On February 23, 2022 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, reported the release of a fully automated GeoMx RNA protocol on BOND RX research staining systems through an expanded partnership with Leica Biosystems (Press release, NanoString Technologies, FEB 23, 2022, View Source [SID1234608904]). The new, improved RNA protocol offers whole transcriptome profiling of Formalin-Fixed Paraffin-Embedded (FFPE), fixed frozen, or fresh frozen tissue, ultimately improving reproducibility and throughput, minimizing manual steps, and reducing hands-on time.

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"This fully automated protocol not only increased our ability to get more slides done in a week but also increased the quality of the data coming off of our instrument by reducing variability between runs," said Carlee Hemphill, formerly a lead scientist with Labcorp, a beta site for the automated workflow, now senior manager, Translational and R&D Services, PathAI.

The GeoMx Digital Spatial Profiler (DSP) combines standard immunofluorescence techniques with digital barcoding technology to perform highly multiplexed, spatially resolved multi-omic profiling studies. The BOND RX staining solution offers investigators an open platform to develop customized protocols for immunohistochemistry (IHC) and In Situ Hybridization (ISH) with open reagents and detection options. The new protocol creates a fully automated GeoMx DSP workflow allowing researchers to quickly see the biological complexity of heterogeneous tissues using GeoMx DSP’s combination of tissue morphological context and high-plex, whole transcriptome RNA expression profiling from a single slide.

"We’re excited to have the Leica workflow as part of our spatial biology ecosystem," said Vice President of Marketing for NanoString, Anna Berdine. "Enabling full automation facilitates translational and multi-sample studies by improving reproducibility and decreasing the hands-on time down to less than one hour, freeing up researchers to focus more of their time on generating insights from their data."

To learn more about NanoString’s GeoMx Digital Spatial Profiler, visit View Source

On February 23, 2022 CDx Diagnostics reported A newly published study as lead article in Gastrointestinal Endoscopy shows that Barrett’s esophagus (BE) and dysplasia progress to esophageal cancer at similar, or even higher, rates when diagnosed by WATS3D (wide-area transepithelial sampling with three-dimensional analysis) as they do when diagnosed by conventional forceps biopsies (Press release, CDx Diagnostics, FEB 23, 2022, View Source [SID1234608903]).

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This study titled "Progression of Barrett’s esophagus, crypt dysplasia, and low-grade dysplasia diagnosed by wide-area transepithelial sampling with 3-dimensional computer-assisted analysis: a retrospective analysis," was authored by Nicholas J. Shaheen, MD, MPH, Michael S. Smith, MD, MBA and Robert D. Odze, MD, FRCPc. It evaluated 4,545 BE patients and illustrated that patients with baseline non-dysplastic BE progressed to either high-grade dysplasia or cancer at a rate of 0.08%/patient-year (95% confidence intervals (CI), 0.02%-0.14%). Progression of BE patients with baseline crypt dysplasia was significantly higher, at 1.42%/patient-year (95% CI, 0%-3.01%) and progression from baseline low-grade dysplasia was the highest, at 5.79%/patient-year (95% CI, 1.02%-10.55%).

"This publication shows for the first time that WATS3D helps to detect clinically-significant pathologic lesions and provides insight into the progression rates of BE and dysplasia to cancer," said Bill Huffnagle, CEO of CDx Diagnostics. "By improving detection of BE and dysplasia, WATS3D can help clinicians treat their patients and prevent cancer development."

WATS3D is a diagnostic platform developed by CDx Diagnostics for the detection of BE and its associated neoplastic conditions. This platform helps clinicians overcome the well-known limitations associated with traditional upper endoscopic methods of screening and surveillance for BE. WATS3D utilizes advanced tissue sampling, 3D imaging technology and an Artificial Intelligence neural network to more accurately and reliably identify BE and dysplasia. WATS3D diagnoses are then made by a highly specialized team of WATS3D trained pathologists.

In other multicenter clinical studies, WATS3D has been found to significantly increase the detection rate of BE and dysplasia, both of which are treatable precursors to esophageal cancer, one of the fastest growing and most fatal cancers in the United States.

WATS3D is included in the American Society for Gastrointestinal Endoscopy (ASGE) Guideline for the screening and surveillance of BE. It is also recognized by several other GI societies for the detection of BE and dysplasia, including the American Foregut Society (AFS) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

On February 23, 2022 LIDDS AB reported that LIDDS AB (publ) Year-end report 2021 (Press release, Lidds, FEB 23, 2022, View Source [SID1234608901])

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October – December

Net sales amounted to 2.4 (0.3) MSEK
The operating result for the period was -8.9 (-12.5) MSEK
The net result was -8.9 (-12.5) MSEK corresponding to earnings per share of SEK -0.26 (-0.42)
Cash flow from operating activities amounted to -9.9 (-10.1) MSEK
Cash and cash equivalents amounted to 34.0 (36.1) MSEK
January – December

