On November 9, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported the publication of a study in Molecular Therapy: Methods and Clinical Development on a methodology for the manufacture of novel types of CAR constructs that employ the Company’s LinearDNA as part of a manufacturing process for the efficient generation of CD19-specific CAR T-cells (CAR19 T-cells) based on co-electroporation of a LinearDNA transposon and mRNA encoding of piggyBac transposase (Press release, Applied DNA Sciences, NOV 9, 2021, View Source [SID1234594870]). PCR-produced LinearDNA is manufactured by LineaRx, the Company’s majority-owned subsidiary, to serve as a pure, fast, and flexible alternative to plasmid DNA (pDNA) for biotherapeutic applications.

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The study, titled "Enzymatically produced piggyBac transposon vectors for efficient non-viral manufacturing of CD19-specific CAR T cells", details the utility of LinearDNA in the cost-effective production of preclinical CAR T cells. Its authors, members of the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, Czechia, and the Faculty of Natural Sciences at Charles University, also in Prague, propose that the combination of LinearDNA and a transposon/transposase system offers therapy developers an effective research tool for making experimental CAR T cells rapidly and efficiently without the need for complicated virus production or the use of pDNA.

Pavel Otáhal, contributing author and Head of the Gene Immunotherapy Research Department at ÚHKT, stated, "Our study compares the manufacture of CAR19 T-cells via PCR-made transposon DNA (LinearDNA) with mRNA encoding of the transposase against a conventional plasmid approach. We found CAR T efficacy of the LinearDNA system versus the plasmid system to be identical. Further, we found no mutations in the coding sequence of LinearDNA and with >99% purity that obliviated the need for purification typical of a plasmid approach. As an institution dedicated to diagnosing and treating serious blood diseases and with the ability to pursue investigational medicines from development to manufacture and clinical trial for patients who have exhausted all approved treatment options, having a cost-effective and rapid production chain is integral to ÚHKT’s mission. We find LinearDNA to be an excellent platform for CAR T-cell therapy development."

Dr. James A. Hayward, president and CEO of Applied DNA, said, "The clinical successes of CAR T-cell therapy against blood cancers have been impressive, though limited by the complex production of viral vectors that are currently needed for T-cell genetic transformation and the use of pDNA. These manufacturing complexities have likewise hindered research on CAR T-cell therapies. As described in the publication, the use of LinearDNA, coupled with non-viral transfection systems, we believe, overcomes many of the existing manufacturing complexities associated with pDNA and viral vectors, thereby offering therapy developers a rapid and cost-effective tool for manufacturing preclinical CAR T cells. The authors’ findings as it relates to LinearDNA coincide with the industry’s growing interest in alternatives to pDNA for CAR T-cell therapies with approximately 50% of recent CRO orders coming from CAR T cell developers."

The detailed study write-up can be found at: Molecular Therapy: Methods and Clinical Development, the leading journal for research in the areas of gene transfer, vector development and design, stem cell manipulation, development of gene-, peptide-, protein-, oligonucleotide-, and cell-based therapeutics to correct genetic and acquired diseases, vaccine development, preclinical target validation, safety/efficacy studies, and clinical trials.

On November 9, 2021 Aadi Bioscience, Inc. ("Aadi"), clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that management will be participating in the upcoming Jefferies London Healthcare Conference and the Piper Sandler Virtual Healthcare Conference (Press release, Aadi Bioscience, NOV 9, 2021, View Source [SID1234594886]).

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Conference details can be found below.

Jefferies London Healthcare Conference
Format: Pre-recorded presentation and one-on-one investor meetings
Presentation accessible on demand starting: Thursday, November 18 3:00 am ET / 12:00 am PT
Webcast link: View Source

A live webcast of this presentation will also be accessible in the Events & Presentations section of the company’s website at View Source Replay will also be available at this link for 90 days.

