On November 11, 2021 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, reported the launch of the nCounter TCR Diversity Panel and companion cloud-based TCR analysis report created for use with the ROSALIND platform (Press release, NanoString Technologies, NOV 11, 2021, View Source [SID1234595300]). This new gene expression panel allows researchers to measure the usage of T cell receptor (TCR) variable regions and shifts in TCR diversity with a simple assay that can deliver results in less than 24 hours.

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A diverse population of TCRs is a hallmark of a healthy immune system. The mix and abundance of TCR variable regions changes upon challenge with a pathogen, cancer, or any disease that triggers an adaptive immune response. TCRs are studied to understand disease onset, progression, response or non-response to treatment, and disease recovery. By directly quantifying the expression of each TCR variable region, the nCounter TCR Diversity Panel can rapidly screen samples without the time and cost of laborious sequencing methods.

"The nCounter TCR Diversity Panel provides an intuitive, powerful new tool for use with clinical samples," said Dr. Léon van Kempen, an early access user and scientific lead at the Laboratory for Molecular Pathology at University Medical Center Groningen, Netherlands. "The panel allows for a TCR diversity score to be easily calculated based on expression and objectively quantifies a T cell response allowing for broad utility of the panel throughout all types of research."

The new panel utilizes the unique oligonucleotide barcoding chemistry of the nCounter Analysis System to detect mRNA transcripts directly. It contains probes for 129 human genes covering all TCR alpha, beta, gamma, delta variable regions as well as constant regions. The panel also allows for customization with the ability for researchers to add in and measure unique TCRs of interest. This novel solution is coupled with an automated data analysis report purchased separately and accessible within the ROSALIND platform, allowing researchers to analyze results and generate TCR diversity scores within minutes.

"We remain committed to developing innovative tools to advance our understanding of the human immune response. Leveraging the simplicity of the nCounter workflow makes it possible to gain broader insights with higher throughput," said Joseph Beechem, Ph.D., chief scientific officer, NanoString. "In the future, we expect to enable our GeoMx Digital Spatial Profiler to study TCRs spatially within tissues, providing an entirely new dimension of knowledge."

Learn more about the nCounter TCR Diversity Panel and the latest scientific advances in the field of immuno-oncology using the nCounter and GeoMx Digital Spatial Profiler platforms at the virtual symposium and booth #8 at the 36th annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference.

Virtual Symposium: "Quantifying T-cell receptor diversity via expression analysis" is on Friday, Nov. 12, from 1:00 – 1:30 pm EST. The symposium is an opportunity to talk with Dr. Léon van Kempen, a clinical scientist in molecular pathology, about getting started with the spatial biology revolution and the GeoMx Whole Transcriptome Atlas. In addition, this workshop will focus on the nCounter TCR Diversity Gene Expression Panel and a case study on the use of the panel for clinical research.

On November 11, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present in a fireside chat at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum being held virtually November 18, 2021 (Press release, Biodesix, NOV 11, 2021, View Source [SID1234595299]).

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Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum
Date: Thursday, November 18, 2021
Time: 4:30 PM ET

The fireside chat will be webcast live and available for replay under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.

On November 11, 2021 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that it will be presenting an ePoster at the 2021 Pancreas Club Annual Meeting being held virtually on November 11-12, 2021 (Press release, Renovorx, NOV 11, 2021, View Source [SID1234595298]).

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The poster describes the RR2 Observational Registry Study, which used RenovoRx’s novel therapy platform, RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion), to deliver gemcitabine, an approved chemotherapeutic agent, intra-arterially to the pancreatic tumor. The results of this study along with the prior Phase 1 study form the foundation of RenovoRx’s ongoing randomized, multi-center Phase 3 clinical trial (TIGeR-PaC) of its lead product candidate, RenovoGem, for the treatment of unresectable, locally advanced pancreatic cancer (LAPC).