Net sales amounted to 3.6 (0.3) MSEK
The operating result for the period was -37.3 (-32.3) MSEK
The net result was -37.3 (-32.3) MSEK corresponding to earnings per share of SEK -1.16 (-1.20)
Cash flow from operating activities amounted to -42.6 (-27.4) MSEK
Significant events during 2021

An R&D agreement was signed with Johnson & Johnson Enterprise Innovation Inc (J&J) with an exclusive option for J&J to sign a global license agreement.
LIDDS’ Chinese partner Puheng Pharma announced that an international multi-center study is requested in phase III for a market approval of Liproca Depot in China.
A directed share issue was carried out, bringing proceeds of 45 MSEK before issue costs to the company.
The dose escalating Phase I study for treatment with NanoZolid formulated docetaxel of solid tumors was closed. Data showed that the combination is safe and well tolerated.
Significant events after the reporting period

The R&D project with J&J has moved into the next phase.
A financing agreement of up to 40.8 MSEK signed with Nice&Green
CEO comment

Lately, we have been making great progress in our projects. LIDDS has been able to report topline results from the NanoZolid formulated docetaxel (nanodotax) project. The results show that the systemic exposure of docetaxel after treating solid tumors with nanodotax is low and that activity in both injected lesions and in systemic inflammatory markers was observed. We are pleased to see that the treatment is safe and well tolerated and that the reported adverse events are generally mild and local. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers that are considered important for efficient recruitment and activation of immune effector cells and for creating a good environment for treatments with immune-modulating drugs such as check-point inhibitors. We intend to submit data from the study for publication in a scientific journal. Based on the unexpected immunological findings in the phase I study it is important to further investigate the treatment mechanism of NanoZolid formulated docetaxel. We plan to do so in the study approved by the Swedish Medical Product Agency (MPA) in May last year investigating docetaxel in prostate cancer patients preoperatively.

We have also reached a key milestone in January 2022 when the R&D project with Johnson & Johnson Enterprise Innovation Inc. progressed into next phase. The aim is to develop an oncology product based on the NanoZolid technology for an undisclosed indication. We are very proud of this collaboration which is also increasing our know-how and experience on both sides. The project has now entered stage 2 of the feasibility program.

An important regulatory milestone achieved is the scientific advice given by the European Medicines Agency (EMA) on our Liproca Depot phase III study protocol. Overall, EMA agreed with our proposed study design including most importantly the primary endpoint being time to progression and to the suggested number of patients. The scientific advice given by EMA is a key regulatory validation of our clinical plans.

In parallel to moving our clinical projects forward, we have continued to set a new direction for the company strategically. Our projects must meet certain requirements to be included in our project pipeline. Projects must have a clear benefit regarding efficacy and safety while simultaneously being able to meet certain commercial requirements. It may seem obvious, but those criteria have been the guiding stars in the strategic revisit of our portfolio meaning that we have decided to focus on the most promising projects. We have also renamed our projects in development. We are eager to give a detailed presentation of our new strategy, vision, and update on our project portfolio on our upcoming Capital Market Day on the 9th of March 2022. Don’t miss it.

The efforts on making the move to Nasdaq’s main market are continuing. A part of that process, but also as a part of visualizing that LIDDS is taking the next phase in its development, has been to develop a new graphic look and content impacting on both the Year-end report and our website. Our new website will be launched shortly. Please visit www.liddspharma.com for further information.

We are also happy to welcome Matthew Lindon as Chief Scientific Officer from March 1. Matthew has over 20 years’ experience of drug discovery and development from the pharmaceutical sector and will be an important asset when developing LIDDS project portfolio. It is also with great pleasure we can announce that LIDDS has recruited a new Project Manager in Charlotta Grånäs Folkesson. Charlotta has a background as a Project Manager at biotechnology companies such as BioImage A/S and Vipergen ApS and as a scientist at the pharmaceutical company Novo Nordisk A/S in Denmark.

The team that will realize LIDDS vision of becoming a global drug delivery company are starting to come together. LIDDS will, through a small, efficient, and highly specialized organization, continue to focus on developing better and safer treatments with a high value. We started this year with a lot of progress and my colleagues, and I are looking forward to an eventful 2022.

This information is information that the company is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the aforementioned contact persons, on February 23, 2022 at 17.30 CET.

On February 23, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported that the Company’s fourth quarter and full year 2021 financial results will be released after market close on Tuesday, March 1, 2022 (Press release, ChemoCentryx, FEB 23, 2022, View Source [SID1234608900]). ChemoCentryx executive management will host a conference call and webcast beginning at 5:00 p.m. Eastern Time on March 1, 2022 to discuss these results and to answer questions.

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To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 3136966. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the call.

