On December 1, 2020 Immunomic Therapeutics, Inc. (ITI) reported that it will be presenting at the 2nd Annual Glioblastoma Drug Development Virtual Summit (Press release, Immunomic Therapeutics, DEC 1, 2020, View Source [SID1234572023]). On Wednesday, December 9th, Chief Executive Officer at ITI, Dr. Bill Hearl, will be presenting a talk titled, "Adaptive T-cell Immunotherapy for Newly Diagnosed Glioblastoma: Using Targeted Antigen Presentation to Enhance Immune Responses." Dr. Hearl will discuss ITI’s investigational platform technology, the company’s lead program and its preliminary data in GBM, as well as the company’s future focus.

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Presentation details are as follows:

Title: Adaptive T-cell Immunotherapy for Newly Diagnosed Glioblastoma: Using Targeted Antigen Presentation to Enhance Immune Responses

Presentation Category: Vaccines

Date and Time: Wednesday, December 9, 2020 12:40 PM EST / 9:40 AM PDT

Location: Virtual Summit

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On December 1, 2020 Biodesix, Inc. (Nasdaq: BDSX) a leading data-driven diagnostic solutions company with a focus in lung disease, reported publication of an analysis of the company’s Nodify XL2 lung nodule test (Press release, Biodesix, DEC 1, 2020, View Source [SID1234572039]). The test supports clinical decision-making for suspicious nodules by more accurately identifying patients with a very low risk of malignancy and shifting those patients into surveillance, thereby minimizing invasive procedures on those with benign nodules.

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In previously published findings from the Pulmonary Nodule Plasma Proteomic Classifier (PANOPTIC) Trial, the Nodify XL2 test was shown to accurately identify patients with lung nodules who have a pre-test risk of malignancy less than 50% as "likely benign." After one year of follow-up, the test demonstrated a sensitivity of 97%, specificity of 44%, and negative predictive value of 98%, which is more accurate than other commonly used lung nodule risk assessment calculators.

The new paper, published in the American College of Chest Physicians (CHEST) Journal, presents findings that all nodules in the study group that were established as benign after one year remained benign after two years of follow-up. This data confirms the performance of the Nodify XL2 test over the guideline-recommended two-year surveillance period to radiologically confirm a benign diagnosis. Additionally, a new analysis suggests that the classifier performs similarly regardless of the whether the nodule of concern was solitary or there were other nodules present.

"This assessment demonstrates our commitment to providing long-term follow-up for patients and to continuously study the performance of our tests," said Scott Hutton, CEO of Biodesix. "Central to our mission is the drive to improve patient outcomes while reducing ineffective and unnecessary treatments and procedures. Nodify XL2 exemplifies this. With this test, part of our Nodify LungTM testing strategy, physicians are equipped with vital and time-sensitive information to help efficiently determine the appropriate course of treatment for each patient."

About Nodify XL2 Lung Nodule Test

The Nodify XL2 blood-based proteomic test helps identify patients who have a suspicious lung nodule that is likely benign or at a reduced risk of being cancerous. Results help physicians to identify patients who may be better candidates for routine CT surveillance to monitor for growth or shrinkage of the nodule over time instead of an invasive diagnostic procedure. The Nodify XL2 test is used for patients who are 40 years or older, have nodules between 8mm and 30mm, and have a pre-test risk of lung cancer of less than or equal to 50%.

The test is performed in Biodesix’s COLA-accredited laboratory in De Soto, Kansas.

On December 1, 2020 atbtherapeutics, a pioneering biopharmaceutical company building an oncology pipeline using its antibody–toxin-bioengineered "atbody", reported that it has entered a long-term manufacturing agreement with iBio CDMO, a global leader in plant-based biologics manufacturing located in the US (Press release, ATB Therapeutics, DEC 1, 2020, View Source [SID1234572054]).

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In this agreement, atbtherapeutics and iBio CDMO will work together for the industrialisation of the GMP manufacturing process of atbtherapeutics’ atbodies – game-changer biologics of targeted antibody-based therapy in development for the treatment of haematological malignancies and solid tumours.

atbody novel biologic is differentiated by a unique composition and novel mechanism of action, together aiming to extend the therapeutic window of current targeted therapies. The atbody is a single entity composed of an antibody that delivers a potent peptide payload, unlocked into the cancer cell following a peptide linker cleavage.

The novelty of this sophisticated atbody results from atbtherapeutics’ truly distinct method of production, the atbiofarm technology. This patented technology leverages plant expression systems to manufacture biologics that classic systems cannot achieve, in a single-step process. atbiofarm technology is transferable within the FastPharming technology developed by iBio CDMO for years. Therefore, iBio CDMO’s plant system knowledge and cutting-edge facility will allow atbtherapeutics to rapidly scale up the production of atbodies at industrial level.

The agreement with iBio CDMO will ensure the manufacturing of 2 main programs for pre-clinical and clinical trials and will allow atbtherapeutics to focus on the development of its oncology pipeline.

Bertrand Magy, CEO of atbtherapeutics, commented: "iBio’s proven expertise in plant-based manufacturing will be highly valuable as we prepare for the first pre-clinical trials for our lead atbody programme. With the support of iBio, we are confident that we will be able to rapidly progress towards the clinic with our lead product candidates for the treatment of cancer. We are thrilled to be working with such a well-established plant molecular farming company."

Tom Isett, Chairman & CEO of iBio, commented: "We are pleased to be chosen as the process development and manufacturing partner for atbtherapeutics, whose platform technology offers a unique approach for hard-to-treat hematological malignancies and solid tumors. We are looking forward to helping atbtherapeutics rapidly build a scalable manufacturing process so that its atbody drug candidates may quickly reach the clinic and begin to realize their potential in oncology."