Piper Sandler Virtual Healthcare Conference
Format: Pre-recorded presentation and one-on-one investor meetings
Presentation accessible on demand for conference registrants starting: Monday, November 22 10:00 am ET / 7:00 am PT

On November 9, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the third quarter ended September 30, 2021 (Press release, Veracyte, NOV 9, 2021, View Source [SID1234594902]).

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"We are pleased with our third quarter performance as we experienced strong year-over-year revenue growth despite the headwind of the COVID-19 Delta variant," said Marc Stapley, Veracyte’s chief executive officer. "With the completion of our acquisition of HalioDx, the launch of our novel noninvasive Percepta Nasal Swab test for early lung cancer risk assessment and of our Decipher Bladder test to help guide bladder cancer treatment decisions, the pieces are coming together to transform our company into a global cancer diagnostics leader."

Third Quarter 2021 Financial Results

For the third quarter of 2021, as compared with the third quarter of 2020:

Total Revenue was $60.4 million, an increase of 94%, including $4.7 million of HalioDx revenue;
Gross Margin was 64%, a decrease of 300 basis points including the impact of HalioDx and the associated purchase accounting; Gross Margin equaled 68%, an increase of 100 basis points, before the impact of HalioDx;
Operating Expenses, Excluding Cost of Revenue, were $55.4 million, an increase of 123%, including $7.5 million of HalioDx expenses and $5.8 million in acquisition-related expenses;
Net Loss was $14.1 million, an increase of 243%, including $5.8 million of acquisition-related expenses and $6.3 million of HalioDx net loss;
Basic and Diluted Net Loss Per Common Share was $0.20, an increase of 150%;
Net Cash Used in Operating Activities was $1.4 million including $3.9 million of acquisition-related expenses; and
Cash and Cash Equivalents were $164.0 million at September 30, 2021.
For the nine months ended September 30, 2021, compared to the prior year:

Total Revenue was $152.2 million, an increase of 83%, including $4.7 million of HalioDx revenue;
Gross Margin was 66%, an increase of 200 basis points including the impact of HalioDx and the associated purchase accounting; Gross Margin equaled 68%, an increase of 400 basis points, before the impact of HalioDx;
Operating Expenses, Excluding Cost of Revenue, were $170.2 million, an increase of 113%, including $7.5 million of HalioDx expenses and $45.3 million of acquisition-related expenses;
Net Loss was $65.0 million, an increase of 142%, including $45.3 million of acquisition-related expenses and $6.3 million of HalioDx net loss;
Basic and Diluted Net Loss Per Common Share was $0.97, an increase of 87%, including $0.68 per share attributable to acquisition-related expenses recorded in general and administrative expenses; and
Net Cash Used in Operating Activities was $40.1 million, including $43.4 million of acquisition-related expenses.
Third Quarter 2021 and Recent Business Highlights

Commercial Growth:

Grew volume to 20,972 tests, including a small contribution from the Immunoscore Colon Cancer test, an increase of 79% compared to the same period in 2020.
Gained a new Blues coverage policy for Decipher Prostate, making the test a covered benefit for the plan’s 5 million members and bringing the total number of covered lives to over 150 million. Also secured contracts for the test with a large Blues plan and national government payer.
Evidence Development and Guideline Inclusion:

Six abstracts demonstrating the performance and utility of our genomic pulmonology and urology tests were presented at the 2021 American College of Chest Physicians (CHEST) and American Society for Radiation Oncology (ASTRO) annual meetings, respectively.
New long-term clinical utility data for the Afirma Genomic Sequencing Classifier were published in the Journal of the Endocrine Society and showed that the test helped reduce unnecessary surgeries in patients with indeterminate thyroid nodule cytology.
Data published in the Journal of Urology demonstrated that the Decipher Bladder genomic test accurately identifies bladder tumors that are most likely to respond to chemotherapy prior to radical cystectomy.
New NCCN Clinical Practice Guidelines for Oncology were published and include specific treatment recommendations for men with prostate cancer uniquely based on their Decipher Prostate RP genomic classifier score.
New Pan-Asian adapted ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines recommended the Immunoscore Colon Cancer test to refine the prognosis of stage 2 and stage 3 colon cancer patients in conjunction with traditional assessment.
Pipeline Advancement:

