On November 5, 2019 QIAGEN (NYSE:QGEN; Frankfurt Prime Standard:QIA) reported a series of agreements that expand its immuno-oncology assets for future commercialization of novel companion diagnostics for precision medicine in immuno-oncology, in particular based on the powerful next-generation sequencing (NGS) technology (Press release, Qiagen, NOV 5, 2019, View Source [SID1234550373]).

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The agreements include a new collaboration with the Japanese company Repertoire Genesis Inc., which will provide access to novel technologies for the development of T-cell / B-cell receptor repertoire assays for use on NGS systems. QIAGEN intends to highlight these new agreements and other elements of its oncology portfolio at the Association for Molecular Pathology (AMP) Annual Meeting, which is being held from November 7-9 in Baltimore, Maryland.

Additionally, QIAGEN has entered into a new licensing agreement with researchers at the University of Bonn in Germany for novel epigenomic biomarkers based on immune checkpoint gene methylation, including CTLA4, PD-L1 and PD1, with rights to co-develop predictive companion diagnostics. In a second licensing agreement, QIAGEN has gained exclusive access to biomarker intellectual property held by the German diagnostic company STRATIFYER Molecular Pathology GmbH that is intended to provide guidance for treatment decisions in bladder cancer.

This series of agreements comes after QIAGEN recently entered into an agreement with Illumina Inc. to accelerate the adoption of NGS in clinical decision-making. QIAGEN has non-exclusive rights to develop and globally commercialize companion diagnostics and other IVD kits to be used together with Illumina’s MiSeq Dx and NextSeq 550Dx Systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic (Dx) systems. The partnership will initially focus on commercializing oncology IVD kits to support patient management and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, as well as inflammatory and autoimmune diseases.

On November 5, 2019 Biodesix, Inc., the leader in lung cancer diagnostic solutions, reported that current Chief Operating Officer Scott Hutton will become Chief Executive Officer on January 1, 2020 (Press release, Biodesix, NOV 5, 2019, View Source [SID1234550372]). Current CEO David Brunel will assume the role of Chairman. Brunel is the co-founder of Biodesix and has led the company for more than 13 years. He will continue in a day-to-day advisory capacity assisting with strategic direction and key partnerships. Mr. Brunel and Mr. Hutton will continue to work together to ensure a smooth transition and to further the Biodesix mission to improve every patient’s lung cancer care by empowering physicians with swift, comprehensive, and actionable insights.

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Hutton currently serves as Chief Operating Officer with more than 20 years of experience in the medical device, medical technology, and diagnostics industries. As COO, Hutton has been responsible for overseeing the corporate strategy, including the acquisition of Integrated Diagnostics and Oncimmune USA, execution of the commercial operations for the Biodesix portfolio of leading lung cancer diagnostics, and the launch of the Nodify XL2 test to improve the assessment of incidental lung nodules. Prior to Biodesix, Hutton was the Sr. Vice President and General Manager, Vascular Interventions at Spectranetics, and Vice President and General Manager, Neurosurgery at Medtronic.

"Scott’s experience building and growing commercial organizations and proven leadership make him the ideal CEO to guide Biodesix into its next level of growth," said Robert Cawthorn, co-founder and current Chairman of the Biodesix Board, who will remain on the Board following the transition. "The Board is grateful to David for his dedication, loyalty, and leadership in taking Biodesix from a concept to a company improving the lives of patients with lung cancer on a daily basis."

"I’m proud and honored to be a part of this talented team working to achieve a worthy mission," stated Hutton. "With our growing portfolio of genomic and proteomic blood tests steadily gaining recognition as valuable non-invasive options to help with more accurate diagnosis and treatment decisions, I believe the Biodesix team is poised to positively impact the lives of patients for many years to come. I look forward to continued collaboration with David and am eager to build upon the legacy that David created."

"Biodesix is growing rapidly and this strategic change in our executive leadership reflects that growth as well as the substantial opportunities we have before us," said Brunel. "Scott has been a tremendous asset to the company as our chief operating officer, he is perfectly suited to lead Biodesix’s continued commercial growth, research and development efforts, which have built, and continue to expand our deep product portfolio in lung cancer diagnostics. I look forward to continuing to work closely with Scott in our new roles, and want to thank our employees, physicians, and partners for their commitment, hard work, and dedication to improving lung cancer care."

