting cell types as well as the tissue regions within which they are organized. A detailed study of both levels of tissue architecture and behavior is now possible with a high dimensional imaging platform such as the CODEX System.

"The results from our study contribute to the growing body of biological knowledge needed to improve the development of immunotherapies," said Garry Nolan, Ph.D., the Rachford and Carlota A. Harris Professor in the Department of Microbiology and Immunology at Stanford University School of Medicine. "Using CODEX technology for highly multiplexed imaging to study cell aggregates in situ and their impact on disease pathology and progression, we were able to gain valuable insights about how tumors can disrupt immune functionality and how antitumoral immunity requires organized, spatially-nuanced interactions between cellular neighborhoods in the tumor microenvironment. The results point to potential diagnostics and new targets for therapeutic intervention."

Brian McKelligon, CEO of Akoya, said, "This study demonstrates not only the continued scientific leadership of the Nolan Lab in the application of advanced technologies for deep cancer profiling but also how the CODEX technology can be used to advance biological research and improve our understanding of disease mechanisms in cancer."