Began offering the Percepta Nasal Swab test to a limited number of sites as part of a clinical utility study to build the clinical evidence needed to support reimbursement.
Commenced the commercial launch of the Decipher Bladder test following Medicare coverage.
HalioDx Acquisition:

Completed the acquisition of HalioDx for $321 million on August 2, 2021, bringing to Veracyte IVD manufacturing and development capabilities, deep scientific expertise in immuno-oncology and the Immunoscore Colon Cancer test.
2021 Financial Outlook

Veracyte is updating its 2021 annual total revenue guidance to $210 million to $218 million, from the previous guidance range of $200 million to $208 million, with HalioDx expecting to contribute approximately $10 million. This range represents 79% to 86% total revenue growth for fiscal 2021 compared to fiscal 2020.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

On November 9, 2021 Rarecells, Inc., a healthcare company in the field of liquid biopsy, focused on the development and commercialization of non-invasive tests for early cancer detection, reported that it has entered into an agreement with Columbia University to fund a clinical study evaluating its ISET -AML test for early detection of acute myeloid leukemia (AML) in patients with myelodysplastic syndrome (MDS) (Press release, RARECELLS, NOV 9, 2021, https://www.prnewswire.com/news-releases/rarecells-inc-to-fund-a-clinical-study-at-columbia-university-of-its-iset–aml-test-for-early-detection-of-acute-myeloid-leukemia-aml-301420287.html [SID1234594918]).

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The study, expected to begin in Q1 2022, will be the first clinical evaluation of the ISET -AML test. Azra Raza, M.D., Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons and Director of the MDS Center at Columbia University’s Herbert Irving Comprehensive Cancer Center, is the study’s principal investigator.

This clinical study aims to assess the clinical performance of the ISET -AML test in the context of early AML detection.

Myelodysplastic syndromes are a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells. For roughly 30% of the patients diagnosed with MDS, this type of bone marrow failure syndrome will progress to AML, which is often fatal. Currently, patients with MDS are monitored with blood tests to measure complete blood cell counts and bone marrow analyses to detect the appearance of leukemic blasts heralding the development of AML. However, blood tests have a very low sensitivity to detect rare blasts and bone marrow tests involve an invasive procedure that cannot be repeated frequently. As a result, AML is often diagnosed when it is already well established and may be resistant to available treatment options.

The ISET patented EC-marked platform is able to extract down to one single cancer cell of any type from 10 ml of blood, thus a tumor cell mixed with 100 million leukocytes and 50 billion erythrocytes, according to peer-reviewed published studies. The ISET -AML test uses the ISET platform to extract from blood the rare leukemic blast cells with unsurpassed sensitivity and detect them through suitable markers labelling, image analysis and AI.

Dr. Raza, who wrote the best-selling book "The First Cell and the Human Costs of Pursuing Cancer to the Last," said: "New non-invasive tests are needed to detect the first leukemic cells in the blood of MDS patients so that we can identify and treat patients at risk of developing AML before the disease becomes established."

Patrizia Paterlini, President and Chief Executive Officer of Rarecells, said: "We are pleased to be working with Columbia University’s Herbert Irving Comprehensive Cancer Center to conduct the first clinical evaluation of the ISET -AML test in patients with MDS. The strategic decision to transition the ISET -AML test to an investigator-sponsored study at Columbia will provide access to world-class expertise and has the potential to accelerate patients’ recruitment in order to expedite our clinical study. We look forward to a continued progress across our ISET Early Cancer Detection program, which also includes ongoing studies in patients at risk of Prostate Cancer".

On November 9, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported the acceptance of an abstract at the upcoming 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held from December 11-14, 2021, both in Atlanta, Georgia, and virtually at View Source (Press release, Antengene, NOV 9, 2021, View Source [SID1234594934]).