On November 5, 2019 Akoya Biosciences, The Spatial Biology Company reported a strategic alliance with Precision for Medicine (formerly ApoCell), a pioneer in customized biomarker solutions, to develop proprietary liquid biopsy and tissue biomarker tests using Akoya’s Vectra Polaris System (Press release, Akoya Biosciences, NOV 5, 2019, View Source [SID1234550371]). By combining the Vectra Polaris system with Precision for Medicine’s ApoStream technology, the collaboration is designed to advance immuno-oncology candidates in clinical trials using both tumor biopsies and liquid biopsies to generate data required for assessing drug efficacy and validation of companion diagnostics (CDx).

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"We are very excited to be the first commercial laboratory to launch the Vectra Polaris system for image analysis of circulating tumor cells following ApoStream’s isolation and enrichment functionality," said Darren Davis, PhD, Precision for Medicine Senior Vice President. "Together, these technologies will enable accelerated drug development through detection of biomarkers in liquid biopsies. These tools have enabled our scientists to better understand the biological correlation of circulating metastatic cancer cells with cancer cells present in the tumor tissue."

Circulating tumor cells (CTCs) have long been known to exist in cancer patients’ blood. However, the promise of clinical application of CTCs as a liquid biopsy has not born fruit because these cells are difficult to detect using current molecular biology techniques. Precision for Medicine’s proprietary ApoStream technology captures significant quantities of rare circulating cancer cells from whole blood for characterization using Akoya’s Opal technology and Vectra Polaris imaging platform. ApoStream has been used in more than 80 clinical trials, including several ongoing phase III studies for CDx development.

Akoya’s Vectra Polaris Automated Quantitative Pathology System, part of the company’s Phenoptics 2.0 next-generation biomarker multiplexing platform, enables researchers to gain a deeper level of understanding of disease mechanisms related to new cancer immunotherapy approaches. The Vectra Polaris system integrates high throughput, seven-color multispectral imaging with whole-slide scanning in a simplified digital pathology workflow to support the quantification and analysis of tissue sections discernible with Opal detection kits. A recent meta-analysis of several studies showed that incorporating spatial information using Akoya’s multiplexed immunofluorescence technology is important for improving the predictive accuracy of immuno-oncology biomarkers.

The Phenoptics portfolio is capable of interrogating multiple protein markers on any tissue or cytology slide preparation. Precision for Medicine has validated several immune biomarker panels across various therapeutic applications using both types of preparation. These immune panels are currently being used to monitor immune cell infiltration including cancer, psoriasis, lupus and atomic dermatitis.

"The Vectra Polaris imaging system offers an innovative approach to assessing immunotherapy candidates in translational and clinical research," said Dr. Cliff Hoyt, Akoya Vice President of Translational and Scientific Affairs. "We are pleased to see this technology paired with ApoStream for a comprehensive method of imaging CTCs and improving our understanding of disease mechanisms in cancer."

On November 5, 2019 EpicentRx, Inc., a clinical cancer immunotherapy company targeting both sides of the immune system to deliver cancer treatments with minimal toxicity, reported that it has dosed the first patient in the Phase 3 REPLATINUM trial evaluating RRx-001 for the treatment of third-line and beyond small cell lung cancer (SCLC) (Press release, EpicentRx, NOV 5, 2019, View Source [SID1234550370]). REPLATINUM is EpicentRx’s first Phase 3 study of RRx-001, a small molecule immunotherapy targeting CD47 – SIRPα.

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Lung cancer is one of the most common cancers in the world, and the most common cause of cancer-related death. SCLC accounts for about 15% of all lung cancers, with a prevalence of over 300,000 patients globally. Almost 70% of SCLC patients present with extensive-stage disease at time of diagnosis and do not respond well to first- and second-line therapies due to the development of treatment resistance.

"The need for progress in third-line or beyond SCLC is clear, as the outcomes for these patients are uniformly fatal," said Corey A. Carter, M.D., President & CEO of EpicentRx and former head of thoracic oncology at Walter Reed Military Medical Center. "SCLC, especially SCLC in third-line or beyond, is dramatically underserved with ineffective options for patients."

REPLATINUM, an open-label, multicenter, crossover trial designed in collaboration with FDA, will evaluate the efficacy and safety of RRx-001 plus platinum doublet chemotherapy versus platinum doublet chemotherapy alone in 126 patients. REPLATINUM’s primary endpoint is progression-free survival, with overall survival and overall response rate as secondary endpoints.

The REPLATINUM trial follows positive results from EpicentRx’s ongoing Phase 2 QUADRUPLE THREAT trial, which is testing RRx-001 plus platinum chemotherapy in multiple cancer types, including SCLC. In patients with previously treated SCLC, RRx-001 plus platinum chemotherapy dramatically increased response rates, overall survival and progression-free survival compared to historical controls while suggesting a decrease in toxicities from chemotherapy. The QUADRUPLE THREAT data were recently published in the British Journal of Cancer.

