On June 22, 2022 LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, reported a study analyzing the current global lung cancer drug development landscape (Press release, LUNGevity Foundation, JUN 22, 2022, View Source [SID1234616195]). The manuscript, which was recently published in the Journal of Thoracic Oncology, reveals the impressive progress that has been made in the lung cancer therapy space and points to an increased need for comprehensive biomarker testing at earlier stages of the disease.

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The authors of the report curated a comprehensive list of lung cancer therapeutic entities (TEs) in preclinical development and clinical trials using publicly available sources. Of the TEs identified, the majority are focused on non-small cell lung cancer and are in the clinical trial stage of development. Targeted therapies for major oncogenic driver targets, such as ALK, EGFR, KRAS, and BRAF, also dominate the landscape.

"Lung cancer has been a proving ground for precision medicine, and we’ve seen several improvements in targeted therapies in recent years," said Amy Moore, PhD, vice president of global engagement and patient partnerships at LUNGevity. "However, we need to consider how these new drugs add value to patients and improve outcomes. Having a holistic landscape of these drugs will help drive future innovation in the areas that need it most."

The report found that new treatment approaches are being developed and tested for both non-small cell and small cell lung cancer, including new classes of drugs such as protein degraders. The analysis also indicates that lung cancer treatment will become increasingly biomarker driven, even for immunotherapy regimens. Also, as more targeted therapies and immunotherapies are being developed for early-stage lung cancer, there will be an increased need for biomarker testing to be implemented at earlier stages of the disease.

The analysis also found that, while there are a wide variety of therapies in development for both small cell lung cancer and non-small cell lung cancer, many of the current therapies in development focus on PD-1 inhibition, for which there are already approved drugs. As targeted therapies continue to be developed, it is important to consider whether there will be enough patients to fill clinical trial recruitment needs and whether there will be oversaturation in the market.

"It’s been highly reassuring to see the number of new breakthroughs for lung cancer therapies, especially for early-stage disease. Researchers are working hard to develop new treatment options so that no patient is left behind," said Upal Basu Roy, PhD, MPH, executive director of research at LUNGevity. "This underscores the need for increased and sustained lung cancer research funding to maintain momentum in this space."

The full text of the manuscript can be accessed from the JTO website. This paper complements LUNGevity’s other work to educate patients about lung cancer treatment options, such as the Lung Cancer Patient Gateways, which provide patients with information on FDA-approved therapies, as well as tools to find clinical trials for their specific subtype of cancer.

On June 22, 2022 Bio-Techne Corporation (NASDAQ:TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, reported it has reached an agreement to acquire Namocell, Inc (Press release, Bio-Techne, JUN 22, 2022, View Source [SID1234616162]). Bio-Techne anticipates the acquisition to close in the first quarter of its fiscal 2023.

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Founded in 2014 and headquartered in Mountain View, California, Namocell is a leading provider of fast and easy to use single cell sorting and dispensing platforms that are gentle to cells, and preserve cell viability and integrity. Single cell selection and sorting is a critical technology in various workflows in both biotherapeutics and diagnostics, including cell and gene therapy development and commercialization, cell engineering, cell line development, single cell genomics, antibody discovery, synthetic biology, and rare cell isolation.

Historically, researchers relied on flow cytometry sorting methods like FACS (Flourescence-Activated Cell Sorting) or manual pipetting methods for single cell sorting and isolation. Most flow cytometry sorting methods inflict potentially damaging stress on cells, are costly and difficult to operate, and require large numbers of cells. Similarly, manual pipetting methods are inefficient, unreliable and time consuming. Namocell’s proprietary single cell technology uniquely combines microfluidics, flow cytometry and liquid dispensing to achieve sorting and dispensing in a single step, while eliminating the risks associated with traditional FACS such as clogging and cross-contamination.

Namocell’s instrument portfolio includes Pala, a 2-laser system with up to 11 fluorescent detection channels and Hana, a single-laser system with 2 fluorescent detection channels. With unparalleled speed and ease of use, both systems utilize Namocell’s proprietary single-use cell cartridges to deliver single cells from sample to plates in minutes. Namocell’s current installed base is approaching 200 placements, including approximately 60 instruments sold in calendar 2021.

