On April 8, 2021 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, reported the highlights of spatial biology abstracts that will be presented at the 2021 meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper), which will be held virtually from April 10 – 15, 2021 (Press release, NanoString Technologies, APR 8, 2021, View Source [SID1234577746]).

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The GeoMx Digital Spatial Profiler (DSP) enables researchers to characterize tissue morphology to rapidly and quantitatively profile RNA and proteins. To date, NanoString and its collaborators have presented DSP data in dozens of abstracts at major scientific meetings and more than 45 peer-reviewed publications, demonstrating DSP’s utility to address a wide range of biological questions in formalin-fixed paraffin-embedded (FFPE) and frozen tissues. At AACR (Free AACR Whitepaper) 2021, eight abstracts that used GeoMx DSP will be presented during the poster session on Saturday, April 10.

Four of the eight abstracts will be presented by investigators from the GeoMx Breast Cancer Consortium (GBCC), an international network of breast cancer researchers. Their goal is to apply innovative approaches and decipher the spatial context of breast cancer to develop a comprehensive atlas and database of novel biomarkers for the disease.

GBCC Abstracts

Poster 2718: Digital spatial profiling in HER2 positive breast cancer: The road to precision medicine

In this work, the GeoMx DSP was used to profile 71 protein targets and gene expression profiling was done using NanoString’s nCounter PanCancer IO360 assay for primary and metastatic tissues from human epidermal growth factor 2 positive (HER2+) breast cancer (BC) patients. A detailed characterization of carefully chosen immune cold, warm and hot regions of interest (ROI) in the tumor and tumor immune microenvironment of (HER2+) of these samples established that primary tumors had a higher number of immune cells than the metastatic sites. These findings, therefore, suggest that immunotherapy in early-stage BC could be more effective than in advanced BC.

Poster 2701: Molecular profiling to assess the immune response to neoadjuvant SABR in early breast cancer

NanoString’s Human PanCancer immune profiling panel was used to assess the impact of localized radiotherapy to elicit an immune response in primary breast carcinomas before lumpectomy. They analyzed 25 patient samples for low-risk primary breast carcinomas from the SIGNAL 2.0 clinical trial using the GeoMx DSP platform, pre, and post stereotactic body radiation therapy (SBRT). Significant differences were found in the gene expression patterns in the immune microenvironment gene expression patterns and cellular composition after radiotherapy, demonstrating that SBRT treatment indeed evokes an immune response, increasing the innate immune response.

Poster 2698: Spatial gene expression profiling in breast cancer

Transcriptome profiling was performed for a cohort of breast cancer lumpectomies using the Cancer Transcriptomic Atlas (CTA) assay on the GeoMx DSP platform. Analysis of 60 patient samples revealed region-specific heterogeneity in unifocal and multifocal cancer tumors. This study demonstrates and establishes the importance of interactions between immune and tumor cells in the tumor microenvironment and the need to develop a strategy to stratify patients to available targeted therapies.

Poster 2726: Characterization of immune microenvironment and heterogeneity in breast cancer subtypes

In this work, the immune microenvironment of Luminal A, Luminal B, Basal, and HER2 tumor subtypes in a cohort of early breast cancer patients was studied using protein biomarkers. The markers were delineated in a spatial context using the GeoMx DSP. Characterization of the immune microenvironment subtypes provided evidence for potential clinical use for GeoMx DSP in diagnosing and better stratifying breast cancer patients based on spatial heterogeneity in tumor and tumor microenvironment.

Other spatial abstracts

Poster 339: Resistance to trastuzumab is associated with alpha-smooth muscle actin expression in the stroma of patients with HER2+ breast cancer

GeoMx DSP was used to identify biomarkers for resistance to trastuzumab in HER2+ breast cancer. Fifty-eight protein targets were analyzed in three different regions of interest (tumor [PanCK+], leukocyte [CD45+/CD68-], and macrophage [CD68+]) in a cohort of 151 breast cancer patients that received trastuzumab. The study uncovered a-SMA as a potential biomarker to augment the predictive value of the current standard of care HER2 assay and justifies its further validation in the light of the many new HER2 targeted therapies.