On February 23, 2022 Poseida Therapeutics, Inc. (NASDAQ: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that the Company plans to highlight its clinical and preclinical pipeline progress during a virtual R&D Day to be held today beginning at 10:00am ET / 7:00am PT (Press release, Poseida Therapeutics, FEB 23, 2022, View Source [SID1234608899]).

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Poseida Therapeutics hosts R&D Day focused on novel pipeline and technology innovations. #celltherapy #genetherapy $PSTX
"R&D Day is a time for us to showcase not only our progress in the clinic but our redefining work in cell and gene therapy using our proprietary genetic engineering technologies in new and innovative ways," said Eric Ostertag, M.D., Ph.D., Executive Chairman of Poseida Therapeutics. "Today we are excited to share new data demonstrating the promise of our platforms. For the first time, we will highlight our capabilities in site-specific transposon-based DNA delivery, which is a technology that could revolutionize gene therapy by allowing insertion of large therapeutic transgenes into potentially any site in nearly any cell type or tissue."

Presentations will cover updates on both platforms and product candidates and will be delivered by the Company’s executive leadership, scientists, clinical team members, and key opinion leaders including Scientific Advisory Board member Dr. Luca Gattinoni, Director of the Division of Functional Immune Cell Modulation at the Leibniz Institute for Immunotherapy, whose research focuses on T-cell-based immunotherapies with an emphasis on T-cell differentiation; and Dr. Susan Slovin, the Associate Vice Chair, Academic Administration, Department of Medicine at Memorial Sloan Kettering, an oncologist with expertise in prostate cancer, clinical immunology, and other genitourinary malignancies and a clinical investigator on Poseida’ s P-PSMA-101 clinical trial.

Key R&D Day Topics and Highlights

TSCM-based CAR-T Therapy Programs

Dr. Gattinoni is presenting on the importance of T-stem cell memory (Tscm) in cell therapy, a desirable cell type that is associated with best responses and a differentiated tolerability profile in the clinic and may be key to CAR-T success against solid tumor indications.
Dr. Slovin is providing expanded commentary on clinical findings in the P-PSMA-101 trial, the autologous CAR-T program for patients with metastatic castrate-resistant prostate cancer, following her presentation of these results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) earlier in the month.
Devon Shedlock, Ph.D., Poseida’s Chief Scientific Officer of Cell Therapy, is presenting on the Company’s allogeneic CAR-T platform, including preclinical findings from P-BCMA-ALLO1 and P-MUC1C-ALLO1, and will discuss the benefits of taking a dual CAR approach with the Company’s P-CD19CD20-ALLO1 program as an example, enabled by utilizing Poseida’s proprietary non-viral piggyBac DNA Delivery System.
Innovative Gene Therapy Programs

P-OTC-101 is the Company’s liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by a deficiency in the ornithine transcarbamylase (OTC) enzyme, a defect that impairs the body’s ability to detoxify ammonia, a byproduct of protein metabolism. Today the Company will show animal data demonstrating use of its hybrid delivery approach to correct the disease markers and achieve durable expression at dramatically lower doses to support a potentially more effective and more tolerable profile, thereby highlighting the ability of Poseida’s technologies to address challenges that have plagued traditional adeno associated virus (AAV)-based gene delivery.
P-FVIII-101 is a liver-directed gene therapy program partnered with Takeda utilizing the Company’s piggyBac DNA Delivery System in combination with Poseida’s biodegradable nanoparticle delivery for the in vivo treatment of Hemophilia A, a bleeding disorder with high unmet medical need caused by a deficiency in Factor VIII production. Today the Company will share data showing potentially therapeutic levels of expression of Factor VIII can be achieved using a fully nanoparticle system to deliver treatment in juvenile animal models, demonstrating the potential to achieve single treatment cures even in the underserved juvenile patient population.
Emerging Technologies

Site-Specific Super PiggyBac DNA Delivery represents the next generation in gene insertion technology, with the potential to drive highly site-specific DNA integration in nearly any cell or tissue type.
Cas-CLOVER Site-Specific Gene Editing System works with high efficiency when editing in vivo and can be delivered using the Company’s proprietary biodegradable mRNA LNPs.
The Company’s TCR-T platform combines piggyBac DNA delivery and Cas-CLOVER gene editing technologies to generate effective off-the-shelf TCR-T product candidates and could be leveraged to address indications in oncology and beyond, including infectious disease and autoimmunity.
The Company’s CAR 3.0 approach uses genetically modified hematopoietic stem cells, or HSCs, to create a next-generation anti-cancer therapeutic for some indications, which could potentially combine the advantages of T cells, NK cells and other cell types that are naturally derived from HSCs in a single CAR-based treatment approach.
R&D Day Webcast Information
A live webcast of the Company’s R&D Day event will be available on the Investors & Media section of Poseida’s website, www.poseida.com. A replay of the webcast will be available for 30 days following the presentation.