"Namocell is very complementary to Bio-Techne’s existing Cell and Gene Therapy franchise and we anticipate significant commercial synergies as we leverage our existing analytical tools sales force to penetrate this market opportunity," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Emerging technologies in cell-based research as well as next-generation therapeutics have created a need for fast, reliable, easy-to-use, and gentle cell sorting. Namocell’s instruments offer unparalleled performance advantages over traditional flow cytometry and manual techniques and we anticipate continued traction with its leading portfolio of cell sorting technologies. We are excited to welcome Namocell to the Bio-Techne team."

"We are very excited to be joining Bio-Techne," said Dr. Junyu Lin, Chief Executive Officer of Namocell. "Bio-Techne’s global reach and strategic deployment in cell and gene therapy will enable Namocell to accelerate its penetration into the global markets, particularly in cell engineering and cell therapy applications, our biggest and fastest growing sectors. We look forward to beginning the next chapter of growth as part of Bio-Techne."

Fredrikson & Byron, P.A. is serving as Bio-Techne’s legal counsel. Wilson Sonsini Goodrich & Rosati is serving as legal counsel to Namocell.

On June 22, 2022 The U.S. National Science Foundation reported a new funding opportunity of nearly $29 million through the Improving Undergraduate STEM Education: Hispanic-Serving Institutions Program, also known as the HSI program (Press release, National Science Foundation, JUN 22, 2022, View Source [SID1234616178]). Through this new solicitation, NSF introduces the HSI Program Network Resource Centers and Hubs, or HSI-Net, which seeks to establish two centers and up to five hubs to develop the infrastructure needed to generate and disseminate new knowledge, successful practices and effective design principles arising from research on and work at HSIs.

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Through the HSI-Net, NSF’s goal is to create a robust national ecosystem consisting of multi-sector partners supporting and sharing knowledge and successful models of undergraduate STEM education at HSIs, building institutional capacity, and effectively broadening participation of students that are historically underrepresented in STEM.

"Enhancing the quality and accessibility of STEM education is far too complex of a challenge for a one-size-fits-all solution and it is imperative that we engage in creative and meaningful partnerships with HSIs at speed and at scale to meet the STEM needs of our nation," said NSF Director Sethuraman Panchanathan. "If we are to successfully advance America’s future STEM workforce, we must enhance educational opportunities, build capacity and increase student participation, retention and career sustainability at our nation’s academic institutions. NSF’s investments in this program will do just that."

NSF’s investment in the HSI-Net will establish:

The HSI Center for Community Coordination, designed to create coordination mechanisms, foster communication, organize collaborations and strengthen connections between HSIs in the U.S. and its territories and its stakeholders, including current and new awardees.

The HSI Center for Evaluation, Research, and Synthesis, designed to develop tools and approaches to support the HSI community in culturally responsive evaluation practices, assessments, research and synthesis efforts.

Up to five HSI Program Resource Hubs, designed to support innovative initiatives addressing key areas of need in the HSI community and to effectively serve the HSI STEM community and its stakeholders.

Together, these centers and hubs will promote excellence in research that impacts the HSI community, including STEM education and broadening participation research. They will conduct activities designed to support and foster collaborations and partnerships in the HSI community, expand student and faculty development and growth, and promote the advancement of historically underrepresented groups in STEM.

"The HSI program is designed to serve the diverse HSI community with unique needs and their students and faculty," said Erika T. Camacho, director of the HSI program. "Through the creation of the HSI-Net, we are supporting community transformation efforts at HSIs to collectively contribute to research on HSIs and their capacity to address equity in education and intentionally serve their students to better prepare them to address future challenges. The HSI-Net will allow us to further impact the STEM research enterprise and workforce for the success and prosperity of our nation."

Since its founding in 2017, the HSI program has made a significant impact on the quality and accessibility of undergraduate STEM education for Hispanic and Latino students. The program now supports more than 150 projects that enable institutions to better serve students from groups historically underrepresented in the sciences and expand the pathways available to them for graduate education and STEM careers.

As part of the White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Hispanics, the NSF HSI program team will host a workshop at the upcoming White House Initiative Latino Economic Summit to be held at Malcom X College, 1900 W. Jackson Boulevard, Chicago, June 23, 9:30 a.m. CDT. This session will offer insight into NSF’s funding priorities for advancing excellence in undergraduate STEM education and investments that enhance educational opportunities, build capacity and increase student uptake and career pathways throughout the nation’s Hispanic-serving institutions.

NSF anticipates that approximately up to $29 million will be available for continuing or standard awards in response to the HSI-Net solicitation, subject to the availability of funds.