Poster 705: SARS-CoV-2 infection of the human heart governs intracardiac innate immune response

Spatial profiling of human post-mortem cardiac samples of SARS-CoV-2 infected myocardium was carried out using NanoString’s Whole Transcriptome Analysis (1,864 genes) panel, along with a matching proteome panel on the GeoMx digital spatial profiler. The purpose of their investigation was to elucidate the molecular mechanisms underlying cardiac toxicity, a severe cause of morbidity and mortality in patients on DOX therapy. The study showed interesting gender-specific differential gene expression patterns in the myocardium between SARS-CoV-2 infected and control regions of interest. Signatures of enhanced innate and acquired immune signaling, apoptosis and autophagy, chromatin remodeling, reduced DNA repair, and reduced oxidoreductase activity were all observed in regions of infection. Additionally, DOX-induced increase in the expression of TMPSS2 and cathepsins A, B, and F, clearly indicated enhanced SARS-CoV-2 susceptibility in the myocardium, thus placing cancer patients on DOX therapy at increased risk of cardiac damage.

Poster 2731: Cell-type deconvolution of African American breast tumors reveals spatial heterogeneity of the immune microenvironment

Researchers at the University of Chicago carried out spatial gene expression analysis within localized segments of TNBC tumors from a cohort of self-reported African American patients in the Chicago Multi-Ethnic Breast Cancer Study (ChiMEC). Regions of interest for spatial characterization of tumor and tumor microenvironment using the GeoMx DSP Cancer Transcriptome Atlas assay were manually selected based on the specific morphologies. The 1,825 genes interrogated in the CTA assay provided a granular understanding of the immune landscape’s heterogeneity within tumors.

Poster 2771: Comprehensive analysis of immuno oncology markers in the tumor microenvironment of solid tumor samples using GeoMxTM digital spatial profiler (DSP) and MultiOmyxTM hyperplexed immunofluorescence (IF)

This study describes a multi-faceted highly multiplexed tissue analysis of critical Immuno oncology (IO) protein markers in a pan-cancer cohort of up to 35 FFPE samples originating from breast, head, and neck, prostate, non-small cell lung cancer (NSCLC), endometrial and colorectal indications using NanoString human IO panel on GeoMx DSP in combination with a complementary MultiOmyx Hyperplexed Immunofluorescence (IF) assay. The spatial and quantitative data outputs from DSP nCounter system and cell classification information from the MultiOmyx assay provided the researchers an ability not only to characterize the immunophenotypes but also to visualize the spatial distribution of tumor-infiltrating immune cells at a single-cell resolution within the TME.

Spotlight Theaters at AACR (Free AACR Whitepaper)

NanoString will be hosting two spotlight theaters during AACR (Free AACR Whitepaper) 2021. The first spotlight theater presentation is April 11 from 1:00-2:00 pm EDT, featuring Joseph Beechem, Ph.D., senior vice president of R&D and chief scientific officer for NanoString, with an overview of the latest developments in spatial biology, True spatial genomics: Measuring the transcriptome in regions, cell and sub-cellular compartments. Dr. Beechem will explain spatial technologies’ evolution and their applications from multi-cell to single-cell and subcellular resolution, using the GeoMx DSP and the company’s Spatial Molecular Imager.

The second NanoString spotlight theater is Tuesday, April 13, from 11:00-12:00 pm EDT, and is entitled: New Approaches for Cellular Therapies: Technology Symposium Featuring the GeoMx DSP and nCounter CAR-T Characterization. This panel will include three speakers, Dr. Ryan Golden, Resident Physician in Clinical Pathology, Carl June Lab, University of Pennsylvania; Dr. Marco Ruella, Assistant Professor of Medicine, University of Pennsylvania; and Ghamdan Al-Eryani, Ph.D. Student, Tumor Progression Group from the Garvan Institute. Each speaker will discuss new approaches to CAR-T characterization using the spatially-resolved and bulk RNA analysis, from understanding resistance in CART immunotherapy in lymphoma to TCR diversity in melanoma.

NanoString has launched a Technology Access Program (TAP) for the recently announced single and subcellular Spatial Molecular Imager to complement the existing TAP program for GeoMx. Under the program, customers can submit tissue samples to NanoString for analysis using the spatial profiling platforms and receive a complete data package. Researchers interested in participating in NanoString’s Technology Access Program should contact the company at [email protected].

On April 8, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary NK cell engager (TriKE) protein biologic technology platform, reported the enrollment of Patient 10 in its GTB-3550 TriKE first-in-human Phase I/II clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML) (Press release, GT Biopharma, APR 8, 2021, View Source [SID1234577763]). Patient 10 will be dosed at 100mcg/kg/day.