On December 1, 2020 PierianDx, the leading clinical genomics informatics company, reported an expanded partnership with Illumina to enable PierianDx genomic reporting solutions for use with AmpliSeqTM for Illumina Focus Panel, AmpliSeqTM for Illumina Myeloid Panel and the TruSight Hereditary Cancer Panel (Press release, PierianDx, DEC 1, 2020, View Source [SID1234572024]). Adding these panels expands the existing relationship between Illumina and PierianDx, which currently covers use of the PierianDx platform to support genomic reporting in key global markets for the TruSight Oncology 500 portfolio.

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Performing a comprehensive NGS test and delivering an accompanying genomic report were once only accomplished via a send-out test to a commercial lab. However, in performing tests as send-outs, healthcare organizations relinquish control over samples, turnaround time, and quality. The PierianDx platform enables healthcare organizations to accelerate their precision medicine programs by empowering them to create accurate, timely, and comprehensive clinical genomic reports in-house.

Illumina’s Senior Vice President and Chief Medical Officer, Dr. Phil Febbo said: "PierianDx has demonstrated its commitment to best-in-class variant reporting solutions. We are excited to expand our partnership to cover the AmpliSeqTM suite of panels which are optimized for clinical cancer research."

PierianDx develops Clinical Genomics Workspace, which consists of intuitive software and a robust clinical Knowledgebase which transforms unstructured variant information into a highly-structured and usable clinical genomic report. In use by academic medical centers, cancer centers, reference laboratories, and healthcare organizations worldwide, it helps users accurately and rapidly classify and interpret variants to produce a physician-ready report.

Lincoln Nadauld, Vice President and Chief of Precision Medicine and Genomics, Intermountain Healthcare explains, "Our partnership with PierianDx has enabled us to advance our precision medicine program by enhancing the classification of variants, accelerating the identification of targeted therapies, and expanding clinical trial opportunities for our patients."

On December 1, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported the development of a spatial molecular imaging platform, a next generation solution for multiplexed analysis of RNA and protein expression for individual cells within a tissue sample (Press release, NanoString Technologies, DEC 1, 2020, View Source [SID1234572040]).

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The spatial molecular imager combines the power of high-plex profiling with high-resolution imaging to enable the analysis of hundreds to thousands of RNAs or proteins directly from single cells within morphologically intact tissue samples. The platform utilizes the company’s advanced Hyb & Seq chemistry, which over the last 18 months has been optimized for in situ spatial analysis. The platform is capable of profiling RNA and protein within a single cell down to sub-cellular resolution in multiple tissue types. To date, prototype systems have imaged RNA from as many as 1,000+ genes simultaneously across thousands of individual cells in Formalin-Fixed Paraffin Embedded (FFPE) tissue.

Tissue biology takes place on several spatial scales including multi-cellular, single cell and the sub-cellular levels. The GeoMx Digital Spatial Profiler (DSP) enables multi-cellular analysis at the whole transcriptome level to elucidate the behavior of populations of cells, such as those within a tumor or the tumor microenvironment. NanoString is developing the spatial molecular imager to address the unmet need for high-plex spatial analysis of single cells and sub-cellular resolution, ideally suited for targeted applications, such as creating cell atlases or studying cell-cell interactions. The GeoMx DSP and the spatial molecular imager are highly synergistic, creating a spatial biology portfolio that spans the continuum from targeted to whole transcriptome analysis, and from multicellular resolutions down to single cell and sub cellular applications.

"Spatial imagers measuring RNA and protein in situ at single-cell and sub-cell resolution are expected to emerge as an important product category over the next several years," said Brad Gray, president and CEO. "Our spatial molecular imaging platform can profile RNA and protein in FFPE with category-leading plex as well as high sensitivity and high resolution. Together, our GeoMx DSP and spatial imager form the leading spatial biology portfolio, spanning from discovery and translational research to clinical diagnostics."

"Researchers and clinicians have gained tremendous insights from the revolution in single cell biology in recent years, but the cellular context was always lost," said Christopher Mason, Ph.D., a geneticist who recently published research using GeoMx. "Now, biological discoveries can be elucidated from high-plex, multi-omic spatial imaging, revealing the key spatial interactions within and between normal or diseased tissues (e.g. COVID-19, cancer) and how these cells communicate and mediate phenotypes, change over time, and respond to therapies."

"Spatial molecular imaging opens up new possibilities to understand the diversity of T-cells infiltrating a tumor at the single cell level without dissociating tissue. Our work under the Technology Access Program has produced results on the location of different T-cell subsets and their interaction with tumors and could reveal which T-cell subsets are most important for controlling tumors," said Evan Newell, Ph.D., Associate Professor, Vaccine and Infectious Disease Division, the Fred Hutchinson Cancer Research Center.

The company plans to provide researchers access to the prototype versions of spatial molecular imaging platform through a Technology Access Program (TAP) beginning in 2021. Under the program, a TAP customer can submit tissue samples to NanoString to be analyzed using the spatial molecular imager and resulting data analysis reported back to the customer by NanoString. Full commercial launch of the spatial imaging solution consisting of instruments, consumables, and software is expected in the second half of 2022.

The Hyb & Seq chemistry was originally developed as part of a hybridization-based sequencing program. The company formed a strategic collaboration with Lam Research, under which Lam Research provided $50 million in funding and access to their industry-leading semi-conductor technology. This collaboration resulted in a robust and scalable chemistry that can be applied to a wide range of applications.

The company is hosting an Investor and Analyst Day webcast at 11:30am ET on Tuesday, December 1st, and will highlight the development program and new capabilities of the platform. Interested parties can access the webcast through the company’s website at View Source The webcast will be available on the company site for 90 days.

Researchers interested in participating in NanoString’s Technology Access Program should contact us at [email protected].