On October 26, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to inform disease management decisions and improve patient outcomes, reported new data further validating the performance of the Company’s DecisionDx DiffDx-Melanoma test as a highly accurate, ancillary tool to aid in the diagnosis of melanocytic lesions with ambiguous histopathology (Press release, Castle Biosciences, OCT 26, 2021, View Source [SID1234591978]). The data was shared in a poster presentation at The American Society of Dermatopathology (ASDP) 58th Annual Meeting, held virtually Oct. 20-24.

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DiffDx-Melanoma is part of Castle’s Comprehensive Diagnostic Offering (CDO), leveraging the strengths of both myPath Melanoma and DiffDx-Melanoma. These two gene expression profile (GEP) tests were designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions.

The poster, titled "Performance of the 35 Gene Expression Profile (GEP) Test for Use as an Adjunctive Melanoma Diagnostic Tool in a New Independent Validation Cohort," describes the performance of DiffDx-Melanoma, independent of myPath Melanoma and also as part of the clinical CDO workflow. The poster can be viewed here.

"In clinical practice, difficult-to-diagnose melanocytic lesions often present a challenge for dermatopathologists, particularly when there is hesitation in the diagnosis of melanoma," said Gregory A. Hosler, M.D., Ph.D., dermatopathologist at ProPath in Dallas. "In this study, DiffDx-Melanoma demonstrated its ability to provide dermatopathologists additional information to help guide and potentially increase confidence in a diagnosis, if any uncertainty exists, to help clinicians provide their patients with the most appropriate care."

Study background and findings:

The Institutional Review Board (IRB)-approved study reviewed 644 melanocytic lesions and associated de-identified clinical data from patients ≥ 18 years of age.
Lesions were independently reviewed by at least two dermatopathologists for diagnostic adjudication and included in the study if they received at least two out of three reviews that were diagnostically concordant.
Accuracy metrics demonstrated highly accurate performance of the DiffDx-Melanoma test (96% sensitivity and 92.2% specificity; intermediate result 2.3%) across lesion subtypes reported (excluding spitzoid lesions), including those with subtype discordance.
Separately, the clinical Comprehensive Diagnostic Workflow leverages myPath Melanoma with DiffDx-Melanoma. Clinical order data from June 3-Aug. 31, 2021, showed that this workflow was able to increase the reporting of actionable test results of either benign or malignant from 78% for myPath Melanoma alone to 99% when used in conjunction with DiffDx-Melanoma.
Overall, the study data demonstrated that DiffDx-Melanoma was an accurate, objective ancillary tool that provided information to aid in the diagnosis of melanocytic lesions of uncertain malignant potential, thus enhancing diagnostic confidence and the delivery of clinically, actionable results to healthcare providers.
About Castle Biosciences’ Comprehensive Diagnostic Offering for Difficult-to-Diagnose Melanocytic Lesions

Castle Biosciences’ comprehensive diagnostic offering leverages the strengths of myPath Melanoma and DecisionDx DiffDx-Melanoma. These gene expression profile tests are designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining highly accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, myPath Melanoma and DecisionDx DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

More information about the test and disease can be found at www.CastleTestInfo.com.

On October 26, 2021 Applied DNA Sciences Inc. reported that it has signed a mutual collaboration agreement with Ganesha Ecosphere Ltd, a major producer of recycled polyester (rPET) fiber in India (Press release, Applied DNA Sciences, OCT 26, 2021, View Source [SID1234591945]). Under the terms of the agreement, Ganesha, with 300-plus customers, more than 250 suppliers and 500-plus product variants, will deploy the CertainT platform, Applied DNA’s traceability system, to tag an initial pilot of rPET.

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On October 26, 2021 Ubiquigent Limited (Ubiquigent) reported the extension and expansion of its long-term collaboration with Bristol Myers Squibb (Press release, Ubiquigent, OCT 26, 2021, https://www.ubiquigent.com/ubiquigent-extends-and-expands-drug-discovery-collaboration-with-bristol-myers-squibb/ [SID1234591961]). Under the terms of the agreement, Ubiquigent will provide Bristol Myers Squibb with increased access to its deubiquitylase (DUB) enzyme inhibitor drug discovery platform to provide further support to additional therapeutic areas.

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The central role of ubiquitylation in diverse cellular processes, including but not limited to protein degradation, makes the enzymes responsible for ubiquitylation and de-ubiquitylation highly attractive drug targets with the potential to address a wide range of human pathologies.