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Highlights from the first nine patients treated with GTB-3550 TriKE include:

Up to 63.7% Reduction in Bone Marrow Blast Levels
Restores Patient’s Endogenous NK Cell Function, Proliferation and Immune Surveillance
No Progenitor-derived or Autologous/Allogenic Cell Therapy Required
No Cytokine Release Syndrome Observed
3 out of the Last 5 Patients Treated (25mcg/kg/day to 100mcg/kg/day) Respond
"We are pleased with the continued clinical performance of our lead TriKE product candidate, and in reaching this important patient enrollment milestone," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "The data from the first nine patients treated with GTB-3550 indicates significant bone marrow blast level reductions in AML and MDS patients without the need for expensive progenitor-derived or autologous/allogenic cell therapies."

About High-Risk Myelodysplastic Syndromes
MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. As a result of this irregular production, MDS patients do not have sufficient normal red blood cells, white blood cells and/or platelets in circulation. High-risk MDS is associated with poor prognosis, diminished quality of life, and a higher chance of transformation to acute myeloid leukemia. Approximately 40% of patients with High-Risk MDS transform to AML, another aggressive cancer with poor outcomes.

About Acute Myeloid Leukemia
Acute myeloid leukemia is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. According to the National Cancer Institute (NCI), the five-year survival rate is about 35% in people under 60 years old, and 10% in people over 60 years old. Older people whose health is too poor for intensive chemotherapy have a typical survival of five to ten months. AML accounts for roughly 1.8% of cancer deaths in the United States.

About GTB-3550 TriKE
GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of AML and MDS, and other CD33+ hematologic cancers. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of Interleukin 15 (IL-15). The natural killer (NK) cell-stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GTB-3550 TriKE Clinical Trial
Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.

On April 7, 2021 Curaleaf Holdings, Inc. (CSE: CURA / OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis reported that it has successfully completed the acquisition of EMMAC Life Sciences Limited ("EMMAC"), the largest vertically integrated independent cannabis company in Europe, for base consideration of approximately US$50 million in cash and 17.5 million shares of Curaleaf, with additional consideration to be paid based upon the successful achievement of performance milestones (Press release, EMMAC Life Sciences, APR 7, 2021, View Source [SID1234577683]). Curaleaf has simultaneously established Curaleaf International Holdings Limited ("Curaleaf International") in Guernsey to hold the EMMAC investment and further its European expansion.

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To accelerate the expansion of Curaleaf International, Curaleaf has secured an investment of US$130 million from a single strategic institutional investor in exchange for 31.5% equity stake in Curaleaf International, implying a $413 million Post Money valuation, with US$80 million in cash available to spend. The subscription will fund the entire cash portion of the EMMAC acquisition consideration of US$50 million with the remaining US$80 million to be used to fund Curaleaf International’s current capital expenditures plan through 2022, as well as its pipeline of potential acquisitions. This infusion of outside capital into Curaleaf International significantly accelerates Curaleaf’s expansion plans in Europe by fully funding Curaleaf’s cash outlay for the EMMAC acquisition and providing the capital required to support Curaleaf International’s near-term European rollout. With its foreseeable expansion budget fully funded, Curaleaf’s new international business can focus on executing its further European expansion.

Curaleaf and the strategic investor have entered into a shareholders’ agreement regarding the governance of Curaleaf International pursuant to which Curaleaf will have control over operational issues as well as raising capital and the ability to exit the business. In addition, the strategic investor’s stake is subject to put/call rights which permits either party to cause the stake to be bought out by Curaleaf for Curaleaf equity starting in 2025.

Boris Jordan, Executive Chairman of Curaleaf, stated, "The successful completion of our acquisition of EMMAC, and the formation of our new Curaleaf International business, marks a transformational launching point for our entrance into the European cannabis market. Building on our market leading position in the U.S., this transaction establishes Curaleaf as the global, pure play, cannabis market leader by revenue and geographic reach. With our single strategic institutional investor, we have set a strong foundation for Curaleaf International’s future growth trajectory. On behalf of the Curaleaf Board of Directors and management team, we are thrilled to welcome Antonio Costanzo, co-founder and CEO of EMMAC, as the CEO of Curaleaf International, and the entire EMMAC team to Curaleaf."