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Antengene will release preliminary results of this Company-sponsored open-label Phase 1b study with selinexor (ATG-010) for the treatment of peripheral T-cell lymphoma and NK/T-cell lymphoma, in an offline poster presentation (full text of the abstract available at: View Source). Meanwhile, another seventeen abstracts related to selinexor and eltanexor will be presented at the 2021 ASH (Free ASH Whitepaper) Annual Meeting as announced by Antengene’s partner, Karyopharm Therapeutics, Inc. (Karyopharm) (see below for details of these abstracts).

"We are very pleased that the poster related to Antengene’s selinexor (ATG-010) T-Cell Lymphoma program has been accepted at the 2021 ASH (Free ASH Whitepaper) Annual Meeting," said Jay Mei, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Antengene. "Selinexor is Antengene’s first commercial stage product. We look forward to sharing more about this program following the poster session."

Details of the abstract that has already been published on the ASH (Free ASH Whitepaper) website are as follows:

XPO1 Inhibitor (ATG-010) Plus Chemotherapy per Investigator’s Choice for Heavily Pretreated Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL) and Extranodal NK/T-Cell Lymphoma (ENKTL)：Preliminary Results from a Multicenter, Single-Arm Phase Ib Study (TOUCH Trial) (Abstract# 2452)

Session:
624. Hodgkin Lymphomas and T/NK cell Lymphomas: Clinical and Epidemiological: Poster II
Abstract #: 2452
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET
Venue: Hall B5, Georgia World Congress Center

Details of these abstracts announced by Karyopharm in a press release dated November 4, 2021.

In total, 17 abstracts were selected for presentation at the meeting, including five oral presentations and 12 posters.

Oral Presentations

Title: A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor in Patients with Myelofibrosis Refractory or Intolerant to JAK Inhibitors
Presenter: Srinivas Tantravahi, University of Utah
Abstract #: 143
Session Type: Oral Presentation
Session: Myeloproliferative Syndromes: Clinical and Epidemiological: Non-JAK Inhibitor Therapies for Myelofibrosis
Date and Time: Saturday, December 11, 2021 at 1:00 p.m. ET

Title: Transcriptomic Correlates of Response to Selinexor in Multiple Myeloma Reveal a Predictive Signature
Presenter: Paula Restrepo, Icahn School of Medicine at Mount Sinai
Abstract #: 457
Session Type: Oral Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Multiple Myeloma and Waldenstrom Macroglobulinemia: Exploring Biomarkers in the Era of Personalized Medicine
Date and Time: Sunday, December 12, 2021 at 12:00 p.m. ET

Title: Enhanced p53 Activation by Dual Inhibition of MDM2 and XPO1 Disrupts MYC Transcriptional Program and Restores Sensitivity to BCL-2 Inhibition in Ven/HMA Resistant AML
Presenter: Yuki Nishida, Saga University
Abstract #: 505
Session Type: Oral Presentation
Session: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Novel Strategies to Overcome Resistance to BCL-2 Inhibition
Date and Time: Sunday, December 12, 2021 at 4:30 p.m. ET

Title: Rationale for Selinexor Treatment in Daratumumab-Refractory MM Patients Identified by Paired Ex Vivo Drug Sensitivity and RNA-Seq
Presenter: Suresh Kumar Balasubramanian, Wayne State University
Abstract #: 683
Session Type: Oral Presentation
Session: Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Targeting
Mitochondrial Survival Pathways
Date and Time: Monday, December 13, 2021 at 3:45 p.m. ET

Title: Comparison of Salvage Autologous Hematopoietic Cell Transplantation with Outcomes Following Selinexor Combinations Among Double/Triple Refractory Myeloma Patients
Presenter: Praneeth Sudalagunta, H Lee Moffitt Cancer Ctr
Abstract #: 893
Session Type: Oral Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Myeloma Pathogenesis and Novel Targets
Date and Time: Monday, December 13, 2021 at 7:15 p.m. ET