"The strength of the Phase 2 trial allows us to keep REPLATINUM at a manageable size and should reduce the time and costs associated with a Phase 3 clinical trial. We are excited to have enrolled the first patient and look forward to working closely with our excellent clinical sites," said Dr. Carter.

RRx-001 has Orphan Drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma, and from EMA for SCLC.

About RRx-001

RRx-001 is a next generation small molecule immunotherapy being developed by EpicentRx. The therapy targets the CD47 – SIRPα axis and repolarizes tumor associated macrophages (TAMs) and other immunosuppressive cells in the tumor microenvironment to an immunostimulatory phenotype. RRx-001 stimulates the immune system and can be used as monotherapy or in combination with chemotherapy, immunotherapy, radiation and targeted agents, giving the therapy the potential to convert "treatment-resistant" tumors into "treatment-sensitive" tumors. RRx-001 is currently in the Phase 3 REPLATINUM trial for the treatment of third-line and beyond small cell lung cancer (SCLC). RRx-001 is also in the Phase 2 QUADRUPLE THREAT trial for the treatment of SCLC, non-small cell lung cancer, neuroendocrine tumors, ovarian and prostate cancer, and the Phase 2 PREVLAR trial for the prevention of oral mucositis. Clinical studies for the drug have also been conducted for the treatment of colorectal cancer, brain metastases and glioblastoma.

On November 5, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC) a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported that new preclinical data from BT7480, a potent tumor-targeted immune cell agonist (TICA) targeting Nectin-4 and agonizing CD137 (4-1BB), will be presented during speaker and poster sessions at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2019 Annual Meeting on November 6-10, 2019 in National Harbor, MD (Press release, Bicycle Therapeutics, NOV 5, 2019, View Source [SID1234550369]).

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"Our novel and proprietary Bicycle tumor-targeted immune cell agonists, or TICAs, are fully synthetic approaches engineered to overcome the limitations of other immunomodulatory mechanisms," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "The constrained nature of Bicycles confers high affinity and selectivity and enables us to easily link tumor targeting Bicycles to Bicycles that agonize CD137, providing tumor-specific effects. In preclinical experiments with BT7480, we have shown these characteristics promote rapid tumor penetration and powerful anti-tumor activity. We believe that these features, along with the modular nature of the Bicycle platform, could position Bicycles at the cutting edge of next generation immuno-oncology treatments and we look forward to progressing BT7480 into IND-enabling studies."

BT7480 has shown very potent and tumor antigen dependent CD137 agonism in ex vivo experiments using patient-derived lung tumor samples that have intact immune microenvironments. In a Nectin-4 overexpressing syngeneic tumor model, 92% (n=24) of animals dosed with BT7480 experienced complete tumor regressions. Five of the complete responder animals were subsequently re-challenged with the same tumor cell implantation and no tumor growth was observed, implying development of immunogenic memory. In addition to these data on BT7480, the Company will also present preclinical data at SITC (Free SITC Whitepaper) on other emergent Bicycle TICA strategies.

Details on Bicycle’s SITC (Free SITC Whitepaper) presentations are as follows:

Session Title: Session 2: Novel Platforms and Innovation
Location: Cherry Blossom Ballroom
Oral Presentation Title: A novel fully synthetic dual targeted Nectin-4/4-1BB Bicycle peptide induces tumor localized 4-1BB agonism
Presenter: Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics
Date & Time: Wednesday, November 6, 2019 4:35 p.m. – 4:45 p.m. ET

Session Title: Novel Single-Agent Immunotherapies
Location: Prince George’s Exhibition Halls AB
Poster Presentation Title: A novel fully synthetic dual targeted Nectin-4/4-1BB Bicycle peptide induces tumor localized 4-1BB agonism
Abstract #: P782
Date & Time: Saturday, November 9, 2019, 7:00 a.m. – 8:30 p.m. ET

Session Title: Novel Single-Agent Immunotherapies
Location: Prince George’s Exhibition Halls AB
Poster Presentation Title: A novel fully synthetic dual targeted EphA2/4-1BB Bicycle peptide induces tumor localized 4-1BB agonism
Abstract #: P794
Date & Time: Saturday, November 9, 2019, 7:00 a.m. – 8:30 p.m. ET

The posters will be available on the Publications section of bicycletherapeutics.com following presentation.