The new Curaleaf International platform includes cultivation, EU GMP-certified processing, distribution, and R&D operations across several key European medical cannabis markets, including the United Kingdom, Germany, Italy, Spain and Portugal. Terra Verde, Curaleaf International’s European market cultivation facility in Portugal, is one of the oldest licensed cannabis growing facilities in Europe with approximately 2 hectares of cultivation area and is an industry leader on the cannabis production cost efficiency front. The Portugal based cultivation facility provides Curaleaf International with the potential to serve customers across key European medical cannabis markets as well as supporting exports to countries such as Israel, among others. Curaleaf International plans to significantly increase its cultivation capacity in 2021, and to exceed 10 tons per year by 2022, in order to accommodate future growth related to the expansion of access to cannabis across the major European medical and adult-use, as well as export markets. Curaleaf International also has an operational presence and partnerships in European Union countries that are enacting new medical cannabis access programs. Curaleaf International will also serve as the platform for other possible acquisitions in Europe and adjacent areas, and for its participation in pilot adult use programs.

Joseph Bayern, CEO of Curaleaf, commented, "As the consumer and political liberalization trends around cannabis that are sweeping the U.S. are increasingly taking hold across Europe, our expansion into the international cannabis market presents tremendous new long-term growth opportunities for Curaleaf. With the European population of nearly 748 million[1], the potential European addressable market is more than twice the size of the U.S. addressable market[2]. With the ability to operate our new European business across country borders, with one or two cultivation sites and one manufacturing center to serve the entire region in most cases, combined with our ability to leverage the strength of our consumer packaged goods strategies and innovations from our U.S. operations, we see enormously positive implications for our ability to quickly and efficiently scale the business across Europe."

Following the successful completion of the transaction, Mr. Antonio Costanzo has been appointed as the new Chief Executive Officer of Curaleaf International, with the former EMMAC management team continuing to lead Curaleaf’s new European presence as well as driving local European strategy and day-to-day operations.

Antonio Costanzo, CEO of Curaleaf International, commented, "This is an important day for the European cannabis market as EMMAC transitions to Curaleaf International. I look forward to working closely with the Curaleaf team to shape the future of cannabis for our patients and customers around the world. We will retain our science-led approach to continue to deliver best in class cannabis products for Europe’s growing medical cannabis market, and will work closely to leverage the consumer packaged goods experience and innovation from the U.S. to capitalize on the emerging adult-use market as legislation allows. We are now very well positioned to realize our aggressive growth ambitions."

On April 7, 2021 Daiichi Sankyo Company, Limited (hereafter Daiichi Sankyo) reported the first patient has been dosed in the first-in-human phase 1/2 study of DS-1594, a selective small-molecule menin inhibitor, in adults with relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) (Press release, Daiichi Sankyo, APR 7, 2021, https://www.businesswire.com/news/home/20210407005234/en/Phase-12-Trial-Initiated-for-Daiichi-Sankyo%E2%80%99s-Menin-Inhibitor-DS-1594-in-Patients-with-Acute-Myeloid-Leukemia-and-Acute-Lymphoblastic-Leukemia [SID1234577699]). The trial is being conducted by The University of Texas MD Anderson Cancer Center under an existing strategic research collaboration.

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Inhibition of the menin protein is being studied as a novel treatment approach for acute leukemias with MLL rearrangement (MLLr) or NPM1 mutation (NPM1m), two gene alterations that drive cancer development and growth.1 MLLr occurs in approximately 5 to 10% of acute leukemia patients and is associated with aggressive disease, reduced treatment response and poor prognosis.2 NPM1m occurs in about 30% of patients with AML.3 There are currently no medicines specifically approved for MLLr or NPM1m leukemias and no approved menin inhibitors.

"Research has shown that the menin protein, which binds to MLL, plays a critical role in the development and growth of leukemias with MLL rearrangement," said Arnaud Lesegretain, Vice President, Oncology R&D and Head, Alpha Portfolio, Daiichi Sankyo. "Our scientists designed DS-1594 to inhibit the menin-MLL interaction and disrupt the intracellular activity implicated in leukemogenesis. Together with MD Anderson, we will evaluate DS-1594 as a potential therapeutic option for patients with AML or ALL who have exhausted standard treatments."

The collaboration with MD Anderson is focused on accelerating development of Daiichi Sankyo pipeline therapies for AML, including phase 1 and 2 clinical trials to evaluate single and combination regimens, translational research to explore novel biomarkers, and pre-clinical studies aimed at identifying resistance mechanisms.

About the Study

MD Anderson will sponsor and lead an open-label, non-randomized, multi-arm phase 1/2 study to evaluate DS-1594 in single and combination regimens for patients with relapsed/refractory AML and ALL.