Poster Presentations

Title: Efficacy and Safety of Selinexor-Containing Regimens in Patients with Multiple Myeloma Previously Treated with Anti-CD38 Monoclonal Antibodies (αCD38 mAb)
Presenter: Suzanne Lentzsch, Columbia University Irving Medical Center
Abstract #: 1651
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Effects of Cytogenetic Risk on Outcomes in Multiple Myeloma Treated with Selinexor, Bortezomib, and Dexamethasone (XVd)
Presenter: Nizar Bahlis, University of Calgary
Abstract #: 1634
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Selinexor in Combination with Daratumumab-Bortezomib and Dexamethasone for the Treatment of Relapse or Refractory Multiple Myeloma: Initial Results of the Phase 2, Open-label, Multicenter GEM-SELIBORDARA Study
Presenter: Paula Rodríguez- Otero, Clínica Universidad de Navarra
Abstract #: 1677
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: Once Weekly Oral Selinexor, Pomalidomide, and Dexamethasone in Relapsed Refractory Multiple Myeloma
Presenter: Darrell White, QEII Health Sciences Center, Dalhousie University
Abstract #: 2748
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor-Based Regimens in Patients with Multiple Myeloma after Prior Anti-B-Cell Maturation Antigen Treatment
Presenter: Muhamed Baljevic, University of Nebraska Medical Center
Abstract #: 2751
Session Type: Poster Presentation
Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Single Cell RNA Sequencing of a Selinexor Clinical Trial Reveals Overexpression of Alternative Nuclear Export Pathways Associated with Resistance to Selinexor in RRMM Patients
Presenter: Yael Cohen, Tel Aviv Sourasky Medical Center
Abstract #: 2725
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor Enhances NK Cell Activation Against Lymphoma Cells Via Downregulation of HLA
Presenter: Matthew Blunt, University of Southampton
Abstract #: 2411
Session Type: Poster Presentation
Session: Lymphomas: Translational—Non-Genetic: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Molecular Response Patterns in Relapsed/Refractory AML Patients Treated with Selinexor and Chemotherapy
Presenter: Piroska Klement, Hannover Medical School
Abstract #: 2369
Session Type: Poster Presentation
Session: Acute Myeloid Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster II
Date and Time: Sunday, December 12, 2021 at 6:00 – 8:00 p.m. ET

Title: Updated Efficacy of Eltanexor Monotherapy in Patients with Higher Risk Hypomethylating Myelodysplastic Syndrome Primary Refractory to Hypomethylating Agents
Presenter: Sangmin Lee, Weill Cornell Medical College
Abstract #: 3676
Session Type: Poster Presentation
Session: Myelodysplastic Syndromes — Clinical and Epidemiological: Poster III
Date and Time: Monday, December 13, 2021 at 6:00 – 8:00 p.m. ET

Title: Clinical Outcomes in Patients with Dose Reduction of Selinexor in Combination with Bortezomib, and Dexamethasone (XVd) in Previously Treated Multiple Myeloma from the BOSTON Study
Presenter: Sundar Jagannath, Mount Sinai School of Medicine
Abstract #: 3793
Session Type: Poster Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster III
Date and Time: Monday, December 13, 2021 at 6:00 – 8:00 p.m. ET

Title: Selinexor in Combination with R-GDP for Patients with Relapsed/Refractory B-Cell Lymphoma: SELINDA Phase Ib LYSA Study
Presenter: Marie Maerevoet, Jules Bordet Institute
Abstract #: 1411
Session Type: Poster Presentation
Session: Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021 at 5:30 – 7:30 p.m. ET

Title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)
Presenter: Seung Tae Lee, University of Maryland School of Medicine
Abstract #: 1420
Session Type: Poster Presentation
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Date and Time: Saturday, December 11, 2021, 5:30-7:30 p.m. ET

About Selinexor (ATG-010)

Selinexor is so far the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) and the first drug approved for the treatment of both multiple myeloma and diffuse large B-cell lymphoma. By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins, thus induces apoptosis without affecting normal cells. Due to its novel mechanism of action, selinexor can be used in multiple combination regimens to improve treatment efficacy.