On April 27, 2021 ImmunoPrecise reported that it will be attending the World Orphan Drug Congress, being held virtually April 28th, 2021 (Press release, ImmunoPrecise Antibodies, APR 27, 2021, View Source [SID1234578549]). There will be a variety of panels and presentations throughout the day from industry experts. The conference is being held to advance the development and bring awareness to rare diseases.

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On April 27, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported the expansion of the Advanced Cell Diagnostics (ACD), a Bio-Techne brand, RNAscope technology with release of new DNAscope Assays (Press release, Bio-Techne, APR 27, 2021, View Source [SID1234578565]). The RNAscope technology is an advanced in situ hybridization (ISH) assay that enables visualization of single-molecule gene expression with single-cell resolution directly in intact cells and tissues.

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Bio-Techne’s new chromogenic DNA in situ hybridization (ISH) technology, DNAscope, employs the proven "double-Z" probe design and signal amplification system of RNAscope, enabling rapid and flexible probe development for any DNA target, enabling visualization of targets in formalin-fixed paraffin-embedded (FFPE) tissues. DNAscope delivers benefits over current commercial FISH techniques that fall short on morphological detail due to the use of fluorescent nuclear staining and rely on high-resolution microscopes to visualize gene rearrangement and copy number variation signals. Additionally, traditional FISH uses Bacterial Artificial Chromosome (BAC) clone-based probes that are large and tend to span multiple genes and lack single gene detection specificity which limits the scale and development of DNA research.

For accurate and reliable detection of DNA aberrations, the DNAscope chromogenic duplex (red/blue) staining allows researchers to use a standard bright-field microscope to visualize and quantify gene copy number variations (amplifications/deletions) and gene rearrangements/fusions in tissues with spatial and morphological context, at single cell resolution. Unlike most commercially available assays, DNAscope utilizes oligo probes coupled with proprietary signal amplification system to enable high resolution and precise target detection for small genomic regions/single gene locus.

"We are thrilled to expand our leadership in spatial genomic analysis with the launch of DNAscope which together with our RNAscope offering, allows for true multi-omic analysis," commented Kim Kelderman, President of Bio-Techne’s Diagnostics and Genomics Segment. "These new assays provide simple workflows, easy data interpretation and enable faster decision making in critical spatial applications within the DNA ISH market."

The DNAscope Assay kits from Bio-Techne are intended for Research Use Only.

On April 27, 2021 BostonGene Corporation, a biomedical software company focused on defining optimal precision medicine-based therapies for cancer patients, reported a research collaboration with the Medical College of Wisconsin (MCW) to analyze the role of the tumor microenvironment of pancreatic ductal adenocarcinoma (PDAC) in modulating the response to various therapies (Press release, BostonGene, APR 27, 2021, View Source [SID1234578581]).

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MCW, based in Milwaukee, is a distinguished leader and innovator in the education and development of the next generation of physicians, scientists, pharmacists and health professionals. With a mission to improve the health of the communities they serve, MCW discovers and translates new knowledge in the biomedical and health sciences while providing cutting-edge, collaborative patient care of the highest quality.

The research study aims to understand the molecular underpinnings of patients with PDAC treated with various therapies. As part of the collaboration, BostonGene will perform large-scale analytics on next generation sequencing (NGS data), including significant somatic alterations, gene expression patterns and enrichment of signaling pathways from an integrated cohort of PDAC patients. Additionally, BostonGene will apply comprehensive integrated genomic (whole exome sequencing) and transcriptomic (RNA-seq) analysis to characterize and classify the tumor and tumor microenvironment of PDAC patients with localized and metastatic disease and will match defined patterns with clinical outcomes. The results of this study could provide insight into the role of pancreatic cancer microenvironment in response to specific therapies and further improve therapy selection.

"We are pleased to collaborate with BostonGene for their sophisticated analysis of RNA-seq and exome sequencing," said Ben George, MD, William F. Stapp Endowed Chair and Associate Professor of Hematology and Oncology at MCW and Medical Director of the Clinical Trials Office at the Froedtert & MCW Clinical Cancer Center. "By partnering with BostonGene we are one step closer to developing prospective, biomarker-driven clinical trials that could personalize treatment options and improve PDAC patient outcomes."

"We are proud to partner with the Medical College of Wisconsin by bringing our next generation multi-platform analytics to the study of PDAC patients," said Andrew Feinberg, President and CEO at BostonGene. "Our sophisticated NGS analysis will identify the genomic and transcriptional alterations that could serve as predictive biomarkers of response to therapy and improve patient outcomes."

On April 27, 2021 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) reported that the Annual Report for 2020 now is available at the company’s website: www.calliditas.com (Press release, Calliditas Therapeutics, APR 27, 2021, View Source [SID1234578599]).

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This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 14:30 CET on April 27, 2021.

On April 27, 2021 Instil Bio, Inc. ("Instil") (Nasdaq: TIL) reported that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV with its ITIL-168 TIL therapy (Press release, Instil Bio, APR 27, 2021, View Source [SID1234583993]).

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"The Orphan Drug Designation incentivizes biotech companies to develop new therapies that are important for patients. We are pleased to advance development of ITIL-168 for the treatment of melanoma stages IIB to IV with this designation," said Bronson Crouch, Chief Executive Officer of Instil.
Orphan Drug Designation confers potential benefits to sponsors, including tax credits for qualified clinical testing, waiver of BLA user fees, and eligibility of market exclusivity for 7 years upon marketing approval.

About ITIL-168

ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. ITIL-168 is manufactured with Instil’s proprietary, optimized, and scalable manufacturing process, which has been designed to capture and preserve the maximum diversity of each patient’s TILs; the manufacturing process also offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. Instil plans to investigate ITIL-168 in a global phase 2 trial in advanced melanoma in 2021 and additional solid tumor indications in Phase 1 clinical trials beginning in 2022.