The primary objective of the phase 1 part of the study is to determine the maximum tolerated dose and recommended phase 2 dose of DS-1594 in up to 54 patients with AML or ALL regardless of mutation status. Primary endpoints include dose-limiting toxicities, recommended phase 2 dose and safety profile. Secondary endpoints include complete remission rate (CR) and CR with partial hematologic recovery rate (CRh).

In the phase 2 part of the study, DS-1594 will be further evaluated at the established dose in four expansion cohorts of patients with specific genetic markers. Patients with relapsed/refractory AML with MLLr or NPM1m will receive DS-1594 as monotherapy (Cohorts A and B) or in combination with azacitidine and venetoclax (Cohort C), and patients with ALL with MLLr will receive DS-1594 in combination with a mini-HCVD regimen (Cohort D). The primary endpoints are safety, CR/CRh rates for the AML cohorts, and CR/CR with incomplete hematologic recovery rates (CRi) for patients in the ALL cohort.

A number of secondary efficacy and pharmacokinetic endpoints along with exploratory pharmacodynamic and biomarker endpoints will also be evaluated. Up to 170 patients will be enrolled in the study, which will initially be conducted only at MD Anderson with global expansion planned for phase 2. For more information, visit Clinicaltrials.gov.

About Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.4 In the U.S., there were approximately 60,530 new cases of leukemia and 23,100 deaths in 2020.5

AML is the most common form of acute leukemia in adults, accounting for about 33% of all new cases.6 An aggressive and heterogenous cancer originating in bone marrow, AML is characterized by a five-year survival rate of 28.7%, the lowest by far among the major leukemia subtypes.7 Standard chemotherapy remains the main treatment option for most patients with AML with or without targeted therapy. Newer treatments for genetically defined AML subtypes have increased options and improved response rates and outcomes for some patients, but primary and secondary resistance remain a challenge and new types of therapies continue to be researched.8

ALL is a less common form of leukemia with 6,150 new cases estimated in the U.S. in 2020.9 The overall five-year survival rate for ALL is 68.8% among patients of all ages but significantly lower for adults.10 ALL is typically treated with standard chemotherapy-based regimens with or without targeted therapy.9

About MLL, NPM1 and Menin

The MLL (mixed-lineage leukemia) gene, also known as KMT2A, is important in sustaining hematopoietic stem cells and is known to undergo chromosomal translocations or epigenetic changes resulting in the expression of MLL fusion proteins that ultimately drive formation and growth of leukemia.11 Approximately 5 to 10% of acute leukemias harbor the MLL rearrangement, with a five-year overall survival rate of about 35%.11

The NPM1 (nucleophosmin 1) mutation causes aberrant expression of the NPM1 protein, which is involved in functions, including cell proliferation. NPM1m is observed in approximately 30% of AML patients with a five-year overall survival rate of about 50%.3

Menin is a scaffold protein that interacts with a multitude of other proteins to regulate gene expression and cell signaling.11 The interaction between menin and MLL proteins is critical to the leukemogenic activity in MLLr leukemia and is also reported to play a key role in development of NPM1m leukemia.1 Scientific evidence supports inhibition of the menin-MLL interaction as a therapeutic approach for acute leukemias.11 There are currently no medicines specifically approved for MLLr or NPM1m leukemias and no approved menin inhibitors.

About DS-1594

DS-1594 is a potent and selective small molecule menin inhibitor in clinical development in the Alpha portfolio of Daiichi Sankyo. DS-1594 was designed to target and disrupt the protein-protein interaction of menin and MLL to inhibit leukemic cell growth and proliferation. In preclinical studies, DS-1594 displayed selective growth inhibition against AML and ALL cells with MLLr and demonstrated robust and durable anti-tumor activity in AML models with an acceptable safety profile.12 DS-1594 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On April 7, 2021 ENTEROME SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, reported that Pierre Belichard, CEO, will present an overview of the Company and take part in 1-on-1 meetings with institutional investors at the following conferences (Press release, Enterome, APR 7, 2021, View Source;utm_medium=rss&utm_campaign=enterome-to-present-at-upcoming-conferences [SID1234577684]):

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European Biotech Investor Days: April 7-8
Jefferies Microbiome-based therapeutics Summit: April 22
Jefferies Virtual Healthcare Conference: June 1-3
Enterome’s CBO, Anne Dagallier, will participate and take part in 1-on-1 meetings with potential business partners at the following conferences:

Digestive Disease Week (DDW): May 21-23
BIO International Convention: June 14-18