The Registry Study, which was designed to assess the effectiveness and feasibility of intra-arterial therapeutic treatment of patients with LAPC, validated prior radiation and treatment location as predictors of overall survival. It included 25 patients (10 treatment naïve, 6 with prior chemotherapy, 8 with prior chemotherapy and radiation, and 1 that had undergone prior Whipple surgery). Patients with prior radiation treatment demonstrated increased survival benefit from RenovoTAMP (median overall survival of 23.1 months) when compared to patients with prior chemotherapy (median overall survival of 16.6 months) and treatment naïve patients (median overall survival of 5.7 months). In addition, treatment via the superior mesenteric artery (SMA) delivered greatest survival benefits, with median overall survival of 31.7 months when compared with treatment via other arteries. The survival benefit for patients treated with RenovoTAMP supports the rationale underlying the potential for intra-arterial, targeted chemotherapy delivery as a treatment for LAPC.

"Standard of care for patients diagnosed with unresectable LAPC is intravenous (IV) systemic chemotherapy, which both has significant side effects and is limited in its effectiveness by the lack of visible tumor feeders to pancreatic tumors," said Dr. Ramtin Agah, Chief Medical Officer and Co-Founder of RenovoRx. "Based on the results of our foundational clinical trials, intra-arterial delivery of chemotherapy via RenovoTAMP not only reduced the tolerability issues associated with systemic chemotherapy, but by targeting delivery of treatment in close proximity to the tumor and pancreatic tissue, it also demonstrated improved patient survival rate."

The details of the presentation are as follows:

Title: Treating locally advanced pancreatic cancer with a novel, dual-occlusion balloon catheter
Poster Number: P108
Authors: H. Charles Li; Carter Hultman; Alexander Rosemurgy, MD; J. Augusto Bastidas, MD; Reza Malek, MD; Emmanuel Zervos, MD; Steven Goldin, MD; Peter Muscarella, MD; Charles Nutting, DO; Barish Edil, MD; Ramtin Agah, MD

A recording of the presentation will be available on RenovoRx’s website.

About the Phase 3 TIGeR-PaC Clinical Trial

The TIGeR-PaC clinical trial is a randomized multi-center study using the RenovoTAMP platform to evaluate RenovoRx’s first product candidate, RenovoGem to treat unresectable LAPC through the intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent. TIGeR-PaC is currently enrolling locally advanced, unresectable pancreatic cancer patients. To learn more about the study and the participating clinical trial sites, visit View Source

On November 11, 2021 Kyowa Hakko Kirin reported that The National Institute for Health and Care Excellence (NICE) has published positive guidance, in the form of a Final Appraisal Determination (FAD), confirming that POTELIGEO (mogamulizumab) is recommended as a treatment option for adults in England and Wales with the ultra-rare blood cancers mycosis fungoides (MF) and Sézary syndrome (SS), two forms of cutaneous T-cell lymphoma (CTCL) (Press release, Kyowa Hakko Kirin, NOV 11, 2021, View Source [SID1234595297]). The treatment is approved for use after two prior systemic treatments for adults living with MF and after one prior systemic therapy for adults living with SS.1

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The FAD comes following a successful appeal lodged by Kyowa Kirin, Lymphoma Action, Leukaemia Care, and the UK Cutaneous Lymphoma Group (UKCLG) in response to a previous appraisal by NICE, published on 4 March 2021, that concluded POTELIGEO would not be made available on the NHS in England and Wales.2

All parties involved in lodging the appeal welcome the new, positive decision by NICE as it represents a distinctive step forward in addressing the high unmet clinical needs of those living with MF and SS. This decision also marks another milestone in the availability of POTELIGEO across the United Kingdom, following the acceptance of POTELIGEO by the Scottish Medicines Consortium (SMC) for adults living with MF and SS in Scotland on 7 June 20213.

Richard Johnson, Northern Cluster General Manager, responsible for the UK at Kyowa Kirin, said: "This is a momentous day for those living with MF and SS in the UK. By issuing positive guidance for POTELIGEO, NICE has helped ensure that those with MF and SS who have few systemic treatment options available to them are now able to access an innovative therapy. This decision is also testament to the dedication, commitment and long-term efforts of the broader CTCL community in advocating for a wider range of treatment options in the UK for those living with conditions like MF and SS."