On June 22, 2022 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported the launch of a research test, codeveloped with Merck (known as MSD outside the United States and Canada) (Press release, Illumina, JUN 22, 2022, https://www.prnewswire.com/news-releases/illumina-launches-research-test-codeveloped-with-merck-to-unlock-deeper-insights-into-the-tumor-genome-301571457.html [SID1234616196]). The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology. The test adds assessment of a new genomic signature to the distributed, market leading TruSight Oncology 500 assay. It will be available globally, excluding the United States and Japan and will enable researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous recombination deficiency (HRD).

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Illumina, Inc. reported the launch of a research test, codeveloped with Merck. The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology.
Illumina, Inc. reported the launch of a research test, codeveloped with Merck. The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology.
"HRD status has emerged as an important biomarker in tumors that harbor high levels of DNA damage, such as ovarian, breast, prostate, and pancreatic cancers," said Phil Febbo, MD, chief medical officer at Illumina. "With one sample and one test, TruSight Oncology 500 HRD assay provides labs with comprehensive, accurate, sensitive results that can greatly enhance our understanding of the genomic nature of a tumor."

The Research Use Only TruSight Oncology 500 HRD test is a next-generation sequencing (NGS)–based assay that harnesses the power of Illumina NGS technology and validated HRD technology from Myriad Genetics (NASDAQ: MYGN), enabling labs to accurately detect genomic instability and analyze more than 500 genes simultaneously, including those relevant to HRD status. HRD is a genomic signature used to describe when cells are unable to effectively repair double-stranded DNA breaks. When this occurs, cells rely on alternative, error-prone DNA repair mechanisms, which may lead to genomic instability and, eventually, tumor formation.

The Molecular Pathology Diagnostic Unit at the Technical University of Munich participated in the TSO 500 HRD early access program in order to compare the results of Illumina’s prototype TSO 500 HRD assay to a validated reference standard, from Myriad Genetics.

"Our institution is delighted by the release of TruSight Oncology 500 HRD and we are very happy with our results from the early access program," said Nicole Pfarr, head of the Molecular Pathology Diagnostic Unit, Technische Universität München. "We look forward to using this assay routinely in our lab for future projects. Combining HRD assessment with TruSight Oncology 500 in one workflow will unlock the most comprehensive view of the tumor genome, while maintaining efficiency in the lab."

Large-cohort studies show that comprehensive genomic profiling (CGP) has the potential to identify relevant genetic alterations in up to 90% of samples. A single, comprehensive assay to assess a wide range of biomarkers uses less sample and returns results more quickly compared to multiple, iterative tests. As a kitted, distributable solution, this test helps to remove barriers for internalization of CGP and HRD testing, so that labs of all sizes can offer this powerful test.

"We are pleased to reach this first milestone with Illumina to commercialize an assay for HRD assessment that will aid in advancing clinical research and broaden access to clinical trials," said Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.

The research test is expected to begin shipping globally (excluding the US and Japan) in August. In addition, as part of the partnership announced in September 2021, work is ongoing to develop a new HRD companion diagnostic (CDx) test for the EU and the UK to aid in the identification of ovarian cancer patients with positive HRD status.

This partnership expands on Illumina’s broad portfolio of oncology partnerships with industry leaders, with the united goal of advancing cancer diagnostics and precision medicine.

About TruSight Oncology 500
TSO 500 is a Research Use Only pan-cancer assay that enables Comprehensive Genomic Profiling. Designed to identify known and emerging tumor biomarkers across 523 genes, TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. In addition, the assay assesses key immune-oncology biomarkers, such as Tumor Mutational Burden (TMB), Microsatellite Instability (MSI) and Homologous Recombination Deficiency (HRD). Due to its comprehensive biomarker content, labs can consolidate multiple single-gene or small-panel workflows into a single assay, saving biopsy specimen and time. Click here to learn more.

On June 22, 2022 Race Oncology Limited ("Race") reported to share further interim results from its preclinical melanoma research program (ASX announcement: 19 March 2021) (Press release, Race Oncology, JUN 22, 2022, View Source [SID1234616228]). The program’s objective was to explore the use of Zantrene (bisantrene dihydrochloride) in novel drug combinations for the treatment of drug and immunotherapy resistant melanomas using cell and animal models.

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Used at low concentrations, Zantrene was found to enhance cancer immunotherapy in three distinct and complementary ways: (1) direct killing of melanoma cells; (2) activation of immune cells targeting the tumour, and (3) reducing the expression of immune evasion genes in the tumour.