Recently, there has been further growing interest in the development of modulators of various components of the ubiquitin-proteasome system (UPS) for therapeutic benefit. Strategies that are being actively pursued include the exploitation of the UPS via PROTACs and molecular glues to target the undruggable proteome and the development of DUB inhibitors.

Ubiquigent has established itself as a respected global partner in the UPS field with a particular focus on the development of DUB inhibitors, with an established track record of supporting the drug discovery efforts of its partners via access to its Drug Discovery Screening Platform and by providing access to its own developing portfolio of novel DUB inhibitors as part of larger partnerships.

Ubiquigent’s CEO, Jason Mundin commented: "We are delighted to have the opportunity to build on our existing relationship with Bristol Myers Squibb in this rapidly evolving field to provide additional support to the development of novel DUB inhibitors for patients with unmet medical needs."

On October 26, 2021 Indivumed, the developer of the world’s leading discovery platform for precision oncology, and Biognosys, a leader in next-generation proteomics solutions for discovery and drug development, reported the extension of their strategic partnership to provide biopharmaceutical customers with immunopeptidomic perspectives in drug discovery in oncology (Press release, Indivumed, OCT 26, 2021, View Source [SID1234591979]).

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The partnership builds on each company’s unique capabilities in omics research, with Biognosys providing proteomic technology and solutions based on mass spectrometry, and Indivumed providing high-quality samples and data, as well as its multi-discovery AI system. -omics, nRavel .

The initial partnership created in December 2019 aimed to enrich IndivuType, Indivumed’s multi-omic cancer database, with proteomic data from thousands of samples analyzed by Biognosys. Since then, Indivumed and Biognosys have successfully collaborated on various clinical research projects and published the results of a large-scale lung cancer study at AACR (Free AACR Whitepaper) 2020 , unveiling new biomarkers for tumor biology. Building on this success, the companies are extending their partnership with immunopeptidomics research.

Immunopeptides play an essential role in the immune system, and can be analyzed to support the development of personalized treatments, in particular for cancers, vaccines, and infectious and autoimmune diseases. Mass spectrometry is currently the only technology to reliably measure and identify immunopeptide profiles from large-scale biological samples.

Biognosys Immunopeptide Stream deploys its patented Hyper Reaction Monitoring (HRM ) mass spectrometry technology for proteome quantification, in conjunction with its proprietary data analysis software Spectronaut and SpectroMine to identify over 10,000 unique immunopeptides from small quantity samples. Highly efficient and scalable, the flux can be used in large-scale clinical studies.

Indivumed can then provide biopharmaceutical customers with further validation and insight on the immunopeptide signatures identified through the Biognosys feed, leveraging IndivuType, the multi-omics cancer database , and the nRavel analytical platform. in order to optimize R&D activities and new discovery programs for individualized therapy.

Biognosys present validate the sensitivity and reproducibility of the workflow during the annual conference of the American Society of Mass Spectrometry (ASMS) on 1 st November Philadelphia. Indivumed will present a clinically relevant multi-omic analysis at the BioData World Congress on November 2 in Basel.

The new immunopeptidomics offer is already being applied successfully to third-party biopharmaceutical companies in order to optimize their drug discovery efforts.

Lukas Reiter, PhD, Chief Technology Officer, Biognosys: " Biognosys HRM technology uniquely addresses key challenges in immunopeptidomics research. Using only small amounts of tissue, our optimized flow provides a comprehensive biological perspective on the immune system. We are delighted to apply this solution to Indivumed’s valuable tissue samples and to support drug discovery in areas of significant unmet need. "

Roald Forsberg, Sales Manager and Head of IndivuType Business Unit at Indivumed: "With our IndivuType database and our nRavel AI system , we have the perfect opportunity to make new discoveries about the role of the immune response in the tumor microenvironment, and to develop novel immunotherapies against cancer.This extended partnership with Biognosys gives us the opportunity to validate and deepen our findings using mass spectrometry technology that will accelerate the transition between these discoveries and the practice of personalized oncology. "

On October 26, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that it will report financial results for the quarter ended September 30, 2021, and provide a corporate update on Thursday, November 11, 2021, after the close of the market (Press release, Aptose Biosciences, OCT 26, 2021, View Source [SID1234591946]).

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Conference Call & Webcast:

The live conference call can also be accessed through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the year and quarter ended September 30, 2021 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.