Ropinder Gill, Chief Executive at Lymphoma Action, commented: "We’re really grateful and delighted with this decision. Mogamulizumab can have a life changing impact for those people affected by cutaneous T-cell lymphoma, a form of the rare condition skin lymphoma. They have limited treatment options – this is a great outcome for them. We were privileged to be part of the process alongside others, and to represent the patient voice with our patient advocate Stan."

Prof Julia Scarisbrick, consultant dermatologist and head of the Cutaneous Lymphoma Service within the Rare Diseases Centre at University Hospital Birmingham, added: "Adults living with CTCL have significant unmet clinical need and a lack of treatment options available to them. There has been a real need to address this for a long time and particularly so for those at the advanced stages of the disease, who have a poorer prognosis and impaired health related quality of life.4 With NICE’s decision, adults with MF and SS across the whole UK now have an effective, well tolerated therapy shown to improve quality of life available to them that can provide a welcome alternative to those who need it."

About POTELIGEO (mogamulizumab)

Mogamulizumab is a first-in-class humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS;5,6,7 once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.8

Mogamulizumab has been shown to offer benefits to many patients with MF and SS.9 The MAVORIC trial compared the efficacy of mogamulizumab with vorinostat in previously treated people with relapsed or refractory mycosis fungoides or Sézary syndrome, two types of Cutaneous T-cell lymphoma (CTCL).9 Patients taking mogamulizumab experienced control over their disease for more than twice as long as those taking the comparator treatment, vorinostat*1 (7.7 months vs 3.1 months of median progression free survival), the primary endpoint of the trial.9 Levels of adverse events were similar between the two treatment groups.9 The MAVORIC trial is the largest in CTCL; it enrolled a total of 372 patients across 61 sites in 11 countries (of which 16 sites were in Europe, including three in England).9

About Mycosis Fungoides (MF) and Sézary Syndrome (SS)

MF and SS are two forms of CTCL,10 which is a serious and potentially life-threatening form of cancer.11 Additionally, there is a significant impact on quality of life for those caring for an individual living with CTCL.12 CTCL is treatable but not curable and there has been a clear unmet need for new treatment options.

MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.13,14 These cancerous T cells consistently express a protein called CC-chemokine receptor 4 (CCR4), which enables them to move from the blood to the skin.5,6,7 When these cancerous T cells move to the skin, they can create a localised inflammatory immune skin response, commonly resulting in visible skin symptoms of red patches or plaques 5,15,16,17,18 which can resemble psoriasis or eczema.13

MF and SS can affect the skin, blood, lymph nodes (part of the body’s immune system which is spread throughout the body) and internal organs.19 All four areas of the body are used to assess disease stage20,21 and clinically significant involvement of the blood, particularly in more advanced disease, is linked with increased morbidity and an overall reduction in patient survival.20,22,23

CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.24 It is critical for doctors to consider CTCL as an early differential diagnosis as the patient’s prognosis can be affected if the disease progresses to later stages.25 Whilst most individuals that present with early stage disease do not progress to a more severe stage,26 patients with advanced disease have significantly poorer outcomes with only around half of patients (52%) surviving for just 5 years.20

CTCL is an ultra-rare disease that affects 0.7 per 100,000 patients across the UK.4 The annual incidence of MF in Europe is estimated to be between 1 in 110,000 to 1 in 350,000.27 The annual incidence of SS is 1 in 10,000,000.28 Together they represent approximately 65% of all cases of CTCL.19

On November 11, 2021 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that members of its executive leadership team will participate in a virtual fireside chat discussion at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum on Nov. 18 at 8:30 a.m., EST (Press release, Quanterix, NOV 11, 2021, View Source [SID1234595293]). The virtual fireside chat discussion will feature Chairman and Chief Executive Officer, Kevin Hrusovsky; President of Quanterix and Diagnostics, Masoud Toloue; Chief Financial Officer, Mike Doyle and Director of Investor Relations and Business Development, Stephen Hrusovsky.

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Hrusovsky will also host virtual one-on-one meetings with institutional investors that day. A live webcast of the conversation will be available on the investor section of the Quanterix website at View Source Replays of the webcast will be available on the Quanterix website for 90 days following the conference.